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

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

Thank you for the opportunity to submit comments on the National Coverage Analysis (NCA) for screening for lung cancer with Low-Dose Computed Tomography (LDCT) referenced above.

Our reasoning is laid out more extensively below, and we wish to associate ourselves with the excellent request on March 9, 2021 by the GO2 Foundation for Lung Cancer, the Society of Thoracic Surgeons, and the American College of Radiology (“the requesters”), for CMS to reconsider the existing February, 2015 National Coverage Determination (NCD) on Screening for Lung Cancer with Low-Dose Computed Tomography (CAG-00439N).

Their request can be found here:

https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id304.pdf.

Although we support each of the four main points in that letter (summarized on their page two), we realize that not all of the proposals will be adopted by CMS and we would like to focus our comments on the following points.

We urge CMS to:

1) Adopt the U.S. Preventive Services Task Force Grade B recommendation to broaden annual lung cancer screening with low-dose computed tomography.

2) Broaden the screening specifically by lowering the start age from 55 to 50 and by reducing the smoking history criteria from 30 pack-years to 20 pack-years.

3) Reconsider the current Counseling and Shared Decision-Making criteria to ensure that these very worthy concepts are not inadvertently causing patients to miss screening.

ICAN, International Cancer Advocacy Network, is a patient advocacy organization headquartered in Phoenix (https://askican.org). Founded 25 years ago, ICAN is a 501(c)(3) tax-exempt charitable organization. We specialize in helping late-stage cancer patients. ICAN has assisted more than 15,000 patients and caregivers in all 50 states and 54 countries.

ICAN handles all cancers from the most common to the rarest. Our goal for each patient is to extend life with the highest achievable quality of life. ICAN has unique expertise in connecting patients with aggressive, brilliant oncologists, finding clinical trials, and arranging pre-approval access and compassionate use/Right to Try requests.

Among the cancers we deal with most frequently are lung cancers. Indeed, we have developed a specialty in rare lung cancers, most specifically those caused by two rare genetic mutations known as exon 20 EGFR mutations and exon 20 HER2 mutations. These are particularly lethal cancers and are a subset of non small cell lung cancer (NSCLC).

To combat exon 20 cancers, we created the Exon 20 Group, an international coalition dedicated to transforming these cancers into manageable conditions—and then cure them. The Exon 20 Group is regarded as a model for tackling a challenging rare disease. In addition to providing thousands of exon 20 patients around the world the same full-spectrum patient advocacy services we provide to all ICAN patients, we have also funded research on resistance mutations and exon 20 issues at the Broad Institute and MD Anderson.

Although exon 20 mutations have been found in 25 different cancers, they are mostly found in lung cancer. And, they seem to particularly attack so-called “never smokers” as well as people who quit smoking years ago. Indeed, if “never smokers” who had lung cancer (from all forms of lung cancer) were treated as a separate group, it would be among the top ten cancers in the United States.

At ICAN, we stress the importance of testing. We encourage appropriate preventive screening for all people, especially those at higher risk due to age, lifestyle, family history, or demographic factors. For patients diagnosed with cancer, we encourage all appropriate tests to determine the most targeted, personalized treatment, such as Next Generation Sequencing.

We support extensive testing for two simple reasons: 1) it saves lives, and 2) it saves money in the long run. Again and again, we have seen patients diagnosed at a much later stage than they should have been. Instead of earlier treatment before metastasis, patients go through the cycle of multiple rounds of chemotherapy, surgeries and other procedures, and repeated hospitalizations —all with a much lower survival rate, a much lower quality of life, and at much greater cost, than if the cancer had been caught early.

Sadly, since ICAN deals primarily with Stage IV patients, they come to us after these mistakes have been made. The failure to diagnose early usually comes down to one of two causes: the patient ignored the symptoms, or the doctor didn’t order the test. One of the main reasons for patients ignoring or delaying getting checked is that many who are on a tight budget were deterred because screening either wasn’t covered or the patient’s share was prohibitive.

That is why ICAN will always support efforts to make screening more affordable and thus more available to patients.

The requesters position, and our support, is based on the recommendation earlier this year by the U.S. Preventive Services Task Force (USPSTF) to broaden the existing policy of recommending screening for adults for lung cancer with low-dose computed tomography (LDCT) who are between the ages of 55 and 77 with a certain history of smoking, to recommending annual screening for lung cancer with LDCT to include all adults from 50-80 with a certain history of smoking. Although we realize that CMS may not increase the eligibility to 80, we wish to stress that we support all increases of eligibility.

ICAN also strongly supports recommendations to revisit and perhaps revise the “Counseling and Shared Decision Making” criteria. We support shared decision making, but shared decision making should aid the patient in getting the best advice, treatment, and testing—in this case screening—and not serve as a barrier to it. Therefore, we also support the recommendations to update the shared decision making criteria to ensure that it is not inadvertently serving as an obstacle to patients getting the best care possible. Specifically, we would urge CMS to not require separate visits by the patient prior to the first low-dose computer tomography screening.

Each of the points made above (p. 2) will, if adopted, increase the availability and/or affordability of testing—and making it more affordable makes it more available. This chart on the five-year survivability of lung and bronchus cancer based on stage at diagnosis makes the argument better than any words (please see the chart from the National Cancer Institute’s Cancer Stat Facts: Lung and Bronchus Cancer. Available here: https://seer.cancer.gov/statfacts/html/lungb.html).

Thank you for your consideration of these comments and these important issues. If you have any additional questions, please do not hesitate to contact me.

Respectfully submitted,

Marcia K. Horn, J.D.
President and CEO
ICAN, International Cancer Advocacy Network

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Thank you for providing the opportunity to comment on the expanded CMS lung cancer screening (LCS) guidelines. The following comments are from eighteen Upper Midwest Lung Cancer Screening Consortium (UMLCSC) members - a collaborative group of those working closely with LCS.

Our group includes administrators, navigators, providers and radiologists. The majority of the UMLCSC are located in Illinois, eastern Wisconsin, northwest Indiana, but it also includes representatives from facilities outside this region.

We have been actively involved with LCS program development and implementation for many years. Some programs launched shortly after publication of the National Lung Screening Trial in 2011. Collectively these 18 centers are responsible for completion of nearly 100,000 lung cancer screenings.

We are experts in the nuances and complexities of program implementation and recognize that LCS is a process and not just an exam.

1. We commend CMS for lowering the age to begin screening from 55 to 50 and reducing pack years from 30 to 20 years as both will begin to address disparities seen with lung cancer.

However, we encourage CMS to consider removing the upper age to end LCS. Cancer is a disease of the aged and lung cancer is often diagnosed after age 80. Age to end screening should be a clinical decision.

2. We encourage CMS to consider eliminating the requirement of having quit smoking within the past 15 years. Risk for developing lung cancer remains past this benchmark. Based on our experience working with patients, we know that despite our best efforts, obtaining a quit date from patients is difficult, often times arbitrary and likely inaccurate.

3. We seek further clarification and rationale regarding less rigorous requirements for radiologists interpreting LCS exams. Although Lung RADs was developed to guide radiologists in exam interpretation, it also serves an important and effective role in patient navigation and care. It also helps ordering providers decide on appropriate follow-up for suspicious exams.

4. We also commend CMS for expanding who can perform shared decision making, however we question why LCS is only cancer screening with this requirement. SDM is an incredibly time consuming process and effectively creates yet another patient barrier. Please understand that we still believe that patients should be educated and informed about LCS.

Thank you again for the opportunity to share our perspective on this life saving exam.

Sincerely,
The Upper Midwest Lung Cancer Screening Consortium

Advocate Aurora Christ Medical Center
Tracy McCarthy, BSN, RN, OCN, tracy.Mccarthy@aah.org

Advocate Aurora Health
Carol Huibregtse RN, MSN, OCN, carol.Huibregtse@aah.org

Advocate Aurora Lutheran General Hospital
Axel Joob, MD Axel.Joob@aah.org
Jennifer Aversano MSN, RN, OCN, BMTCN, jennifer.Aversano@aah.org

AMITA Health St. Mary Cancer Institute
Morgan Lotz, DNP, FNP-BC, morgan.Lotz@amitahealth.org

Community Healthcare System
Patricia Higgins, RN, OCN, patricia.Higgins@comhs.org

Cone Health Alamance Regional
Shawn Perkins BSN,RN,OCN, Shawn.perkins@conehealth.com

Duly Health and Care
Melinda Willis, MPH RT(R)(CT), melinda.Willis@dulyhealthandcare.com

Loyola Medicine
Linda Ippolito, APN, AOCNS, linda.Ippolito@luhs.org

Mercy Health
Christine Schroeder BSN, RN, cschroeder@mhemail.org

MercyOne
Kacey Strovers, BS, RT(R)(CT)(M), kacey.strovers@commonspirit.org

Northwest Health
Cheryl Wallace, RN, BSN, Cheryl.wallace@nwhealthin.com

Northwest Community Healthcare
Juli Aistars, APN, JAistars@NCH.ORG

Northwestern Memorial Hospital
Denise Wojcik, RN, BSN, Denise.Wojcik@nm.org

Northwestern Medicine South Region
Jean Toth, RN, jean.Toth@nm.org

Northwestern Medicine Lake Forest Hospital
Karin Rogers, RN, BSN, krogers2@nm.org

Rush Copley Medical Center
Judi Bonomi, RN, MS, MSN, OCN, NE-BC, judi.Bonomi@rushcopley.com

Rush University Medical Center
Annie Lally, RN, BSN, Ann_M_Lally@rush.edu

UnityPoint Health Peoria
Tammy Pierson, MOA, tammy.Pierson

@unitypoint.org

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We are writing to express our views on Centers for Medicare & Medicaid Services’ (CMS) proposed decision memo on the national coverage determination regarding screening for lung cancer with low dose computed tomography (LDCT).

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We agree that former smokers would benefit from a higher rate of LDCT screening. However, we are concerned with several major aspects of the Proposed Decision Memo’s discussion of Counseling and Shared Decision-Making.

1. We urge CMS to amend language in the final draft of the Decision Memo to more accurately reflect the science-based evidence. The proposed memo currently reads that “Professional societies and provider groups have noted that providers have gained considerable experience and expertise and believe flexibility will reduce burden.” However, there is no evidence that providers have become better at counseling and shared decision-making regarding LDCT; on the contrary, there is evidence that there is already too much flexibility in how these discussions are framed. For example, research has found that shared decision-making conversations regarding LDCT focus on the advantages and rarely discuss the potential harms.[1] Healthcare providers spent less than a minute explaining the procedure and there was no evidence that decision aids were used. Patients deserve to make informed choices, and this is not possible under the current norms, which are too flexible. Rather than increase flexibility, CMS should provide explicit guidance for shared decision-making discussions on LDCT, such as requiring a checklist of key benefits and risks for the procedure that patients must sign after having read and discussed each point with their healthcare provider. For example, a decision-making tool could include a checklist that explains each benefit and risk in non-technical language, where the patient must initial each section to indicate that they read it, and then the physician must sign it to indicate the conversation took place, in the presence of the patient. In addition, any decision-making tool should highlight beneficiary eligibility criteria to ensure that patients who do not meet these criteria are aware that they are more likely to be harmed by LDCT screening.

2. We urge that CMS maintain the requirement that shared decision-making conversations include a patient’s healthcare provider. Although research indicates that the decision-making conversations with physicians and non-physician practitioners are often inadequate, we believe the solution is to improve training for those conversations, rather than allowing health educators and others who are not healthcare experts to provide counseling and shared decision-making without the inclusion of healthcare professionals. Shared decisions regarding medical options should be made between a patient and a healthcare provider with whom they have an established relationship, which is generally their primary care physician. That is important because if there are any abnormal findings from the LDCT, it is the healthcare provider that the patient will need to follow-up with, not an educator. Shared decision making also provides an important opportunity to discuss smoking cessation options, which primary care physicians are best equipped to do. In summary, when patients engage in shared decision-making with their healthcare provider, that aids in informed decision-making while also helping ensure continuity of care. While health educators and others who are specifically trained to discuss the risks and benefits of LDCT can be an important addition to those doctor-patient conversations, spending more time with patients than physicians do and ensuring that patients clearly understand their options, they should not replace doctor-patient shared decision-making.

3. We also urge that CMS reconsider its proposal to remove the specifications for the components of the shared decision-making tools. The agency justifies this change by stating that “the tools and guidance has matured since the early inception of shared decision-making.” We are not aware of evidence that the tools and guidance have matured, and ask CMS to provide guidance regarding decision-making tools that are based on peer-reviewed research-based articles.

4. CMS also proposes removing the LDCT lung cancer screening registry requirement. We disagree with that proposal, since the ongoing revisions to guidance regarding LDCT screening can best be evaluated using a required registry.

As a final point, we question the assumptions that patients’ current low level of screening is a function of lack of flexibility in shared decision-making and of the criteria for eligibility. We believe it more likely that the major causes are:

• Former smokers are aware that their smoking put them at risk of lung cancer and they are reluctant to get tested to find out they could have a fatal disease that they were warned about for years.
• Former smokers who have friends or relatives that died of lung cancer are especially afraid of a diagnosis because they have seen the ravages of lung cancer.
• Discussions about LDCT that extol the benefits and ignore the risks (which research indicates are typical of these conversations) are likely to be perceived as a sales pitch by skeptical patients. A more balanced conversation about what the procedure is like, the potential risks of screening, and what research says about the benefits is likely to be more effective. NCHR firmly believes that patients deserve to make informed choices and need access to counseling and evidence-based shared decision-making tools in order to do so. For the reasons outlined above, we urge CMS to reconsider the proposed changes, to better ensure that patients receive accurate, balanced, unbiased information on whether or not they would benefit from LDCT screening.

The National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.

References
1. Brenner, A. T., Malo, T. L., Margolis, M., Lafata, J. E., James, S., Vu, M. B., & Reuland, D. S. (2018). Evaluating shared decision making for lung cancer screening. JAMA internal medicine, 178(10), 1311-1316.

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December 17, 2021

Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Submitted to: https://www.cms.gov/medicare-coverage-database

RE: Docket No. CAG-00439R, Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

Dear CMS Memo Review Committee:

I am writing to you in my capacity as the President of the Society for Research on Nicotine and Tobacco (SRNT). We are the largest and oldest international association dedicated to research on nicotine and tobacco. On behalf of SRNT and our members we are very pleased to have the opportunity to comment on the national coverage determination for lung cancer screening with low dose computed tomography (LDCT). We urge the Centers for Medicare and Medicaid Services (CMS) to make tobacco treatment a larger focus within the context of lung cancer screening.

As you know, tobacco use leads to 480,000 deaths annually in the US and is the leading cause of preventable death in our country. Moreover, tobacco consumption is linked to at least 18 human cancers and accounts for 30 percent of cancer deaths each year (1).

SRNT Supports Aligning CMS Determinations with the New USPSTF Recommendations for Lung Cancer Screening

Annual LDCT screening for lung cancer among high-risk populations (i.e., 50 years and older and those with 20 or more pack years) reduces mortality by 20% or more. When you factor in smoking cessation, that benefit is increased to almost 40% (2). Consistent with this evidence, SRNT supports implementing the newly published LDCT recommendations of the U.S. Preventive Services Task Force (USPSTF) (3). Specifically, USPSTF has proposed new guidelines that lower the lung cancer screening eligibility age from 55 to 50 and lower pack years from 30 to 20 (3). Of note, this will expand the reach of LDCT to larger numbers of women and historically marginalized racial and ethnic minorities. This is critical for reducing smoking-related health inequities. For instance, although black people have lower rates of smoking (i.e., fewer pack years) they have higher rates of lung cancer deaths. Therefore, this is a population who will benefit greatly from lung cancer screening. We applaud CMS aligning with these new recommendations.

SRNT Encourages Use of Evidence-Based Tobacco Treatment Interventions at Lung Cancer Screening Appointments and at Independent Diagnostic Testing Facilities

Provision of tobacco treatment at lung cancer screening appointments will increase patient health and reduce lung cancer and all cause mortality over and above lung screening alone. Indeed, tobacco treatment is the single best intervention providers can engage in to improve lung screening patients’ overall health. Thus, we strongly urge CMS to alter the proposed national coverage determination to require tobacco treatment as a part of lung screening and to reimburse providers for tobacco treatment counseling in conjunction with regular LDCT screening appointments and Shared Decision-Making appointments.

The proposed decision memo states “It is vitally important to provide information about tobacco cessation or cigarette smoking abstinence to the patient at every touchpoint between provider and patient along the clinical pathway for lung cancer screening”. However, the proposal does not cover evidence-based tobacco treatment counseling, as recommended by the US Public Health Service (4), during every LDCT visit.

SRNT strongly supports the above statement, and we urge CMS to encourage tobacco treatment for all patients who smoke and interact with clinicians in the lung screening context. We recommend including coverage of tobacco treatment in subsequent screenings as described in CAG-00439N “Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)” while adhering to removing the requirement for a written order from a health care provider.

The proposed CMS memo has the potential to remove barriers for providers and broaden eligibility criteria, all of which will greatly benefit US healthcare patients. Currently, the tobacco treatment counseling burden is placed on referring providers at Shared Decision-Making visits. While, tobacco treatment should be offered by the referring provider, it could also be provided by local cessation resources, collaborative efforts with eligible telehealth providers, and referral to a tobacco treatment specialist and/or behavioral therapy (5). Of course, treatment would ideally align with the latest tobacco treatment guidelines from major US medical associations (4, 6, 7).

In conclusion, SRNT strongly supports the proposed revisions to CMS eligibility for LDCT coverage, which will expand access and save lives. Importantly we also urge CMS to expand coverage of evidence-based tobacco treatment for this vitally important group of patients. Indeed, we feel that this is a watershed moment in US history in that this is the first time US clinical medicine is directly targeting patients who smoke. It is vitally important that we provide life saving tobacco treatment to all lung cancer screening patients.

Sincerely,

Megan Piper, Ph.D.
President
Society for Research on Nicotine & Tobacco

References

1. Toll, B.A., Brandon, T. H., Gritz, E. R., Land, S. R., Warren, G. W., & Herbst, R. S.; Writing Committee for the AACR Task Force on Tobacco and Cancer. (2013). Assessing and Stopping Cancer Patients’ Tobacco Use: An American Association for Cancer Research (AACR) Policy Statement. Approved by the governing board of the AACR and published in Clinical Cancer Research, 19, 1941-1948.
2. Tanner, N.T., Kanodra, N.M., Gebregziabher, M., Payne, E., Hughes Halbert, C., Warren, G.W., Egede, L.E., & Silvestri, G. (2016). The Association between Smoking Abstinence and Mortality in the National Lung Screening Trial. American Journal of Respiratory and Critical Care Medicine, 193, 534-541.
3. US Preventive Services Task Force. (2021). Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement, JAMA, 325, 962-970. doi:10.1001/jama.2021.1117
4. Treating Tobacco Use and Dependence: 2008 Update. Content last reviewed February 2020. Agency for Healthcare Research and Quality, Rockville, MD.
https://www.ahrq.gov/prevention/guidelines/tobacco/index.html
5. Fucito, L.M., Czabafy, S., Hendricks, P.S., Kotsen, C., Richardson, D., Toll, B.A. (2016). Pairing Smoking Cessation Services with Lung Cancer Screening: A Clinical Guideline from the Association for the Treatment of Tobacco Use and Dependence and the Society for Research on Nicotine and Tobacco. Cancer, 122, 1150-1159. doi: 10.1002/cncr.29926.
6. Leone FT, Zhang Y, Evers-Casey S, Evins AE, Eakin M, Fathi J, Fennig K, Folan P, Galiatsatos P, Gogineni H, Kantrow S, Kathuria H, Lamphere T, Neptune E, Pacheco MC, Pakhale S, Prezant D, Sachs DPL, Toll, B, Upson D, Xiao D, Cruz-Lopes L, Fulone I, Murray RL, O’Brien KK, Pavalagantharajah S, Ross S, Zhang Y, Zhu M, and Farber HJ. Initiating Pharmacologic Treatment of Tobacco Dependence in Adults: An Official American Thoracic Society Clinical Practice Guideline. (2020). American Journal of Respiratory and Critical Care Medicine, 202, e5–e31.
7. Barua, R.S., Rigotti, N.A., Benowitzh, N.L., Cummings, K.M., Jazayeri, M-A, Morris, P.B., Ratchford, E.V., Sarna, L., Stecker, E.C, Wiggins, B.S. (2018). 2018 ACC Expert Consensus Decision Pathway on Tobacco Cessation Treatment. Journal of the American College of Cardiology, 72, 3332-3365.

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On behalf of LUNGevity Foundation, please find the below comments in response to the Medicare Proposed National Coverage Decision (CAG-00439R): Screening for Lung Cancer with Low Dose Computed Tomography (LDCT).
Thank you.

December 17, 2021

SUBMITTED ELECTRONICALLY:

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Medicare Proposed National Coverage Decision (CAG-00439R): Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

Dear Ms. Jensen:

On behalf of LUNGevity Foundation, the nation’s preeminent lung cancer nonprofit that funds research, provides education and support, and builds communities for the approximately 230,000 Americans diagnosed with lung cancer each year and the estimated 582,631 Americans currently living with the disease,¹ we appreciate the opportunity to provide comments in response to the Centers for Medicare and Medicaid Services’ (CMS) Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) posted November 17, 2021. LUNGevity Foundation has had a long-standing focus on the early detection of lung cancer, and we have strategically invested in both translational and implementation sciences research to increase lung cancer screening and early detection.

Lung cancer continues to be the largest cause of cancer-related mortality in the United States.¹ When detected at an early stage, when the cancer is localized, the 5-year relative survival rate is 59.8%. However, only 18% of lung cancer cases will be diagnosed at this stage, when potentially curative surgery is a treatment option.¹ In contrast, 56% of lung cancer cases are diagnosed after the cancer has metastasized, when the 5-year relative survival rate is only 6.3%.

LDCT screening for the early detection of lung cancer is a promising technology for the early detection of lung cancer. The National Lung Screening Trial clearly demonstrated that use of LDCT led to a 20% decrease in mortality from lung cancer in the LDCT group, compared with the radiography group.² Based on the NLST results, the US Preventive Services Task Force (USPSTF) recommends lung cancer screening.

Despite CMS’ decision in 2015 to cover lung cancer screening, a 2019 study showed that only a small proportion (approximately 2%-16%) of eligible patients were being screened.³ In light of new evidence, the USPSTF Recommendation Statement on screening for lung cancer updated their 2015 recommendations and now recommend “annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.”⁴

We support the updated proposed decision memo for CMS to reconsider the existing February 2015 NCD on Screening for Lung Cancer with LDCT (CAG-00439N) in light of the updated USPSTF grade B recommendation. Specifically, we favor CMS’ proposal to lower the minimum age for LCS eligibility to age 50 from the current 55, and the required smoking history to 20 pack-years from the current 30 pack-years to match new USPSTF criteria

Implementation of the 2021 USPSTF guidelines will strategically expand screening access for at-risk populations who are ineligible by age and smoking habits by the 2013 guidelines. In particular, access would be expanded among African Americans and women.

In a recent cohort study looking at of 48,364 adult smokers in the United States, it was found that a larger percentage of African Americans were diagnosed with lung cancer, compared to Whites. When the 2013 USPSTF criteria were applied, a majority of African American patients did not qualify for lung cancer screening because they had a lower pack-year history, compared to Whites (17% vs. 31%, respectively). The same study found that African American smokers diagnosed with lung cancer had significantly lower median smoking pack-years compared with White smokers, and were also diagnosed with lung cancer at an earlier age. The authors reported that “modifying the minimum age to 50 years for African American smokers would increase the percentage eligible for screening and also allow detection of earlier-stage disease that would otherwise be missed with the present age minimum of 55 years.”⁵ Furthermore, decreasing the pack-year requirement from 30 pack-years to 20 pack-years would correct for the lower pack-year history seen in African Americans, making screening more accessible and decreasing screening disparities between Whites and African Americans by expanding eligibility by 107% for African Americans.⁶

It is well known that women start smoking at an older age compared to men and smoke fewer cigarettes per day, leading to cumulative fewer pack-years compared to men.⁷ A recent study in the New England Journal of Medicine demonstrated that despite a decline in smoking prevalence in women since 1965, there has been an increase in the incidence of lung cancer in women (specifically in White and Hispanic women), compared to men. Application of the 2021 USPSTF guidelines would expand eligibility by 96% for women, thereby increasing the potential of early detection of lung cancer in women.⁶

As described above, the 2021 USPSTF guidelines have the potential to bridge existing health disparities and also allow a slightly younger population with a lower pack-year history to derive benefits of lung cancer screening. For LDCT to become a public health good, we applaud CMS for the proposed criteria to align reimbursement criteria with the 2021 USPSTF guidelines.

However, other criteria proposed by CMS will continue to impede the uptake of lung cancer screening. We therefore urge CMS to re-consider their position regarding the upper age limit, maximum years since quitting limit, and shared decision-making for the following reasons.

Raising the upper age threshold for coverage from 77 to 80 to reflect current USPSTF guidelines

We strongly believe that the ultimate decision to get screen should be jointly made by the patient and their doctor, and should take into account the patient’s comorbidities and clinical history. Stipulations in the current NCD propose that a CMS beneficiary will no longer qualify for lung cancer screening after the age of 77. This is because major lung cancer clinical trials were restricted to this upper age limit.⁸ While clinical trials are useful in developing levels of evidence, they do not reflect the real-world circumstances of the community. It is now well-established that thoracic oncology care for the elderly has significantly improved over the past decade. Treatment modalities commonly used to treat early-stage lung cancer, such as surgery and stereotactic body radiotherapy (SBRT), have been shown to have superior outcomes in patients who are 80 years old or above.^9-11 These advancements suggest that patients above the age of 77 can clearly benefit from lung cancer screening followed by treatment with curative intent. We therefore urge CMS to reconsider the age restrictions

Eliminating the maximum 15 years since quitting (YSQ) limitation for screening eligibility among those who formerly smoked will expand the benefit of lung cancer screening

Currently, individuals who have had 15 or more YSQ (currently ineligible for screening) but averaged 45 pack-years of smoking have risk similar to that of individuals who used to smoke who have a history of >30 pack-years and have had < 15 YSQ (currently eligible for screening), after adjusting for other risk factors.¹² The Framingham Heart study showed that 40.8% of all lung cancers seen in the study had occurred in those who had ever smoked and had quit smoking for more than 15 years.¹³ A retrospective study looking at the implications of the 2013 USPSTF screening criteria in a well-defined cohort (1984 through 2011) of individuals found that the proportion of lung cancer patients who smoked more than 30 pack-years declined, while the proportion of former smokers, especially those who quit smoking more than 15 years ago, increased, especially the number of women.¹⁴ Together, these findings suggest that eliminating the maximum YSQ limitation will expand the benefits of screening to those who are still at risk of developing lung cancer but remain currently ineligible.

Removing Counseling and Shared Decision Making (SDM) as a condition for LCS coverage and reimbursement will make SDM more patient-centric and less burdensome

SDM should be integrated into discussion of screening with patients, but not be a rigid reimbursement requirement, which creates a referral barrier and is not required with other recommended cancer screenings.

SDM is an excellent opportunity for patient-centered care.¹⁵ LUNGevity Foundation firmly believes that all patients should be empowered with knowledge on the risks and benefits of lung cancer screening. Currently, CMS mandates a shared decision-making engagement with all lung cancer screening-eligible beneficiaries.

However, there are several barriers to conducting SDM in a patient-centric manner. Several studies have noted that primary-care providers feel ill-equipped to conduct SDM.^16,17 Physicians also noted other barriers such as insufficient time, competing clinical priorities, difficulty accessing SDM aids, limited patient comprehension, and anticipated patient emotions.^16,18 Furthermore, current SDM aids are written above the recommended sixth-grade reading level advised by the American Medical Association and are largely written for English speakers. There is a paucity of SDM aids that are culturally appropriate for diverse populations. In addition, current decision aids do not take into account a patient’s numeracy skills, which impact how a patient will make an informed decision based on the SDM visit.^19-21

Given the complexity of SDM, we agree with the requesters’ suggestion on bundling the SDM with the actual LDCT event. This bundling would ensure that the SDM occurs in a dedicated radiology clinic with staff who are well-versed in SDM and have access to standardized information to conduct SDM in a patient-centric fashion.

Recent state-level analysis of screening rates proves without doubt that insurance status is a major predictor of lung cancer screening and is the biggest barrier to access. ²² In summary, LUNGevity is supportive of some of the updates made in the proposed decision memo and we urge CMS to reconsider the above comments before finalizing the National Coverage Decision on Screening for Lung Cancer with LDCT (CAG-00439R) in light of the updated USPSTF grade B recommendation and increase coverage to CMS beneficiaries, as per the requesters’ suggestions.

The comments outlined above can be discussed with me, my staff, and LUNGevity’s Scientific Advisory Board, which is made up of some of the world’s leading experts in lung cancer biology, practice management, access to innovative medicines, and overall patient care. I can be reached at 240-454-3100 or aeferris@LUNGevity.org if you have any questions or would like to engage in further dialogue.

Thank you for your attention to this important matter.

Sincerely,

Andrea Stern Ferris
President and Chief Executive Officer
LUNGevity Foundation

ABOUT LUNGEVITY:
LUNGevity’s mission is to improve outcomes for people diagnosed with lung cancer. Our goals are three-fold: (1) to accelerate research to patients that is meaningful to them; (2) to empower patients to be active participants in their care and care decisions; and (3) to help remove barriers to access to high quality care. We have the largest lung cancer survivor network in the country and actively engage with them to identify, understand, and address unmet patient needs. We also have a world class Scientific Advisory Board that guides the programs and initiatives of the organization. Additionally, we collaborate with other lung cancer patient advocacy groups and organizations, such as the American Lung Association and CHEST, who serve the lung cancer community.

REFERENCES:
1. SEER. Cancer Stat Facts: Lung and Bronchus Cancer. https://seer.cancer.gov/statfacts/html/lungb.html. Published 2021. Accessed November 30, 2021.
2. National Lung Screening Trial Research T, Aberle DR, Adams AM, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. The New England journal of medicine. 2011;365(5):395-409.
3. Triplette M, Thayer JH, Pipavath SN, Crothers K. Poor Uptake of Lung Cancer Screening: Opportunities for Improvement. J Am Coll Radiol. 2019;16(4 Pt A):446-450.
4. USPSTF. Final Recommendation Statement - Lung Cancer: Screening. U.S. Preventive Services Task Force Web site. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening. Published 2021. Accessed June 13, 2021.
5. Aldrich MC, Mercaldo SF, Sandler KL, Blot WJ, Grogan EL, Blume JD. Evaluation of USPSTF Lung Cancer Screening Guidelines Among African American Adult Smokers. JAMA oncology. 2019;5(9):1318-1324.
6. Reese TJ, Schlechter CR, Potter LN, et al. Evaluation of Revised US Preventive Services Task Force Lung Cancer Screening Guideline Among Women and Racial/Ethnic Minority Populations. JAMA Netw Open. 2021;4(1):e2033769.
7. McDuffie HH, Klaassen DJ, Dosman JA. Female-male differences in patients with primary lung cancer. Cancer. 1987;59(10):1825-1830.
8. Jonas DE, Reuland DS, Reddy SM, et al. Screening for Lung Cancer With Low-Dose Computed Tomography: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2021;325(10):971-987.
9. Kreinbrink P, Blumenfeld P, Tolekidis G, Sen N, Sher D, Marwaha G. Lung stereotactic body radiation therapy (SBRT) for early-stage non-small cell lung cancer in the very elderly (>/=80years old): Extremely safe and effective. J Geriatr Oncol. 2017;8(5):351-355.
10. Miura N, Kohno M, Ito K, et al. Lung cancer surgery in patients aged 80 years or older: an analysis of risk factors, morbidity, and mortality. Gen Thorac Cardiovasc Surg. 2015;63(7):401-405.
11. Ganti AK, deShazo M, Weir AB, 3rd, Hurria A. Treatment of non-small cell lung cancer in the older patient. J Natl Compr Canc Netw. 2012;10(2):230-239.
12. Rivera MP, Katki HA, Tanner NT, et al. Addressing Disparities in Lung Cancer Screening Eligibility and Healthcare Access. An Official American Thoracic Society Statement. Am J Respir Crit Care Med. 2020;202(7):e95-e112.
13. Tindle HA, Stevenson Duncan M, Greevy RA, et al. Lifetime Smoking History and Risk of Lung Cancer: Results From the Framingham Heart Study. J Natl Cancer Inst. 2018;110(11):1201-1207.
14. Wang Y, Midthun DE, Wampfler JA, et al. Trends in the proportion of patients with lung cancer meeting screening criteria. JAMA. 2015;313(8):853-855.
15. Tanner NT, Silvestri GA. Shared Decision-making and Lung Cancer Screening: Let's Get the Conversation Started. Chest. 2019;155(1):21-24.
16. Kanodra NM, Pope C, Halbert CH, Silvestri GA, Rice LJ, Tanner NT. Primary Care Provider and Patient Perspectives on Lung Cancer Screening. A Qualitative Study. Ann Am Thorac Soc. 2016;13(11):1977-1982.
17. Wiener RS, Koppelman E, Bolton R, et al. Patient and Clinician Perspectives on Shared Decision-making in Early Adopting Lung Cancer Screening Programs: a Qualitative Study. J Gen Intern Med. 2018;33(7):1035-1042.
18. Rajupet S, Doshi D, Wisnivesky JP, Lin JJ. Attitudes About Lung Cancer Screening: Primary Care Providers Versus Specialists. Clinical lung cancer. 2017;18(6):e417-e423.
19. Gagne SM, Fintelmann FJ, Flores EJ, et al. Evaluation of the Informational Content and Readability of US Lung Cancer Screening Program Websites. JAMA Netw Open. 2020;3(1):e1920431.
20. Haas K, Brillante C, Sharp L, et al. Lung cancer screening: assessment of health literacy and readability of online educational resources. BMC Public Health. 2018;18(1):1356.
21. Reyna VF, Nelson WL, Han PK, Dieckmann NF. How numeracy influences risk comprehension and medical decision making. Psychol Bull. 2009;135(6):943-973.
22. Fedewa SA, Kazerooni EA, Studts JL, et al. State Variation in Low-Dose Computed Tomography Scanning for Lung Cancer Screening in the United States. J Natl Cancer Inst. 2021;113(8):1044-1052.

