December 10, Dear Ms. Syrek Jensen:

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1 December 10, 2014 Tamara Syrek Jensen, Esq. Director, Coverage and Analysis Group Centers For Medicare & Medicaid Services Mail Stop C Security Boulevard Baltimore, MD Dear Ms. Syrek Jensen: Our facilities represent a network of over 250 lung cancer screening facilities across the United States that have earned the designation "Screening Center of Excellence" from Lung Cancer Alliance (LCA). As Screening Centers of Excellence, we endorse a set of guiding principles for high quality care set forth in LCA's National Framework for Excellence in Lung Cancer Screening and Continuum of Care, which was launched in These principles are: Empower patients by providing them clear information on the benefits and risks of lung cancer screening and prompt information about their results Require smoking cessation counseling to current smokers Adhere to best practices in radiation dosage and nodule management Work with multidisciplinary medical teams of experts and provide clear pathways to follow up care Commit to quality improvement and data collection to support advances in lung cancer screening and the continuum of care As Screening Centers of Excellence, we have already demonstrated our profound commitment to ensuring that lung cancer screening is performed well and right in the community. We are driven by our knowledge that the greatest hope for surviving lung cancer is its early detection. When lung cancer screening is made fully and equitably available to those at high risk, we know that it will transform lung cancer from the nation's deadliest cancer to a survivable diagnosis. We write collectively today to express our views on the Draft Coverage Decision Memorandum ("Draft Decision Memo") issued by the Centers for Medicare and Medicaid Services (CMS) on November 10, We are pleased that elements of the National Framework are included in the Draft Decision Memo. However, we have several concerns that are outlined below. 1. UPPER AGE LIMIT Coverage of LDCT must be extended to age 80, consistent with the United States Preventive Services Task Force (USPSTF) recommendation.

2 We are deeply concerned by the decision to limit the age of Medicare coverage to the year old population that participated in the National Lung Screening Trial (NLST) rather than the USPSTF upper age limit of 80. Extending the age of Medicare coverage to 80 is crucial for several reasons. First, there will be confusion among patients and providers. In the best of circumstances, it is difficult to achieve adequate adherence with any screening protocol. Inconsistencies in eligibility criteria will create confusion and substantially contribute to challenges with adherence. For providers, the incongruence in age range for coverage will create practical burdens where there is a different set of criteria for those with private insurance, which MUST comply with full USPSTF recommendation, versus those with Medicare coverage - including potential disparities between coverage for those with Medicare Advantage plans (which typically mirror private market place benefits) versus traditional Medicare Part B. There must be a uniform and consistent public health message for patients and health care providers. There is also no scientific justification for limiting access for the Medicare population to age 74. This age was used by NLST as part of their clinical trial criteria and was not intended to establish medical or public health policy. On the other hand, there is scientific justification for extending coverage beyond age 74. The median age for lung cancer diagnosis is 70 years. According to SEER data, 31.4% of lung and bronchus cancers are diagnosed in patients The next highest incidence age group is 74-84, with 28.1% of lung and bronchus cancers diagnosed here. Ending coverage at age 74 is too soon and will mean that a very high-risk population, with years of life expectancy before it, will be denied access to this life saving screening. There are also important health equity issues that could come into play if Medicare coverage is not extended to age 80. The fact is, some seniors (or their loved ones) will be able to cover the cost of lung cancer screening out of pocket, while others will not. CMS will have created a situation that could lead to striking racial and class disparities in access care and life expectancy at the upper end of the coverage bracket. USPSTF carefully and thoroughly considered the NLST findings, weighing all the pros and cons in issuing its recommendation to extend coverage to age 80. This recommendation was not made arbitrarily but was based on solid mathematical modeling and confidence that follow up curative care could be delivered safely and effectively to the year old age bracket. The age range for the CMS' coverage decision should be revised to align with the USPSTF recommendation. 2. SHARED DECISION MAKING Lung Cancer Screening Centers of Excellence believe "shared decision making" based on fair and unbiased information is a crucial element to initiate a regiment of responsible lung cancer screening.

3 We support the "shared decision making" requirement set forth by CMS, noting that the information provided to patients must be fair and unbiased, without an over emphasis of risks or an under emphasis of the benefits of lung cancer screening. However, we believe it is important to clarify that the shared decision making discussion is only required to initiate the lung cancer screening regiment. However, we do not believe such an intensive requirement is reasonable or necessary for subsequent annual screenings. We therefore recommended that CMS retain the requirement for the initial screen and remove it for the subsequent screens. 3. NO SIGNS OR SYMPTOMS OF LUNG DISEASE Requirement should be revised to no symptoms suggestive of lung cancer." As currently drafted, this definition is too expansive and inappropriate. Denying screening to patients with any symptoms of lung disease is contrary to the NLST, has no basis in evidence, and is contrary to the intent of screening those at highest risk of lung cancer. Many of the highest risk patients who would benefit from lung cancer screening are patients with COPD, a smoking cough, asthma, emphysema, and other pulmonary symptoms. These patients should not be excluded from LDCT lung cancer screening exams. We agree that patients with symptoms of possible lung cancer (hemoptysis, chest pain, cough), or patients with acute pulmonary symptoms (pneumonia, productive cough, fever, chills) should not receive lung cancer screening but instead should be evaluated for their symptoms using more appropriate methods. 4. [A]CCREDITED ADVANCED DIAGNOSTIC IMAGING CENTERS Additional clarification is needed to ensure that the training and experience of Screening Centers of Excellence are appropriately recognized We believe it is important that lung cancer screening take place in facilities with appropriate training and experience. Facilities should be able to demonstrate adequate training and experience through participation in major clinical trials such as NLST, medical studies that follow best published practices such as I- ELCAP or earned accreditation from appropriate professional societies such as ACR. 5. REGISTRIES Screening Centers of Excellence support the registry requirement; however, we seek clarification regarding the elements of a "qualified registry" and want to ensure that the burdens of this reporting requirement