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Dear Ms. Syrek Jensen:

AstraZeneca appreciates the opportunity to provide comment to the Centers for Medicare and Medicaid Services (CMS) on its proposed decision memorandum (“proposed decision memo”) on “Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)” (CAG-00439R).

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide.

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities, and to discover, develop and deliver life-changing medicines to patients. AstraZeneca has a robust pipeline pursuing therapies for hematological and solid tumor cancers. In solid tumors, our research seeks to harness the power of four scientific platforms – Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Repair and Antibody-Drug Conjugates – along with new developments in Epigenetics and Cell Therapies.

We are also a founding partner of the Lung Ambition Alliance. Its programs are funded directly and in kind by AstraZeneca, the Global Lung Cancer Coalition (GLCC), Guardant Health, and the International Association for the Study of Lung Cancer (IASLC). Our goal is to one day double five-year survival rates in lung cancer by 2025.

AstraZeneca stands committed in helping patients achieve better outcomes with their cancer care through continued engagement within the oncology community and support of early detection/diagnosis of lung cancer through effective screening practices. Through these investments we hope to one day eliminate cancer as a cause of death.

As CMS continues to focus on making meaningful, evidence-based revisions to its policies involving lung cancer screening (LCS), we hope a major focus will be on reducing the barriers to screening eligible persons at high risk for developing lung cancer. In response to the proposed decision memo, we offer the following comments.

Beneficiary Eligibility Criteria

AstraZeneca commends CMS for proposing to expand the patient eligibility criteria for LCS with LDCT. Specifically, we support CMS’s proposal for reducing the eligibility age from 55 to 50 and also support the proposal to lower the tobacco smoking history requirement from at least 30 pack-years to at least 20 pack years. Both of these changes are consistent with the lower age bound and pack-years smoking requirement recently adopted by the U.S. Preventive Services Task Force (USPSTF) in a recent update to its recommendation on screening for lung cancer with LDCT.

While AstraZeneca supports these expansions in beneficiary eligibility criteria, we respectfully request CMS reconsider its proposal to retain the existing criterion establishing a maximum age limit of 77 on LCS.

CMS should expand the upper age limit from 77 to 80 years

Lung cancer is the second most common cancer, and the leading cause of cancer death in the United States. In 2020, 235,760 persons were diagnosed with lung cancer, with 131,880 dying from the disease. LCS through LDCT has been shown to reduce mortality through early detection. Two key studies, the National Lung Screening Trial (NLST) in the US and the Dutch-Belgian NELSON lung cancer screening trial have shown a reduction in lung cancer-related deaths of 20–25% using LDCT compared with control groups. As CMS correctly notes in their decision memo, none of the controlled clinical trials cited for LCS (COSMOS, DANTE, DLCST, ITALUNG, LSS, LUSI, MILD, NELSON, NLST, and UKLS) had persons age 77-80-years-old in the study populations.

We are concerned by CMS’s proposal to maintain the upper age limit at 77 for LCS considering it is not supported by clinical evidence—due in part by CMS’s upper age criteria being based upon the arbitrarily chosen age cutoffs in various LCS trials. Furthermore, CMS electing to maintain the upper age limit at 77 years would make its coverage policy inconsistent with several existing guidelines recommending an upper age bound of 80 years. This includes the recently updated USPSTF recommendations for LCS, which revised the previous age criterion by raising the upper age limit from 75 to 80 years of age. By expanding the age criterion to at least 80, it is estimated that an additional 10% to 15% cases of lung cancer will have been made eligible for screening. Although CMS’s decision memo recommends additional studies in populations above age 77, it would likely take several years to conduct any new research. Waiting for such studies within elderly, at-risk populations beyond the age of 77, could potentially lead to delayed, or missed diagnosis of lung cancer in Medicare beneficiaries.

Moreover, an individual’s risk for developing lung cancer does not end at age 77. According to the National Cancer Institute’s (NCI’s) Surveillance, Epidemiology, and End Results (SEER) Program database, 36.3% of new lung cancer cases are frequently diagnosed among people aged 75-84 (28.7%) and 84 or older (9.7%). Mortality stemming from lung cancer within these age groups stand at 28.7% and 13.1%, respectively. In calendar year 2019, total Medicare enrollment stood at 61,514,510. Enrollees aged 75 years or older accounted for 37.2% of the total enrollment (22,853,753). Enrollees were further stratified by age as follows: 75-84, 26.3%; 85-94, 9.6%; and 95+ 1.3%. Maintaining the upper age limit at 77 makes as many as one-third of Medicare beneficiaries ineligible for LCS, regardless of their physical status. These data further underscores the importance of expanding the upper age criteria to at least 80 years of age.

Counseling and Shared Decision-Making (SDM) Visit

AstraZeneca recognizes and commends CMS for simplifying the requirements for counseling and SDM visits and we support the improved flexibility of these requirements in the proposed decision memo. AstraZeneca recognizes and supports SDM between providers and patients as a foundational element to all care decision making, including screening services.

While we support SDM holistically, we are concerned that the NCD SDM requirements may present an administrative burden for providers and may create an unnecessary requirement and care step, serving as a potential barrier to screening care delivery. While informed discussion should be encouraged, we request CMS consider that its inclusion serves as an effective service “step” that becomes an additional burden for providers and potential delay in patient care. This service “step” is especially challenging for patients and providers in rural settings, necessitating the need to find additional appointment times for lung-cancer-specific SDM services, and also challenging for patients with family, transportation, employment, and other personal constraints. We further note that SDM is a requirement that only exists for LCS. Screening services for mammography, or colon cancer screening contain no similar SDM requirements for Medicare coverage.

To ensure ongoing patient support, we believe SDM services can be recommended, but should not be required. For example, the USPSTF guidelines only recommends an SDM visit prior to screening, as opposed to the mandatory requirement found in the current Medicare coverage requirements.

AstraZeneca believes that to improve LCS utilization, screening programs should continue to embrace patient-focused models that streamline processes and improve patient compliance. SDM and provider/patient conversations are important and valuable for all cancer screenings, but should not be required for the coverage and reimbursement of a screening test.

Therefore, while we support SDM as an important component of LCS, we believe it should not be a mandatory requirement for coverage as outlined in the proposed decision memo and recommend CMS consider the following revision approaches (in priority order of recommendation):

CMS should consider eliminating the NCD requirement for SDM entirely.

The NCD SDM requirements presents added complexity to the delivery of LCS, resulting in lower screening rates and lost opportunities for earlier lung cancer diagnosis and timely care plan execution.

CMS should consider providing alternate opportunities for the SDM appointment or discussion to occur.

SDM appointments should be allowed to occur in conjunction with the screening appointment. SDM should be a continued discussion between a patient and health care provider, and should not be limited to a singular visit in a given point in time.

CMS should consider removing the requirement that a decision aid/tool be used.

The requirement for use of an aid/tool is not well defined and its ambiguity potentially creates more complexity and potentially additional administrative burden for providers. There exists no uniform decision aid tool for LCS SDM that is considered a standard, nor is there a recognized consensus for utilization in the LCS SDM process. (This is also acknowledged in the proposed decision memo).

Either removing or streamlining these SDM processes will help patients avoid unnecessary delays in the screening process and will also relieve providers of cumbersome administrative requirements, who are sometimes unfamiliar with the SDM process leading to inconsistent/inaccurate information being provided to potential LCS patients.

Although language around SDM has been simplified in the proposed decision memo, we remain concerned that the counseling and SDM requirements, as proposed, remains a significant barrier to LCS.

AstraZeneca recommends the counseling and SDM visit requirements be revised further by CMS to safeguard against barriers to uptake in screening.

AstraZeneca Supports Working to Eliminate Smoking Stigma and Continued Ongoing Review of the Evolving Evidence Base for Lung Cancer Screening

As a more general comment for CMS’s consideration, we continue to advocate for working to eliminate smoking stigma associated with lung cancer. While smoking certainly is among risk factors, we recognize that lung cancer risks and development of disease is not only tied to smoking. We appreciate and support consideration of the varying impact that LCS may have on different populations, regardless of smoking history. We hope that CMS will continue to consider how LCS can further reach at-risk Medicare beneficiaries who have no smoking history, but may have other potential risk factors. Ultimately, we believe that a holistic model that incorporates age, smoking status, family history, environmental and occupational exposures, and other factors to sub-stratify populations by risk can inform future personalized screening recommendations. We feel that it is important to note that lung cancer patients often do not fit phenotypic stereotypes, such as an older male smoker. For example, Flatiron data show that for EGFRm NSCLC metastatic patients, 57% have never smoked and 69% are female. We appreciate and support consideration of the varying impact that LCS may have on different populations, regardless of smoking history.

Furthermore, we support continued efforts to improve diagnostic accuracy of screening protocols and standardize data analysis, reporting, quality control and follow-up coverage analyses. We also believe that different types and categories of evidence, such as real-world evidence, can play a critical role in informing and determining appropriate, value-based care.

AstraZeneca thanks you for the opportunity to comment as CMS finalizes its National Coverage Determination on “Screening for Lung Cancer with Low Dose Computed Tomography (LDCT).”

Sincerely,

Christie Bloomquist
Vice President Corporate Affairs, North America

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December 16, 2021

Tamara Syrek Jensen, JD, Director
Joseph Chin, MD, Deputy Director
Attn: Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Electronically Submitted: CMS_caginquiries@cms.hhs.gov

Re: Public Comment on the Proposed NCD for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) CAG-00439R

Dear Ms. Jensen and Dr. Chin:

The GO2 Foundation for Lung Cancer¹, American College of Radiology® (ACR)², and The Society of Thoracic Surgeons (STS)³ appreciate the opportunity to submit comments on the Proposed National Coverage Decision for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT).

Our organizations applaud the Centers for Medicare and Medicaid Services’ (CMS) expanded lung cancer screening eligibility criteria reflecting a lower start age of 50 years and lower smoking history of 20 pack-years parallel with the U.S. Preventive Services Task Force (USPSTF) grade B recommendation. We support the efforts made by CMS to simplify and streamline the patient workflow for lung cancer screening in the radiology imaging facility and its clarification that smoking cessation is performed by the health care provider within the context of a shared decision making consultation, as Medicare Administrative Contractors (MACs) have misidentified LDCT lung cancer screening (LCS) imaging as a “therapeutic test and intervention” and erroneously denied beneficiaries coverage when performed in independent diagnostic testing facilities.

We strongly disagree with CMS’s evidence review summary rationale and proposed decision to 1) stop screening once a person has not smoked for 15 years, 2) stop screening at age 77 years, 3) require counseling and shared decision making visit before a beneficiary can obtain Medicare coverage for their first lung cancer screening, and with 4) the removal of the radiology imaging facility eligibility criteria.

Our joint societies continue to urge CMS to remove items 1-3 from the final National Coverage Determination (NCD) as inherent barriers to lung cancer screening access for individuals at high risk for developing lung cancer. We strongly urge the agency to modernize its evidence review towards increasing lung cancer screening and survivorship in the Medicare population. The proposed CMS evidence summary on these topics is too narrow, and contradicts the evidence review and research summary prepared by the AHRQ used by the USPSTF. We urge CMS to recognize that clinical trials have limited ability to define the extent of a high risk population for lung cancer. Given the primacy of lung cancer mortality burden across the United States population, and with the historic challenges with health disparities related to tobacco use, there is a critical need to provide Medicare coverage in a responsible and equitable fashion to address the need of the at-risk populations. To this end, we encourage CMS to fully consider other studies including modeling and real world data to address the Medicare population and public health benefit of early detection and health equity. In addition to our recommendations below, we refer CMS to our formal comments dated March 9th and June 16th, 2021 calling for broader evidence review with a public health outlook.

At a minimum, CMS should allow Medicare patients the same benefit as recommended by the USPSTF for the upper age screening eligibility criteria of 80 years based on their modeling evidence. It is unjust and inequitable to disregard the medically fit, upper age group of the Medicare population based on the proposed CMS evidence review that excluded all modeling, driving patients to pay out of pocket to receive this life saving service. The focus on lung cancer screening discontinuation should be based on an individual’s overall health, comorbidities, and ability or willingness to undergo treatment rather than age limits and an arbitrary 15-year quit smoking time frame.

We recommend CMS remove the upper age cutoff of >77, as decisions to discontinue screening should be individualized and based on the overall health status of the patient. This is also recommended in the National Comprehensive Care Network (NCCN) lung cancer screening guideline.⁴ The one size fits all approach for lung cancer screening and upper age limit is antiquated and medically contraindicated for a sizeable risk population that may have healthy lifestyles and little or no comorbidities.

CMS should consider the increasing life expectancy in the U.S., advances in lung cancer treatments, increased benefits of early detection with LDCT screening (overall improvements over the last decade), multiple publications regarding safety and efficacy of lung cancer surgery for individuals over age 77, real-world evidence of screening older individuals including registries and other types of studies outside of randomized controlled clinical trials, and a personalized medicine approach by replacing the upper age limit with clinical guidance, such as, “discontinue screening once a person develops a health problem that substantially limits life expectancy or the ability or willingness to have curative intent therapy.”

With the increasing life expectancy of the American population, in 2014 Varlotto et al. investigated whether lung cancer screening benefits individuals 75-84 years old, concluding that screening may benefit individuals at increased risk of lung cancer in the upper age group. Specifically, they found that the survival benefits of aggressive therapy are similar in females between 55–74 and 75–84 years old.⁴

Well-established data from institutional reports and registry analyses document the favorable patient outcomes from the surgical management of early-stage lung cancer. Objective assessments of surgical efficacy should use contemporary results reported within the last decade, including screening studies [e.g., International Early Lung Cancer Action Program (I-ELCAP)]. In addition, other advances in other therapeutic modalities including stereotactic body radiation therapy (SBRT), standard radiation therapy (RT), chemotherapy, and immunotherapy have dramatically increased survival beyond 77 years of age.

The CMS evidence summary indicates that no randomized clinical trials (RCTs) included the upper age in their study populations. However, it is vitally important to apply context and modernize the CMS evidence approach. Although the RCT studies and enrollment parameters CMS identified a good target population, they were not intended or framed to define the extent of lung cancer risk or to limit screening access and eligibility as previously pointed out by the USPSTF. CMS is inadvertently misrepresenting the NLST and other studies by concluding the RCTs omission of the upper age population is the basis for not allowing Medicare patients screening coverage once they turn 78 and beyond.

In addition, CMS is misinterpreting various clinical guidelines and standards from organizations and again, should apply context and revise the evidence review and proposed decision. It’s incongruous and inaccurate for CMS to conclude that the screening guidelines from the American College of Radiology, and the National Comprehensive Care Network, etc., included recommendations that restrict the aging Medicare population from reasonable and medically appropriate screening. The context is crucial, as these are evolving and advancing guidelines that often reflect key coverage parameters by Medicare or the USPSTF to help educate due to broad and significant coverage implications.

Specifically, while NCCN guidelines notes in a footnote that “there is uncertainty about the upper age limit to initiate or continue screening” they follow this with recommendations that “consider screening beyond age 77 years as long as patient functional status and comorbidity allow consideration for curative intent therapy.” The algorithm of NCCN guidelines quite specifically avoids an upper age limit because of recognition by the panel that non-inclusion of older age individuals in the large randomized trials is a pragmatic detail of trial design and does not define the true upper age limit for benefit from early detection. NCCN panel experts from pulmonary medicine, thoracic radiology, thoracic surgery, epidemiology, medical oncology, and patient advocacy have consensus that the end of screening should be an individualized decision between an individual and their health care provider based on health status, comorbidity, and patient values that determine eligibility for curative-intent therapy.

The proposed decision by CMS to cease screening at age 78 and/or when an individual has stopped smoking for >15 years is not justified by the omission of evidence outlined in the review summary. This acts as a barrier to patient access for a reasonable and medically appropriate lung cancer screening test in the Medicare population.

We strongly urge CMS to delete the 15-year smoking quit date screening eligibility criterion, as there is no substantive data to support a significant reduction in lung cancer risk at that time frame. Current NCCN guidelines do not have this restriction for recommended screening eligibility.⁴ Patients that meet eligibility criteria should continue screening unless they develop a health problem that substantially limits life expectancy or the ability or willingness to have curative intent treatment.

CMS is misrepresenting RCT enrollment criteria as the basis for not allowing Medicare patient screening coverage once they stop smoking for 15 years. It is well-known that these RCTs were not intended or designed to limit screening eligibility. For example, the NLST 15-year quit smoking enrollment criterion was not and is not indicative of the broader high-risk screening population and does not represent the clinical utility of screening for those individuals having quit smoking for more than 15 years. The USPSTF and CMS are arbitrarily re-applying the 15-year quit smoking restriction based on NLST study entry criteria alone. This inappropriately limits eligibility for screening and in doing so dismisses the level of higher-risk lung cancer among the population that quit smoking more than 15 years ago.

To require and wait for an RCT for individuals that stopped smoking more than 15 years ago when there is data that concludes 40% of all lung cancers still occur in the 15 years since quit (YSQ) smoking population is a flaw in the draft coverage decision . The existing evidence on the objective relative risk for lung cancer after the 15 YSQ smoking does not support excluding screening for 4 out of 10 lives diagnosed with lung cancer.⁷

CMS is misunderstanding various clinical guidelines and standards from organizations and, should apply relevant context and revise their evidence review and proposed decision. NCCN has eliminated a quit date limitation to screening eligibility as they recognize that risk remains high for former smokers, even beyond 15 years of cessation, as well as the perverse incentive that this criterion may have to encourage individuals to resume smoking to remain eligible for screening. It is inaccurate and misleading for CMS to conclude that the screening guidelines from the American College of Radiology, and the National Comprehensive Care Network (NCCN), etc., include recommendations that are used to restrict the screening population that stopped smoking 15 years ago or more. As mentioned, the context is important for these evolving and advancing guidelines which often include key coverage considerations by Medicare and the USPSTF. These guidelines were not intended to exclude screening from the respective Medicare population (15 YSQ) but rather help educate due to broad and significant coverage parameters/restrictions instituted by federal agencies like CMS etc.

In a prospective study, Yang et al. observed two cohorts of individuals with lung cancer and identified the chronological patterns among 1) eligible individuals per USPSTF lung cancer screening risk criteria and 2) those individuals who would have “missed out” on screening who were outside the USPSTF criteria. The lung cancer incidence levels among those who would have “missed out” were high, demonstrating continued high-risk. The largest group (approximately 30%) of individuals among the cohort that “missed out” was solely based on a quit smoking date of more than 15 years ago. The authors concluded that their “current and previous studies provide evidence that former smokers with 15 to 30 quit-years remain at high-risk and should be considered eligible for LDCT screening for lung cancer. The current USPSTF recommendation to stop screening after 15 years of smoking cessation is not reflective of the continued high-risk.” Their results underscored that the inclusion of former smokers that have quit smoking more than 15 years may yield substantial increases to screen-detected lung cancers with more lives saved.⁸

The 2021 USPSTF relaxation of age and pack-years requirements was prompted in part to increase the proportion of Black individuals eligible for screening given their younger age at diagnosis of lung cancer and higher risk of lung cancer associated with fewer smoking pack-years compared with White individuals.2,6 As recently as November 24, 2021, Potter et al., found the impact of the 15-year quit smoking screening restriction on black women to be significant. While the proportion of Black women diagnosed with lung cancer eligible for screening increased by 50% under the updated 2021 USPSTF guidelines, still 66% of patients with lung cancer would have been ineligible for screening. Removing the 15 YSQ requirement would increase the proportion of Black women eligible for screening from 33.9% to 48.2%. Similar recent findings by Pasquinelli et al. looked at racial disparities and risk prediction models versus USPSTF. In their analysis, they found that 49.1% would qualify for screening among a Black cohort of ever-smokers ineligible by the USPSTF criteria and would be deemed ineligible due to the 15-year quit smoking restriction. The study concluded that the PLCOm2012 model was preferable to USPSTF criteria at identifying Black ever-smokers for screening and that broader use of the model in racially diverse populations may help overcome racial disparities in lung cancer screening and outcome.

At a time when lung cancer deaths remain the number one cancer killer and when screening uptake trends are very low⁹, CMS should not diminish and discriminate against thousands of Americans who stopped smoking more than 15 years ago when real world evidence and observational studies, etc. shows this population remains at a high-risk of lung cancer. Given public health responsibility, health maximization, efficiency, justice, and proportionality¹⁰, to exclude millions of former Medicare and Medicaid smokers who remain at high-risk of lung cancer based on an arbitrary threshold of 15 years since having quit smoking is not supported by the evidence and is punitive against Medicare beneficiaries that have managed to stop smoking.

The proposed NCD criterion (15 YSQ restriction) unintentionally but paradoxically incentivizes Medicare patients to continue or resume smoking in order to obtain or continue screening. Patients beyond the 15-year quit date are no longer eligible for insurance coverage and would have to incur out-of-pocket costs on a self-pay basis or not get screened. The unintended consequence is significant, perverse, and should be eliminated. To simplify eligibility requirements, reduce harms, and further promote screening we urge CMS to remove the 15-year smoking cessation quit date.

We recognize that CMS has made efforts to streamline the SDM criterion in the proposed NCD. However, SDM is not a coverage requirement for any other cancer screening and lung cancer should be no different.

Our joint societies fully support the importance of SDM and the provider/patient conversation as a valuable part of all cancer screenings and other tests. However, the added burden of medical record documentation should not be a requirement for lung cancer screening by tying it to coverage and reimbursement. The NCD process is not the best mechanism for ensuring responsible and appropriate SDM and best practice standards and instead should be directed to medical professional societies, accrediting bodies, and groups like the National Quality Forum.

CMS should mirror the USPSTF approach emphasizing the importance of smoking cessation counseling, SDM, and other practice considerations¹¹ and reference appropriate national bodies for quality screening implementation and other best practice measures. Patient/provider informed discussions regarding risks and benefits are important across all cancer screenings and are done so without an NCD requirement. For example, there are no SDM requirements for coverage of screening mammography or colon cancer screening. Individuals should be offered the opportunity to discuss smoking abstinence or cessation by trained health care professionals as appropriate.

We disagree with CMS’ proposed NCD and basis (i.e., complex patient criteria, benefits, harms, adherence) for requiring SDM before the initial lung cancer screening although we acknowledge such concerns were included in the 2015 NCD during its early adoption. The maturity and effectiveness of LDCT LCS across settings all reported over the last five years are significant.¹² CMS should give weight to and recognize the advances and improvements made over the last decade in radiation dose optimization in CT technology, the low dose protocols established by professional societies (e.g., ACR, AAPM), standardized reporting, and management systems (i.e., Lung-RADS)¹³, incidental findings white papers, and incidental findings resources and management¹⁴. These advances in standardized screening protocols and implementation, the magnitude of annual lung cancer deaths, persistent low screening uptake in the U.S., and existing and potential NCD SDM criteria burdens, should all bear thoughtful consideration by CMS in revising and removing the proposed NCD language.

Significant concerns remain among medical professional societies, physician groups, screening centers, patient communities, and other stakeholders that the counseling and SDM requirement in the proposed NCD has had an unintended yet major barrier to lung cancer screening. This is especially problematic with medically underserved populations. The SDM proposed NCD requirement results in an unfortunate health equity issue, as marginalized populations have much less access to health care professionals in both urban and rural settings. This also targets a group of patients that have been stigmatized and underrepresented in screening compared to other cancer types.

The joint societies urge CMS to remove the “Counseling and Shared Decision Making (SDM)” NCD requirement altogether to ensure equitable access and mitigate this barrier to lung cancer screening uptake.

We disagree with CMS’ proposal to remove the radiology imaging facility eligibility criteria. While this may expand access to care, we want to ensure quality assurance remains central to new and continued screening programs as LCS is made available to more Americans and programs will need to grow and expand to reach individuals eligible for screening. We recommend CMS reconsider removing the radiology imaging facility eligibility criteria and instead seek modifications. We recommend maintaining the radiology imaging facility eligibility criteria to safeguard Medicare beneficiaries from harm. We recommend the following criteria:

• Performs LDCT with volumetric CT dose index (CTDIvol) of = 3.0 mGy (milligray) for standard size patients (defined to be 5’ 7” and approximately 155 pounds) with appropriate reductions in CTDIvol for smaller patients and appropriate increases in CTDIvol for larger patients;
• Utilizes a standardized lung nodule identification, classification and reporting system;
• Collects and submits data to a CMS-approved registry for each LDCT lung cancer screening performed.

Radiation Dose
We support the required standardized volumetric CT dose index criteria to monitor radiation dose and minimize the risk for patients undergoing this screening option. We agree with CMS’s analysis that found an awareness of the potential for radiation related harm can help programs thoughtfully plan ways to minimize this risk through proper patient selection, the performance of the CT scan, tracking of the radiation dose being administered, and appropriate management of screen detected findings” (Mazzone, Panel Report 2021). If the dose criteria are eliminated there will be no distinction between low dose and regular dose protocols.

Lung Nodule Reporting System
We recommend maintaining the eligibility criteria for utilizing a standardized lung nodule identification, classification, and reporting system. Lung-RADS is a quality assurance tool designed to standardize lung cancer screening CT reporting and management recommendations, provide consistency in lung cancer screening CT interpretations, and facilitate outcome monitoring. Lung-RADS is an example of a system that is deemed appropriate by the lung cancer screening community. As lung cancer screening programs screen more patients, this will be even more critical. Society guidelines are being updated to reflect current practices and experience of screening programs to reflect updates to the 2021 USPSTF screening recommendations. Without a lung cancer screening reporting tool, this will blur the lines with management recommendations for incidentally detected lung nodules designed for patients at much lower risk of lung cancer, such as the well-recognized Fleischner criteria.

Lung Cancer Screening Registry
Our joint societies support maintaining the registry reporting for lung cancer screening programs. We have reviewed the CMS approved registry minimum required data elements and believe they capture the information necessary to screen the appropriate patients and monitor the screening population. The information available through registry reporting helps practices and program coordinators establish best practices and high-quality lung cancer screening programs that are sustainable. These criteria serve as a major national infrastructure for facilities and radiologists to collect, submit and review their data with benchmark data from other practices. Without an alternative structure for quality, there is concern that discontinuing it at this time could set back quality efforts in screening as practices build and grow further to increase the number of patients being screened. LCS quality activities and efforts over the years have relied on registry data and have served as a central resource and reference for LCS research and quality measures.

We have reviewed the reading radiologist training eligibility criteria and support modifications outlined in the proposed decision memo. Specifically, we support CMS’s proposal to remove the training documentation requirement, the requirement of interpretation of 300 chest CT in three years, and the radiology facility eligibility criteria. We support CMS retaining the eligibility criterion that the reading radiologist must be board certified or board eligibility with the American Board of Radiology or equivalent and must have documented participation in continuing medical education in accordance with current American College of Radiology standards.

Expanded access to lung cancer screening will help doctors strike a blow against the nation’s leading cancer killer. Screening providers, particularly those starting new screening programs, should seek quality assurance activities to maximize the lifesaving benefit of lung cancer screening. The ACR is committed to both increasing our work with screening facilities and radiologists to provide education on lung cancer screening performance by using registry data to perform quality audits with a goal of quality improvements, and to using the national practice data to inform the development of performance benchmarks made possible by registry data. This effort took 15-20 years to develop for breast cancer screening in the absence of such data. The Coverage and Analysis Group must similarly align its coverage activities with the Center for Clinical Standards and Quality to ensure favorable outcomes for Medicare beneficiary lung cancer screening.

Summary

Despite the seven years since the Feb. 2015 NCD, lung cancer screening rates remain low due to several contributing factors^15,16, including the screening discontinuation at 78 years of age, discontinuation of screening once an individual stops smoking for >15 years, the SDM requirement tied to coverage, and certain radiology imaging facility eligibility criteria.

We believe there is sufficient evidence to conclude that lung cancer screening with LDCT is reasonable and necessary for the early detection of illness or disability and appropriate for Medicare beneficiaries under the conditions recommended by the current NCCN guidelines. We recommend that CMS’ final NCD echo the current NCCN guidelines and remove the aforementioned screening restrictions. NCCN evaluates emerging and ongoing evidence on an annual basis as part of their guidelines process, producing well-respected national cancer guidelines/standards, and are responsible stewards of evidence for lung cancer screening across the Medicare population and beyond. In addition, we recommend that CMS retain the radiology facility criteria necessary to ensure the quality of lung cancer screening during a time period of screening growth to include millions more individuals in the United States in order to minimize unintended harms.

Our joint societies commend CMS for revising the NCD to help reach the lung cancer screening eligible population and appreciate the opportunity to comment on this important life-saving preventive service. We welcome further dialogue and encourage NCD adoption of patient centered language.

If you have any questions, please contact Anita McGlothlin, Director of Economics and Health Policy, at amcglothlin@go2foundation.org.

Sincerely,

Laurie Fenton Ambrose,
Co-Founder, President and CEO
GO2 Foundation for Lung Cancer

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

Sean C. Grondin, MD
President
The Society of Thoracic Surgeons

Cc: Scientific Leadership Board

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1 The GO2 Foundation for Lung Cancer is a national non-profit organization, founded by patients and survivors, dedicated to saving, extending, and improving the lives of those vulnerable, at-risk, and diagnosed with lung cancer.
2 The ACR is a professional organization representing 40,000 radiologists, radiation radiologists, nuclear medicine physicians, and medical physicists, committed to advancing the science and quality of radiological care for patients.
3 The Society of Thoracic Surgeons is a not-for-profit organization representing more than 7,600 surgeons, researchers, and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lungs, and esophagus, as well as other surgical procedures within the chest.
4 Varlotto JM, DeCamp MM, Flickinger JC, et al. Would Screening for Lung Cancer Benefit 75 to 84 Year-Old Residents of the United States? Front Oncol. 2014; 4: 37. Published online 2014 Mar 7. doi: 10.3389/fonc.2014.00037.
5 I-ELCAP Publications | I-ELCAP.
6 Tindle HA, Duncan MS, Greevy RA, et al. Lifetime Smoking History and Risk of Lung Cancer: Results From the Framingham Heart Study. JNCI J Natl Cancer Inst. 2018;110(11): djy041.
7 Reitsma M, Kendrick P, Anderson J, et al. Reexamining Rates of Decline in Lung Cancer Risk after Smoking Cessation: A meta-analysis. ANNALSATS Articles in Press. 2020;10.1513/AnnalsATS.201909-659OC.
8 Yang P, Wang Y, Wampfler JA, et al. Trends in Subpopulations at High Risk for Lung Cancer. J Thorac Oncol. 2016;11(2):194-202.
9 Okereke IC, Nishi S, Zhou J. Trends in lung cancer screening in the United States, 2016-2017. J Thorac Dis. 2019;11(3):873–881.doi: 10.21037/jtd.2019.01.105. PMCID: PMC6462682.
10 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4196023/
11 https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening#bootstrap-panel—6
12 Copeland A, Criswell A, Cuipek A, et al. Effectiveness of Lung Cancer Screening Implementation in the Community Setting in the United States | JCO Oncology Practice (ascopubs.org). DOI: 10.1200/JOP.18.00788 Journal of Oncology Practice 15, no. (July 01, 2019) e607-e615.
13 Lung CT Screening Reporting & Data System (Lung-RADS). https://www.acr.org/Clinical-resources/Reporting-and-Data-Systems/Lung-Rads
14 https://www.acr.org/Clinical-Resources/Incidental-Findings
15 Jemal A, Fedewa SA. Lung cancer screening with low-dose computed tomography in the United States – 2010 to 2015. JAMA Oncol. 2017;39:1278-1281.
16 National Academies of Sciences, Engineering, and Medicine. 2017. Implementation of lung cancer screening: Proceedings of a workshop. Washington, DC: The National Academies Press. https://www.ncbi.nlm.nih.gov/books/NBK431132/.
17 https://www.iaslc.org/IASLCLanguageGuide

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I. Delete the annual screening eligibility criterion that discontinues screening once an individual turns 78 years old.

We recommend CMS remove the upper age cutoff of >77, as decisions to discontinue screening should be individualized and based on the overall health status of the patient. This is also recommended in the National Comprehensive Care Network (NCCN) lung cancer screening guideline.4 The one size fits all approach for lung cancer screening and upper age limit is antiquated and medically contraindicated for a sizeable risk population that may have healthy lifestyles and little or no comorbidities.

CMS should consider the increasing life expectancy in the U.S., advances in lung cancer treatments, increased benefits of early detection with LDCT screening (overall improvements over the last decade), multiple publications regarding safety and efficacy of lung cancer surgery for individuals over age 77, real-world evidence of screening older individuals including registries and other types of studies outside of randomized controlled clinical trials, and a personalized medicine approach by replacing the upper age limit with clinical guidance, such as, “discontinue screening once a person develops a health problem that substantially limits life expectancy or the ability or willingness to have curative intent therapy.”

To put this into perspective, the very first patient screened in our program was part of the "C" suite; age 80 (yes, we know) and a former smoker with an over 120 PYH. She was a LR 1 in 2013. Seven short years later, she died of lung cancer, which was diagnosed Stage IV—because she did not meet screening criteria.

II. Delete the screening eligibility criterion that discontinues annual screening for individuals who quit smoking > 15 years ago

We strongly urge CMS to delete the 15-year smoking quit date screening eligibility criterion, as there is no substantive data to support a significant reduction in lung cancer risk at that time frame. Current NCCN guidelines do not have this restriction for recommended screening eligibility.4 Patients that meet eligibility criteria should continue screening unless they develop a health problem that substantially limits life expectancy or the ability or willingness to have curative intent treatment.

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Dear Ms. Kimberly Long,

Johnson & Johnson ("J&J") is pleased to submit comments on the referenced National Coverage Analysis (NCA).

J&J is the world’s most comprehensive and broadly-based healthcare company, delivering products and services for the consumer, pharmaceutical, and medical devices and diagnostics markets. For more than 135 years, we have supplied the world’s healthcare systems 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.

The J&J Lung Cancer Initiative (LCI), (https://www.jnj.com/tag/johnson-johnson-lung-cancer-initiative) is dedicated to transforming the standard of care for this devastating disease. The vision for the LCI is to bring together world class science and innovation to develop holistic solutions that prevent, intercept, and cure lung cancer. Leveraging J&J’s expertise across its consumer, pharmaceutical, and medical device segments, its goal is to enable a future vision where there is a world without this devastating disease.

Lung cancer is the leading cause of cancer-related deaths.(1) Its diagnosis and treatment are particularly important among the Medicare population given the age at diagnosis. The frequency of late-stage detection of the disease is a key contributor to a low overall survival rate, despite notably better 5-year overall survival rates that are associated with early-stage detection.(2) Thus, lung cancer screening (LCS), and specifically low dose computed tomography (LDCT) screening, is a critical tactic in diagnosing and treating lung cancer patients successfully.

Unfortunately, utilization of LDCT screening among the at-risk eligible population has remained low since its first year of coverage in 2015 and highly variable across states.(3) Even more concerning, evidence suggests Black populations have a higher risk of lung cancer at lower levels of smoking intensity.(4) Consistent with the Administration’s priorities to address social disparities, all efforts to update this National Coverage Decision (NCD) should ensure diverse populations have equitable access to appropriate screening services, including LDCT.

We offer our comments for the agency’s consideration and also support the recommendations submitted by the GO2 Foundation for Lung Cancer, The Society of Thoracic Surgeons, and the American College of Radiology.

We applaud CMS for proposing expanded screening criteria that are more consistent with the United States Preventive Service Task Force (USPSTF) recommendation but encourage flexibility around the year since quitting criteria.

In March 2021, the USPSTF published an updated recommendation (grade B) for annual screening for lung cancer with LDCT. In May 2021, CMS initiated an NCA to reconsider its NCD in light of the updated recommendation. In November 2021 CMS opened a public comment to solicit feedback on the proposed changes to beneficiary eligibility and counseling and shared-decision making (SDM) visit requirement before their first lung cancer LDCT screening.

We are encouraged by the agency’s proposed decision to cover adults from the lower start age of50 and lower smoking history of 20 pack-year smoking history. We support the agency’s decision to expand age eligibility and lower the smoking history criterion to reflect updated evidence that is inclusive of minority populations and improve access to LCS.

The updated beneficiary eligibility criteria will continue to include those who are currently smoking or have quit within the past 15 years. At present the studies used to inform the USPSTF recommendation do not examine patients who have a quit smoking history greater than 15 years. As such, there currently is no evidence cited of declining risk for these patients. We urge CMS to carefully consider whether there are subpopulations for whom a longer period since quitting is appropriate to ensure that Medicare beneficiaries who may face ongoing risk from lung cancer have access to LDCT screening. Until evidence has been generated and cited to support this eligibility criteria, we urge the agency to increase flexibilities around this requirement.

We support stakeholder recommendations for CMS to remove the “Counseling and Shared Decision-Making (SDM)” NCD criteria entirely.

As noted in our comments from June 2021, we understand and appreciate the importance of counselling patients to ensure all are well-informed about the opportunity and implications of lung cancer screening. At the same time, detailed specifications for the shared decision-making visit before the first screening in the NCD has been a barrier to more widespread screening.

The agency has proposed to remove the specification of the type of practitioner and documentation requirements as a means to reduce burden and broaden access to LDCT screening. While we appreciate and agree with the changes to these requirements, we continue to urge the removal of SDM as a required coverage criteria for lung cancer screening entirely. Such counselling is not required for other types of cancer screenings, and it should not be the case in lung cancer. Removal of this criteria is especially important as lung cancer continues to persist as the leading cause of cancer death and any obstacle to the critical role LCS plays in early detection and improved patient outcomes should be removed.

We reiterate two key aspects of the current SDM requirement that merit further consideration by CMS:

• To increase lung cancer screening utilization, screening programs and the accompanying steps for enrollment should embrace patient-centric models such as allowing the SDM appointment or consultation to occur in conjunction with the actual screening examination rather than requiring a separate SDM visit; and
• Since the 2015 NCD, reporting, management protocols, and technology have significantly improved and advanced with higher specificity and sensitivity with standardized approaches (e.g., comparable accuracy to screening for breast and colon cancer, which are covered by Medicare without shared decision-making requirements), which led to the 2021 updated USPSTF recommendation.

We appreciate and support the proposed changes to simplify SDM visit requirement and the importance of patient counselling. At the same time, we continue to urge the need to remove it entirely to ensure more accessible to lung cancer screening.

J&J is encouraged by CMS’s continued efforts and proposed changes to expand the beneficiary eligibility criteria for LDCT screenings. While we are very supportive of the proposed changes, we encourage CMS to consider opportunities to go beyond the USPSTF recommendations to cover additional risk populations as evidence becomes more available.

Johnson & Johnson appreciates the opportunity to comment on this NCA and look forward to future opportunities to engage with CMS to improve access and utilization of LDCT screenings for eligible patients. Please do not hesitate to contact us for additional information or with additional questions discussed in our comments.

Sincerely,

Vadi Esmailizadeh, MPH, MBA
Manager, Coverage & Reimbursement and Global Policy Planning
Worldwide Government Affairs & Policy

References:
1. NCI (National Cancer Institute). Surveillance, Epidemiology, and End Results Program: Cancer Stat Facts: lung and bronchus cancer. https://seer.cancer.gov/statfacts/html/lungb.html. Accessed October 1, 2021.
2. Progress And Prospects Of Early Detection In Lung Cancer, Sean Blandin Knight, Phil A. Crosbie, Haval Balata, Jakub Chudziak, Tracy Hussell and Caroline Dive, Open Biology - Volume 7, Issue 9 Published:06 September 2017, https://doi.org/10.1098/rsob.170070.
3. Fedewa SA, Kazerooni EA, Studts JL, et al. State Variation in Low-Dose Computed Tomography Scanning for Lung Cancer Screening in the United States. J Natl Cancer Inst. 2021;113(8):1044-1052. doi:10.1093/jnci/djaa170
4. US Preventive Services Task Force. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021;325(10):962–970. doi:10.1001/jama.2021.1117.

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Rush University System for Health (RUSH) is comprised of Rush University Medical Center in Chicago, IL, Rush Oak Park Hospital in Oak Park, IL and Rush Copley Medical Center in Aurora, IL. Rush University Medical Center and Rush Oak Park Hospital have been designated as centers for excellence for lung cancer screening by the Lung Cancer Alliance (now Go2 Foundation) since 2016. RUSH has completed over 3,600 lung screens since the program’s inception.

As a part of our commitment to providing exceptional care to our patients RUSH would like to commend CMS for the proposed changes that match the USPSTF and NCCN guidelines to change the pack year minimum from 30 to 20 and the minimum age from 55 to 50.

However RUSH will encourage CMS to consider the following changes to the proposed guidelines:

1. The upper age limit of 77 should be eliminated to match the NCCN guidelines for lung cancer screening. A patient’s health status and individual decision to stop or continue screening should be decided by the ordering provider’s assessment.
2. The tobacco cessation upper limit of 15 years should be eliminated, also to align with NCCN guidelines. The risk for developing lung cancer remains past the 15 year benchmark.
3. Shared decision making should be recommended and not required for baseline lung cancer screens, to align with USPSTF and NCCN guidelines. As lung cancer screening is the only cancer screening where this is a requirement, this could be a barrier in getting providers to order a lung screen at annual preventative care visits when all other cancer screens are more easily ordered.
4. The former requirements for radiologists interpreting and reading exams should be reinstated. Removing the standardized documentation requirements (LungRADS) could have a significant effect on the quality of lung screens, increase ambiguity in follow up and management recommendations made to ordering providers. LungRADS provides clear and consistent communication between radiologist and referring providers.”

RUSH would like to thank CMS for the opportunity to share our ideas on the proposed changes.

Sincerely,

Dr. Palmi Shah, Director of Thoracic Radiology
Dr. Ramya Gaddikeri, Thoracic Radiology
Dr. Michael Liptay, Director of Thoracic Surgery
Dr. Christopher Seder, Chief of Thoracic Surgery
Dr. Justin Karush, Thoracic Surgery
Dr. Gaurav Marwaha, Director of Radiosurgery
Dr. Philip Bonomi, Medical Oncology
Dr. Marta Batus, Medical Oncology
Dr. Mary Jo Fidler, Medical Oncology
Dr. Babak Mokhlesi, Chief of Pulmonology
Dr. Catherine McGinness, Family Medicine
Dr. Jennifer Earvolino, Internal Medicine
Dr. Michael Cui, Internal Medicine, Clinical Informatics
Judi Bonomi, Director of Cancer Care and Inpatient Nursing, Rush Copley
Terese Raabe, Assistant Vice President of Operations, Rush Copley
Annie Lally, Manager, Lung Cancer Screening Program

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Tamara Syrek Jensen, J.D.
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

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

Dear Ms. Jensen:

The American Cancer Society (ACS) and American Cancer Society Cancer Action Network (ACS CAN) welcome the opportunity to respond to the Proposed Decision Memo (PDM) for Screening for lung cancer with low dose computed tomography (LDCT). The ACS is the nation’s largest voluntary health organization, dedicated to eliminating cancer as a major health outcome through research, education, and service. The ACS has a long history of promoting early cancer detection, having been active in promoting early cancer detection since the mid-20th century and issuing the first evidence-based cancer screening guidelines in 1980. ACS also has a long history of promoting quality assurance in cancer screening, and related to this proposed decision memo, was actively involved in the development of the evidence leading to the current recommendations for lung cancer screening with LDCT. ACS CAN is making cancer a top priority for public officials and candidates at the federal, state, and local levels. ACS CAN empowers advocates across the country to make their voices heard and influence evidence-based public policy change, as well as legislative and regulatory solutions that will reduce the cancer burden. As the American Cancer Society’s nonprofit, nonpartisan advocacy affiliate, ACS CAN is critical to the fight for a world without cancer.

We appreciate CMS’ interest in updating its national coverage determination with respect to lung cancer screening. Although considerable progress has been made in reducing the burden of lung cancer, it still is the leading cause of mortality from cancer. Moreover, we have entered into a new era of lung cancer control. Until recently, whether an adult currently smokes, formally smoked, or had never smoked, there was not an evidence-based strategy for early detection of lung cancer, most lung cancers were diagnosed at an advanced stage, and treatment for advanced stage disease had poor outcomes. Today we have a proven screening strategy, and rapid progress in biomarker driven targeted and immunotherapies have provided new hope for longer survival and better outcomes. In combination, lung cancers that are found at an early stage can be treated more easily, and lead to better survival.¹

When CMS decided to cover lung cancer screening for Medicare beneficiaries, the agency was forward thinking in their decision to require adherence to a range of quality measures tied to reimbursement, and to establish a registry to measure adherence and uptake of screening. We support the agency’s decision to update the 2015 coverage decision.²

We offer the following comments on the process and standards CMS proposes with respect to Medicare coverage of lung cancer screening.

In March 2021, the U.S. Preventive Services Task Force (hereon “the Task Force”) released an update to its previous lung cancer screening (LCS) recommendation statement for LDCT screening of asymptomatic adults at high risk of lung cancer.³ The two major changes from its previous recommendation include: (1) lowering the starting age of screening from 55 to 50, and (2) lowering the pack-year smoking history criteria from 30 years to 20 years. The implication of these changes is that more adults who formally smoked or currently smoke will be eligible for LCS. In particular, lowering the eligibility requirements benefits Black, Asian, and Hispanic adults, who are at a higher risk of lung cancer with lighter smoking histories compared with white adults.⁴

CMS has proposed some changes in the beneficiary eligibility criteria, but has not entirely adopted the new USPSTF recommendation, i.e.

• Asymptomatic (no signs or symptoms of lung cancer) ages 50 – 77 years;
• Adults who currently smoke, or formally smoked and quit smoking within the last 15 years;
• Tobacco smoking history of at least 20 pack-years; and
• Receive an order for lung cancer screening with LDCT.

Lowering the Starting Age from 55 Years to 50 Years

The evidence basis for the proposed update in the eligibility criteria, and those eligibility criteria retained from the previous coverage decision, is stated on page 32 in the evidence review summary, i.e., “The evidence base for this reconsideration of low dose CT for lung cancer screening has a primary focus on randomized controlled clinical trials of the effect of screening with low dose CT on the outcome of lung cancer mortality (page 32).” This statement lays the foundation for the decision to lower the age to begin screening from age 55 to age 50 and is the basis for choosing not to extend Medicare coverage from age 77 to age 80, since none of the randomized controlled trials (RCTs) included adults over age 75. The PDM also notes that modeling studies were not included in the internal technology systematic review (page 33), and thus supportive evidence from the modeling studies was not considered. We agree with CMS’s decision to not focus on meta-analysis studies in the evidence review. There simply is too much heterogeneity in the existing RCTs of LDCT screening for meta-analysis results to be informative, and there is sufficient evidence in the small number of larger trials.

Regarding the decision to lower the age to begin screening to age 50, the PDM relies mostly on the NELSON, LUSI, and MILD trials, and notes (1) a mortality reduction in the 50-54 age group; (2) the overall mortality reduction in the age range invited to screening; and (3) noting specifically that none of the RCTs were powered to answer age-specific, or sex-specific questions about the relative risk of dying from lung cancer associated with invitation to screening. We agree with the conclusion that the evidence is sufficient for broadening the age eligibility criteria for lung cancer screening from starting at age 55 to age 50. We also wish to add that our guideline presently is being updated, and in the interim, we have taken down our 2013 (with a small modification in 2018) lung cancer screening guideline, which is represented in the PDM. In the interim, we state:

Changing the Stopping Age from 77 years to 80 years

As noted above the PDM emphasizes that the evidence review focuses entirely on the RCTs as the basis for the NCD, and given that none of the RCTs included adults over age 76 at the time of entry, and the absence of additional empirical evidence, CMS finds a lack of sufficient empirical evidence for adults over age 77 to extend coverage to age 80.

We disagree with the decision to not extend coverage for LDCT screening to age 80. The USPSTF’s recommendation to continue screening to age 80 is based on favorable results from predictive models that informed the recommendation statements in 2013 and 2021. Given that the median age of lung cancer incidence is age 70, and nearly 27% of all incident lung cancers are diagnosed in adults ages 75-84, the three (or four) years from ages 77-80 are years of considerable disease burden from lung cancer,⁵ and approximately 8% of adults currently eligible for lung cancer screening are ages 75-80.⁶ Early lung cancer screening guidelines adopted the NLST study entry eligibility criteria, and did not recommend lung cancer screening after age 74. The original CMS coverage decision chose to extend eligibility for screening to age 77, since an adult who entered the trial at age 74 would have been 77 at the end of the trial and would have contributed evidence from ages 74-77 to the outcome. Thus, we believe CMS made the right decision to include eligibility to age 77. However, until recently, guidelines and recommendations for lung cancer screening had three different stopping ages (74, 77, and 80), which very likely was bewildering to clinicians, the at-risk target group, and anyone else who noticed.

We want to emphasize that although the PDM is correct in asserting that there is a lack of empirical evidence on outcomes associated with LDCT screening in adults ages 78-80, it is reasonable to infer that the outcome would be similar in healthy adults who were undergoing lung cancer screening at age 77. Second, more than one modeling study supports LDCT screening up to age 80 in qualifying adults.^{7, 8} Third, it is a safe assumption that there will not be another LDCT lung cancer screening trial, and there especially would not be one only focused on adults older than age 77. Thus, the only data that will be available are modeling data, and observational data from adults ages 78-80 undergoing screening. CMS has not described whether any future non-RCT data could lead to a modification of the age to stop screening. Since the USPSTF and other organizations have been persuaded by both inferential evidence and modeling that extending screening to age 80 is effective and efficient, we believe CMS should likewise feel confident to add three additional years to screening coverage. SEER data reveals rising risk of lung cancer in this age group, and it also is clear that there are adults in this age group in reasonably good health with significant expected longevity.

Some of these adults older than 77 may never have undergone lung cancer screening, and some may have undergone screening and may lose coverage at a time when risk is still rising. We feel it also would be forward thinking to adopt a common stopping age to minimize confusion, and avoid unnecessarily causing confusion related why organizations differ in their recommendations. Finally, CMS does have the opportunity to monitor whether clinicians who refer adults 78-80 to LCS are doing so responsibly, and also to gather empirical evidence to measure the degree to which there is concordance with empirical findings and modeling estimates. We expect CMS would find organizational partners willing to collaborate in a prospective study that evaluates the experience of LDCT screening in adults ages 78-80, or more formally, CMS could conduct coverage with evidence development.

Lowering Pack-Year Smoking History From 30 Pack-Years to 20 Pack-Years

We agree with the PDM to lower the qualifying pack year history from 30 years to 20 years. The RCT data show that screening is beneficial in adults with 20+ pack year histories, and observational studies of minority groups in the US also shows elevated lung cancer risk at younger ages and with lighter than 30 pack year histories of smoking.^4,9

Maintaining Quit Smoking History at Quitting Within Past 15 Years

Eligibility criteria for LDCT screening includes years since quit, presently set at 15 years (YSQ-15), among adults who formally smoked. Although the NLST established YSQ-15 as an eligibility requirement, it is not clear that the NLST disqualified adults enrolled in the trial who reached that threshold during the trial. No study staff we have spoken with recalls disqualifying a person in the NLST for reaching the YSQ-15 mark. Thus, it may be that current USPSTF recommendations to either not qualify for LCS if YSQ exceeds 15 years, or if an adult has initiated LCS, to no longer be eligible once YSQ exceeds 15 years, are not based on empirical evidence. Although the PDM bases the decision to retain the 15 YSQ criteria due to the lack of NLST lung cancer mortality data from persons who had quit beyond 15 years, it is possible that the NLST data does, in fact, include some adults who continued screening past YSQ-15. The absence of RCT data, and current LCS data on adults with greater than YSQ-15 simply is due to arbitrary RCT study decisions and current coverage decisions. Indeed, Pinsky, et al. stated in 2015 that “…no direct evidence or quantitative risk estimates have been cited to support the 15 year limit.”¹⁰ What is empirically evident is rising lung cancer risk after YSQ-15 in adults who formally smoked associated with increasing age, and these observations also are supported by modeling data, along with estimates of a favorable benefit from LCS.

In our response to the proposed reconsideration of the national coverage determination, we cited studies that had observed rising lung cancer risk associated with increasing age in adults who formerly quit smoking. We draw your attention to several publications (there are others), each revealing a well-documented pattern of reduced lung cancer risk in adults from the age of quitting compared with adults who continued smoking, reinforcing the value of quitting smoking at any age. However, each of these studies revealed significant enduring risk in adults who formally smoked compared with adults who never smoked, and similar risk after 15 years compared with adults who quit within 15 years.

• Halpern and colleagues examined the absolute risk of lung cancer death following smoking cessation as a function of age at cessation.¹¹ They observed similar patterns of lung cancer death at all ages of cessation up until the mid-60s, meaning depending on quit age, an adult with the same risk of lung cancer death would be disqualified from screening compared with an adult who could continue screening if they had a later quit age. The investigators also observed that this leveling off of risk to the risk obtained at the quit age did not remain level but rose sharply after age 75. 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 current criteria they would no longer be eligible for coverage for lung cancer screening. If they quit at age 60, they would cease to be eligible at age 75 at a time when their lung cancer risk was rising.
• Pinsky, et al. examined lung cancer risk as a function of time since quit in adults with 30+ pack-year histories from the National Cancer Institute’s PLCO study. Compared with adults with years since quit (YSQ) of 15 years, lung cancer incidence was only 20 percent lower in adults with YSQ of 30 years (38.5 vs. 30 per 1,000).10
• Tindle, et al. utilized Framingham Heart Study data to examine lung cancer risk in adults who formally smoked and were 25+ YSQ. They observed at 25 YSQ, lung cancer risk remained more than three times greater compared with adults who never smoked. In this cohort, they also observed that 40 percent of lung cancers that occur in adults who formally smoked occur in adults with > 15 YSQ.¹²

We also note that in the modeling conducted for the Task Force, program protocols with varying YSQ were evaluated and programs with YSQ of 20 & 25 years were among the 20-pack year recommended consensus scenarios (Table 1 in the 2021 modeling report),¹³ with a 25 YSQ eligibility resulting in a 11% improvement in lung cancer deaths averted for 100,000 population. Just as it has become clear that the NLST age and pack-year history was overly restrictive with respect to risk and lung cancer screening eligibility, it also appears that ending eligibility at 15 YSQ should be reconsidered since it does not reliably identify a group that is no longer at high risk for lung cancer. We strongly urge CMS to not accept YSQ-15 simply because it was an eligibility criteria in the NLST. This includes the contribution of YSQ-15 as a qualifying criteria for LCS at age 50, and the age at which an adult with a 20+ pack-year history, which the Framingham Heart Study labeled as a “heavy” smoking history, would lose eligibility to continue screening because they had exceeded YSQ-15. CMS should examine the literature on risk of lung cancer in the context of smoking history and rising age, and determine whether strict adherence to YSQ-15 may have the unintended consequence of disqualifying adults from eligibility when their risk of lung cancer is equal to and rising within the age range of adults who do qualify for screening due to a different pattern of smoking and YSQ.

Counseling and Shared Decision Making

Since the original coverage decision, there has been considerable discussion about the degree to which the CMS requirements associated with referral to LDCT screening were overly burdensome, a disincentive to referral, and a factor in low screening rates.^14-17 The published literature does not provide much granular evidence to support these complaints, but it is nonetheless true that primary care clinicians face insurmountable demands on their time, and thus any new requirements may seem overly burdensome, unachievable, and may contribute to delays in initiating the routines required for identifying patients, having discussions, and referring eligible patients to LDCT screening. However, it also may be the case that labeling counseling discussion as “shared decision making” gives the impression that lung cancer screening is different, for example, than breast and colorectal cancer screening, and that it shares more in common with prostate cancer, where the balance of benefits and harms is uncertain and preferent sensitive on an individual level. A good measure of whether a screening test has that status is a “C” rating from the USPSTF, which is the current rating for prostate cancer screening. The USPSTF has given lung cancer screening a “B” rating; thus, lung cancer screening is recommended, and as is the case for other screening tests, all organizations endorse the importance of informing adults about the test, benefits and limitations, and what to expect from regular screening. Organizations that issue recommendations and guidelines recommend lung cancer screening, whereas the primary recommendation for prostate cancer is shared decision making. Recommending lung cancer screening does not imply that an individual can choose not to undergo screening, and in fact, after a discussion some (not many) individuals chose not to undergo screening, similar to other cancer screening tests. At this time, it also is the case that lung cancer screening is not a quality measure, and until health systems measure screening uptake (not “did you have a discussion”), there may be a disincentive to put time into lung cancer screening relative to services that are tracked as performance measures. The ACS-NLCRT is working with NCQA to initiate the development of a lung cancer screening HEDIS measure, which based on past experience, should contribute to greater engagement in referring eligible adults to screening.

We agree with CMS that LCS is no longer new, and that the experience since 2015 provides confidence that some changes can be made in the counseling and referral process. We also recommend that CMS amend the language for the counseling discussion and emphasize informed decision making rather than shared decision making.

With respect to the requirements for pre-referral in the original coverage decision regarding counseling and shared decision-making:

• We agree with the PDM to (1) remove the specificity regarding the type of provider who must furnish the counseling and shared decision-making, and (2) to simplify the process by removing some of the specificity for documentation of the information on beneficiary eligibility criteria.
• We agree that providers should use a decision aid, since use of decision aids can increase efficiency and ensure that key information is communicated and not overlooked. The ACS-National Lung Cancer Roundtable is collaborating with the American Academy of Family Physicians on the development of second-generation decision aids that will be efficient, address the key information elements on benefits, limitations, and potential harms, and can be delivered within the time of the average visit. We also believe that they key information elements that CMS would like to be included in counseling should be included in any well-designed decision aid.
• We agree with the importance of informing patients of the importance of adherence to annual screening, the impact of comorbidities, and ability and willingness to undergo diagnosis and treatment if the LCS test is positive. Again, any well designed decision aid should include these elements.
• We strongly agree that smoking cessation interventions should be offered to adults who currently smoke during the shared decision making visit, and more broadly within the “screening program.” Smoking cessation messages are important and it is not problematic if patients hear these messages from multiple sources. Although the PDM does not say which practice setting is the most logical for smoking cessation to be managed, it likely will be better managed in clinical settings other than the imaging facility.
• We agree with the decision to remove the requirement for a written (specifically) order for initial and subsequent LCS. This makes sense since it is time consuming and an order can be achieved more efficiently and consistent with other orders that are transmitted electronically.

When CMS reached a decision to provide coverage for LCS to Medicare beneficiaries, there were concerns about the level of quality that could be delivered by imaging facilities across the US, many of which had no experience with lung cancer screening, and downstream harms associated with abnormal findings on screening. At the time, the ACS stressed that the interplay between quality assurance requirements and gaining experience through providing LCS was the key to advancing quality. During this early period, these requirements, which were somewhat similar categorically to some those that exist for mammography screening under the Mammography Quality Standards Act (MQSA), were sensible, as was the additional requirement for a national registry to track the uptake and outcomes of LCS. The uptake of LCS has been slow, but is accelerating, and the new guidelines have nearly doubled the size of the target population. These initial requirements are no less important, and perhaps are more important, today. Even with MQSA, quality indicators of various aspects of mammography screening show considerable variability, and poor quality has a measurable impact on performance outcomes, resulting in harms and missed opportunities to avert avoidable morbidity and mortality. If anything, quality standards should be strengthened much in the way the UK breast cancer screening program establishes progressively higher quality benchmarks as a facility’s performance improves.

Our comments below reflect our concern that it is too soon to withdraw these requirements, and we fear that doing so will likely undo much of the progress that has been made since the first national coverage determination.

Reading Radiologist Training and Eligibility Criteria

We agree with the decision to modify the reading radiologist eligibility criteria by removing the training documentation requirement. As noted, training is basic and also included in maintenance of certification (MOC).

We disagree with the decision to eliminate the reading radiologist eligibility criteria by removing the 300 chest CT acquisitions in 3 years requirement. The PDM argues that if the American Board of Radiology does not require any further training beyond residency, it must not be necessary. This is not a compelling argument, especially for imaging screening tests vs. diagnostic and interventional procedures. No evidence is provided that a newly board certified radiologist is prepared to accurately interpret LCS exams. Training during residency is highly variable, may or may not have included LCS, and a section on LCS may have occurred at any point in the residency training. The PDM also does not mention the degree to which LCS is included on the Board exam, and whether poor performance on the LCS section can be a reason for failing the Board exam. The PDM cites the absence of any screening guideline/recommendation specifying a specific number of LDCT readings, but this would be unprecedented and also is outside of the purview of screening guideline development, and we also note that the PDM stops short of claiming that such a recommendation would be a persuasive basis for retaining the requirement.

There is a growing body of evidence showing a high degree of variability in LDCT interpretive ability and highly variable screening outcomes in different institutions, some of which is due to individual experience and ability, different usage of computer-assisted systems, and other factors.^18-21 Requiring 300 chest CT acquisitions within 3 years is an arbitrary number, not a particularly demanding volume over 3 years, may be valuable to introduce a radiologist to some of the challenges of interpreting LDCT lung screening exams in asymptomatic adults, but probably would be more valuable if the 300 exams were interpreted from a well-designed training set. The simple requirement that a reading radiologist have some exposure to reading LCS exams prior as a basis for eligibility sends a clear signal that the reading radiologist should have some prior exposure to screening images, ideally accompanied by mentoring regarding factors that contribute to missed lesions and avoidable recalls.

We do not understand the logic for retention of eligibility criterion that the reading radiologist must have documented participation in continuing medical education in accordance with current American College of Radiology standards. Unlike MQSA, which requires a specific number of hours of mammography related CME every 3 years, the PDM does not specify any requirement for CME specific to LCS within the 75 CME credits required for Maintenance of Certification (MOC), only that CMS receive the documentation of participating in CME that the radiologist would also submit to the ACR and ABR. Wouldn’t submission of evidence that MOC requirements has been satisfied, or the receipt of board recertification be simpler and in keeping of the requirement that the reading radiologist be board certified or board eligible?

Low Dose CT Lung Cancer Screening Imaging Facilities: Lung Nodule Reporting System

We are strongly opposed to the PDM proposal to remove the radiology imaging facility eligibility criteria for utilizing a standardized lung nodule identification, classification and reporting system.

Reporting systems became a standard of care with the introduction of the Breast Imaging Reporting and Data System (BI-RADS), and the standard has led to subsequent imaging reporting systems taking the same format (i.e., specific organ—RADS). BI-RADS was established because free-form reporting not only was confusing to referring physicians and patients, but the lack of a standard resulted in failure to consistently report findings consistently and completely, and of particular importance, the lack of clear specification of next steps based on the findings. Lung-RADS is a complete reporting system because it not only provides a finding that is an indicator of risk, but also what should happen next and the time frame. Given that these next steps are driven by evidence, a common structured reporting system results in improved outcomes, and in the case of LDCT screening, a measurably reduced recall rate. We should not overlook the advantage and importance of a standard measurement tool for outcome data which contributes to evaluation; this is essential for on-going evaluation of LDCT screening, and has served us in this regard in the published literature and in the ACR-Lung Cancer Screening Registry. The PDM appears to emphasize that the requirement that facilities qualify for eligibility by using a structured reporting system, i.e., generally Lung-RADS, is not necessary since so many professional organizations emphasize using a structured reporting system, “such as Lung-RADS.” It is our opinion that any relaxing of this standard will open Pandora’s Box. It will open the door to home-grown reporting systems, entrepreneurial efforts by competing groups, and the gains that have been made by everyone using a common system that is periodically updated based on new evidence will be undermined. We believe CMS should take credit for the contribution of requiring a common standard for communication of results and next steps for patient management. It has been very important. We implore CMS to not turn back the clock.

Low Dose CT Lung Cancer Screening Imaging Facilities: Smoking Cessation

We agree with removing the responsibility of the imaging facility to provide smoking cessation interventions. We refer to our comments above regarding smoking cessation.

Low Dose CT Lung Cancer Screening Registry

We are strongly opposed to removing the radiology imaging facility eligibility criteria for collecting and submitting data to a CMS approved LDCT lung cancer screening registry along with the minimum required data elements. We agree with the original intent of the registry as outlined in the PDM, i.e., that it will document the degree to which there is adherence to recommended LCS guidelines, and also serve as an aid to those seeking to study the clinical benefits of screening, in particular, the uptake rate of screening. The PDM reports the results of several studies and then concludes, “We believe the results of the three studies fulfill the purpose of the LDCT lung cancer screening registry, which is to study the clinical benefit of low dose CT screening.” We feel it is more appropriate to state that rather than fulfilling the purpose, the studies reinforce the purpose of the registry. The ACS has collaborated with the ACR and used the facility data for GIS analysis,^22,23 and the ACR-LCSR data to measure state-based patterns of lung cancer screening.^24-26

At this time, the ACR-LCSR is the only nationwide source of near-time data on lung cancer screening in the U.S. The CDC-NHIS survey is only conducted every 5 years, and the CDC-BRFSS will begin collecting data on recent screening in 2022, with data unavailable to late 2023. Each of these surveys are self-reported data on recent screening. The ACR-LCSR data allow organizations like the ACS-NLCRT, which is supporting state-based lung cancer initiatives, to have near-time data on the number of screening exams taking place in the state. Using census data, it allows us to estimate a recent screening rate to inform state-based initiatives, and gain some insight into the demographic groups that are undergoing screening. It is an important asset, and as we noted before, at a time when the introduction of lung cancer screening is in its infancy, this data tool provides us with a clear picture of what is taking place at the state level and in different subgroups of the at-risk population. This data are very important to identify opportunities for applied interventions. We do not believe that 3 studies satisfy the original purpose of the registry, nor that the ACR not mentioning the LCSR in their comments is an indicator of indifference to its value. We request that CMS reverse this decision and leave the registry requirement in place.