4 are balanced against the important public health goal of fair and equitable access to quality care. Many Screening Centers of Excellence are familiar with registry reporting requirements and recognize the importance of registries both as a mechanism to ensure that only high quality responsible care is being delivered and as a way to continuously improve the delivery of this care through the lessons learned from the data collected in the registries. We also recognize, however, that data registry reporting requires the time of a suitably qualified professional team member -- which requires money. Screening centers affiliated with larger medical centers and typically found in larger urban may be able to readily comply with this requirement. But smaller practices in towns or rural areas may not have the staffing or funding capacity to comply with extensive data reporting requirements. Thus, it is important that an appropriate balance be struck between the burdensomeness of data collection and access to care. Many screening centers are already participating in registry reporting as part of research protocols. We believe continuing to report to these registries should be adequate, provided the registry collects an agreed upon minimum set of data elements that can be reported in a standardized way. 6. NCCN HIGH RISK CATEGORY 2 CMS should open a CED for this high risk category In the September 26, 2014 letter to CMS, which was signed by dozens of Screening Centers of Excellence, we specifically requested that CMS permit "coverage with evidence development" for lung cancer screening in patients between 50 and 54, with a twenty pack year smoking history and an additional risk factor including family history or exposure to certain environmental toxins. This group was identified by the National Comprehensive Cancer Network (NCCN) as an additional high-risk category (NCCN 2). A significant percentage of Screening Centers of Excellence screen individuals who fall within this highrisk category. For this reason, we reiterate the request to CMS that is open a CED for this the NCCN 2 high-risk category. There will never be another NLST. By opening a CED, CMS will not only help save lives today but it will also close a perceived evidence gap and save many more lives in the future. 7. SMOKER WHO HAS QUIT WITHIN THE PAST 15 YEARS This requirement is paradoxical, arbitrary, and lacking in medical evidence. Like the age 74 cut off, the decision to restrict participation in the NLST to former smokers who had quit in the past 15 years was a merely a clinical trial inclusion

5 criteria and was not intended as a bright line standard for medical or public health policy. We recognize that even the USPSTF accepted this "15 year" limit. However, we believe this limit is arbitrary and is not based in scientific evidence. Although not included in the NLST, others studies show that the risk of smoking-related cancers is predominantly related to the length of time someone has smoked. This risk gradually decreases over time, but former heavy smokers may remain at significant risk of lung cancer development many years after quitting. Practically speaking, the arbitrary cutoff at 15 years would result in an implementation dilemma where patients are seemingly penalized for quitting smoking while those who continue to smoke continue to receive the benefits of screening. The 15-year smoking cessation criteria thus creates a paradox that could encourage patients to restart their smoking habit to become eligible or retain eligibility for the screening benefit. CONCLUSION The Screening Centers of Excellence appreciate the opportunity to share our concerns with you. We are grateful that CMS has issued a Draft Decision that proposes to offer significant coverage of lung cancer screening. Our hope is that CMS will be able to refine this decision and give appropriate weight to our experiences on the frontline delivering lung cancer screening safely and responsibly, each and every day. Respectfully submitted, Addison Gilbert Hospital Brigham and Women s Health Care Center for Chest Care Central DuPage Hospital, Northwestern Medicine Clark Memorial Hospital Conemaugh Health System Deaconess Health System Delnor Hospital, Northwestern Medicine Edward Hospital Eisenhower Medical Center Fairfield Medical Center Fox Chase Cancer Center Franciscan St. Francis Health Frederick Regional Health System Hartford HealthCare Helen G. Nassif Community Cancer Center - UnityPoint St. Lukes Huntsman Cancer Institute Inova Lung Cancer Screening Program

6 Inspira Health Network John Muir Medical Center John T. Mather Memorial Hospital Keck Medical Center of University of Southern CA Lahey Outpatient Center Lancaster General Health Lima Memorial Health System Lung Cancer Screening Program, MD Anderson Cancer Center Lutheran Hospital of Indiana Maimonides Medical Center, Lung Cancer Screening Program MedStar Georgetown University Hospital Memorial Health System Middlesex Hospital Total Lung Care Center Mount Sinai Comprehensive Cancer Center Nebraska Methodist Hospital PIH Health Hospital-Whittier Pinnacle Health Pocono Medical Center Premier Radiology Providence Regional Medical Center, Everett Roper St Francis Healthcare Saint Agnes Hospital Saint Alphonsus Health System Saint Francis Hospital, Lung Cancer Screening Program Seattle Radiologists IELCAP Study Site St Elizabeth's Medical Center St Thomas Health St. Joseph Mercy Hospital St. Joseph Mercy Oakland Hospital Stony Brook Cancer Center Sylvester Comprehensive Cancer Center The Center for Cancer Prevention and Treatment at St Joseph Hospital The Lung Cancer Institute at Saint Barnabas Medical Center Tuality Healthcare UC Health University of Cincinnati Cancer Institute Comprehensive Lung Cancer Center University Hospitals Seidman Cancer Center University of California Davis Health System University of Kansas Hospital University of Maryland Baltimore Washington Medical Center University of Maryland Upper Chesapeake Health Upstate Medical University Wellstar Health System

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