We also feel that an important opportunity for utilizing the registry data is for facility and individual reading radiologist improvement. Just as MQSA stresses the importance of regular review of outcomes and providing feedback on individual performance, at this early point in the uptake of lung cancer screening by both health professionals and the target groups, feedback on performance is critically important for measuring quality and gaining insights into improving quality.

Conclusion

The ACS and ACS CAN appreciate the opportunity to provide comments on the Proposed Decision Memo (PDM) for Screening for lung cancer with low dose computed tomography. It is our opinion that CMS’ decision to provide LCS to Medicare beneficiaries conditional on reading radiologists and imaging facilities meeting specific quality assurance and reporting requirements was a bold move that has enabled the initiation of lung cancer screening in a manner that protected patients and set some clear parameters for best practices. In the absence of a national system that would automatically set standards broadly to safeguard the quality of care, taking guidance from MQSA and the ACR mammography accreditation program to issue standards as a condition of reimbursement has led to an orderly and higher quality initiation of nationwide lung cancer screening that could have been expected in the absence of these standards. The ACS-NLCRT has organized over 170 organizations with interests in lung cancer control, and over 200 national experts in lung cancer to address similar and other needs focused tobacco control, screening, diagnosis, and treatment. Screening has been described as a cascade of events, or links in a chain, and using either analogy the imagery is clear….failure at any one point can undo the good that was done up that point, and arrest the ability to move forward to complete the process. In our opinion, some of the changes proposed in the PDM are sensible, based on the first five years of experience, but others leave us very concerned that the guardrails that CMS put in place to promote safe, high quality screening are being taken down prematurely. Where we have disagreed with the PDM, we strongly urge CMS to reconsider their decision.

Sincerely,

/filed electronically/
Robert A Smith, PhD
Senior Vice President, Cancer Screening
American Cancer Society

References
1. American Cancer Society. American Cancer Society Facts and Figures 2021. Atlanta: American Cancer Society, 2021:1-72.
2. Centers for Medicare and Medicaid Services. Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N) Available from URL: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274 [accessed April 16, 2021].
3. Krist AH, Davidson KW, Mangione CM, et al. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021;325: 962-970.
4. Landy R, Young CD, Skarzynski M, et al. Using Prediction-Models to Reduce Persistent Racial/Ethnic Disparities in Draft 2020 USPSTF Lung-Cancer Screening Guidelines. J Natl Cancer Inst. 2021.
5. National Cancer Institute. Surveillance, Epidemiology, and End Results (SEER) Program. Available from URL: https://seer.cancer.gov/statfacts/html/lungb.html [accessed December 10, 2021].
6. National Center for Health Statistics. Data File Documentation, National Health Interview Survey, 2015. . Hyattsville, Maryland: National Center for Health Statistics, Centers for Disease Control and Prevention, 2015.
7. Meza R, Jeon J, Toumazis I, et al. Evaluation of the Benefits and Harms of Lung Cancer Screening With Low-Dose Computed Tomography: Modeling Study for the US Preventive Services Task Force. JAMA. 2021;325: 988-997.
8. Tammemagi MC, Church TR, Hocking WG, et al. 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. 2014;11: e1001764.
9. Pasquinelli MM, Tammemagi MC, Kovitz KL, et al. Risk Prediction Model Versus United States Preventive Services Task Force Lung Cancer Screening Eligibility Criteria: Reducing Race Disparities. J Thorac Oncol. 2020;15: 1738-1747.
10. Pinsky PF, Zhu CS, Kramer BS. Lung cancer risk by years since quitting in 30+ pack year smokers. J Med Screen. 2015;22: 151-157.
11. Halpern MT, Gillespie BW, Warner KE. Patterns of absolute risk of lung cancer mortality in former smokers. J Natl Cancer Inst. 1993;85: 457-464.
12. Tindle HA, Stevenson Duncan M, Greevy RA, et al. Lifetime Smoking History and Risk of Lung Cancer: Results From the Framingham Heart Study. J Natl Cancer Inst. 2018.
13. Meza R, Jeon J, Toumazis I, et al. Evaluation of the Benefits and Harms of Lung Cancer Screening With Low-Dose Computed Tomography: A Collaborative Modeling Study for the U.S. Preventive Services Task Force. Rockville (MD), 2021.
14. Wang GX, Baggett TP, Pandharipande PV, et al. Barriers to Lung Cancer Screening Engagement from the Patient and Provider Perspective. Radiology. 2019;290: 278-287.
15. Melzer AC, Golden SE, Ono SS, Datta S, Triplette M, Slatore CG. "We Just Never Have Enough Time": Clinician Views of Lung Cancer Screening Processes and Implementation. Ann Am Thorac Soc. 2020.
16. Lam S, Tammemagi M. Contemporary issues in the implementation of lung cancer screening. Eur Respir Rev. 2021;30.
17. Coughlin JM, Zang Y, Terranella S, et al. Understanding barriers to lung cancer screening in primary care. J Thorac Dis. 2020;12: 2536-2544.
18. Han D, Heuvelmans MA, Vliegenthart R, et al. Influence of lung nodule margin on volume- and diameter-based reader variability in CT lung cancer screening. Br J Radiol. 2018;91: 20170405.
19. van Riel SJ, Jacobs C, Scholten ET, et al. Observer variability for Lung-RADS categorisation of lung cancer screening CTs: impact on patient management. Eur Radiol. 2019;29: 924-931.
20. Hwang EJ, Goo JM, Kim HY, et al. Variability in interpretation of low-dose chest CT using computerized assessment in a nationwide lung cancer screening program: comparison of prospective reading at individual institutions and retrospective central reading. Eur Radiol. 2021;31: 2845-2855.
21. Del Ciello A, Franchi P, Contegiacomo A, Cicchetti G, Bonomo L, Larici AR. Missed lung cancer: when, where, and why? Diagn Interv Radiol. 2017;23: 118-126.
22. Sineshaw HM, Sahar L, Osarogiagbon RU, Flanders WD, Yabroff KR, Jemal A. County-Level Variations in Receipt of Surgery for Early-Stage Non-small Cell Lung Cancer in the United States. Chest. 2020;157: 212-222.
23. Sahar L, Douangchai Wills VL, Liu KK, Kazerooni EA, Dyer DS, Smith RA. Using Geospatial Analysis to Evaluate Access to Lung Cancer Screening in the United States. Chest. 2021;159: 833-844.
24. Fedewa SA, Kazerooni EA, Studts JL, et al. State Variation in Low-Dose Computed Tomography Scanning for Lung Cancer Screening in the United States. J Natl Cancer Inst. 2021;113: 1044-1052.
25. Fedewa SA, Bandi P, Smith RA, Silvestri GA, Jemal A. Lung Cancer Screening Rates During the COVID-19 Pandemic. Chest. 2021.
26. Lozier JW, Fedewa SA, Smith RA, Silvestri GA. Lung Cancer Screening Eligibility and Screening Patterns Among Black and White Adults in the United States. JAMA Netw Open. 2021;4: e2130350.

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I have worked with the low-dose computed tomography (LDCT) screening program since 2015. I would ask you to please consider the following changes in the program.

1. Please lower the screening age to 50 years and the smoking history to 20 pack-years for the Medicare population. I have had to turn people away who had significant risk. Please mirror the National Comprehensive Cancer Network (NCCN) guidelines. We have found cancers in this group.
2. Consider raising the upper age limit of 77 years to 80. We have also found cancers in this age group and care for the cancer at this stage is easier on the patient and less expensive.
3. Please revise the "Counseling and Shared Decision Making" as currently written it is a barrier to screening. Offices are doing the counseling but they are not always documenting it and or including it on the orders which holds up care or prevents it.
4. Please allow IDTF Facilities to perform the LDCT screenings.
5. Swift coverage expansion by Medicare and the private insurers is essential. This program is very time intensive and has caused exclusion of the most vulnerable. The expanded coverage would help to address the regional disparities. Waiting for symptoms means lives lost, finding cancer early is saving lives.

These changes will help us to address and strike back at a leading cancer killer by using the screening program to its maximum efficiency. Please help us ease the way of patients and the emotional toll on patients and families.

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Dear Administrator Brooks-LaSure:

Intuitive appreciates the opportunity to submit comments on the Centers for Medicare & Medicaid Services proposed decision memo, expanding beneficiary eligibility and access to low dose CT (LDCT) scans for lung cancer screening. Intuitive, the manufacturer of the da Vinci robotic-assisted surgical system and Ion Endoluminal system, was founded with the goal of developing minimally invasive robotic-assisted technologies that help healthcare providers provide better care to the patients they serve. The da Vinci surgical system is available in all 50 states and 67 countries around the globe. Ion is a robotic assisted platform for minimally invasive biopsy in the lung that enables greater precision. Both da Vinci and Ion have been developed with a mission to improve patient outcomes, cost of treatment, patient experience and provider experience (i.e. the pillars of the Quadruple Aim).

Intuitive supports CMS’s proposed decision memo to expand eligibility for low dose CT scans for lung cancer screening. Our detailed comments follow.

I. We support CMS’ alignment with the updated United States Preventative Service Taskforce (USPSTF) recommendation.

• We support increasing screening eligibility to individuals with 20 pack years of smoking history from those with 30 pack years of smoking history as screening should be offered to individuals at high risk for lung cancer, which is largely defined based on tobacco use history, currently one of the dominant criteria for patient selection.¹ This change will increase early identification of lung cancer and allow for earlier intervention resulting in improved survival.
• Additionally, we support changing individual eligibility for LDCT scans from 55 to 50 years of age. This enables expansion for screening in persons who have enrolled in Medicare early, due to disability or ESRD thereby providing a similar opportunity for early cancer identification.

II. We strongly support CMS’s operational recommendations to increase patient access to screening with LDCT scans, specifically:

• Elimination of the radiology imaging facility criteria removes current barriers for facilities who have staff and technology available but lack the manpower or processes for mandatory participation in a registry.
• A written order given to the patient leaves the decision to move forward in their hands whereas an electronic order is more likely to generate patient follow-up for scheduling and care coordination, thus improving overall patient compliance.
• Covid-19 has augmented the already high levels of stress and burnout in the medical profession. The allowance for non-physician practitioners to perform shared decision-making visits eases the burden on physicians and expands the pool of capable individuals to counsel eligible beneficiaries on compliance with screening and smoking cessation.
• Inclusion of Independent Diagnostic Treatment Facilities (IDTFs) as places of service where a LDCT scan can be performed directly impacts inequities to access screening today, especially since IDTFs can be mobile. This enables beneficiaries without access to transportation to have greater accessibility to screening sites. Additionally, LDCT scans for lung screening aligns to other diagnostic imaging services performed by IDTFs today.²

III. We urge CMS to consider ways to address the following additional barriers which may impact patient access to lung cancer screening, via LDCT scans, and to be considered in future rulemaking.

• Lack of Primary Care Physician (PCP) engagement: Understanding why PCPs aren’t utilizing LDCT scans for lung cancer screening may help to shape future policy, similar to the recent implementation of curtailed patient co-insurance for screening to diagnostic colonoscopy in a single encounter.³ Coughlin et al surveyed PCPs to understand provider knowledge of LDCT screening criteria, screening practices and barriers to utilization. Results indicated failure of EMRs to notify providers of eligible patients, patient refusal and perceived high false-positive rate leading to unnecessary procedures as the leading reasons for lack of PCP engagement to refer patients for a LDCT scan.⁴ Education, awareness, and EMR system capture should be evaluated to prompt and optimize PCP awareness and engagement in patient eligibility.
• Lack of Patient Engagement: Patients receiving a positive result from their LDCT scan that leads to a follow-up medical encounter (i.e, additional CT scan or a biopsy) can expect to incur an out-of-pocket expense, which may contribute to patient reluctance or poor compliance given the perceived financial burden. Zheng et al completed a large retrospective cohort study of patients receiving a diagnostic biopsy and concluded that the median out of pocket cost for a patient receiving any type of biopsy is $600.^5,6 The impact of out-of-pocket costs on patient reluctance or adherence to screening given the anticipation of financial burden for a follow-up medical encounter should be further understood.

In summary, a patient has a better prognosis if lung cancer is detected, diagnosed and aggressively treated early versus in late stages. Advancements in CT technology, dosing protocols and reporting in the past 10 years have increased accuracy and lessened patient exposure to radiation. Incorporating the proposed decision memo into the current NCD allows for expanded patient access and a more streamlined referral and screening process. As compared to other screening protocols, LDCT scans require no patient self-prep, are non-invasive and require minimal time investment by the patient. Despite this, adherence on behalf of PCPs and patients remain low. We encourage continued dialogue on investigation and considerations to help inform future policy that would lead to further increased PCP and patient engagement.

Intuitive appreciates the opportunity to comment on this proposed decision memo. We hope our comments are useful to CMS when finalizing the NCD reconsideration. We would be pleased to answer any questions regarding these comments. Please contact me or Betsy Gross, Head of Global Health Policy & Reimbursement at betsy.gross@intusurg.com for further discussion or assistance.

Respectfully,

Myriam J. Curet, MD, FACS
Executive Vice President and Chief Medical Officer
Myriam.curet@intusurg.com
(408) 523-2499

References:

1Douglas Arenberg, MD; Update on screening for lung cancer; Transl Lung Cancer Res 2019;8(Suppl I):S77-S87 http://dx.doi.org/10.21037/tlcr.2019.03.01
2https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ICN909060-IDTF-Fact-Sheet.pdf
3federalregister.gov/d/2021-24011, page 674-684
4Couglin et al; Understanding barriers to lung cancer screening in primary care J Thorac Dis 2020;12(5):2536-2544 http://dx.doi.org/10.21037/jtd.2020.03.66
5Yong, et al; Lung Cancer Screening Uptake in the United States; Chest. 2020 Jan; 157(1): 236–238. https://linkinghub.elsevier.com/retrieve/pii/S0012369219337286
6Feibi Zheng, James Lavin & J. Michael Sprafka (2021) Patient out-of-pocket costs for suspicious pulmonary nodule biopsy in lung cancer patients, Journal of Medical Economics, 24:1, 1173-1177, DOI: 10.1080/13696998.2021.1988282

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To: The Coverage and Analysis Group
December 17, 2021

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

I write in support of the expanded eligibility criteria for LDCT screening as the agency has proposed, but on several fronts I would recommend caution against changing other elements of the established criteria.

Retain the Registry requirement

CMS should keep in place the lung cancer screening registry, rather than eliminate it as the agency has proposed. The agency itself notes how central the lung screening registry has been to understanding the mismatch between LDCT screening and the burden of lung cancer regionally. It has been equally valuable in documenting overall low rates of uptake and annual return visits. Systems can only be improved if they are monitored. Absent empirical evidence that the registry impedes uptake more than it helps ensure ongoing understanding of utilization, CMS should leave it in place.

Retain the documentation requirement in the SDM visit

CMS is wise to expand the number of providers who can deliver shared decision making (SDM). But, if anything, it should further specify what is needed to deliver the service in a way that aids individuals who are eligible for screening. The rationale that SDM is now an established practice runs counter to published data estimating that SDM is rarely delivered prior to LDCT screening (Shih et al, MDM Policy Pract 2021).

Given that SDM is still a new service that is not widely used, the agency should recognize the substantial risk associated with a decision to lift the documentation of eligibility requirements. The features that make an individual eligible for screening – age and smoking history most importantly – are the same features that enable the type of individual level risk assessment that is a cornerstone of risk-benefit determination for LDCT screening and thus the central element of an SDM visit. Moreover, there are very substantial efforts currently underway that aim to identify and validate biomarkers that could further refine estimation of individual lung cancer risk in service of determining who is most likely to benefit from an LDCT scan. If these efforts are successful, one could anticipate that future SDM visits would be even better informed and more individualized.

CMS should seek a rationale for lifting the 15 years or less of quitting limitation on screening:

I appreciate that the agency may be hemmed in on its ability to broaden eligibility beyond the group recommended for screening by the USPSTF. But it seems worth noting that the years of quitting limitation is not objectively workable in clinical practice nor sensible from an epidemiologic perspective. The only rationale for this limit would be if lung cancer risk declined after a certain period of time after an individual has quit smoking. Unfortunately, studies examining this question have demonstrated instead that the risk of lung cancer continues to rise in individuals who have quit smoking, albeit at far lower rates than seen among individuals who continue to smoke (Bach et al. J Natl Cancer Inst 2003).

Peter B. Bach, MD
Chief Medical Officer, Delfi Diagnostics, Baltimore, MD
Attending Physician, Memorial Sloan Kettering Cancer Center, NY, NY.

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December 17, 2021

Tamara Syrek Jensen, JD
Director
Coverage and Analysis Group
Center for Medicare & Medicaid Services

Re: Reconsideration—Proposed National Coverage Determination for Lung Cancer Screening with Low Dose Computed Tomography (LDCT)

Dear Ms. Syrek Jensen:

As the premier trade association representing the manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound devices, the Medical Imaging & Technology Alliance (MITA) is submitting comments on the proposed National Coverage Determination (NCD) for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT).

The Centers for Medicare & Medicaid Services (CMS) is reconsidering the NCD established at section 210.14 of the Medicare National Coverage Determinations manual and proposes that the evidence is sufficient to expand the eligibility criteria for Medicare beneficiaries receiving low dose computed tomography (LDCT). CMS is proposing to expand eligibility for LDCT when the following criteria are met:

• Beneficiary eligibility criteria:
  • Age 50 – 77 years;
  • Asymptomatic (no signs or symptoms of lung cancer);
  • Tobacco smoking history of at least 20 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes);
  • Current smoker or one who has quit smoking within the last 15 years; and
  • Receive an order for lung cancer screening with LDCT.
• Before the beneficiary’s first lung cancer LDCT screening, the beneficiary must receive a counseling and shared decision-making visit that meets all of the following criteria, and is appropriately documented in the beneficiary’s medical records:
  • Determination of beneficiary eligibility;
  • Shared decision-making, including the use of one or more decision aids;
  • Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment; and
  • Counseling on the importance of maintaining cigarette smoking abstinence if former smoker; or the importance of smoking cessation if current smoker and, if appropriate, furnishing of information about tobacco cessation interventions.
• Reading radiologist eligibility criteria:
  • Board certification or board eligibility with the American Board of Radiology or equivalent organization; and
  • Documented participation in continuing medical education in accordance with current American College of Radiology standards.

Lung cancer is the leading cause of cancer death among American men and women.¹ For this reason, MITA supports increased access to lung cancer screening programs that detect the disease earlier, when it is more treatable. Screening programs are important in reducing mortality and disease burden.

The proposed expanded eligibility criteria largely track with the final recommendation statement issued on March 9, 2021, by the United States Preventive Services Task Force (USPSTF) in which the Task Force recommended “annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years.” The Task Force further recommended that screening should “be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.” This updated recommendation statement appropriately expands on the previous USPSTF recommendation for “annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years.”²

We are concerned, however, about potentially arbitrary limitations on the eligible population in the proposed CMS NCD and USPSTF final recommendation statement. MITA strongly recommends that CMS not adopt the smoking cessation quit date and that the upper age limit cut-off be removed. These eligibility constraints do not align with current National Comprehensive Cancer Network (NCCN) lung cancer screening guidelines.³ Currently, NCCN recommends lung cancer screening for two groups of high-risk patients:

• Group 1:
  • Age 55 to 77 years
  • 30 or more pack years of smoking and has quit within the past 14 years
  • Current smoker
• Group 2:
  • 50 years of age or older
  • 20 or more pack years of smoking
  • Other risk factors (other than second-hand smoker)

MITA strongly recommends that CMS adopt eligibility criteria in line with those prescribed by NCCN.

Although CMS has streamlined some of the requirements, we are also concerned that maintaining shared decision-making requirements would create undue barriers to access for Medicare beneficiaries. Lung cancer screening rates for the eligible population remain abysmally low, arguing in favor of lowering barriers to access.⁴ CMS does not require shared decision-making for other screening services, such as screening mammography and colonoscopy. Application to lung cancer screening is arbitrary and unnecessarily burdensome on patients and providers. We believe that the decision to screen for lung cancer should be left to a patient and their physician who best understand the individual patient’s personal health history and overall health status. Shared decision-making should not be a requirement for CMS coverage.

MITA fully supports a robust quality program for lung cancer screening. Currently, registries are a cornerstone of ensuring quality and a requirement for facilities providing lung cancer screening to Medicare beneficiaries. As it is reconsidering this NCD, CMS should explore additional routes to promote quality in addition to or in lieu of registries.

MITA welcomes this opportunity to comment on the lung cancer screening proposed NCD. Please contact Peter Weems, Senior Director, Policy & Strategic Operations, at pweems@medicalimaging.org or (703) 841-3238 if MITA can be of any assistance.

Sincerely,

Patrick Hope
Executive Director, MITA

MITA is the collective voice of manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging innovations. These products include: magnetic resonance imaging (MRI), medical X-Ray equipment, computed tomography (CT) scanners, ultrasound, nuclear imaging, radiopharmaceuticals, and imaging information systems. MITA Member company technologies are an important part of our nation’s healthcare infrastructure and are essential for the screening, diagnosis, staging, managing and effectively treating patients with cancer, heart disease, neurological degeneration, and numerous other medical conditions.

1 https://www.cdc.gov/cancer/lung/statistics/index.htm
2 https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/lung-cancer-screening
3 https://jnccn.org/view/journals/jnccn/16/4/article-p412.xml?rskey=yXhRT1&result=1
4 https://acpinternist.org/weekly/archives/2020/06/23/5.htm

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December 17, 2021

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Reconsideration—Proposed National Coverage Determination for Lung Cancer Screening with Low Dose Computed Tomography (LDCT)

Dear Ms. Syrek Jensen,

On behalf of the Alliance of Dedicated Cancer Centers (“ADCC”), I am pleased to submit comments on the Centers for Medicare and Medicaid Services (CMS) proposed National Coverage Decision regarding “Screening for Lung Cancer with Low Dose Computed Tomography (LDCT).” Lung cancer is the leading cause of cancer death among both men and women. As you are aware, early detection of lung cancer significantly prolongs and saves lives. We are appreciative that the agency is attending to this important issue.

ADCC is comprised of the nation’s premier cancer centers focusing exclusively on the care of cancer patients. Dedicated Cancer Centers are at the forefront of innovations in the field of cancer, with a shared singular commitment to discovering and implementing the most effective treatment strategies for patients living with or at risk for cancer. All of our institutions have been designated as Comprehensive Cancer Centers by the National Cancer Institute (“NCI”). NCI-Designated Comprehensive Cancer Centers are recognized for their scientific leadership in laboratory and clinical research as well as diagnosing and treating cancer patients.

We generally support aligning the National Coverage Decision with the US Preventive Services Task Force recommendations for lung cancer screening, and offer recommendations and comments of support below.

Beneficiary Eligibilty Criteria

• We support eliminating the cessation limit. Limiting access to lung cancer screening to active smoking within the last 15 years is a lingering policy from the National Lung Screening Trial (NSLT). Research demonstrates a benefit when the cessation limit is eliminated.
• Allow screening up to 80 years. Most insurers in will cover screening up to 80 years because there is still evidence of cost savings and improved quality of life. We should have the option to continue screening to 80 years if the individual will benefit from the early detection of lung cancer and can tolerate to treatment.
• Expand eligibility to include other high-risk patients. Limiting tobacco smoking history of at least 20 pack-years (one pack-year = smoking one pack per day for one year; one pack = 20 cigarettes) does not take into account patients who smoked less than one pack per day or smoked for less than 20 years, including patients with substantial occupational exposures, such as first responders, who are still at an increased risk of lung cancer.

Additional Comments

• We support the proposal to remove the restriction that the LDCT must be ordered by a physician or non-physician practitioner. There is no provision to require American College of Radiology to mandate any certification or training for radiologists to read LDCT scans which would ensure a high-quality LDCT report.
• We support the proposal to simplify requirements for the counseling and shared decision-making visit. Cancer care is a team effort between the patient, their families, and the entire clinical staff. Facilitating these discussions is critical.

Thank you for your consideration. If you have any questions, please contact Blair Cantfil, counsel to the ADCC (bcantfil@manatt.org).

Sincerely,

Jack Kolosky
Executive Director
Alliance of Dedicated Cancer Centers

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December 16, 2021

On behalf of the Association for the Treatment of Tobacco Use and Dependence (ATTUD), we would like to provide comments regarding the CMS proposed decision for Lung Cancer Screening (LCS).

ATTUD is the leading organization of clinicians involved in treating patients for tobacco use disorder, with over 500 members. Given the national prevalence along with the frequent and deleterious health effects of tobacco product use, predominantly from smoking cigarettes, Tobacco Treatment Specialists are integrated across the healthcare delivery continuum, including lung cancer screening. We agree with and highlight the recommendations by Fucito et. al (2016) on pairing tobacco treatment services with lung cancer screening, since LCS is a teachable moment (SGR on Smoking Cessation, 2020).

We support changing the eligibility based on the evidence for screening patients ages 50 and older who have a 20-pack year history. While some are concerned about over utilization of lung cancer screening services, evidence demonstrates this is not the case. Moreover, with only 12.7% utilization of LCS (Richards et. Al, 2017), a majority of people who meet the qualifying criteria for lung cancer screening do not accrue the benefits of early detection of lung cancer and improved survival, not to mention the benefits of tobacco cessation services at the time of screening.

Using the 2014 USPSTF LCS criteria, 8 million people would qualify for LCS, however the updated USPSTF 2021 expanded the recommendation for LCS eligibility to 50 and older who have a 20-pack year history. We support the current CMS mandate to provide tobacco cessation counseling to LCS enrollees by referring to qualified providers or for LCS programs to provide such services directly (Richards et. al, 2019; USPTFS, 2020). With an estimated 50% of LCS beneficiaries currently smoking at the time of LCS (based on the National Lung Screening Trial experience [Aberle et. al, 2011]), the need for more providers who are equipped to provide tobacco cessation services is on an exponential upward trajectory.

The evidence suggests that 79% of LCS eligible smokers attempt to quit smoking each year compared to 50% in the general population, and participation in lung cancer screening promotes interest and motivation in smoking cessation (Glynn et. al, 2018; Ostroff et. al, 2001; Pineiro et. al, 2016; Quaife, 2020). More importantly, former smokers enrolled in LCS benefit from a 35% to 39% mortality risk reduction over current smokers (longer cessation duration correlated with higher benefit). This represents a 3-5-fold mortality reduction with sustained cessation (Pastorino et. al, 2016). Therefore, wherever possible, LCS programs can benefit from in-house tobacco dependence treatment programs, since a typical quitter can take 20-30 self-quit attempts to achieve long-term abstinence (Borland et. al, 2012; Chaiton et. al, 2016), and Tobacco Treatment Specialists use a longitudinal or chronic treatment model of care (Joseph et. al, 2011).

With the above context, on behalf of ATTUD, its Board of Directors and members, we explicitly recommend against accepting the proposed CMS decision to limit LCS program efforts to provide tobacco treatment, as it currently states: “We propose that it is not appropriate for Medicare beneficiaries to receive smoking cessation interventions for current smokers within the setting of a radiology imaging facility, and that this eligibility criterion be removed from the radiology imaging facility eligibility criteria.” If finalized, we believe this decision will have the opposite effect from what CMS is aiming to achieve, by decreasing access to effective interventions and lowering the frequency that a smoker gets evidence-based tobacco treatment. If finalized, this decision will limit smokers’ exposure to a longitudinal tobacco treatment/s at every point of care including at LCS facilities. Instead, we recommend requiring LCS to provide tobacco treatment options including referrals to primary care providers and utilizing trained and credentialed Tobacco Treatment Specialists to fulfill this need via referrals or internally wherever possible.

Tobacco Treatment Specialists are providers trained to the national competency standards (ATTUD.org) at programs accredited by the Council for Tobacco Treatment Training Programs (CTTTP.org), and therefore provide standardized, evidenced based and effective tobacco treatment.

Respectfully and on behalf of ATTUD members and Board of Directors,

Maher A. Karam Hage, MD
President, Association for the Treatment of Tobacco Use and Dependence (ATTUD)
Director, Area VIII American Academy of Addiction Psychiatry (AAAP)
Professor, Departments of Behavioral Science and Psychiatry
Medical Director, Tobacco Treatment Program

References
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
Borland R, Partos TR, Yong HH, Cummings KM, Hyland A. How much unsuccessful quitting activity is going on among adult smokers? Data from the International Tobacco Control Four Country cohort survey. Addiction. 2012;107(3):673–677
Chaiton M, Diemert L, Cohen JE, et al. Estimating the number of quit attempts it takes to quit smoking successfully in a longitudinal cohort of smokers. BMJ Open. 2016;6(6):e011045.
Fucito LM, Czabafy S, Hendricks PS, Kotsen C, Richardson D, Toll BA; Association for the Treatment of Tobacco Use and Dependence/Society for Research on Nicotine and Tobacco Synergy Committee. Pairing smoking-cessation services with lung cancer screening: a clinical guideline from the Association for the Treatment of Tobacco Use and Dependence and the Society for Research on Nicotine and Tobacco. Cancer. 2016;122(8):1150–1159.
Glynn T, Hurt, R., Westmaas, J. Tobacco. The American Cancer Society's Principles of Oncology: Prevention to Survivorship. First ed. Atlanta, GA: The American Cancer Society; 2018:58-71
Joseph AM, Fu SS, Lindgren B, Rothman AJ, Kodl M, Lando H, Doyle B, Hatsukami D. Chronic disease management for tobacco dependence: a randomized, controlled trial. Archives of internal medicine. 2011;171(21):1894-900. Epub 2011/11/30. doi: 10.1001/archinternmed.2011.500. PubMed PMID: 22123795; PMCID: PMC4110895.
Ostroff JS, Buckshee N, Mancuso CA, Yankelevitz DF, Henschke CI. Smoking cessation following CT screening for early detection of lung cancer. Prev Med,. 2001;33(6):613-621
Pineiro B, Simmons VN, Palmer AM, Correa JB, Brandon TH. Smoking cessation interventions within the context of Low-Dose Computed Tomography lung cancer screening: A systematic review. Lung Cancer. 2016;98:91-98
Pastorino U, Boffi R, Marchiano A, et al. Stopping Smoking Reduces Mortality in Low-Dose Computed Tomography Screening Participants. J Thorac Oncol,. 2016;11(5):693-699
Quaife SL, Ruparel M, Dickson JL, et al. Lung Screen Uptake Trial (LSUT): Randomized Controlled Clinical Trial Testing Targeted Invitation Materials. Am J Respir Crit Care Med,. 2020;201(8):965-975
Richards TB, Soman A, Thomas CC, et al. Screening for Lung Cancer - 10 States, 2017. MMWR Morb Mortal Wkly Rep. 2020;69(8):201-206
Richards TB, Doria-Rose VP, Soman A, et al. Lung Cancer Screening Inconsistent With U.S. Preventive Services Task Force Recommendations. Am J Prev Med,. 2019;56(1):66-73.
Sheffer CE, Payne T, Ostroff JS, Jolicoeur D, Steinberg M, Czabafy S, Foulds J, Bars M, Wassum K, Perry B. Increasing the Quality and Availability of Evidence-based Treatment for Tobacco Dependence through Unified Certification of Tobacco Treatment Specialists. Journal of Smoking Cessation. 2016;11(4):229-35. Epub 2014/12/30. doi: 10.1017/jsc.2014.30
United States Preventive Services Task Force. United States Preventive Services Task Force. Draft Recommendation Statement: Lung Cancer Screening. 2020; https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening#fullrecommendationstart
United States Department of Health and Human Services. Smoking Cessation. A Report of the Surgeon General. Centers for Disease Control and Prevention. National Center for Chronic Disease Prevention and Health Promotion; Office on Smoking and Health. Atlanta, GA. 2020.

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December 16, 2021

SUBMITTED ELECTRONICALLY

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group (CAG)
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

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

Dear Ms. Jensen,

Medtronic appreciates the opportunity to comment on the recent Proposed Decision Memo for Screening for Lung Cancer with LDCT (CAG-00439R) as posted November 17, 2021.

Medtronic is the world's leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. We are committed to the continual research and development necessary to produce high-quality products and to support innovative therapies that improve health outcomes for patients. Through our Surgical Innovations and Lung Health businesses, our goal is to offer solutions that streamline a fragmented care continuum, with the ultimate objective of improving patient outcomes. In particular, Medtronic Lung Health aims for a unified approach to lung cancer care that will expand access, answers, and options, from early identification and accurate diagnosis, to effective treatment, and accelerated recovery.

Lung cancer screening with LDCT plays a critical role in the transformation of lung cancer to a treatable condition. Lung cancer is the second most common type of cancer in the United States and is the leading cause of cancer regardless of age, race, or ethnicity. The American Cancer Society estimates over 235,000 new cases of lung cancer, and over 130,000 deaths from lung cancer in 2021. When lung cancer is found at an early stage, it is more likely to be treated successfully. Screening for lung cancer using LDCT is a critical tool for early detection and decreasing mortality in lung cancer patients. We applaud CMS’ efforts to expand access to LDCT lung cancer screening for Medicare beneficiaries, and we appreciate this opportunity to address three key aspects of the proposed National Coverage Determination (NCD) – specifically, eligibility age, smoking cessation, and shared decision-making (SDM).

Eligibility Age
Medtronic is concerned the eligibility for screening as outlined in the Proposed Decision Memo is not aligned with the United States Preventive Services Task Force (USPSTF) and provider group recommendations. Specifically, the proposed NCD would limit the covered age to 77, in contrast to both the National Comprehensive Cancer Network (NCCN) and USPSTF recommendations, which support lung cancer screening up to the age of 80. As life expectancy in the United States is projected to rise, we encourage CMS to align the covered age with evidence-based recommendations and allow Medicare beneficiaries between the ages of 78 and 80 to access lung cancer screening.

In addition to the increasing life expectancy in the US, advances in lung cancer treatment and similar survival rates between age cohorts support the revision or removal of the age requirement. According to surveillance data released by the National Cancer Institute, the median age for a diagnosis of lung cancer in the United States is 71 and most lung cancer-related deaths occur later in life. Further, age alone cannot predict how a patient may respond to treatment. Varlotto et al. investigated whether screening for lung cancer might benefit individuals aged 75-84 years. The conclusion of the study supports that screening for lung cancer may benefit individuals at increased risk of lung cancer in the upper age group. Researchers found the survival benefits of aggressive therapy are similar in females between the ages of 55 and 74 and those 75–84 years old. The aging population, combined with increasing life expectancy and the advancement in therapies, support expansion of the age criteria.

Smoking Cessation
Medtronic supports the decision to reduce the pack-years of smoking to align with USPSTF. We also encourage CMS to revise the smoking cessation quit date, and at a minimum adopt the guidelines from NCCN or remove the years since quitting (YSQ) requirement completely. The requirement is overly restrictive and does not consider the significant number of former smokers who quit greater than 15 years ago that are newly diagnosed with lung cancer.

There is evidence to support the revision to the YSQ criteria. The Framingham Heart Study, a multigenerational seminal study that analyzes family patterns of cardiovascular and other diseases, found that more than 40% of lung cancers in former smokers occurred more than 15 years since quitting. Other studies have concluded that people who have quit smoking longer than 15 years ago remain at high risk for developing lung cancer.

Due to the significance of findings outlined in the studies above, Medtronic encourages CMS to expand coverage to Medicare beneficiaries who quit smoking greater than 15 years previously, so that screening is available to more beneficiaries who are still at risk for lung cancer.

Shared Decision Making (SDM)
We thank CMS for the incremental changes made to the SDM requirements and encourage CMS to continue to seek additional strategies to reduce barriers related to the SDM visit. Informed discussion with patients should be encouraged and utilized in a patient centric approach. Flexibilities with the SDM to allow the consult to occur in conjunction with the screening exam rather than requiring a separate SDM visit, or coverage of the SDM visit through telehealth, may help remove barriers to screening and address disparities. Utilization of lung cancer screening remains low, with marked variations in rates of lung cancer screening based on race, income, literacy, and geographic location. Lung cancer disproportionately affects these vulnerable populations who may need additional support to achieve health equity in lung cancer screening.

Conclusion
Thank you again for the opportunity to comment on the Screening for Lung Cancer with LDCT Proposed Decision Memo. We appreciate your consideration. If you have questions or need further information, please contact me at (774) 571-2970 or susan.i.slaton@medtronic.com.

Sincerely,

Susan Slaton
Director, Health Economics, Policy and Reimbursement

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Dear CMS Review Panel,

As a collective group of healthcare providers and professionals, the Kentucky Health Collaborative (KHC), and lung cancer screening clinician-researchers, the Kentucky LEADS Collaborative, appreciate that the Centers for Medicare and Medicaid Services (CMS) is accepting public comment regarding the recent proposed recommendation for the National Coverage Determination (NCD) regarding low dose computed tomography (LDCT) Lung Cancer Screening (LCS).

Lung cancer kills more Kentuckians than the next three most common cancers combined. Reducing lung disease and lung cancer mortality in Kentucky is one of our greatest challenges, but equitable implementation of high-quality LCS is our greatest opportunity. LCS among eligible adults allows clinicians to diagnose lung cancer cases at earlier stages of disease, improves coordination of treatment, and decreases Kentucky’s lung cancer mortality rate.

Consistent with the evidence, the need and urgency to expand the eligibility criteria for LDCT LCS is unquestionably supported. However, we do have concerns regarding portions of the recommendation. The KHC and Kentucky LEADS support CMS’ decision to expand the eligibility criteria for Medicare beneficiaries receiving low dose computed tomography (LDCT) and broadening the Shared Decision Making (SDM) counseling and education to include a larger pool of clinicians. We are pleased that the requirement for a physician, APP, or Clinical Nurse Specialist ordering the baseline screen has been proposed to be eliminated, but that the SDM requirement has been retained as a key element of achieving equitable implementation of high-quality LCS that enhances adherence to the screening algorithm. Overall, it is estimated that expansion of the LCS eligibility criteria will nearly double the eligible LCS patient population in Kentucky.

However, it is important to express to CMS that we do not support the removal of the radiology imaging facility eligibility criteria that would remove the requirement that facilities participation in a registry, as listed in Appendix B of the memo. Additionally, our teams contend that the required standardized volumetric CT dose index is critical for maintaining the low dose approach. Eliminating this requirement and oversight will potentially cause confusion and blur the lines between low and regular dose scans. Moreover, we do not support the relaxation of requirements for radiologists and imaging facilities. While this may contribute to improving access, it will likely result in lowering the standards and overall quality of LCS.

KHC and Kentucky LEADS Requests from CMS regarding Lung Cancer Screening:

1. The KHC and Kentucky LEADS urge CMS to maintain and continue to mandate the requirement of facility participation in the American College of Radiology (ACR) Lung Cancer Screening Registry (LCSR). Standardizing and ensuring lung cancer screening data is reported and captured consistently is critical to maintaining the quality and integrity of healthcare systems and/or imaging facilities program databases. Facility participation in the ACR Registry, is undeniably beneficial in directing guidance for required, as well as optional fields. Through a well-constructed and data driven program, we and our members can identify where fractures lie, with respect to healthcare inequities and areas in our catchment with constrained access and education. Additionally, it is crucial to note that there is major concern, that without this reporting mandate from LCS, facilities may choose not to report LCS data. This is a great concern because unlike other cancer screenings, lung cancer does not have a nationally endorsed quality measure that its facilities and providers report. If the removal of the reporting requirement were to occur, it is likely the progress that has occurred in LCS over the past few years would be diminished. Accurate and consistent reporting of program data is crucial to a lung cancer program’s growth and monitoring at the individual, regional, state, and national level. In this regard we strongly urge CMS to maintain the requirement that facilities continue to report their LCS data to the ACR LCSR until another method can be used or adopted to track and report screening data.

The KHC has been working diligently with its members over the last year to develop the construct of a KHC Lung Cancer Screening Data Initiative. We are on the brink of implementing an innovative collaboration among our member’s 10 hospital systems, to share deidentified data from the Kentucky Cancer Registry (KCR) and the American College of Radiology (ACR) LCSR, noting that both organizations have been extremely supportive of the Collaborative to establish this initiative. This cooperative endeavor will be transformative in establishing benchmarks and enabling quality improvement initiatives to enhance the efforts to lower the risk of lung cancer mortality in Kentucky. Assimilating and sharing data will be paramount to advancing the quality and outcomes for lung cancer in our state and beyond. We feel removing the data reporting requirement from facilities will substantially lower the ability to continue the level of progression and momentum of our lung cancer programs.

2. The KHC and Kentucky LEADS urge CMS to renew the NCD CAG-00439N to reflect the recommended age range as indicated in the April 2021 USPSTF’s LCS guidelines (50 to 80 years). Extending the upper age limit to 80 years old will better allow our clinicians to expand screening efforts and achieve the anticipated benefits of screening among 78–80-year-old individuals as suggested by previous analyses conducted by a number of investigative teams, while serving proportionately more females.

3. The KHC and Kentucky LEADS request that CMS move to reduce existing barriers such as requiring a face-to-face visit with a qualifying health professional. As part of the COVID-19 Public Health Emergency (PHE) Blanket Waivers for Healthcare, SDM was considered a telehealth service. At a minimum, we advocate for the permanent adoption that SDM can be administered via telehealth.

4. The KHC and Kentucky LEADS also urge CMS to work with appropriate federal and state stakeholders to address additional barriers that exist for both clinicians and patients. We advocate that SDM and LCS be added to hospital performance and quality measures in such reporting systems such as the Healthcare Effectiveness Data and Information Set (HEDIS), Merit-based Incentive Payment System (MIPS), and National Quality Forum (NFQ). Measuring LCS as an area of quality improvement will create a greater need for healthcare systems around the nation to focus on LCS importance, urgency, and effectiveness. Current cancer screenings included in the HEDIS Measures (“Effectiveness of Care” category) are Breast Cancer, Cervical Cancer and Colorectal Cancer.

Unfortunately, too many lung cancers continue to be diagnosed at later, less treatable stages. Expanding the screening criteria to align with the evidence will help discover new lung cancer cases in its earliest stages when chance of cure is greatest, and the cost of management is less. We are proud that our members are among a growing number of institutions and healthcare organizations that have validated the role of LCS in the care of qualifying patients. The proposed expansion of the CMS guidelines will inevitably widen the impact of life-saving screening, while capturing proportionately more females, African Americans, and underserved populations.

Unquestionably, lung cancer screening has steadily increased since its adoption by CMS in 2015. Members of the KHC and Kentucky LEADS are leading these efforts regionally and nationally, leading to the second highest rate of LCS uptake across all 50 states. At the coalition and state level, we are seeing significant uptake in our members LCS efforts over the past 18-24 months; this is widely attributable to individual and state-based efforts that are being adopted by our members and other Kentucky clinicians. Some KHC members are on track to screen over 40% of their eligible population, which of course, compares quite favorably to the national average of approximately 6.5%. Without accurate and accessible data, through which the ACR LCSR reporting requirements play a major role, lung cancer programs may be perceived as less valuable, potentially resulting in program dormancy, particularly for new and developing lung cancer screening programs. Further, the lack of registry data will restrict efforts to improve LCS delivery and outcomes

Again, we appreciate this opportunity to provide CMS with our feedback and comments and thank you in advance for your review and consideration of our recommendations included in this letter. Should CMS have any questions or like for the KHC Lung Cancer Steering Committee or the Kentucky LEADS Collaborative to assist in any efforts felt to be of value, please do not hesitate to contact the Andrea Slone, Manager, Advocacy and Clinical Quality Programs at andrea.slone@kentuckyhc.com or Allyson Yates, Project Coordinator, Kentucky LEADS Collaborative at a.yates@uky.edu.

Sincerely, Kentucky Health Collaborative and Kentucky LEADS Collaborative Leadership Teams

Additional Information about the KHC:
The KHC, formed in 2016, is a health care organization comprised of 10 leading health care systems, representing 60+ hospitals across Kentucky as well as locations in Indiana and West Virginia. Members include Appalachian Regional Healthcare, Baptist Health, Ephraim McDowell Health, LifePoint Health, Med Center Health, Norton Healthcare, Owensboro Health, St. Claire HealthCare, St. Elizabeth Healthcare and UK HealthCare. Together our organizations seek to serve patients across the Commonwealth by providing a full complement of community, tertiary and quaternary health care services in ambulatory and hospital settings. Based on a triple-aim approach, the KHC Members work collaboratively together to identify cost savings opportunities, address areas of health care reform, and improve health outcomes for the citizens of the communities they serve. The KHC members are collectively providing more than 55 percent of all health care services to citizens of the Commonwealth including lung cancer screenings.
As lung cancer and tobacco-related disease imposes such an inordinate burden on our state and its citizens the Collaborative’s Executive Committee chose to launch a Lung Cancer Committee as its first coordinated clinical quality improvement effort. Several taskforces have been created that will be instrumental in coordinating the efforts of many member providers, associates, and healthcare systems. The objectives of these initiatives are to diagnose more lung cancer cases in earlier stages of disease, improve access and coordination of treatment, and decrease Kentucky’s lung cancer mortality rates. Key components of this efforts consist of roundtable series and best practice sharing for: screening and early detection, patient retention and adherence, improving areas of health care policy, data gathering and benchmarking and prevention and awareness. Our members are working tirelessly to form and manage evidence based clinical approaches such as further advancements and implementation of centralized care models, nodule review boards, and carefully orchestrated and implemented nurse navigation and other clinical team approaches that guide Kentucky’s patients from screening through survivorship. We intend to demonstrate that evolved and well-coordinated thoracic programs can achieve these means. Additionally, we intend to prove that together, we are and can improve Kentucky’s health outcomes, especially in lung cancer.

Additional Information about the Kentucky LEADS Collaborative:
The Kentucky LEADS Collaborative (LEADS = Lung Cancer Education, Awareness, Detection, and Survivorship) is a community-engaged effort forged by the University of Kentucky, the University of Louisville, the Kentucky Cancer Consortium and the Go2 Foundation for Lung Cancer. The Kentucky LEADS Collaborative is dedicated to reducing the burden of lung cancer in Kentucky and beyond through development, evaluation, and dissemination of novel, community-based interventions to promote provider education, survivorship care, and prevention and early detection regarding lung cancer. This collaborative promotes lung cancer survivorship in Kentucky and moves forward with a broad array of partnerships across the Commonwealth united by the mission to improve lung cancer care and outcomes in Kentucky and beyond.

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I would like to take the opportunity to commend CMS for lowering the age to begin LCS screening from 55 to 50 and reducing pack years from 30 to 20 years as both will begin to address disparities seen with lung cancer. I would definitely like to encourage CMS to consider removing the upper age cap of 77. Regardless of smoking history, I feel putting an age limit on this LCS criteria, continues to enhance the stigma for patients with tobacco smoking history. Please allow the ordering providers to have the Shared Decision Discussion with their patient to make this decision.

In addition to the prior requests, I would like to have you reconsider the requirement of quitting smoking in the last 15 years. From a clinical and administrative standpoint, this has consistently been a roadblock in acquiring this information from patients, due to lack of consistency and accuracy.

As a lung cancer screening coordinator and imaging technologist, with a history of performing both CT Lung Screens and Mammography, the patient path to scheduling and receiving mammograms is a much easier and seamless process. With Lung Cancer causing more mortalities than any other cancer, we need to do better and this would be a great opportunity for CMS to take a stand on this front.

Thank you for providing me the opportunity to discuss this on the CMS Expanded Screening Guideline, public platform.

Sincerely,
Kacey Strovers

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To whom it may concern:

On behalf of Roswell Park Comprehensive Cancer Center, an institution solely focused on treating patients with cancer, I am pleased to submit comments on the Centers for Medicare and Medicaid Services (CMS) proposed National Coverage Decision regarding “Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)” as covered by Medicare. As you well know, early detection of lung cancer significantly prolongs and saves lives. While Roswell Park is generally supportive of aligning the National Coverage Decision with the US Preventive Services Task Force recommendations for lung cancer screening, we would like to share our comments as outlined below.

Concerns regarding beneficiary eligibility criteria:

1. The proposed upper age limit of 77 years is incredibly arbitrary. Most insurers in our area will cover up to 80 years because there is still evidence of cost savings and improved quality of life. We should have the option to continue screening to 80 years if the individual will benefit from the early detection of lung cancer and can tolerate to treatment.

2. Tobacco smoking history of at least 20 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes) does not take into account patients who smoked less than 1 pack per day or smoked for less than 20 years, including patients with substantial occupational exposures, such as first responders, who are still at an increased risk of lung cancer.

3. Limiting access to lung cancer screening to active smoking within the last 15 years is a left over from the NLST. Several papers, including Toumazis I et al (JAMA Oncology, doi:101001/jamaoncol.2021.4942) have shown cost effectiveness when cessation limit is eliminated. Roswell Park strongly supports eliminating the cessation limit.

Other comments on the proposal:

1. Roswell Park supports the proposal to simplify requirements for the counseling and shared decision-making visit. Cancer care is a team effort between the patient, their families, and the entire clinical staff. Shared decision making is a burden often carried by the community-based primary providers and has been shown to be a barrier to recommending lung cancer screening.

2. There is no provision to require American College of Radiology to mandate any certification or training for radiologists to read LDCT scans which would ensure a high-quality LDCT report. This certification requirement is in place for mammography review. Additionally, Roswell Park supports the proposal to the removal of the restriction that the LDCT must be ordered by a physician or non-physician practitioner.

3. Roswell Park strongly supports the proposal to eliminate the requirement that radiology facilities participate in a lung cancer screening registry as this has been shown to be a financial disincentive to small radiology practices to provide lung cancer screening services, a substantial barrier to overall to lung cancer screening, particularly for rural and minority populations. See Appendix B for the draft manual language. This has been a huge barrier to treatment.

4. Roswell Park supports the development of a free lung cancer screening registry that removes the financial barrier posed by the current structure. Additionally, CMS should own and make publicly available data associated with any lung cancer screening registry.

Thank you for the opportunity to comment,

Mary Reid, PhD
Chief, Cancer Screening & Survivorship
Associate Dean for Graduate Curriculum, Division of Education

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To whom it may concern:

As President and CEO of the North American Quitline Consortium (NAQC), I would like to thank CMS for excellent analysis and decision-making on the proposal for Lung Cancer Screening requirements. The required elements are based on sound science as well as practicality.

While NAQC agrees that smoking cessation counseling can and should take place within the context of a shared decision-making visit between healthcare provider and patient, we feel strongly that this is not the only venue for cessation treatment. The radiology imaging facility should be required to provide cessation treatment. We do not agree with your statement, “We propose that it is not appropriate for Medicare beneficiaries to receive smoking cessation interventions for current smokers within the setting of a radiology imaging facility, and that this eligibility criterion be removed from the radiology imaging facility eligibility criteria.” This language is counter to the current U.S. Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence (available at Treating Tobacco Use and Dependence: PHS Clinical Practice Guideline | Agency for Healthcare Research and Quality (ahrq.gov)) which states “Clinicians should identify tobacco users at each visit and intervene with those individuals who are willing to quit (go to Five Major Steps to Intervention [The "5 A's"]). Tobacco users willing to make a quit attempt should receive both counseling and pharmacotherapy, except in the presence of special circumstances.” Dr. Michael Fiore, the senior author of the Guide and Director of the Center for Tobacco Research and Intervention at the University of Wisconsin Medical School has stated “In my view, a doctor isn't providing an appropriate standard of care for his or her patients if he or she doesn't ask two key questions —'Do you smoke?' and 'Do you want to quit?'—and then work with that individual to make it happen."

Tobacco cessation is even more effective than lung cancer screening in saving years of life from the disease. NAQC asks that you revise your proposal to encourage that both interventions are made available to as many at-risk patients as possible.

Thank you for the opportunity to submit comments. If you have any questions on the comments please contact me at lbailey@naquitline.org or 800-398-5489 ext 706.

Sincerely,

Linda A. Bailey
President and CEO
North American Quitline Consortium

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December 16, 2021

Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Submitted to: https://www.cms.gov/medicare-coverage-database

RE: Docket No. CAG-00439R, Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

To Whom It May Concern:

On behalf of the American Association for Cancer Research’s (AACR) more than 49,000 laboratory researchers, physician-scientists, other health professionals, and patient advocates who constitute our national and international membership, we thank the Centers for Medicare and Medicaid Services (CMS) for the opportunity to comment on the national coverage determination for lung cancer screening with low dose computed tomography (LDCT).

Tobacco use is the leading preventable cause of premature mortality in the United States, with nearly a half million deaths every year from active and secondhand smoking. Tobacco use has a particularly profound impact on cancer incidence and mortality and has been attributed to 19 percent of all cancers diagnosed in the United States and nearly 30 percent of cancer deaths each year (1). More than 85 percent of lung cancer cases and deaths were attributed to smoking. Continued smoking by patients with cancer and survivors increases risk for overall mortality, cancer-related mortality, second primary cancer, and cancer treatment toxicity. Smoking cessation at the time of cancer diagnosis reduces the risk of dying by 30%-40% (2,3), improves physiological/psychological functioning and QOL (4–6), and has benefits that equal or exceed those of the best cancer treatments available (7). To curb the burden of tobacco-related illness, including lung cancer, the federal government should implement evidence-based policies and programs to treat tobacco use including for patients with cancer and survivors.

The AACR Supports Aligning CMS Determinations with the USPSTF Recommendations for Lung Cancer Screening

Annual LDCT screening for lung cancer among high-risk populations is vital for detecting lung cancer at an early stage. By identifying cancers early, screening greatly improves the ability to treat cancers and thus improve cancer-related morbidity and mortality. For these reasons, the AACR strongly supports the CMS proposed decision to align eligibility criteria for LDCT with the recommendations of the U.S. Preventive Services Task Force (USPSTF). Specifically, lowering the age of eligibility to 50 years and smoking history to 20 pack years is estimated to nearly double the number of Americans eligible for lung cancer screening (8). Importantly, this expansion is especially beneficial for women and historically marginalized racial and ethnic minorities who have an elevated risk of developing lung cancer from tobacco use, but lower average pack years compared to White men.

The AACR Encourages Use of Evidence-Based Smoking Cessation Interventions at Lung Cancer Screening Appointments and Independent Diagnostic Testing Facilities

Screening alone is just one step people who smoke can take to reduce lung cancer mortality. Assisting patients with evidence-based smoking cessation is one of the most impactful tools healthcare providers can utilize to improve the health of patients (9). Patients who are counseled by providers about smoking cessation are 62 percent more likely to attempt quitting (10). Unfortunately, only four out of nine adults who smoked in 2015 received advice from their providers on how to quit (11), and among those who attempted to quit, fewer than one third used evidence-based cessation therapies. The data suggest that more frequent and effective engagement from clinicians or cessation specialists with patients could increase the use of evidence-based therapies and improve quit rates, even if it is simply brief advice (12).

Two recent studies estimate that including cessation counseling with LDCT visits would greatly decrease tobacco-related mortality and increase quality-adjusted life years (QALY) saved (13,14). Meza, et al. estimated lung cancer deaths avoided and QALY gained for adults born in 1960 and are eligible for LDCT under the 2021 USPSTF guidelines with and without a cessation intervention (14). Over the lifetimes of the 1960 birth cohort, screening 30 percent of the eligible individuals would prevent 6,845 lung cancer deaths and save 103,725 QALY. In comparison, adding a 15 percent effective cessation intervention to LDCT screening visits would prevent 9,267 lung cancer deaths (35 percent increase) and save 322,785 QALY (211 percent increase). Additionally, Cadham et al., found the incremental cost ratio of providing cessation services in conjunction with an LDCT visit ranged from $555 to $35,531 per QALY, depending on the method of delivery, which is well below the common threshold for cost effectiveness ($50,000 to $100,000 per QALY) (13). Furthermore, smoking cessation would likely result in net cost savings for CMS. An analysis of a comprehensive smoking cessation benefit in the Massachusetts Medicaid program found that every dollar spent on cessation reduced spending on tobacco-related illness by $3.12 (15). Therefore, we encourage CMS to alter the proposed national coverage determination to require and reimburse providers for smoking cessation counseling in conjunction with regular LDCT screening appointments and Shared Decision-Making appointments. We find the proposal to not cover cessation counseling during every LDCT visit contradictory from the following excerpt in the proposed decision memo:

The AACR supports this statement and strongly suggests that it necessitates reimbursement for cessation counseling “at every touchpoint” patients who smoke have with the healthcare system. The proposed national coverage determination only requires one Shared-Decision Making appointment in a patient’s lifetime; offering cessation counseling only once in relation to LDCT screening is grossly insufficient. On average, fewer than 10 percent of smoking quit attempts are successful (9). Thus, patients attempt to quit multiple times before they are successful and could greatly benefit from regular cessation counseling to support every quit attempt from this highly addictive substance. We recommend including coverage of cessation counseling in subsequent screenings as described in CAG-00439N “Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)” while adhering to removing the requirement for a written order from a health care provider.

The proposed decision memo has the potential to remove restrictions for practitioners and broaden eligibility criteria for beneficiaries that use tobacco products. However, the proposal places the onus of smoking cessation counseling and intervention on referring providers at Shared Decision-Making visits. For beneficiaries, their needs could be addressed with cessation counseling that entails advice on the benefits of cessation, evidence-based therapies, local cessation resources, collaborative efforts with eligible telehealth providers, and referral to a tobacco cessation specialist and/or behavioral therapy. Ideally, counseling in conjunction with an LDCT screening appointment would entail an in-depth discussion consistent with the Agency for Healthcare Research and Quality’s clinical guidelines on “Treating Tobacco Use and Dependence” (16), and referral to further behavioral therapy. Healthcare providers should also be supported and reimbursed for their efforts to support their patients as they navigate smoking cessation interventions that reduce the health risks associated with tobacco consumption.

In conclusion, the AACR supports the proposed revisions to CMS eligibility for LDCT coverage which will expand access and save lives. However, by neglecting the value of cessation interventions at LDCT screenings, the AACR believes CMS would miss opportunities to help adults who smoke try to quit. The AACR urges CMS to expand coverage of evidence-based smoking cessation services to meet this vital need. These comments are based on careful discussion and evaluation by the AACR’s Tobacco and Cancer Subcommittee (roster attached) and are approved by the AACR’s CEO, Chair of the Tobacco Products and Cancer Subcommittee, and Chair of the Science Policy and Government Affairs Committee. If the AACR can provide any additional information or assistance to CMS, please do not hesitate to contact Dana Acton, Director of Science Policy and Legislative Affairs, at dana.acton@aacr.org.

Thank you again for the opportunity to comment on this important issue.

Sincerely,

Margaret Foti, PhD, MD (h.c.)
Chief Executive Officer
American Association for Cancer Research

George D. Demetri, MD
Chair, Science Policy and Government Affairs Committee
American Association for Cancer Research

Roy S. Herbst, MD, PhD
Chair, Tobacco Products and Cancer Subcommittee
American Association for Cancer Research

References

1. Islami F, Goding Sauer A, Miller KD, Siegel RL, Fedewa SA, Jacobs EJ, et al. Proportion and number of cancer cases and deaths attributable to potentially modifiable risk factors in the United States. CA Cancer J Clin. 2018;68:31–54.
2. U.S. Department of Health and Human Services. The health consequences of smoking—50 years of progress: a report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2014. Available from: http://www.ncbi.nlm.nih.gov/books/NBK179276/
3. Gritz ER, Toll BA, Warren GW. Tobacco use in the oncology setting: advancing clinical practice and research. Cancer Epidemiol Biomark Prev Publ Am Assoc Cancer Res Cosponsored Am Soc Prev Oncol. 2014;23:3–9.
4. Jang S, Prizment A, Haddad T, Robien K, Lazovich D. Smoking and quality of life among female survivors of breast, colorectal and endometrial cancers in a prospective cohort study. J Cancer Surviv Res Pract. 2011;5:115–22.
5. Duffy SA, Ronis DL, Valenstein M, Fowler KE, Lambert MT, Bishop C, et al. Depressive symptoms, smoking, drinking, and quality of life among head and neck cancer patients. Psychosomatics. 2007;48:142–8.
6. Danson SJ, Rowland C, Rowe R, Ellis S, Crabtree C, Horsman JM, et al. The relationship between smoking and quality of life in advanced lung cancer patients: a prospective longitudinal study. Support Care Cancer. 2015;24:1507–16.
7. Toll BA, Brandon TH, Gritz ER, Warren GW, Herbst RS. Assessing tobacco use by cancer patients and facilitating cessation: an American Association for Cancer Research policy statement. Clin Cancer Res Off J Am Assoc Cancer Res. 2013;19:1941–8.
8. U.S. Preventive Services Task Force. U.S. Preventive Services Task Force Issues Final Recommendation Statement on Screening for Lung Cancer. 2021. Available from: https://www.uspreventiveservicestaskforce.org/uspstf/sites/default/files/file/supporting_documents/lung-cancer-newsbulletin.pdf
9. U.S. Department of Health and Human Services. Smoking cessation: a report of the surgeon general. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2020. Available from: https://www.hhs.gov/sites/default/files/2020-cessation-sgr-full-report.pdf
10. Cunningham P. Patient engagement during medical visits and smoking cessation counseling. JAMA Intern Med. 2014;174:1291.
11. Babb S, Malarcher A, Schauer G, Asman K, Jamal A. Quitting smoking among adults — United States, 2000–2015. Morb Mortal Wkly Rep. 2017;65:1457–64.
12. Ramsey AT, Prentice D, Ballard E, Chen L-S, Bierut LJ. Leverage points to improve smoking cessation treatment in a large tertiary care hospital: a systems-based mixed methods study. BMJ Open. 2019;9:e030066.
13. Cadham CJ, Cao P, Jayasekera J, Taylor KL, Levy DT, Jeon J, et al. Cost-effectiveness of smoking cessation interventions in the lung cancer screening setting: a simulation study. JNCI J Natl Cancer Inst. 2021;113:1065–73.
14. Meza R, Cao P, Jeon J, Taylor KL, Mandelblatt JS, Feuer EJ, et al. Impact of joint lung cancer screening and cessation interventions under the new recommendations of the U.S. Preventive Services Task Force. J Thorac Oncol. 2021;
15. Richard P, West K, Ku L. The return on investment of a Medicaid tobacco cessation program in Massachusetts. PLOS ONE. 2012;7:e29665.
16. Fiore M, Jaen CR, Bailey W, Benowitz NL, Curry S, Dorfman SF, et al. Treating tobacco use and dependence: 2008 update. Rockville, MD: US Department of Health and Human Services. Public Health Service; 2008. Available from: https://www.ncbi.nlm.nih.gov/books/NBK63952/

AACR Tobacco Products and Cancer Subcommittee Roster

Roy S. Herbst, MD, PhD
Chairperson
Ensign Professor of Medicine
Professor of Pharmacology
Chief of Medical Oncology
Associate Director for Translational Research
Yale Cancer Center
Smilow Cancer Hospital at Yale-New Haven
Yale School of Medicine
New Haven, CT

Christopher I. Amos, PhD
Director, Institute for Clinical and Translational Research
Associate Director, Quantitative Sciences
Daniel L. Duncan Comprehensive Cancer Center
Baylor College of Medicine
Houston, TX

Barbara A. Burtness, MD
Professor of Medicine Oncology
Interim Associate Cancer Center Director
Yale University School of Medicine
Yale Cancer Center Yale
New Haven, CT

Paul M. Cinciripini, PhD
Professor and Chair, Department of Behavioral Science
Director, Tobacco Treatment Program
University of Texas MD Anderson Cancer Center
Houston, TX

Maciej L. Goniewicz, PharmD, PhD
Professor of Oncology
Department of Health Behavior
Roswell Park Comprehensive Cancer Center
Buffalo, New York

Dorothy K. Hatsukami, PhD
Associate Director, Cancer Prevention and Control
Forster Family Chair in Cancer Prevention
Professor of Psychiatry
Masonic Cancer Center
University of Minnesota
Minneapolis, MN

Brian King, PhD, MPH, ex officio (CDC liaison)
Deputy Director, Research Translation
Office on Smoking and Health
Centers for Disease Control and Prevention
Atlanta, GA

Suchitra Krishnan-Sarin, PhD
Professor of Psychiatry
Chair, Human Investigations Committee
Yale University School of Medicine
New Haven, CT

Stephanie R. Land, PhD, ex officio (NCI liaison)
Program Director and Statistician
Tobacco Control Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
Bethesda, MD

Scott J. Leischow, PhD
Professor and Director of Clinical and Translational Science
College of Health Solutions
Arizona State University
Phoenix, Arizona

Timothy R. Rebbeck, PhD
Vincent L. Gregory, Jr. Professor of Cancer Prevention, Harvard TH Chan School of Public Health and Division of Population Sciences, Dana Farber Cancer Institute
Boston, MA

Nancy A. Rigotti, MD
Professor of Medicine
Professor of Population Medicine
Harvard Medical School
Director, Tobacco Research and Treatment Center Massachusetts General Hospital
Boston, MA

Peter G. Shields, MD
Deputy Director, Comprehensive Cancer Center
Professor, College of Medicine
Julius F. Stone Chair in Cancer Research
James Cancer Hospital
The Ohio State University Wexner Medical Center
Columbus, OH

Avrum E. Spira, MD, MSc
Professor of Medicine, Pathology and Bioinformatics Global Head, Johnson & Johnson Lung Cancer Initiative
Boston University School of Medicine
Boston, MA

Benjamin A. Toll, PhD
Professor of Public Health Sciences and Psychiatry
Vice Chair for Research, Public Health Sciences
Chief of Tobacco Cessation and Health Behaviors
Co-Director, Lung Cancer Screening Program
Hollings Cancer Center
Director, MUSC Health Tobacco Treatment Program
Medical University of South Carolina
Charleston, SC

Kasisomayajula (Vish) Viswanath, PhD
Lee Kum Kee Professor of Health Communication
Harvard T. H. Chan School of Public Health
Dana-Farber Cancer Institute
Director, Center for Translational Health Communication Science, DFCI/HSPH
Director, Harvard Chan India Research Center
Co-Director, Lee Kum Sheung Center for Health and Happiness
Boston, MA

Wendell Gray Yarbrough, MD, MMHC, FACS
Chair, Thomas J. Dark Distinguished Professor
University of North Carolina at Chapel Hill
Otolaryngology, UNC Comprehensive Cancer Support Program
Chapel Hill, NC

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December 16, 2021

By Overnight and Electronic Submission

Tamara Syrek Jensen, JD, Director
Joseph Chin, MD, MS, Deputy Director
Attn: Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop: S3-02-01
7500 Security Boulevard
Baltimore, MD 21244

Re: Public Comment on Proposed New National Coverage Determination on Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) – CAG-00439R

Dear Ms. Jensen and Dr. Chin:

The Association for Quality Imaging (“AQI”) appreciates the opportunity to submit comments relevant to Centers for Medicare and Medicaid Services’ (“CMS”) proposed new National Coverage Determination on Screening for Lung Cancer with Low Dose Computed Tomography (also referred to herein as “NCD”), published on November 17, 2021.

Our comments focus on the need to ensure coverage and reimbursement of LDCT lung cancer screening performed in independent diagnostic testing facilities (“IDTFs”).
AQI represents over seven hundred independent diagnostic testing facilities and freestanding radiology practice-based imaging centers, and three hundred mobile imaging units throughout the United States. Our members are on the front lines in the fight against lung cancer by providing high-quality screening and diagnostic services to Medicare beneficiaries across the country.

AQI offers the following action items for the benefit of CMS:

1. CMS should clarify the NCD language and instructions for Medicare Administrative Contractors (“MACs”) to ensure consistent coverage and reimbursement of LDCT lung cancer screenings performed in IDTFs.
AQI applauds the elimination of the radiology imaging facility eligibility criterion that imaging facilities make available smoking cessation interventions to current smokers. This criterion has been the reason that the various MACs have refused to allow IDTFs to participate in this program. MACs have stated that IDTFs were unable to perform LDCT lung cancer screenings due to perceived belief that making available smoking cessation interventions constituted a “therapeutic intervention.” Since IDTFs are enrolled for the purpose of performing tests and, thus, are restricted against providing therapeutic services, the MACs deemed IDTFs ineligible to perform LDCT scans pursuant to the NCD. Eliminating this confusion over smoking cessation intervention is welcome news, and it should remove the barrier that currently exists for IDTFs’ participation in this program.

IDTFs have experienced a history of erroneous claim denials for LDCT lung cancer screenings performed in qualifying IDTF settings as a result of ambiguous and inconsistent instructions from MACs. We believe IDTFs, freestanding imaging centers and mobile imaging units all serve as convenient, affordable, and accessible alternatives to other health care facilities for Medicare beneficiaries.

2. We request that, in order to assure that there is no confusion; CMS should instruct its MACs that there are no barriers that prevent IDTFs from providing LDCT lung cancer screening studies for eligible individuals referred to them consistent with the requirements of this program.
Removing the smoking cessation intervention from the imaging facility criteria, while retaining it for the counseling and shared decision-making visit (code G0296), fortunately eliminates the therapeutic requirement from the LDCT study (CPT Code 71271). We request CMS inform its MACs on the clarification to assure that IDTFs are not required to enter into business arrangements with physicians “for cooperatively performing this portion of the benefit [smoking cessation interventions] and the IDTF [need not] look to the physician for payment.” Consequently, we ask that CMS instruct MACs that there are no barriers to IDTFs from: (1) performing the LDCT lung cancer screening scans for eligible beneficiaries and (2) billing them to Medicare directly.

AQI and its members appreciate the opportunity to provide CMS with recommendations to consider in the proposed new national coverage determination for LDCT lung cancer screenings. As always, we would welcome the opportunity to discuss our comments with you.

Respectfully submitted,
Board of Directors,
Association for Quality Imaging

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Dear CMS Review Panel,

As a hospital system with eight of our nine hospitals operating in Kentucky, the state with the highest lung cancer incidence, Baptist Health Systems (BHS) Inc. is deeply invested in lung cancer screening. We appreciate the opportunity to respond to the recent proposed recommendation for the National Coverage Determination (NCD) on the expansion of low dose computed tomography (LDCT) Lung Cancer Screening (LCS).

Baptist Health Systems supports the urgent need to expand eligibility criteria for LDCT for LCS. Baptist Health Systems does not support the removal of the radiology imaging facility eligibility criteria that would remove requirement that facilities participate in a registry, as listed in Appendix B of the memo. Additionally, our providers contend that the required standardized volumetric CT dose index is critical for maintaining the low dose approach. Eliminating this requirement and oversight will potentially cause confusion and blur the lines between low and regular dose scans. Moreover, we do not support the relaxation of requirements for radiologists and imaging facilities. While this may attribute to improving access, it will likely result in lowering the standards and overall quality of LCS.

BHS Requests from CMS regarding LDCT Lung Cancer Screening:

1. BHS urges CMS to maintain and continue to mandate the requirement of facility participation in the American College of Radiology (ACR) lung cancer data registry.

2. BHS urges CMS to renew the NCD CAG-00439N to reflect the recommended age range as indicated in the April 2021 USPSTF’s LCS guidelines (50 to 80 years). Extending the upper age limit to 80 years old will better allow our providers to expand screening efforts to a greater portion of the population and will inevitably widen the impact of life-saving screening, while capturing proportionately more females, African Americans, and underserved populations. Our members are witnessing smoking related cancers in the 78–80-year age range, considering this and USPSTF’s recommendations, we advocate that CMS consider the national coverage to extend at least to the age of 80 years old. Furthermore, we believe that removing any upper age limitations would allow providers to determine if LCS is appropriate on an individual basis; overall, it would undoubtedly expand all provider’s LCS efforts.

3. BHS urges CMS to revise its current NCD language regarding “Counseling and Shared Decision Making (SDM)” to avoid unintentional screening barriers. Many of our clinicians believe that mandating SDM for LCS further adds to imposing stigma around LCS, as other cancer screenings do not require a SDM counseling session. Therefore, we urge CMS to consider further reductions that improve adherence to LCS rather than adding barriers. Additionally, we would request that CMS move to reduce existing barriers such as requiring a face-to-face visit with a qualifying health professional and the Shared Decision Making (SDM) component. As part of the COVID-19 Public Health Emergency (PHE) Blanket Waivers for Healthcare, SDM was considered a telehealth service. At a minimum we advocate for the permanent adoption that SDM can be administered via telehealth.

4. BHS also urges CMS to work with appropriate federal and state stakeholders to address additional barriers that exist for both providers and patients, including:

Again, we appreciate this opportunity to provide CMS with our feedback and comments and thank you in advance for your review and consideration of our recommendations included in this letter.

Sincerely,

Amanda Henson, MSHA, MBA, FACHE
System Vice President, Oncology Service Line
Baptist Health
2701 Eastpoint Parkway
Louisville, KY 40223
Office: 502.896.5020

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December 16, 2021

The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Reconsideration—Proposed National Coverage Determination for Lung Cancer Screening with Low Dose Computed Tomography (LDCT) (CAG-00439R)

Dear Administrator Brooks-LaSure:

Thank you for the opportunity to provide comments on the reconsideration of the Proposed National Coverage Determination for Lung Cancer Screening with Low Dose Computed Tomography (LDCT).

The American Lung Association is the oldest voluntary public health association in the United States, representing the millions of Americans living with lung diseases, including lung cancer. The Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease through research, education and advocacy.

In 2021, an estimated 235,760 new cases of lung cancer are expected to be diagnosed.[1] Lung cancer remains the leading cause of cancer deaths, with 131,880 deaths expected in 2021.[2] The Lung Association strongly supports lung cancer screening for high-risk populations as early detection and treatment improves the chances of survival. Screening individuals at high risk is essential to saving lives, particularly since lung cancer is typically found in the later stages and has an overall 5-year survival rate of only 21.8%.[3]

The Lung Association remains concerned about the low uptake of lung cancer screening. The Lung Association is committed to continuing to improve lung cancer screening rates for the high-risk population in Medicare by educating patients, providers and policymakers about eligibility for screening and addressing other challenges and barriers to improving utilization.

In February 2015, the Centers for Medicare and Medicaid Services (CMS) issued a national coverage determination for lung cancer screening with LDCT for individuals who are between the ages of 55 and 77, have a tobacco smoking history of at least 30 pack-years, currently smoke or have quit within the last 15 years, are asymptomatic (no signs or symptoms of lung cancer), and receive a written order for lung cancer screening with LDCT. Since that time, additional scientific evidence has become available that strongly supports the expansion of this eligibility criteria, as well as other updates to Medicare’s coverage policy. The Lung Association offered comments on updating the national coverage determination for lung cancer screening during the June 2021 comment period[4] and is pleased to offer the following recommendations on the proposed decision memo:

Age Range
The Lung Association supports CMS’ proposal to lower the age for individuals to start screening from 55 to 50 years, but urges CMS to raise the upper age limit from 77 to 80 years as well. In March 2021, the United States Preventive Services Task Force (USPSTF) finalized an update to its 2013 recommendation for lung cancer screening for individuals at high risk, expanding eligibility to individuals between the age of 50 and 80.

Lowering the age range would be an important step forward in addressing racial disparities associated with lung cancer. For example, Black individuals have a younger average age of onset of lung cancer and are more likely to be diagnosed at advanced stages compared to white individuals.[5] Lowering the age of eligibility for screening from 55 to 50 years will therefore be critical in improving early detection for this and other populations at high risk for lung cancer.

The Lung Association urges CMS to increase the upper age limit to 80 years to match the USPSTF guidelines. USPSTF has a rigorous, evidenced-based process for developing and updating all of its recommendations. As part of its update to the 2013 recommendation for lung cancer screening, USPSTF commissioned a systematic evidence review that included over 223 publications.[6] USPSTF also commissioned modeling studies to examine key variables, including various ages to begin and end screening.[7] These studies provide a strong rationale for CMS to adopt the expanded age range of 50 to 80 years for lung cancer screening.

Aligning eligibility criteria between USPSTF and Medicare could also help to address low uptake of lung cancer screening. According to the American Lung Association’s 2021 State of Lung Cancer Report, only 5.7% of those at high risk were screened nationally.[8] Standardizing guidelines across different payers would simplify efforts to educate providers, patients and other stakeholders about the eligibility criteria and facilitate screening for more individuals at high risk.

Pack Year History
The Lung Association supports the recommendation to lower the pack year eligibility for lung cancer screening from 30 pack years to 20 pack years. This change was also included in the final USPSTF recommendation after the thorough review process mentioned above. In particular, results from the NELSON trial, which enrolled individuals with less than 30 pack year histories (half of a pack per day for more than 30 years or three-fourths of a pack per day for more than 25 years), confirm the benefits of screening for individuals with lighter pack year histories.[9]

Additionally, as with the decrease in the eligibility age from 55 years to 50 years mentioned above, research has shown that the decrease in the pack year history from 30 to 20 years is especially important to improve early detection and survival rates among Black individuals.[10] Data also show that Latino and Hispanic smokers have fewer pack year histories than white smokers, suggesting that reducing the pack year threshold will particularly benefit these populations as well.[11]

Continuing Screening 15 Years After Quitting
The Lung Association believes that there is strong evidence to support including patients who have quit smoking for more than 15 years in CMS’ final eligibility criteria. Since 2015, multiple studies have concluded that that there are benefits of screening beyond the 15-year cut-off. [12-15] , , , For example, one recent meta-analysis concluded that “at the critical screening threshold of 15 years since quitting, the percentage of excess risk for lung cancer remains high and only marginally declines at time points afterward, excluding millions of former smokers who remain at elevated risk of malignancy.”[16] The Lung Association urges CMS to include patients who have quit smoking for more than 15 years in the final eligibility criteria.

Shared Decision-Making Visit
In our June 2021 letter, the Lung Association urged CMS to consider whether there were improvements that could be made to the shared-decision making process to reduce administrative and other requirements that create barriers to broad access to the lung cancer screening benefit. The proposed decision memo includes changes removing the restriction for the type of practitioner who can furnish the counseling and shared decision-making visit, removing the specificity of redundant documentation requirements and eliminating the requirement for a written order. The Lung Association supports these changes and believes they will be a step forward in addressing the barriers to broader uptake of lung cancer screening by individuals at high risk.

Registry
Finally, the Lung Association has concerns with CMS’ proposal to remove the requirement that radiology imaging facilities collect and submit data to a CMS-approved low dose CT lung cancer screening registry. This requirement supports collection of a common, minimum set of data elements for purposes of continued research and evaluation of lung cancer screening. The Lung Association believes it is still beneficial to incentivize this data collection in order to facilitate additional research on lung cancer screening, including additional expansions of eligibility criteria. We encourage CMS to consider alternative approaches to reducing the financial and other burdens of the current requirement while still preserving this critical data collection.

Conclusion
The number one strategic imperative of the American Lung Association is to defeat lung cancer, and expanding screening for those at high risk is critical to improving survival rates. The Lung Association urges CMS to expand eligibility for lung cancer screening to individuals ages 50 to 80 years old and who have a tobacco smoking history of at least 20 pack-years, as well as include patients who have quit smoking for more than 15 years. Thank you for considering our comments.

Sincerely,

Harold P. Wimmer
National President and CEO

1. Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2021. CA: A Cancer Journal for Clinicians. 2021.
2. Id.
3. US National Institutes of Health, National Cancer Institute, SEER Cancer Statistics Review 1975-2017. Available at: https://seer.cancer.gov/csr/1975_2017/.
4. American Lung Association Comments to CMS re National Coverage Analysis for Lung Cancer Screening. June 17, 2021. Available at: https://www.lung.org/getmedia/ca77747d-bc6e-43e2-ae42-bb08cbb7f18b/american-lung-association-comments-medicare-lung-cancer-ncd-(final).pdf.
5. Annangi, S., Nutalapati, S., Foreman, M.G. et al. Potential Racial Disparities Using Current Lung Cancer Screening Guidelines. J. Racial and Ethnic Health Disparities 6, 22–26 (2019).
6. Jonas DE, Reuland DS, Shivani SM, et al. Screening for lung cancer with low-dose computed tomography: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. Published March 9, 2021. doi:10.1001/jama.2021.0377
7. Meza R, Jeon J, Toumazis I, et al. Evaluation of the benefits and harms of lung cancer screening with low-dose computed tomography: modeling study for the US Preventive Services Task Force. JAMA. Published March 9, 2021. doi:10.1001/jama.2021.1077
8. American Lung Association. State of Lung Cancer Report. 2021. Available at: https://www.lung.org/research/state-of-lung-cancer/key-findings.
9. de Koning HJ, van der Aalst CM, de Jong PA, et al. Reduced lung-cancer mortality with volume CT screening in a randomized trial. N Engl J Med. 2020;382(6):503-513. doi:10.1056/NEJMoa1911793
10. Aldrich MC, Mercaldo SF, Sandler KL, Blot WJ, Grogan EL, Blume JD. Evaluation of USPSTF Lung Cancer Screening Guidelines Among African American Adult Smokers [published online ahead of print, 2019 Jun 27] [published correction appears in JAMA Oncol. 2019 Aug 1;:]. JAMA Oncol. 2019;5(9):1318-1324.
11. Kaplan RC, Bangdiwala SI, Barnhart JM, et al. Smoking among U.S. Hispanic/Latino adults: the Hispanic community health study/study of Latinos. Am J Prev Med. 2014;46(5):496-506. Medline:24745640 doi:10.1016/j.amepre.2014.01.014
12. Luo YH, Luo L, Wampfler JA, et al. 5-year overall survival in patients with lung cancer eligible or ineligible for screening according to US Preventive Services Task Force criteria: a prospective, observational cohort study. Lancet Oncol. 2019;20(8):1098-1108. doi:10.1016/S1470-2045(19)30329-8
13. Wang Y, Midthun DE, Wampfler JA, et al. Trends in the Proportion of Patients With Lung Cancer Meeting Screening Criteria. JAMA. 2015;313(8):853–855. doi:10.1001/jama.2015.413;
14. McKee BJ, Regis S, Borondy-Kitts AK, Hashim JA, French Jr RJ, Wald C, McKee AB. NCCN Guidelines as a model of extended criteria for lung cancer screening. J Natl Compr Canc Netw. 2018;16:444-449. doi: 10.6004/jnccn.2018.7021;
15. Tindle HA, Stevenson Duncan M, Greevy RA, et al. Lifetime Smoking History and Risk of Lung Cancer: Results From the Framingham Heart Study [published correction appears in J Natl Cancer Inst. 2018 Oct 1;110(10):1153]. J Natl Cancer Inst. 2018;110(11):1201-1207. doi:10.1093/jnci/djy041
16. Reitsma M, Kendrick P, Anderson J, et al. Reexamining Rates of Decline in Lung Cancer Risk after Smoking Cessation: A meta-analysis [published online ahead of print, 2020 Jun 30]. Ann Am Thorac Soc. 2020;10.1513/AnnalsATS.201909-659OC. doi:10.1513/AnnalsATS.201909-659OC

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December 16, 2021

Tamara Syrek Jensen, JD
Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore MD 21244

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

Dear Ms. Syrek Jensen:

The National Comprehensive Cancer Network® (NCCN®) is pleased to comment on the Center for Medicare and Medicaid Services (CMS) Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) as it relates to NCCN®’s mission to improve and facilitate quality, effective, equitable, and accessible cancer care. NCCN applauds the USPSTF for its extension of the high-risk group for lung cancer screening and appreciates CMS’ attention to the implications for Medicare coverage. NCCN appreciates the opportunity to comment and will focus our comments on the appropriateness of expanding the high-risk group, the evidence for screening coverage for those older than 77 years and those with smoking cessation duration greater than 15 years, unintended negative consequences of the Shared Decision-Making (SDM) documentation requirement, radiology imaging facility criteria, and the references to NCCN Guidelines.

NCCN Background

As an alliance of 31 leading academic cancer centers in the United States that treat hundreds of thousands of patients with cancer annually, NCCN is a developer of authoritative information regarding cancer prevention, screening, diagnosis, treatment, and supportive care that is widely used by clinical professionals and payers alike. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) are a comprehensive set of guidelines detailing the sequential management decisions and interventions that currently apply to 97 percent of cancers affecting patients in the United States.

NCCN Guidelines® and Library of Compendia products help ensure access to appropriate care, clinical decision-making, and assessment of quality improvement initiatives. The NCCN Drugs & Biologics Compendium (NCCN Compendium®) has been recognized by CMS and clinical professionals in the commercial payer setting since 2008 as an evidence-based reference for establishment of coverage policy and coverage decisions regarding off-label use of anticancer and cancer-related medications.

1) Evidence for Expansion of Coverage Group

NCCN supports the lowering of eligibility age to age 50 years from the current age of 55 years and the proposal to lower the smoking history requirement from 30 pack-years or greater to 20 pack-years or greater. This recommendation is rooted in evidence and supported by both USPSTF and NCCN Guidelines. ^i,ii Updating coverage to reflect evidence-based guidelines will dramatically expand identification of lung cancer at earlier stages, saving thousands of additional lives.

The NCCN Clinical Practice Guideline for Lung Cancer Screening® has endorsed the recommendation to begin screening at age 50 years for those with a 20 pack years or greater smoking history since 2011 ⁱⁱⁱ The current version of the NCCN Guidelines for Lung Cancer Screening recommend, as a Category 1 intervention, annual screening as determined through a shared decision making process between the patient and healthcare provider for those in the high-risk group.ⁱ High-risk individuals are defined as individuals age 50 years or older with a 20 pack-year or greater smoking history. Risk factors to consider in addition to smoking include radon exposure, occupational exposure, cancer history, family history of lung cancer, lung disease history, and smoking exposure. Additionally, the guideline panel notes that African American patients with less smoking exposure have been shown to have a similar risk of lung cancer as white patients with higher smoking exposure. This should be taken into consideration in shared decision making and risk assessment.ⁱ

Using just the criteria currently covered by CMS, only 27% of patients currently being diagnosed with lung cancer would be candidates for LDCT screening.^iv Data suggest that the lung cancer risk for individuals with a 20 to 29 pack year smoking history is similar to that of individuals with a 30 or more pack year history.^v Expanding the groups at high risk who are candidates for screening will save thousands of additional lives. ^{vi, vii, viii, ix, x}

2) Restrictions for Individuals with Greater than 15 Years Smoking Cessation

The proposed decision memo restricts coverage of screening for lung cancer with LDCT to individuals who are currently smoking or have quit within the past 15 years. NCCN encourages CMS to remove this restriction. NCCN acknowledges that the cessation of tobacco smoking decreases the risk for lung cancer. However, even former smokers have a higher risk for lung cancer compared with individuals that have never smoked, and there is not a substantive drop off in that risk after 15 years.

An analysis of the Framingham Heart Study found that “Among heavy former smokers, lung cancer risk drops within five years since quitting (YSQ) relative to continuing smokers, yet it remains more than threefold higher than never smokers after 25 YSQ. Four of ten lung cancers occurred in former smokers with more than 15 YSQ.” ^xi Additionally, a study published in the Journal of Clinical Oncology found that “Compared with never smokers, former smokers had an elevated lung cancer risk (relative risk, 6.6; 95% confidence interval, 5.0 to 8.7) up to 30 years after smoking cessation for all former smokers”. ^xii A prospective study of patients with lung cancer evaluated those that would have “missed out” on lung cancer screening using the 2013 USPSTF recommendations. By far, the largest percentage of those patients with lung cancer not eligible for screening using the USPSTF criteria were due solely to having quit smoking for more than 15 years. ^xiii

NCCN believes that a 15-year restriction for these individuals at high risk for lung cancer is not based on or justified by evidence. Further, this restriction creates an unintended consequence and a paradox of incentives for former smokers who are at high risk for lung cancer and wish to continue screening. By this criteria, CMS encourages individuals to resume smoking, or lie about their smoking history in order to remain eligible for screening. Neither result is what we want to encourage in patient engagement for early detection. NCCN recommends that CMS remove this restriction and consider the value in extending screening eligibility to prevent barriers to screening for high-risk individuals who may benefit.

3) Prespecified Upper Age Limit for Screening

NCCN encourages CMS to reconsider the current upper age limit of age 77 and instead use candidacy for definitive treatment as the criteria for coverage. Twenty seven percent of lung cancer is diagnosed in older patients aged 75 to 84 years, and ten percent occurs in patients older than 84 years. ^{ix, xiv, xv} The NCCN Guidelines for Lung Cancer Screening state that “Screening with LDCT should only be recommended for select individuals at high risk if they are potential candidates for definitive treatment (i.e. curative intent).” Determining factors to consider include good functional status, the absence of serious comorbidities that would impede curative treatment, and an individual’s interest and willingness to undergo treatment. ii

Modern treatment of lung cancer now frequently involves surgery or radiation for octogenarians with well-established positive outcomes. ^{xvi, xvii} Surgical management frequently uses minimally invasive techniques with fewer complications, shorter hospital stay, and excellent long-term outcomes. ^{xviii, xix} Patients also have the option of advances in radiation therapy, including stereotactic body radiotherapy (SBRT) that offers curative intent therapy that is safe and effective in octogenarians. ^xx Surgical resection, is recommended for patients with early-stage lung cancer, including in octogenarians without major comorbidity and with good performance status. No United States treatment guidelines for lung cancer set upper age limits for surgical or radiation therapy. ⁱⁱ Therefore, NCCN recommends that CMS remove the upper age limit of 77 years and instead add language requiring eligibility for definitive treatment as aligned with the individual’s preference and values.

4) Shared Decision-Making (SDM) documentation requirements

Substantial concerns remain among medical professional societies, physician groups, screening centers, patient communities, and other stakeholders that the counseling and SDM criteria as written in the existing National Coverage Determination (NCD) is an unintended yet major barrier to lung cancer screening. Although NCCN agrees that SDM is an essential component of lung cancer screening, we remain concerned that the existing documentation requirements act as a barrier to screening uptake. Indeed, a 2018 peer-reviewed study reports that in 2016 just 1.9% of eligible smokers were screened for lung cancer. ^xxi NCCN appreciates that CMS proposes to significantly reduce the burden of the current SDM visit requirements by simplifying SDM visit documentation requirements, removing the requirement that it must be furnished by a physician or non-physician practitioner, reducing the eligibility criteria for the reading radiologist, and removing the radiology imaging facility eligibility criteria. However, NCCN is concerned that for some physicians, the criteria as written may still pose administrative burden on an already overstressed healthcare system. While the informed discussion is important and medically appropriate, CMS should consider mirroring the USPSTF and NCCN approach with an emphasis on informed discussion importance without requiring additional documentation.

The maturity and effectiveness of LDCT lung cancer screening across settings are significant. ^xxii We are hopeful that CMS will give weight to and recognize the advances and improvements made over the last decade in radiation dose optimization in CT technology, as well as the low dose protocols established by professional societies (e.g., ACR, AAPM), standardized reporting, and management systems (i.e., Lung-RADS) , incidental findings white papers, and incidental findings resources and management . ^{xxiii, xxiv} These advances in standardized screening protocols and implementation, the magnitude of annual lung cancer deaths, persistently low screening uptake in the U.S., and existing and potential NCD SDM criteria burdens, should all bear thoughtful consideration by CMS in revising the NCD language. While SDM should be encouraged and utilized, CMS should eliminate the NCD documentation requirement for SDM entirely, especially since it is not required for coverage of screening mammography or colon cancer screening.

5) Radiology Imaging Facility Criteria

CMS proposes to remove several eligibility criteria for radiology imaging facilities including the requirement that they use a structured reporting and management system. While NCCN appreciates CMS’ efforts to reduce provider burden, we are concerned that the removal of these requirements may impact the quality of screening and monitoring patients receive. The current version of the NCCN Guidelines for Lung Cancer Screening provide detailed recommendations for evaluation and follow up of lung screening findings, including immediate assessment of nodules that are highly suspicious for lung cancer. The American College of Radiology has developed Lung Image Reporting and Data Systems (Lung-RADS) that has been shown to improve the detection of lung cancer and decrease the false positive rate. ^{xxv, xxvi , xxvii, xxviii} Removing the requirement that facilities use a reporting and management system may lead to confusion among providers and lead to an increase in false positive rates. This is also not congruent with current practices in breast cancer which utilize the Breast Imaging Reporting and Data System (BI-RADS). NCCN encourages CMS to maintain this criterion to ensure quality of screening and reporting.

6) NCCN References Within the Evidence Review

NCCN thanks CMS for including the NCCN Clinical Practice Guidelines in Oncology: Lung Cancer Screening Guideline within the guideline and evidence review sections. As NCCN Guidelines are updated at least once annually, NCCN would like to highlight changes to the guidelines since the development of the Proposed Decision Memo. First, NCCN respectfully requests that the evidence review be updated to reflect the most current version of the guideline, currently referenced as the following:

Wood DE et al. NCCN Clinical Practice Guidelines in Oncology: Lung Cancer Screening, Version 1.2022. To view the most recent version, visit NCCN.org

Notable requested changes impacting the content within the evidence review include:

• Evidence-based Guidelines Section: Within the algorithm image please note the most recent Guideline version has changed shared decision-making recommendation terminology from patient/physician to patient/provider.
• Changing Stopping Age From 77 years to 80 years Section: Removal of language stating that NCCN discusses uncertainty around Low Dose CT after 77 years.
• Smoking cessation section: Changing “smoking cessation counseling is recommended” to “current smokers should be advised to quit smoking, and former smokers should be advised to remain abstinent from smoking”.
• Please note that the NCCN Guidelines for Lung Cancer Screening contain detailed recommendations for evaluating and follow up on lung screening findings including immediate assessment of nodules that are highly suspicious for lung cancer. The NCCN Guidelines and the Lung-RADS recommendations have been harmonized to provide consistent and clear recommendations to clinicians seeking to interpret LDCT scans.

In closing, NCCN appreciates the opportunity to comment on the CMS Proposed Decision Memo for Screening for Lung Cancer with LDCT and its impact on Medicare beneficiaries at high risk for lung cancer. We again thank and applaud the USPSTF for expanding the definition of the high-risk group for lung cancer screening and also applaud CMS for your prompt attention to coverage needs. NCCN respectfully requests that CMS update the decision memo to reflect:

• Finalize reducing the screening eligibility start to age 50 years
• Finalize reducing required pack-year smoking history to 20 years or greater
• Remove the 15-year limit on smoking cessation duration
• Remove the upper age limit of 77 years and instead insert language on eligibility for definitive treatment
• Remove the documentation requirement for Shared Decision-Making
• Reinstate the requirements that radiology imaging facilities use a standardized lung nodule identification, classification, and reporting system.
• Update the evidence review section to reflect the most recent version of NCCN Guidelines.

NCCN again thanks CMS for your attention to this important advancement in appropriate access to lung cancer screening. We welcome the opportunity to discuss our comments further and look forward to working together to ensure patient access to high-quality cancer care.

Sincerely,

Douglas E. Wood, MD, FACS, FRCSEd
Chair, NCCN Lung Cancer Screening Panel
Vice Chair, NCCN Non-Small Cell Lung Cancer Panel

Ella A. Kazerooni, MD, MS
Vice Chair, NCCN Lung Cancer
Screening Panel

Endnotes/References
i. Wood DE et al. NCCN Clinical Practice Guidelines in Oncology: Lung Cancer Screening, Version 1.2022. To view the most recent version, visit NCCN.org
ii. United States Preventative Task Force. Lung Cancer Screening. Retrieved from: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening
iii. Wood DE et al. NCCN Clinical Practice Guidelines in Oncology: Lung Cancer Screening, Version 1.2011. To view the most recent version, visit NCCN.org
iv. Pinsky PF, Berg CD. Applying the National Lung Screening Trial eligibility criteria to the US population: what percent of the population and of incident lung cancers would be covered? J Med Screen 2012;19:154 156. Available at: https://www.ncbi.nlm.nih.gov/pubmed/23060474.
v. Pinsky PF, Kramer BS. Lung cancer risk and demographic characteristics of current 20 29 pack year smokers: implications for screening. J Natl Cancer Inst 2015;107:djv226. Available at: https://www.ncbi.nlm.nih.gov/pubmed/26483244.
vi. McKee BJ, Regis SM, McKee AB, et al. Performance of ACR Lung RADS in a clinical CT lung screening program. J Am Coll Radiol 2016;13:R25 29. Available at: https://www.ncbi.nlm.nih.gov/pubmed/26846532.
vii. McKee BJ, Hashim JA, French RJ, et al. Experience with a CT screening program for individuals at high risk for developing lung cancer. J Am Coll Radiol 2015;12:192 197. Available at: https://www.ncbi.nlm.nih.gov/pubmed/25176498.
viii. Miller DL, Mayfield WR, Luu TD, et al. Community based multidisciplinary computed tomography screening program improves lung cancer survival. Ann Thorac Surg 2016;101:1864 1869. Available at: https://www.ncbi.nlm.nih.gov/pubmed/26876342.
ix. Katki HA, Kovalchik SA, Berg CD, et al. Development and validation of risk models to select ever smokers for CT lung cancer screening. JAMA 2016;315:2300 2311. Available at: https://www.ncbi.nlm.nih.gov/pubmed/27179989.
x. Li K, Husing A, Sookthai D, et al. Selecting high risk individuals for lung cancer screening: a prospective evaluation of existing risk models and eligibility criteria in the German EPIC cohort. Cancer Prev Res (Phila) 2015;8:777 785. Available at: https://www.ncbi.nlm.nih.gov/pubmed/26076698.
xi. Tindle HA, Stevenson Duncan M, Greevy RA, et al. Lifetime Smoking History and Risk of Lung Cancer: Results From the Framingham Heart Study [published correction appears in J Natl Cancer Inst 2018;110(10):1153]. J Natl Cancer Inst 2018;110:1201-1207. Available at: https://pubmed.ncbi.nlm.nih.gov/29788259/.
xii. Ebbert JO, Yang P, Vachon CM, et al. Lung cancer risk reduction after smoking cessation: observations from a prospective cohort of women. J Clin Oncol 2003;21:921-926. Available at: https://pubmed.ncbi.nlm.nih.gov/12610194/.
xiii. Yang P, Wang Y, Wampfler JA, et al. Trends in Subpopulations at High Risk for Lung Cancer. J Thorac Oncol 2016;11:194-202. Available at: https://pubmed.ncbi.nlm.nih.gov/26811226/.
xiv. Howlader N, Noone AM, Krapcho M, et al (eds). SEER Cancer Statistics Review, 1975-2017, National Cancer Institute. Bethesda, MD, https://seer.cancer.gov/csr/1975_2017/, based on November 2019 SEER data submission, posted to the SEER web site, April 2020.
xv. Pinsky PF, Gierada DS, Hocking W, et al. National Lung Screening Trial findings by age: Medicare eligible versus under 65 population. Ann Intern Med 2014;161:627 633. Available at: https://www.ncbi.nlm.nih.gov/pubmed/25199624.
xvi. Koren JP, Bocage JP, Geis WP, Caccavale RJ. Major thoracic surgery in octogenarians: the video-assisted thoracic surgery (VATS) approach. Surg Endosc 2003;17:632-635. Available at: https://pubmed.ncbi.nlm.nih.gov/12582766/.
xvii. Pagès PB, Mariet AS, Madelaine L, et al. Impact of video-assisted thoracic surgery approach on postoperative mortality after lobectomy in octogenarians. J Thorac Cardiovasc Surg 2019;157:1660-1667. Available at: https://pubmed.ncbi.nlm.nih.gov/30711277/.
xviii. Feczko A, McKeown E, Wilson JL, et al. Assessing Survival and Grading the Severity of Complications in Octogenarians Undergoing Pulmonary Lobectomy. Can Respir J 2017;2017:6294895. Available at: https://pubmed.ncbi.nlm.nih.gov/28270738/.
xix. Blanchard EM, Arnaoutakis K, Hesketh PJ. Lung cancer in octogenarians. J Thorac Oncol 2010;5:909-916. Available at: https://pubmed.ncbi.nlm.nih.gov/20521358/.
xx. Kreinbrink P, Blumenfeld P, Tolekidis G, et al. Lung stereotactic body radiation therapy (SBRT) for early-stage non-small cell lung cancer in the very elderly (=80years old): Extremely safe and effective. J Geriatr Oncol 2017;8:351-355. Available at: https://pubmed.ncbi.nlm.nih.gov/28739159/.
xxi. Pham D, Bhandari S, Oechsli M, Pinkston CM, Kloecker GH. Lung cancer screening rates: Data from the lung cancer screening registry. JCO. 2018;36(15_suppl):6504-6504. doi:10.1200/JCO.2018.36.15_suppl.6504
xxii. Copeland A, Criswell A, Cuipek A, et al. Effectiveness of Lung Cancer Screening Implementation in the Community Setting in the United States | JCO Oncology Practice (ascopubs.org). DOI: 10.1200/JOP.18.00788 Journal of Oncology Practice 15, no. 7 (July 01, 2019) e607-e615.
xxiii. Lung CT Screening Reporting & Data System (Lung-RADS). https://www.acr.org/Clinical-Resources/Reporting-and-Data-Systems/Lung-Rads
xxiv. https://www.acr.org/Clinical-Resources/Incidental-Findings
xxv. Mazzone P, Powell CA, Arenberg D, Bach P, Detterbeck F, Gould MK, 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. 2015 Feb;147(2):295-303. doi: 10.1378/chest.14-2500. PMID: 25356819; PMCID: PMC4502754.
xxvi. Pinsky PF, Gierada DS, Black W, Munden R, Nath H, Aberle D, Kazerooni E. Performance of Lung-RADS in the National Lung Screening Trial: a retrospective assessment. Ann Intern Med. 2015 Apr 7;162(7):485-91. doi: 10.7326/M14-2086. PMID: 25664444; PMCID: PMC4705835.
xxvii. Fintelmann FJ, Bernheim A, Digumarthy SR, Lennes IT, Kalra MK, Gilman MD, Sharma A, Flores EJ, Muse VV, Shepard JA. The 10 Pillars of Lung Cancer Screening: Rationale and Logistics of a Lung Cancer Screening Program. Radiographics. 2015 Nov-Dec;35(7):1893-908. doi: 10.1148/rg.2015150079. Epub 2015 Oct 23. PMID: 26495797.
xxviii. Kazerooni EA, Austin JH, Black WC, Dyer DS, Hazelton TR, Leung AN, McNitt-Gray MF, Munden RF, Pipavath S; American College of Radiology; Society of Thoracic Radiology. ACR-STR practice parameter for the performance and reporting of lung cancer screening thoracic computed tomography (CT): 2014 (Resolution 4). J Thorac Imaging. 2014 Sep;29(5):310-6. doi: 10.1097/RTI.0000000000000097. PMID: 24992501.

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December 15, 2021

Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Submitted to: https://www.cms.gov/medicare-coverage-database

RE: Docket No. CAG-00439R, Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

To Whom It May Concern:

On behalf of the Smoking Cessation at Lung Examination (SCALE) Collaboration, an initiative sponsored by the National Cancer Institute (NCI) to conduct research on lung cancer screening and smoking cessation treatment, via 8 funded clinical trials, we thank CMS for the opportunity to offer comments on the national coverage determination for lung cancer screening with low dose computed tomography (LDCT). (1)

The 2015 Center for Medicare and Medicaid Services (CMS) decision to cover lung cancer screening (LCS) with low dose CT (LDCT) included the requirement that prior to screening, patients participate in shared decision making (SDM) and counseling on the importance of smoking cessation, and that radiology imaging facilities make smoking cessation interventions available for people who smoke. It is appropriate, essential, and feasible for Medicare beneficiaries to receive smoking cessation interventions at every touchpoint in the lung cancer screening process, including at the SDM visit, at the point of service for LDCT, at the time of disclosure of LDCT screening results, and at annual follow up LDCT visits. Therefore, we urge CMS to alter the proposed change in the national coverage determination and require and reimburse providers for smoking cessation counseling in conjunction with regular LDCT screening and SDM-Making appointments.

There is overwhelming evidence that requiring LCS settings to offer smoking cessation support enhances the health benefits of screening attributable to reductions in lung cancer and overall tobacco-related mortality. (2-4) Removing this requirement will diminish the overall benefit of LCS and the opportunity to reduce tobacco-related disparities. Below we outline the strong rationale and evidence for offering cessation support in the context of LCS.

First, approximately 54% of individuals seeking LCS report current cigarette use. (5) With the 2021 United States Preventive Service Task Force’s (USPSTF) expansion of LCS eligibility criteria, the total number of smokers who are referred for LCS will grow substantially.(6) For practical reasons, offering smoking cessation support to all smokers seeking LDCT provides an unprecedented opportunity to reach smokers and offer evidence-based smoking cessation interventions.

Second, the LDCT visit, and at the time patients receive results, both represent “teachable moments” when the health risk of tobacco use is most salient, and therefore smokers may be more willing to engage in tobacco use treatment.(7) Prior studies have demonstrated that smokers seeking LDCT are more worried about lung cancer and motivated to quit smoking than the general population.(8) On the other hand, there remains concern that smokers with negative scans will experience a “license to smoke” in the absence of abnormal findings. Providing onsite education about the risks of persistent smoking and the benefit of cessation is likely to attenuate the unintended risk of lowering quitting motivation for individuals with negative scan findings.

Third, tobacco dependence is a chronic, relapsing disorder that, like other chronic diseases, often requires repeated intervention and support. Most people who use tobacco want to quit and may try to quit multiple times before succeeding. These facts underlie the recommendation to make cessation support available at every point of contact in the health care system. According to the 2020 US Surgeon General’s Report “numerous healthcare professionals can treat nicotine addiction in smokers. Thus, by extension, the various settings in which such professionals work represent appropriate venues for providing these services.” (9) Applying this to the context of LCS, the USPSTF (2021) recommends that “because persons may enter screening through pathways besides referral from primary care,” cessation interventions should be incorporated into LCS programs. The potential lag time between the primary care shared decision-making visit and the LDCT scan provides an additional rationale for cessation support at the time of screening. Patients may not have been ready to quit at the time they were referred for LDCT. The absence of additional support at the time of screening is a missed opportunity to reinforce the benefits of cessation and remove barriers for accessing smoking cessation treatment. In sum, the provision of information about the health benefits of tobacco cessation and smoking cessation support should occur at every patient visit along the clinical pathway for lung cancer screening, including at the time of the LDCT scan.

Fourth, effective smoking cessation interventions, offered at the time of LCS, enhance the impact of LDCT by averting premature death related to other tobacco-related chronic diseases. (2,3) Meza and colleagues modeled the impact of bundling LDCT screening and cessation interventions on lung cancer and overall mortality. In terms of life-years gained, adding a cessation intervention of modest effectiveness (i.e., 15%) to LDCT screening results in gains in life years saved that are comparable to increasing screening uptake from 30% to 100%. (2) During the last meeting of the National Cancer Advisory Board, Dr. Ned Sharpless, National Cancer Institute Director, highlighted these findings and the need to incorporate cessation programs into screening practice to maximize overall benefits. Other research has demonstrated that smoking cessation interventions provide benefits at reasonable costs. (4)

Finally, the prevalence of smoking is increasingly concentrated in the U.S. in priority populations that may face barriers to quitting. These include persons with poor access and low utilization of primary care, including individuals with behavioral health conditions (i.e., mental health conditions, substance use disorders), persons of low socioeconomic status, and specific racial and ethnic minorities. (9) Disparities in access and utilization of tobacco use treatment contribute to the growing disparities in tobacco-related health outcomes. Similarly, the prevalence of key indicators of smoking cessation—quit attempts, receiving advice to quit from a health professional, and using cessation therapies—also varies across the population, with lower prevalence among these same groups. The revised USPSTF recommendations will substantially increase the number of racial and ethnic minorities eligible for screening and likely reduce disparities in lung cancer screening eligibility. (10) This change creates new opportunities for increasing access to cessation treatment among these underserved populations, and further emphasizes the importance of requiring that patients are connected to treatment resources at each point of contact across the lung cancer screening care continuum.

All major medical and professional organizations have endorsed making smoking cessation services available in the context of lung cancer screening. The American College of Chest Physicians’ (CHEST) guidelines specifically recommended that evidence-based tobacco cessation treatment should be provided by LDCT screening programs. The CMS proposal to remove the requirement for radiology imaging facilities to offer even minimal cessation advice, quitting resources and referral information is short-sighted and will lead to missed opportunities to engage high-risk people who smoke in tobacco use treatment. While acknowledging that more research on strategies for optimizing smoking abstinence in the context of lung cancer screening is needed, that does not preclude integrating what we know works as a routine part of LCS program services.

We recommend that rather than reverse the 2015 CMS cessation support requirements related to LCS settings, the recommendations should be strengthened to specify the provision of behavioral and pharmacologic cessation treatment options that are consistent with current guidelines at both the point of referral and the LCS visit.(9) There are a range of safe and effective tobacco use treatment interventions, including evidence-based state and national cessation resources to which LCS programs could easily refer patients for treatment. These include national Quitlines in all 50 states. Specifically, we recommend that at a minimum, all LCS sites should be required to adopt the Centers for Disease Prevention and Control recommended Ask, Advise, Refer (AAR) or Connect (AAC) brief tobacco treatment models.(11) This includes the following steps: 1) Ask all patients about current tobacco use; 2) Provide clear advice to quit and information (e.g., it is not too late to benefit from smoking cessation, quitting saves lives even after a lung cancer diagnosis);(12) and 3) Refer patients to evidence-based tobacco cessation treatment (e.g., provide a list of smoking cessation resources that include free telephone-based state tobacco Quitlines and the National Cancer Institute’s text-messaging quit smoking program).(9,10) One particularly effective approach to engaging people who smoke in treatment is to actively connect tobacco users at the point of service to a resource like a state Quitline (i.e., AAC).(11) An important advantage of the AAR or AAC models is that they can be delivered by site coordinators or administrative staff in LCS programs in which health care professionals are not readily available.

This brief model for providing cessation support is particularly relevant for Independent Diagnostic Testing Facilities (IDTFs) in which health care professionals are not readily available. Even these LCS sites can implement an Ask, Advise and Refer model, or at a minimum, provide handouts with information for the Quitline and other services.

Additional evidence for effective models for delivering cessation interventions that are feasible in the context of LCS are emerging from the SCALE Collaboration. These trials include 57 different LCS sites and have, to date, enrolled more than 4,500 participants, demonstrating the feasibility of engaging people who smoke at various times during the LCS process and indicating smokers’ interest in receiving cessation support in this context. (13) Early outcomes from one study confirmed that a telephone-based cessation intervention in the LCS setting is cost effective. Findings from another study have informed the design of a tool kit that uses an algorithm based on a clinic’s available resources to guide the process of integrating smoking cessation support during the lung screening encounter. LCS program site coordinators enrolled in another of the national trials reported that identifying tobacco users and referring patients to state Quitlines was highly feasible and an important component of the LCS process. SCALE studies will continue to contribute important information about the feasibility, design, and implementation of smoking cessation interventions in the context of LCS to optimize patient engagement and outcomes.

In conclusion, there is overwhelming evidence that promoting the integration of smoking cessation support and treatment within the context of lung cancer screening saves lives. In addition, there are cost effective models for referring and connecting patients to evidence-based interventions that are highly feasible to implement across the full range of LCS settings. In 2015, the CMS coverage determination mandating offering smoking cessation in the context of lung cancer screening was seen as a forward-thinking breakthrough in reducing the burden of lung cancer. Now more than ever, members of the SCALE Collaboration recommend that CMS continue to support the delivery of at least brief tobacco treatment within the context of lung cancer screening, including, but not limited to smoking cessation support provided at the point of service at the radiology imaging facility.

Sincerely,

The SCALE collaborative
Donna Shelley, MD MPH, NYU School of Global Public Health, Paul Cinciripini, PhD, University of Texas MD Anderson Cancer Center, Kristie L. Foley, PhD, Wake Forest University Health Sciences, Anne M. Joseph, MD, MPH, University of Minnesota, Jeanne S. Mandelbatt, MD, Georgetown University, Rafael Meza, PhD, University of Michigan School of Public Health, Jennifer Minnix, PhD, University of Texas MD Anderson Cancer Center, Jamie S. Ostroff, PhD, Memorial Sloan Kettering Cancer Center, Elyse Park, PhD, Massachusetts General Hospital, Nancy Rigotti, MD, Massachusetts General Hospital, Alana Rojewski, PhD, Medical University of South Carolina, Kathryn Taylor, PhD, Georgetown University, Benjamin Toll, PhD, Medical University of South Carolina, Randi Williams, PhD, Georgetown University, Steven Zeliadt, PhD, MPH, University of Washington School of Public Health

1. Smoking Cessation at Lung Examination (SCALE) Collaboration https://cancercontrol.cancer.gov/brp/tcrb/scale-collaboration
2. Meza R, Cao P, Jeon J, Taylor KL, Mandelblatt JL, Feuer EJ. Impact of Joint Lung Cancer Screening and Cessation Interventions Under the New Recommendations of the U.S. Preventive Services Task Force. J Thorac Onc. Published online: October 11, 2021
3. Cao P, Jeon J, Levy DT, et al. Potential impact of cessation interventions at the point of lung cancer screening on lung cancer and overall mortality in the United States. J Thorac Oncol. 2020; 15: 1160-1169.
4. Cadham CJ, Jayasekera JC, Advani SM, et al. Smoking cessation interventions for potential use in the lung cancer screening setting: a systematic review and meta-analysis. Lung Cancer. 2019; 135: 205-216.
5. Richards TB, Soman A, Thomas CC, VanFrank B, Henley SJ, Gallaway MS, Richardson LC. Screening for lung cancer—10 states, 2017. Morbidity and Mortality Weekly Report. 2020 Feb 28;69(8):201.
6. Potter AL, et al. The 2021 USPSTF lung cancer screening guidelines: a new frontier. Lancet Respir Med. 2021. Jul;9(7):689-691.
7. Hahn EJ, Rayens MK, Hopenhayn C, Christian WJ. Perceived risk and interest in screening for lung cancer among current and former smokers. Res Nurs Health. 2006;29:359–370.
8. Anderson CM, Yip R, Henschke CI, Yankelevitz DF, Ostroff JS, Burns DM. Smoking cessation and relapse during a lung cancer screening program. Cancer Epidemiol Biomarkers Prev. 2009;18(12):3476-3483. doi:10.1158/1055-9965.EPI-09-0176.
9. U.S. Department of Health and Human Services. Smoking Cessation. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2020.
10. Ritzwoller DP, Meza R, Carroll NM, Blum-Barnett E, Burnett-Hartman AN, Greenlee RT, Honda SA, Neslund-Dudas C, Rendle KA, Vachani A.Evaluation of Population-Level Changes Associated With the 2021 US Preventive Services Task Force Lung Cancer Screening Recommendations in Community-Based Health Care Systems. JAMA Netw Open. 2021 Oct 1;4(10):e2128176.
11. Piñeiro B, Vidrine DJ, Wetter DW, Hoover DS, Frank-Pearce SG, Nguyen N, Zbikowski SM, Vidrine JI. Implementation of Ask-Advise-Connect in a safety net healthcare system: quitline treatment engagement and smoking cessation outcomes. Transl Behav Med. 2020 Feb 3;10(1):163-167.
12. Rigotti NA. Treating Tobacco Smoking After the Diagnosis of Lung Cancer: It's Not Too Late and a Call to Action. Ann Intern Med. 2021 Sep;174(9):1317-1318.
13. Joseph AM, Rothman AJ, Almirall D, Begnaud A, Chiles C, Cinciripini PM, Fu SS, Graham AL, Lindgren BR, Melzer AC, Ostroff JS, Seaman EL, Taylor KL, Toll BA, Zeliadt SB, Vock DM. Lung Cancer Screening and Smoking Cessation Clinical Trials. SCALE (Smoking Cessation within the Context of Lung Cancer Screening) Collaboration. Am J Respir Crit Care Med. 2018 Jan 15;197(2):172-182.

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I have been researching the risks and benefits of cancer screening for over 10 years. We have consistently found that information is frequently not presented in a clear manner to patients, rendering informed decision-making challenging. As such, I am greatly concerned that CMS is considering a "one-two punch" of expanding clinical eligibility for lung cancer screening, while at the same time relaxing the requirements for informed decision making. Specifically, the new "simplification" of SDM is actually removing the core elements of shared decision-making. This is not a "simplification' - the CMS proposal removes the explicit requirement that SDM must include benefits and harms of screening, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure. Given that prior research has demonstrated - again and again - that shared decision-making is sub-optimal - it is not in the best interests of Medicare beneficiaries to decrease the expectations of SDM as applied to lung cancer screening.

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Dec 14, 2021

Dear Centers for Medicaid & Medicare Services Committee Members,
Regarding (CAG-00439R)

We would like to make the CMS LDCT Lung Screening Assessment Committee aware of our recently published article in Lancet Oncology on the results of the International Lung Screening Trial (ILST). (A copy of the article is attached along with an accompanying editorial, if the CMS website allows.) The article is:

USPSTF2013 versus PLCOm2012 lung cancer screening eligibility criteria (International Lung Screening Trial): interim analysis of a prospective cohort study

Authors: Martin C Tammemägi, Mamta Ruparel, Alain Tremblay, Renelle Myers, John Mayo, John Yee, Sukhinder Atkar-Khattra, Ren Yuan, Sonya Cressman, John English, Eric Bedard, Paul MacEachern, Paul Burrowes, Samantha L Quaife, Henry Marshall, Ian Yang, Rayleen Bowman, Linda Passmore, Annette McWilliams, Fraser Brims, Kuan Pin Lim, Lin Mo, Stephen Melsom, Bann Saffar, Mark Teh, Ramon Sheehan, Yijin Kuok, Renee Manser, Louis Irving, Daniel Steinfort, Mark McCusker, Diane Pascoe, Paul Fogarty, Emily Stone, David C L Lam, Ming-Yen Ng, Varut Vardhanabhuti, Christine D Berg†, Rayjean J Hung, Samuel M Janes, Kwun Fong*, Stephen Lam* Lancet Oncol 2021 Published Online December 10, 2021 https://doi.org/10.1016/ S1470-2045(21)00590-8

The findings of this study are relevant to your current considerations.
The ISLT is a large, multinational, prospective study of the implementation of CT lung screening in 4 countries with 5819 participants. Eligibility to participate in screening was determined by meeting either the United States Preventive Services Task Force 2013 (USPSTF2013) categorical age and smoking history criteria or by lung cancer risk prediction model threshold (PLCOm2012). ILST results showed that PLCOm2012 risk eligibility criteria were more efficient than the USPSTF criteria.

The PLCOm2012 had a significantly greater cancer detection rate (sensitivity) than the USPSTF criteria.
Individuals selected for screening by the PLCOm2012 were slightly older, had slightly more comorbidities and shorter life expectancies than the USPSTF-selected individuals. However, because many more individuals were identified by the PLCOm2012 criteria who were diagnosed with lung cancer, the cumulative life-years potentially gainable in those diagnosed with lung cancer was significantly greater in the PLCOm2012-selected individuals than in the USPSTF-selected individuals.

Also importantly, although more men were enrolled in ILST, significantly more women were diagnosed with lung cancer than men and the PLCOm2012 identified significantly more lung cancers in women than the USPSTF criteria did. This is important in overcoming sex disparities, which is now becoming a recognized problem using USPSTF-like criteria, including both the USPSTF 2013 and 2021 criteria.(Reference 1)
Past studies which have demonstrated the superiority of using an accurate risk prediction model over categorical age-smoking criteria have been retrospective or used microsimulation modeling. This is the first study which is prospective, large and multinational. The study design is equivalent in validity to a randomized control trial in that confounding and selection biases have been minimized, as all individuals have been evaluated by both criteria and are thus matched on themselves. Consequently, the findings carry considerable credibility.

In summary, we recommend that you consider the new evidence we present here, and that you consider incorporating using an accurate risk prediction model in your screening criteria. Links to article
https://authors.elsevier.com/sd/article/S1470-2045(21)00590-8

USPSTF2013 versus PLCOm2012 lung cancer screening eligibility criteria (International Lung Screening Trial): interim analysis of a prospective cohort study - The Lancet Oncology

Risk-based lung cancer screening eligibility criteria: towards implementation - The Lancet Oncology

Sincerely,
Martin Tammemägi
Alain Tremblay
David Lam
Sam Janes
Kwun Fong
Stephen Lam
For the International Lung Screening Trial Research Team

1. Pasquinelli MM, Tammemagi MC, Kovitz KL, et al. Addressing Gender Disparities in Lung Cancer Screening Eligibility: USPSTF versus PLCOm2012 Criteria. Chest 2021.

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We appreciate the opportunity to provide comments on the reconsideration of the national coverage determination regarding screening for lung cancer with low dose computed tomography (LDCT).

We strongly urge CMS to reconsider multiple provisions focused on Counseling and Shared Decision-Making in its Proposed Decision Memo.

First, CMS states, “Professional societies and provider groups have noted that providers have gained considerable experience and expertise and believe flexibility will reduce burden. We propose to remove specificity regarding the type of provider who must furnish the counseling and shared decision-making and remove some specificity around documentation of the information on the beneficiary eligibility criteria.” Such specifications that no longer need to be discussed “include benefits and harms of screening, follow-up diagnostic testing, over-diagnosis, false positives, and total radiation exposure”.

We find no evidence to support the assessment that providers have gained considerable experience and expertise. A peer-reviewed publication (Brenner AT et al JAMA Intern Med 2018) in which recorded conversations of 14 patients were analyzed demonstrated that the quality of shared decision-making was poor. Physicians were universally positive about LDCT and almost never discussed harms. They spent less than 1 minute, on average, discussing LDCT. Despite CMS’ requirements, there was no evidence of the use of decision aids. We think that this study demonstrates significant concern about the quality of shared decision-making that physicians do not lack expertise; they are, in general, providing biased information to patients that is likely to lead to many patients getting screened who would not otherwise want screening and is likely to lead to harms including unnecessary additional testing and biopsies and surgeries, as well as decisional regret. Rather than increase flexibility around what should be discussed during SDM, we think it is more helpful for CMS to provide more clear guidance on what should be included in SDM encounters, given that this encounter is reimbursable. One option would be to require a checklist of the key facts about risks and benefits of LDCT, in which a patient has initialed receipt and understanding of their risks and benefits.

CMS also notes that, given that there are not recommendations in multiple other policy statements and guidelines, that the agency proposes to remove the type of practitioner who can engage in the SDM encounter. CMS proposes that SDM can be performed by “other health care practitioners, such as health educators and others beyond physicians or non-physician practitioners. This proposed change may broaden access to LDCT screening.”

We firmly disagree with this recommendation. SDM should be performed by clinicians who know the patient well, generally clinicians in primary care. Additionally, if there are abnormal findings – as there commonly are – these will be followed up by a clinician in primary care; they will not be followed by health educators. The SDM encounter also provides a critical opportunity for the discussion of smoking cessation for CMS beneficiaries with active tobacco use; smoking cessation is undoubtedly the most important intervention for these patients. Clinicians in primary care are the best equipped to provide this counseling, including offering resources that may assist with smoking cessation.

Additionally, CMS states that “To reduce the burden of documentation paperwork, we propose removing the specifications for the components of the shared decision-making tools. We believe this is appropriate as the tools and guidance has matured since the early inception of shared decision-making.”

However, CMS does not offer any evidence that the tools and guidance have matured. We urge CMS to provide further guidance on the decision-making tools, based on the peer-reviewed literature.

The proposed decision memo also states, “Another reason for removing the detailed data elements is that we are proposing to remove the low dose CT lung cancer screening registry requirement” with the reasoning being “We believe the results of three studies fulfill the purpose of the low dose CT lung cancer screening registry which is to study the clinical benefit of low dose CT screening.”

The role of registries in health care is valuable and needed. They can provide data-driven insights to better understand clinical outcomes, make evidence-based decisions, and determine best practices in care. The removal of an important data collection and evidence generation mechanism is concerning because future studies that may come about from the lung cancer screening registry data, beyond the three cited in the proposed decision memo, may serve as aids to all seeking to understand the clinical benefits of low dose CT screening. Thus, we urge CMS to maintain the requirement for radiology imaging facilities to participate in the Lung Cancer Screening registry, as the benefits of registry data collection outweigh the “burden of administrative paperwork on providers and institutions” (as phrased in the proposed decision memo) that they may bring about. Furthermore, we urge CMS to make the Lung Cancer Screening registry (maintained by the American College of Radiology) publicly available, so all can benefit from its information.

Finally, CMS also requires SDM documentation for placement of implantable cardioverter-defibrillators and use of left atrial appendage occlusion devices. Although not relevant to this specific NCD, we firmly urge CMS to strengthen these requirements.

Sanket S. Dhruva, MD, MHS
Rita F. Redberg, MD, MSc
Robin Ji, BA

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Comment on a Proposed Decision Memorandum:
Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)
CAG-00439R
Frederic W. Grannis Jr. MD
Long Beach, CA

It is time long past due for the Centers for Medicare and Medicaid Services (CMS) to review and revise its restrictive eligibility criteria as well as its experimental requirements for shared decision making (SDM), use of decision aids (DA) and electronic data entry in CT lung cancer screening (LCS). The decision by CMS in 2014 to provide first dollar coverage, but also to tightly restrict eligibility and to require SDM using DA, to require special certification of radiologists and to require electronic data registration of data were injudicious and have caused considerable harm during the intervening years.

Specifically, each of these regulations created barriers that slow and/or restrict implementation of LCS and have led directly to disastrously low uptake of LCS. Although, Medicare first approved coverage of CT screening in the U.S., in 2014, multiple current surveys show very low national uptake of CT screening (2-6% screened, among those eligible). Although LCS uptake is as high as 16-20% in some states, in the largest state, California, only 1.1% are currently screened. An opportunity to save many lives has been squandered.

Many people, who might have had their lives saved by early-stage detection, diagnosis and treatment of lung cancer, have died unnecessarily. I and many others warned seven years ago that CMS provisions would restrict access to LCS for millions at high risk of the disease and that many deaths would ensue. These warnings were ignored by CMS.

The process by which the initial CMS decision on coverage of LCD was carried out was biased and improper from its inception. Specifically, when CMS’s Medical Evidence Development Advisory Committee (MEDCAC) met in Bethesda, Maryland to discuss and vote on LCS coverage, in April 2014, the deck was heavily stacked against screening. Doctor Rita Redberg, a vocal critic of radiographic screening was appointed to chair the proceedings. She repeatedly cited major risks of radiation carcinogenesis from diagnostic CT scans and appeared to favor speakers against LCS implementation. Peter Bach MD, a long-term and vociferous opponent of LCS, was chosen to present the evidence. Bach was a former chief advisor to the Director of CMS who had not reported this employment in his many published articles on LCS.

The panel that was chosen to review and vote on implementation of LCS represented a stacked deck. For example, four panelists (Dr. Mark Grant, PhD; Dr. Jo Carol Hiatt; Dr. Curtis Mock; and Dr. Michael Gould) worked for healthcare payors (Blue Cross, United Healthcare, and Kaiser). Another panelist (Dr. Jeffrey Rich) neglected to disclose that he was a former director of Medicare.

Michael Gould had been a co-author, with Bach, of a 2012 article urged using SDM and a specific DA in LCS. The panel gave LCS very low scores and recommended against CMS coverage of LCS.

At the MEDCAC meeting, Bach told the audience that he had no potential conflicts of interest and yet, in an op-ed Bach wrote for the Washington Post[4] in 2015, he listed numerous sources of funding for his work from industry, including:

• Association of Community Cancer Centers
• America’s Health Insurance Plans
• AIM Specialty Health
• American College of Chest Physicians
• American Society of Clinical Oncology
• Barclays
• Defined Health
• Genentech
• Goldman Sachs
• McKinsey and Company
• MPM Capital
• National Comprehensive Cancer Network
• Biotechnology Industry Organization
• American Journal of Managed Care
• Boston Consulting Group
• Anthem Inc.

During an intermission, I reported to the attorney representing MEDCAC and CMS, Tamara Syrek Jensen, JD, that Peter Bach had many unreported conflicts of interest with respect to lung cancer screening. She shrugged and took no action.

The origin of the CMS requirement for SDM is clear. During the MEDCAC proceedings, although Bach had consistently advised against coverage of LCS, he went on to advise that if CMS chose to cover LCS, it be tightly restricted to those at very high risk - those 55 years and older, including only those up to age 74 - as per NLST eligibility criteria, with 30 pack-years of exposure and who had quit not more than 15 years earlier. Both a transcript and a video of his presentation are accessible on the Internet.
Although CMS chose to ignore the recommendation by MEDCAC, against coverage of LCS, they adopted the provisions suggested by Bach. Specifically, SDM using DA was mandatory. Second, LCS would be restricted to those above age 55 and up to age 77. Third, a 30 pack-year minimum of tobacco exposure would be required. Fourth, radiologists providing LCS services must be specially registered. Fifth, data from screening programs must be collected in electronic databases and reported to CMS. For emphasis, these are all provisions that were specifically recommended by Bach to MEDCAC/CMS.

Each of these provisions has proven ill advised. As noted in the current proposed decision memorandum, CMS is recommending, to reduce eligibility exclusions; i.e. to provide coverage for people between the ages of 50 and 80 years of age, with twenty or more pack-years exposure. This decision is based on strong evidence, showing that the previous criteria restricted access to millions of people at known high risk and specifically have resulted in major disparity among racial minorities and the underserved. The criteria set by CMS in 2014 exclude approximately 2/3 of patients diagnosed with lung cancer in the United States today. The decision of CMS to now expand eligibility criteria is wise, just and long past due.

I do not have sufficient information or expertise to comment in greater detail on the wisdom of requiring registration of radiologists or of requiring electronic database, except to say that these requirements will tend to restrict the number of centers available to patients at risk and accordingly will reduce uptake of lung cancer screening in the United States, particularly in rural and underserved urban locations.

The most damaging of the errors CMS made in 2014 was the requirement of SDM using DA. Public policy is supposed to be based on strong evidence. A Pub Med search on shared decision making in lung cancer screening shows no publications prior to April 2014. There was, accordingly, zero data on the effects of SDM in LCS. A recent review demonstrates that even today evidence is sparse that SDM has even a minor benefit. Furthermore, no other form of cancer screening has mandated SDM with DA. It was both improper and a major error to incorporate an experimental, untried public health policy, not supported by strong evidence. That experiment has clearly failed, as indicated by very low uptake of LCS throughout the country.

Far worse, was the CMS requirement for use of DA. When Bach recommended mandatory use of DA as part of the LCS process, he clearly intended that his own DA be used in SDM. This is exactly what ensued. When I searched the Internet for LCS DA a few years ago I found eight medical society decision aids that all contained the same misinformation and stadium graphics, culled from the Bach and Gould 2012 manuscript. Specifically, these DA told individuals considering LCS that, if they had lung cancer and it was detected by CT screening, only 21% would be cured and that four of five would “sneak through” to die from lung cancer. They also included information suggesting that 320 people would need to be screened to save one life, and that many people would be harmed by screening. DA informed readers that the rate of false positives would be very high and many people would have invasive procedures, with complications and deaths in the process of work up. DA also warned that a high percentage of those diagnosed with lung cancer would have overdiagnosed cancers; that would never cause symptoms or kill, but would be treated, without any potential benefit. All of this information was gratuitously inaccurate. Multiple publications from the National Lung Screen Trial (NLST), IELCAP and other large research trials provide far different information.

A large majority of patients diagnosed with lung cancer by LCS survive after ten years. LC survival after CT screening detection in NLST is 62% and is 82% in the IELCAP study. Overdiagnosis is very uncommon. There are very few excess lung cancers in the NLST CT screening arm; i.e. there is no empirical evidence of putative overdiagnosis.

With respect to the oft quoted estimate that 320 must be screened to save one life, long term follow-up of a high-risk group at the university of Toronto showed incidence of lung cancer in a high-risk group to exceed 20% at ten years; i.e. one in five. Using the survival experience from NLST, i.e. with 62% of CT diagnosed cancers surviving long term, the number needed to save a life would approximate one in eight, forty times more favorable than the current DA estimate.

False positives and invasive procedures on patients without lung cancer are uncommon. There is general agreement that the benefits of LCS far outweigh the risks.

Second, the chance that a patient diagnosed by CT screening, properly conducted, using modern LCS diagnostic algorithms, will be cured is 80%, ti.e. four of five will experience long time cure and only one will go on to die from lung cancer.

Similarly, the incidence of false positives cited in most DA is far higher than has been recorded in multiple large experiment employing modern methods. For example, in a large RCT using a defined diagnostic algorithm, false positives were not a significant clinical problem. ”This means that 264 of 22,600 screened participants over all rounds (1.2%) had a false positive test. No adverse events were reported. “

The harm resulting from the bad decisions that CMS made in following Dr. Bach’s recommendations is clear. As detailed above, a number of published articles show, unquestionably, that uptake of LCS in the United States since 2014 has been dismally low. Why?

A recent Veteran’s administration study illustrates the harm caused by misinformation in SDM DA. In the words of Otis Brawley MD.

“When consenting is done right, 42% of screening candidates in the Veterans Health Administration system refused screening.”

We can estimate, conservatively, that 10% of veterans at high risk who decide not to be screened will develop lung cancer over a decade and that more than 80% of them will die of lung cancer. Thus, if 10,000 veterans are provided SDM - in current format- 4200 will refuse screening. 420 will develop lung cancer over the next 10 years and 336 die of lung cancer – specifically because inaccurate information in a DA convinced them that screening was not in their self-interest.

CMS should also remove the exclusion of those who quit smoking more than 15 years earlier. We know, from clinical practice of thoracic surgery, that a very high percentage of patients who are currently being treated for lung cancer, had quit smoking more than 15 years earlier. Continued exclusion of former heavy smokers who quit 15 years earlier will continue to result in large numbers of unnecessary deaths.

Although certification for special expertise and rigorous collection of electronic data are desirable features of clinical medicine, they also make it more difficult for smaller hospitals and freestanding radiology clinics to comply. Such provisions are expensive and require information technology infrastructure that many smaller facilities cannot meet. This will predictably result in diminished access to LCS, particularly in rural underserved urban areas.

Most harmful is the provision of inaccurate information in the process of SDM. It is axiomatic that, if you give patients bad information, they will predictably make unwise decisions.

When an individual at known high risk of lung cancer is told that their chance of cure is only one in five with CT screening, this misinformation will predictably have a powerful negative effect on their decision. Similarly, informing people that there is a high chance that they have a lung cancer that will never cause symptoms or kill them, and that they will receive surgery with possible complications or death, is also a strong deterrent against their acceptance of a recommendation for lung cancer screening.

Grossly inaccurate information regarding the percentage of false positives in current screening practice will have a further deterrent effect on acceptance of LCS among those at risk. The Coverage and Analysis Group should carefully weigh the information above in their final decision-making process. It is too late for the thousands of unfortunate individuals, who died in the past seven years, either excluded from LCS by eligibility criteria or dissuaded from participation by misinformation in biased and inaccurate DA, but there is an opportunity to save hundreds of thousands of lives in the future – if CMS actions are wise and just now.

1. CMS must rescind its mandate on shared decision making in lung cancer now.
2. Inaccurate decision aids must be discarded and replaced with documents, web sites and videos that provide timely and accurate information on benefits and risks of lung cancer screening.
3. Individuals with prior lung cancer or high risk who quit more than 15 years prior must not be excluded from LCS eligibility.

It is also long past due for CMS to investigate whether Peter Bach was truthful when he reported no conflicts of interest with regard to LCS to MEDCAC in 2014 and consider whether it is appropriate for him to participate in future CMS policy on lung cancer screening.

CMS should also review whether Tamara Syrek Jensen acted appropriately in her duty to investigate a report of failure to disclose conflict of interest on April 20, 2014. This is particularly appropriate since Jensen is the Director of the Coverage & Analysis Group that will make the final decision on these critically important issues.

References:

NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Tracking Sheet (cms.gov)
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N) - Decision Memo (cms.gov)
Jemal A, Fedewa SA. Lung Cancer Screening With Low-Dose Computed Tomography in the United States-2010 to 2015. JAMA Oncol. 2017 Sep 1;3(9):1278-1281. doi: 10.1001/jamaoncol.2016.6416.PMID: 28152136 v
Li J, Chung S, Wei EK, Luft HS. New recommendation and coverage of low-dose computed tomography for lung cancer screening: uptake has increased but is still low. BMC Health Serv Res. 2018;18(1):525.
Bian Liu, PhD,a,* Kavita Dharmarajan, MD,b Claudia I. Henschke, PhD, MD,c and Emanuela Taioli, MD, PhDa State-Level Variations in the Utilization of Lung Cancer Screening Among Medicare Fee-for-Service Beneficiaries: An Analysis of the 2015 to 2017 Physician and Other Supplier Data. Chest. 2020 Apr; 157(4): 1012–1020. doi: 10.1016/j.chest.2019.11.005 PMCID: PMC7768942 PMID: 31759960
Triplette M, Thayer JH, Pipavath SN, Crothers K. Poor Uptake of Lung Cancer Screening: Opportunities for Improvement. .J Am Coll Radiol. 2019 Apr;16(4 Pt A):446-450. doi: 10.1016/j.jacr.2018.12.018. Epub 2019 Feb 15.PMID: 30777648
Patrick C. Yong, MPH,a,* Keith Sigel, MD, PhD,a Sadiq Rehmani, MD,a Juan Wisnivesky, MD, DrPH,a,b and Minal S. Kale, MD, MPHb Lung Cancer Screening Uptake in the United States Chest. 2020 Jan; 157(1): 236–238. PMCID: PMC7609956 PMID: 31916962
Fedewa SA, Kazerooni EA, Studts JL, Smith RA, Bandi P, Sauer AG, Cotter M, Sineshaw HM, Jemal A, Silvestri GA. State Variation in Low-Dose Computed Tomography Scanning for Lung Cancer Screening in the United States. J Natl Cancer Inst. 2021 Aug 2;113(8):1044-1052. doi: 10.1093/jnci/djaa170.PMID: 33176362
New decision aids may revamp CT lung cancer screening (auntminnie.com) Grannis FW Jr. CT lung screening meeting: A travesty of public health policy. AuntMinnie.com website. https://www.auntminnie.com/index.aspx?sec=ser&sub=def&pag=dis&ItemID=107339. Published May 8, 2014.
Grannis FW Jr. CT lung screening meeting: A travesty of public health policy. AuntMinnie.com website. https://www.auntminnie.com/index.aspx?sec=ser&sub=def&pag=dis&ItemID=107339. Published May 8, 2014.
MEDCAC Meeting 4/30/2014 - Lung cancer screening with low dose computed tomography. Centers for Medicare and Medicaid Services website. https://www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=68&NCAId=6&. Accessed March 8, 2021
Grannis FW Jr. There are major problems with the American College of Chest Physicians Second Lung Cancer Guidelines. Chest. 2008 Apr;133(4):1049; author reply 1050-1. doi: 10.1378/chest.07-2419.PMID: 18398132
Bach PB, Gould MK. When the average applies to no one: Personalized decision making about potential benefits of lung cancer screening. Ann Intern Med. 2012;157:571-573.
Peter Bach Why the U.S. should pay Irish drug prices if Pfizer wants to pay Irish tax rates. Washington Post, December 7, 2015. , , accessed December 10, 2021.
MEDCAC Meeting 4/30/2014 - Lung Cancer Screening with Low Dose Computed Tomography https://www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=68
Matthew Bin Han Ong. CMS Advisors Express Low Confidence In Low-Dose CT Screening for Lung Cancer The Cancer Letter

May 9, 2014 Vol. 40 No. 19
Pasquinelli MM, Tammemägi MC, Kovitz KL, Durham ML, Deliu Z, Rygalski K, Liu L, Koshy M, Finn P, Feldman LE. Risk Prediction Model Versus United States Preventive Services Task Force Lung Cancer Screening Eligibility Criteria: Reducing Race Disparities. J Thorac Oncol. 2020 Nov;15(11):1738-1747. doi: 10.1016/j.jtho.2020.08.006. Epub 2020 Aug 18.PMID: 32822843
Wu GX, Goldstein L, Kim JY, Raz DJ.Proportion of Non-Small-Cell Lung Cancer Patients that Would Have Been Eligible for Lung Cancer Screening. Clin Lung Cancer. 2016 Sep;17(5):e131-e139. doi: 10.1016/j.cllc.2016.01.001.
Tools to Promote Shared Decision-Making in Lung Cancer Screening Using Low-Dose CT Scanning: A Systematic Review Fukunaga MI. CHEST. 2020 158 2646-2657.
Sands J, Tammemägi MC, Couraud S, et al. Lung screening benefits and challenges: A review of the data and outline for implementation. Thorac Oncol. 2021;16(1):37-53.
International Early Lung Cancer Action Program Investigators, Henschke CI, Yankelevitz DF, Libby DM, Pasmantier MW, Smith JP, Miettinen OS. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med. 2006 Oct 26;355(17):1763-71. doi: 10.1056/NEJMoa060476.PMID: 17065637
Yip R, Henschke CI, Yankelevitz DF, Boffetta P, Smith JP; International Early Lung Cancer Investigators. The impact of the regimen of screening on lung cancer cure: a comparison of I-ELCAP and NLST. Eur J Cancer Prev. 2015 May;24(3):201-8. doi: 10.1097/CEJ.0000000000000065.PMID: 25089376
Gierada DS, Pinsky PF. Survival following detection of stage I lung cancer by screening in the National Lung Screening Trial. Chest. 2021;159(2):862-869.
National Lung Screening Trial Research Team. Lung cancer incidence and mortality with extended follow-up in the National Lung Screening Trial. J Thorac Oncol. 2019;14(10):1732-1742.
Grannis FW Jr. Lung cancer incidence and mortality with extended follow-up during screening. J Thorac Oncology. 2019;14(10):1692-1694.
Kavanagh J, Liu G, Menezes R, et al. Importance of long-term low-dose CT follow-up after negative findings at previous lung cancer screening. Radiology. 2018;289(1):218-224.
Harry J. de Koning, M.D., Ph.D., Carlijn M. van der Aalst, Ph.D., Pim A. de Jong, M.D., Ph.D., Ernst T. Scholten, M.D., Ph.D., Kristiaan Nackaerts, M.D., Ph.D., Marjolein A. Heuvelmans, M.D., Ph.D., Jan-Willem J. Lammers, M.D., Ph.D., Carla Weenink, M.D., Uraujh Yousaf-Khan, M.D., Ph.D., Nanda Horeweg, M.D., Ph.D., Susan van ’t Westeinde, M.D., Ph.D., Mathias Prokop, M.D., Ph.D., et al. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial (NELSON.) N Engl J Med 2020; 382:503-513
Kinsinger LS et al. Implementation of Lung Cancer Screening in the Veterans Health Administration. JAMA 2017 Mar 1;177(3):399-406.
Brawley O.W.. The Argument for Caution in Advocating Lung Cancer Screening: A U.S. Perspective (A Pro/Con) https://www.iaslc.org/iaslc-news/ilcn/experts-discuss-benefits-challenges-lung-cancer-screening-pro/con Accessed December 10, 2021.
Cindy Mong 1, Edward B Garon, Clark Fuller, Ali Mahtabifard, James Mirocha, Zab Mosenifar, Robert McKenna. High prevalence of lung cancer in a surgical cohort of lung cancer patients a decade after smoking cessation. J Cardiothorac Surg 2011 Feb 25;6:19. doi: 10.1186/1749-8090-6-19. PMID: 21352550 PMCID: PMC3056729
Grannis F. Second Opinion: Medicare CT screening decision raises questions. Aunt Minnie November 14, 2014. Second Opinion: Medicare CT screening decision raises questions (auntminnie.com) Accessed December 10, 2021.

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We appreciate the opportunity to provide comments as Centers for Medicare and Medicaid Services (CMS) reconsiders their national coverage decision for Lung Cancer Screening with Low Dose Computed Tomography (LDCT). We respectfully encourage CMS to allow independent diagnostic testing facilities (IDTF’s) to perform lung cancer screening with LDCT. IDTF sites can benefit appropriate patients in multiple ways by providing potentially lower cost of care services, ease of access, and outpatient-only efficiencies.

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December 7, 2021

SUBMITTED ELECTRONICALLY:

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Medicare Proposed National Coverage Decision (CAG-00439R): Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)

Dear Ms. Jensen:

Boston Scientific Corporation appreciates the opportunity to provide comments in response to the Centers for Medicare and Medicaid Services’ (CMS) Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) posted November 17, 2021.

As one of the world’s largest companies dedicated to developing, manufacturing, and marketing less-invasive therapies, Boston Scientific supplies medical devices and technologies that are used by the following medical specialty areas, all of which provide Medicare beneficiary care:

• Cardiac Rhythm Management;
• Electrophysiology;
• Gastroenterology;
• Interventional Bronchoscopy;
• Interventional Cardiology;
• Interventional Radiology;
• Oncology;
• Neuromodulation;
• Urology; and
• Peripheral Interventions

Boston Scientific commends CMS for the proposed decision to expand access to LDCT lung cancer screening for Medicare beneficiaries. As CMS notes in the Proposed Decision Memo, lung cancer causes more cancer-related deaths in the US than any other type of cancer, despite being less common than breast cancer or prostate cancer.¹ CMS cites National Cancer Institute data showing that in 2021, lung cancer caused over 130,000 deaths (more than the total number of estimated deaths from colon, breast and prostate cancer combined).¹ The largest driver of this mortality discrepancy is the late stage at which lung cancer is currently identified.¹ We believe that the expanded eligibility criteria proposed, including the reduced age criterion (50 years of age) and the reduced smoke exposure criterion (20 pack-years), will save lives.

However, Boston Scientific would like CMS to reconsider additional expanded criteria as proposed by both the United States Preventative Services Task Force (USPSTF)², the National Comprehensive Cancer Network (NCCN)³, the America Thoracic Society (ATS), the Society of Thoracic Surgery (STS), the American College of Chest Physicians (CHEST), the American College of Radiology (ACR) and numerous patient advocacy organizations.

Age Criterion

Currently, CMS is proposing to cover LDCT for patients 50 to 77 years of age.

Notably, both the NCCN and USPSTF recommend lung cancer screening to include an older population. Specifically, the NCCN Guidelines for Lung Cancer Screening state that physicians may screen any individual over the age of 50 with = 20 pack-year smoking history. The NCCN does not recommend screening for patients with symptoms of lung cancer, previous history of lung cancer or a functional status and/or comorbidity that would prohibit curative intent of treatment.³ Given the new treatments for lung cancer and the increased lifespan of Medicare beneficiaries, Boston Scientific believes that lung cancer screening should also be extended to Medicare patients =77 years old, given the aforementioned exclusions.

The USPSTF recommends lung cancer screening for patients up to and including 78, 79 and 80-years old. Boston Scientific urges CMS to expand the covered age to, at a minimum, include 78-, 79- and 80-year-old beneficiaries, in line with the USPSTF recommendations.²

Boston Scientific believes CMS should eliminate the cap on screening beyond 77 years old, or at minimum, raise the cap to 80 years old.

Smoking Criterion

Boston Scientific supports CMS in their decision to reduce the pack-years of smoking from 30 to 20, in line with USPSTF and NCCN recommendations.^2,3 However, only allowing individuals who are currently smoking or less than 15 years from quitting potentially misses patients who may have lung cancer. In a recent publication from the Framingham Heart Study, researchers found that more than 40% of lung cancers occurred after 15 years since quitting (in the 20+ pack-year cohort) and that compared to never smokers, those that had = 20 pack-years of exposure had significantly higher risk of lung cancer, even past 25 years since quitting.⁴

To support identifying all Medicare beneficiaries at risk of having lung cancer, Boston Scientific believes, and current Framingham Heart Study research supports, that CMS should remove the years since quitting criterion.

Counseling and Shared Decision-Making (SDM) Criterion

Boston Scientific encourages shared decision-making in all healthcare/patient interactions and appreciates CMS’ proposal to simplify the requirements for the counseling and shared decision- making visit. However, given the significant mortality benefit of LDCT screening for lung cancer, and lower-than-desired patient compliance with LDCT screening recommendations, Boston Scientific supports the removal of the requirement for a formal, shared decision-making visits prior to first screening.

While geographically heterogeneous, a meager 2.0% of the 7.6 million eligible smokers received LDCT screening as of 2016, despite the 2013 USPSTF recommendations.⁵ Although the causes of low utilization are multi-factorial, lack of primary care time has been identified as one associated factor.⁵ Given that primary care is the entry to lung cancer screening, removing an extra visit may help improve utilization.⁵

Boston Scientific acknowledges the evidence that supports the benefit of shared decision-making. However, to increase utilization and decrease barriers– CMS should consider treating lung cancer screening as it does breast and colon cancer screening, which do not require a prospective shared decision-making visit.

Lung cancer screening is no different than breast cancer screening; specifically, mammography also exposes patients to radiation and has a risk of false positives (leading to unnecessary tests), yet shared decision making is not required for Medicare coverage of breast cancer screening.

Rather than mandating a single shared decision-making visit in advance of screening, Boston Scientific would recommend that primary care providers, nurse educators and patient navigators continuously encourage smoking cessation in current smokers. Smoking cessation and adherence to annual LDCT screenings should be discussed at each wellness (annual) visit as well as at any interaction with the lung cancer screening clinic. A team effort should serve the same goals as a single prospective shared decision-making visit, namely, to develop trust and build long-term relationships with the healthcare system with the goal to reduce mortality from lung cancer.

Boston Scientific also believes that telehealth visits could serve as a safe mechanism for providing counseling and shared decision-making, if CMS elects to retain the counseling and shared decision-making visit requirement.

Finally, counseling and SDM visits have been inappropriately classified as part of the LDCT screening by some Medicare Administrative Contractors. Due to this misunderstanding, many LDCT screening exams being performed at independent diagnostic testing facilities (IDTFs) who meet CMS NCD requirements are being denied by the MACs as “therapeutic”. This may leave the patient and facility to cover the cost of the screening and may lead to patients forgoing future screenings – a key goal of the SDM visit. Not mandating a prospective counseling and SDM visit (G2096) will decouple this activity (considered “therapeutic”) from the LDCT itself (CPT 71271, considered “diagnostic”). At minimum, CMS should explicitly clarify that 71271 is a stand-alone diagnostic procedure and should be covered and reimbursed by MACs at IDTFs under all circumstances.

• Boston Scientific encourages CMS to remove the requirement for a counseling and shared decision-making visit prior to first LDCT lung cancer screening.
• If shared-decision making is continued, at a minimum, Boston Scientific encourages CMS to allow visits via telehealth.
• CMS should clarify through the proposed NCD that LDCT screening is a diagnostic exam that is currently covered when provided at IDTFs that meet NCD criteria. Denials can cause undue burden for patients who require annual screening.

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Thank you for the opportunity to comment on the Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) proposed decision memo. Boston Scientific thanks CMS for the important changes in this draft NCD and encourages even more liberal application of criteria to help reduce the devastating toll from lung cancer. Please contact Geri Cramer at geri.cramer@bsci.com or me at 571.228.3479 or jenifer.levinson@bsci.com if you have any questions.

Sincerely,
Jenifer Levinson
Vice President, Global Health Economics and Market Access
Boston Scientific Corporation

1. NCI (National Cancer Institute). Surveillance, Epidemiology, and End Results Program: Cancer Stat Facts: lung and bronchus cancer. https://seer.cancer.gov/statfacts/html/lungb.html. Accessed October 1, 2021.
2. US Preventative Services Task Force. Screening for Lung Cancer Recommendation Statement. JAMA. 2021;325(10):962-970. doi:10.1001/jama.2021.1117
3. National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology: Lung Cancer Screening. Version 1.2022 – October 26, 2021. Available at https://www.nccn.org/professionals/physician_gls/pdf/lung_screening.pdf
4. Tindle HA, Stevenson Duncan M, Greevy RA, et al. Lifetime Smoking History and Risk of Lung Cancer: Results From the Framingham Heart Study [published correction appears in J Natl Cancer Inst. 2018 Oct 1;110(10):1153]. J Natl Cancer Inst. 2018;110(11):1201-1207. doi:10.1093/jnci/djy041
5. Danh Pham, Shruti Bhandari, Christina Pinkston, Malgorzata Oechsli, Goetz Kloecker. Lung Cancer Screening Registry Reveals Low-dose CT Screening Remains Heavily Underutilized. Clinical Lung Cancer, Volume 21, Issue 3, 2020, Pages e206-e211,https://doi.org/10.1016/j.cllc.2019.09.002.

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Dear CMS Review Panel,

The proposed decision memo is excellent news, and the efforts behind this and the evidence-based considerations for expanded lung cancer screening are commendable. In Kentucky, we feel significantly impacted as we are clear outliers in the battle against lung cancer and smoking-related disease, ranking an uncontested last place with a lung cancer incidence of 89.4 per 100,000 population, 55% higher than the national average.

Action Points:

1) We simultaneously believe that the number one cancer causing death in our state, and the United States, should not be treated differently than other cancers with screening tests that catch cancers in the earliest stages, including colon, breast, and cervical cancers. We believe that requiring this SDM mandate fosters the continued stigma that our patients who smoke and have lung cancer face.

2) We find the relaxation of requirements for radiologists and imaging facilities while improving access troubling in lowering the standards for this life-saving offering.

3) We contend that the required standardized volumetric CT dose index is critical for maintaining the low dose approach so important in minimizing risk for patients undergoing this screening option. Eliminating this requirement and oversight will confuse and blur the lines between low and regular dose scans.

4) We favor mechanisms to offer more widespread access to LDCT LCS but believe that the 300 CTs of the chest over three (3) years is not a prohibitive requirement for radiologists.

5) Similarly, we advocate that the standardized reporting requirement remains in place. Standardizing this reporting is critical to maintaining the quality and integrity of healthcare systems and/or imaging facilities participating in this modality to maximize the benefits while minimizing the potential risks and managing suspicious nodules.

Background:

Lung cancer kills as many Kentuckians as the subsequent four (4) cancers combined. Our state ranks fifth from the bottom in lung cancer survival. We are barely behind West Virginia in smoking prevalence at 23.6% of adults. The excellent news is that Kentucky ranks second from the top in lung cancer screening rates, at 14.6% eligible population per the ALA State of Lung Cancer Report, released November 16, 2021. We expect that we will soon occupy the top position. We will begin shifting these less favorable metrics through our screening efforts and lung cancer evaluation and treatment progress. We are also part of several state-based initiatives that will continue to improve our ranking and the health of our state. January 8, 2020, the Wall Street Journal reported the largest recorded drop in U.S. cancer deaths, a 2.2% decline. Lung cancer alone accounted for nearly a third of this decline. Decreased smoking rates, improved surgical and medical treatments, and enhanced screening and early detection together contributed to this impact. Our system continues to employ multi-disciplinary and team-based approaches to lessen the impact through all these channels. St. Elizabeth HealthCare has performed over 20,000 Lung Cancer Screens to date, finding one lung cancer for every 63 screens completed. We draw from 14,000 qualifying patients utilizing our Epic EMR smoking data. Since beginning our program in late 2013, we have identified 315 lung cancers, 56% of which are in stage I, 68.4% in early stages I or II, where not only the chance for survival is substantially higher, but the treatment approaches are more cost-effective.

We have just initiated efforts to expand from USPSTF 2013 to USPSTF 2021 criteria by 1/1/22, screening to risk and benefit, and not coverage, adding nearly 7,000 individuals to our pool of eligibility, and potentially 111 additional lung cancers found through screening efforts. In 2019, 36.3% of our patients that met eligibility and were attributed to a primary care provider obtained a screening scan or other qualifying CT of the chest. This dropped in the pandemic to 29.3%. We are on track to exceed 40% for 2021 and aim to move the dial on this measure to 50% over the next two years. This, of course, compares quite favorably to the National Uptake Average of 6.5%. We know there are still many other unaccounted lung cancer, incidental findings, and tobacco-related disease in our system. Expanding the screening criteria will help discover these in the earliest stages when the chance of cure is the greatest and management cost is less.

To that means, we have a weekly nodule review board and a carefully orchestrated and implemented nurse navigation approach that guides our patients from screening through survivorship. Just recently, we have begun a similar process through our Incidental Nodule Program and anticipate similar success. We intend to continue to demonstrate that an evolved and well-coordinated thoracic program can achieve these means. Our community hospital has replicated NLST findings, substantiating notable stage migration, presently finding 133% more patients in stage I and 73% fewer in stage IV, when comparing our screened to our non-screened (incidental and symptomatic patients) lung cancer patients. We are proud to be among a growing number of institutions and healthcare organizations that have validated the role of lung cancer screening in the care of qualifying patients. The proposed expansion of the CMS guidelines will inevitably widen the impact of life-saving screening while capturing proportionately more females, African Americans, and underserved populations. We strongly advocate this expansion and would ask that further consideration be given to further expanding these guidelines.

Additionally, we would request that CMS reduce existing barriers such as requiring a face-to-face visit with a qualifying health professional and the Shared Decision Making (SDM) component. We are pleased that the requirement to be a physician, APP, or Clinical Nurse Specialist for ordering the baseline screen has been proposed to be eliminated. Similarly, lowering the complexity and number of requirements of the SDM is a step in the right direction from our perspective. This population of patients has compliance issues that are often greater than many of the patients we serve. Lowering impediments will allow us to more easily capture pathology in this vulnerable group of individuals that disproportionately and adversely affect healthcare costs.

Building a robust foundational program has been critical in attracting our provider’s support, buy-in, and confidence, especially the PCPs and our administrators and executives. We contend that using accurate and impactful homegrown data has been critical in moving the dial in our hospital system. Participating in a Registry with the ACR is very helpful in directing guidance for required and optional fields. Through a well-constructed and data-driven program, we can identify where fractures lie regarding healthcare inequities and areas in our catchment with strained access and education. The adoption of the USPSTF 2021 criteria by the American Academy of Family Practice (AAFP) has been transformative in promoting lung cancer screening (Grade “B”) for the eligible population in our state, as well as nationally. The AAFP has collaborated with the National Lung Cancer Round Table (NLCRT) to promote lung cancer awareness, lung cancer screening, and lowering and simplifying the barriers for SDM and lung cancer screening.

We recognize that the ten (10) major studies reviewed by CMS did not include the 78 – 80 year age range and that this age bracket falls outside of the preponderance of evidence-based guidelines. We also recognize that although these studies failed to include this age range in the RCTs, the risk of developing lung cancer in patients at high-risk, based on smoking history, never completely goes away. Every week in our Nodule Review Board and our Thoracic Oncology Tumor Board, we witness smoking-related cancers in the 78 – 80 year age range. While anecdotal, the experience lends support to mirroring this facet of the USPTF 2021 guidelines. We would advocate that CMS consider national coverage to extend at least to the age of 80 YO. We would also like to request that the SDM mandate be dropped. We fully recognize the value of SDM in communicating with our patients when ordering screening tests that clearly provide life-saving benefits yet present some inherent risks. We will continue to recommend that our providers engage in SDM for all the cancer screening tests that are available for the five cancers that have screening available.

We are engaged with the Kentucky Health Collaborative (KHC) in lowering the burden of lung cancer and tobacco-related diseases in our state. We are on the brink of implementing a landmark collaboration between the ten (10) hospital systems in our state, collectively supplying healthcare to over 60% of our citizens, to share de-identified data from the Kentucky Cancer Registry (KCR) and the American College of Radiology (ACR). The ACR has been highly cooperative in working with our Collaborative and is sharing their Registry Submission Data. This endeavor will be transformative by establishing benchmarks and allowing quality improvement initiatives that will enhance the efforts in our state to find lung cancers at an earlier stage when the chance of cure is substantially higher, and the costs are much lower. Assimilating and sharing data will be paramount to advancing the quality of care, research, and outcomes for lung cancer in our state, as well as nationally and internationally. We feel removing this requirement will substantially lower the ability to get ahead of this silent epidemic.

Our successes and ability to promote our program have placed us in the top 4% of healthcare systems in our country respective of volume. We are accredited by both the ACR and the GO2 Foundation, and components of our accreditation recognize high standards for our radiologists and imaging sites and the attention we give to the continuum of lung cancer care, from prevention, screening, and treatment through survivorship. We recognize that significant healthcare inequities exist and are committed to confronting these and improving the disparities in our region. Obtaining actionable data will be critical in addressing these disparities and documenting objective and recordable improvements. We would advocate that CMS adjusts the proposal wording to, at least, strongly encourage the continuance of radiologist and facility requirements but, perhaps, not mandate it to allow the availability of screening to less advantaged locales and healthcare systems. Regardless, we would hope that the more highly evolved and established programs will continue to aspire to the value that full accreditation brings, especially among the KHC member hospital systems.

We recognize that lung cancer screening and risk determination will continue to evolve; this is an exciting field, and we commend your efforts to change in step. Unquestionably, more sophisticated algorithmic approaches, including expanded demographic and health history determinants, biomarker assessment, and the assistance of AI will ultimately replace the present and proposed recommendations. We appreciate that CMS has given this timely consideration to the evidence and appropriately adjusted lung cancer screening guidelines. We feel fortunate to have this opportunity to provide feedback and comment and would be pleased to assist in any way with your efforts if deemed to be of value.

Sincerely,

The Lung Cancer Screening and Thoracic Oncology Disease Management Teams of St. Elizabeth Healthcare, 1 Medical Village Drive, Edgewood, Ky, 41017.

Douglas B. Flora M.D., LSSBB
Executive Medical Director, Oncology
Douglas.Flora@stelizabeth.com
Michael R. Gieske M.D.
Director of Lung Cancer Screening
Michael.Gieske@stelizabeth.com
Royce Calhoun, M.D.
Director Thoracic Surgery
Royce.Calhoun@stelizabeth.com
Gary Schmitt, M.D.
Vice Department Chair Radiology
Gary.Schmitt@stelizabeth.com
Irfan Budhani, M.D.
Pulmonology
Irfan.Budhani@stelizabeth.com
Goetz Kloeker, M.D.
Thoracic Oncology
Goetz.Kloeker@stelizabeth.com
Dwinelva Zackery, LCSW
Director of Integrative Oncology
Dwinelva.Zackery@stelizabeth.com
Stephanie Bonfilio, MSN, RN, OCN, ONN-CG
Manager of Navigation Oncology
Stephanie.Bonfilio@stelizabeth.com
Megan Lockwood, BSN, RN, OCN, ONN-GC
Nurse Navigator – Lung Cancer Screening
Megan.Lockwood@stelizabeth.com
Jessica Kerns, BSN, RN, OCN, CMSRN
Nurse Navigator – Lung Cancer Screening
Jessica.Kerns@stelizabeth.com

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Nice improvements generally, thank you!
The DRAFT as currently written includes the beneficiary/patient requirement: "Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment."
This would be improved by changing "or willingness" to "and willingness" as it is both illogical and wasteful to perform the study if it is known beforehand the beneficiary is unwilling.
Thank you for considering.

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[PHI Redacted] Since then, I have been advocating for better research, better screening, more effective treatment, and more awareness that lung cancer is a crisis in the US. I urge you to adopt the proposed update to the policy re. Medicare coverage for lung cancer screening.

Catching lung cancer early yields cures—cures. Screening for lung cancer with the current criteria AND, better yet, the expanded proposed criteria, is PROVEN to catch lung cancer far earlier than waiting for symptoms to occur. Even if a full cure is not possible, treatments that preserve life and quality of life are much more effective when cancer is caught early. ALL treatments for lung cancer are LESS EXPENSIVE when the cancer is found at early stages.

The proposed update will save the lives of many more Americans. It will save money. It is the right thing to do. Expand the criteria for lung cancer screening by adopting the proposal.

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Thank you for considering the expansion of guidelines per USPSTF recommendations. I see, however, that your proposal does not include patients aged 78-80. This is an unfortunate choice. As the GO2 foundation, ACR, and The Society of Thoracic Surgeons stated in their Requestor letter dated March 9, 2021, "It is well-established that the medical appropriateness of lung cancer screening and therapy is subject to physiologic status, comorbidities, and the ability to undergo treatment. CMS should recognize that lung cancer risk is not eliminated at age 77. Health status, personalized medicine, and individualized decisions more appropriately inform providers and their older patients in determining when to stop cancer screening. Personalized considerations are essential determinants of the harms and benefits of screening and, therefore, we believe that decisions to continue or cease screening should be individualized based on a person’s overall health and preferences. This is also recommended by NCCN per their lung cancer screening guidelines." So not only is your new proposal not considering the USPSTF recommendation to raise the age limit to 80, you are also ignoring the fact that many people of advanced age (over 80) are eligible for lung cancer treatment. This should not be a one size fits all exam.

Additionally, the length of cessation should be removed entirely as it was an arbitrary number used in the NSLT study. According to the Yang et al. study, "The lung cancer incidence levels among those who would have “missed out” on screening were at high rates and demonstrated a continued high-risk status. Of significance, the study showed that the largest percentage (approximately 30%) were among the cohort that “missed out” on screening and was solely based on having quit smoking more than 15 years ago."
I do commend you for proposing to lower the age limit to 50 and also for eliminating the requirement to report to a national registry. Lung cancer treatment has come far; with the correct guidelines we can continue saving lives. Thank you.

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