National Coverage Analysis (NCA) View Public Comments

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

Public Comments

Commenter Comment Information
Grossman, Hildy Title: President
Organization: Upstage Lung cancer
Date: 12/10/2014
Comment:

Please consider the following issues:

  1. The CMS age range for coverage should align with the USPSTF recommendation of 55-80.
  2. Shared decision making must be fair and balanced and must not create an unnecessary barrier to access
  3. People with ashthma, emphysema, COPD, smokers cough or other lung disease should still have access to screening so long as they are not symptomatic for lung cancer.
  4. Registries are important but the data elements

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Phillips, Steve Title: Senior Director
Organization: Government Affairs & Policy, Johnson and Johnson
Date: 12/10/2014
Comment:

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

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Tran, Ho Luong Organization: National Council of Asian Pacific Islander Physicians
Date: 12/10/2014
Comment:

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

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

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Rios, MD, MSPH, Elena Organization: National Hispanic Medical Association
Date: 12/10/2014
Comment:

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

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

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Ivory, Paris Organization: Kaiser Permanente
Date: 12/10/2014
Comment:

To Whom It May Concern,

The Kaiser Permanente Medical Care Program is the largest private integrated healthcare delivery system in the United States, delivering health care to approximately 9.1 million members in eight states and the District of Columbia and comprising Kaiser Foundation Health Plan, Inc., the nation’s largest nonprofit health plan; the nonprofit Kaiser Foundation Hospitals, which operates 38 hospitals and over 600 other clinical facilities; and the Permanente

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McMahon, Katie Organization: American Cancer Society Cancer Action Network
Date: 12/10/2014
Comment:

December 10, 2014

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

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

Dear Administrator Tavenner:

The American Cancer Society Cancer Action Network (ACS CAN) appreciates the opportunity to

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Copeland, Amy Organization: Lung Cancer Screening Centers of Excellence National Network
Date: 12/10/2014
Comment:

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

  • Empower patients by

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McKee, Andrea Title: Chairman, Radiation Oncology, LHMC
Organization: Rescue Lung, Rescue Life
Date: 12/10/2014
Comment:

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

By Online Submission

Dear Ms. Syrek Jensen:

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

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Donaldson, Dusty Joy Title: Executive Director
Organization: Dusty Joy Foundation
Date: 12/10/2014
Comment:

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

  1. Increase the age limit to match the USPSTF guidelines to include seniors up to age 80, rather than 74.
  2. Lift restrictions preventing those most at-risk for developing lung cancer, specifically, people with COPD, emphysema, asthma or persistent cough.
  3. Adapt a successful registry

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Knight, Jennifer Date: 12/10/2014
Comment:

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

1. Extended coverage to age 80, consistent with the United States Preventive Services Task Force (USPSTF) recommendation. As a public health professor and practitioner, I recognize the importance of consistent and clear evidence-based guidelines when working with the public, providers and policy makers. Since the USPSTF did mathematical modeling and provided rational for their

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Troccoli, Gayle Title: Sr. Consultant Regulatory Compliance Support
Organization: HCA Healthcare
Date: 12/10/2014
Comment:

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

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Harbut, MD, MPH, FCCP, Michael Title: Clinical Professor
Organization: Wayne State University School of Medicine
Date: 12/10/2014
Comment:

There are many occupational and environmental agents which rival or exceed the incidence of lung cancer caused by smoking or are synergistic with tobacco smoke.

The data for this is especially robust for asbestos.

I believe that for purposes of calculating eligibility for LDCT Screening, each elapsed year since the time of first exposure to asbestos should be counted as equal to one pack/year of tobacco smoking.

Mulshine, James Title: Dean, Graduate College (Acting)
Organization: Rush University
Date: 12/10/2014
Comment:

December 8, 2014

Tamara S. Syrek Jensen, JD
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244
By Online Submission
Re: National Coverage Analysis for Lung Cancer Screening with Low Dose Computed Tomography (CAG-00439N)

Dear Ms. Syrek Jensen:

Thank you Ms. Jensen for the considerable effort you and your colleague have invested in

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Canal, Judy Title: Director
Organization: Lowell General Hospital
Date: 12/10/2014
Comment:
My hospital will be implementing a LDCT screening program. We have not participated in prior trials but are ACR accredited with CT scanners fully capable of performing LDCT and board-certified radiologists with the requisite training. We intend to apply for ACR accreditation as a LDCT screening provider. Will this meet the critera to be an eligible imaging center under the CMS guidelines? We would recommend this be the case as we are a high quality, low cost provider serving a patient

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Erasmus, Jeremy Title: President
Organization: Society of Thoracic Radiology
Date: 12/10/2014
Comment:

The Society of Thoracic Radiology (STR) is greatly appreciative of the opportunity to comment on the recently proposed Decision Memorandum for National Coverage Determination (NCD) for Lung Cancer Screening with Low Dose Computed Tomography (CAG-00439N). We applaud the Centers for Medicare and Medicaid’s (CMS) proposed decision to extend this life saving benefit to the Medicare age population. STR joins and supports all of the submitted comments of the joint societies, The Lung Canc

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Henschke, Claudia Title: Principal Investigator of I-ELCAP
Organization: International Early Lung Cancer Action Program (I-ELCAP)
Date: 12/10/2014
Comment:

December 9, 2014

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

By Online Submission

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

Dear Ms. Syrek Jensen:

I-ELCAP greatly appreciates the opportunity to provide comments on the

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Aldigé, Carolyn Title: President and Founder
Organization: Prevent Cancer Foundation
Date: 12/10/2014
Comment:

December 10, 2014

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

By Online Submission

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

Dear Ms. Syrek Jensen:

On behalf of the Prevent Cancer Foundation, the only national nonprofit

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Midthun, David Title: MD, Director Mayo Lung Screening Program
Organization: Mayo Clinic
Date: 12/10/2014
Comment:

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

We applaud the decision to proceed with coverage for Medicare and Medicaid recipients age 55-74 with 30 pack-years of smoking. We are particularly pleased with the emphasis on smoking cessation

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Jaklitsch, Michael Title: CoChair,AATSTaskForce for LCScreening&Surveillance
Organization: American Association for Thoracic Surgery
Date: 12/10/2014
Comment:

The American Association for Thoracic Surgery (AATS) agrees with the Centers for Medicare and Medicaid Services (CMS) that there is sufficient evidence to support an annual low dose computed tomography (LDCT) as a preventive service benefit for Americans with a 30 pack year smoking history between the ages of 55 and 74. The AATS, however, is critical of the CMS draft proposal because it denies an equal or greater number of equally vulnerable Americans who would benefit from this method of

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Neville, Christine Organization: Roper St Francis Healthcare
Date: 12/10/2014
Comment:
In response to the proposed decision memo for Screening for Lung Cancer with Low dose computed Tomography (LDCT), we would like to suggest the beneficiary age eligibility be amended to include ages 55-80 to remain consistent with the recommendations of the US Preventive Services Task Force.
Pratt, Christie Organization: Moffitt Cancer Center
Date: 12/10/2014
Comment:

December 10, 2014

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

Dear Ms. Syrek Jensen:

Lung cancer affects approximately 1 in 6 current- and former smokers and is the leading cause of cancer-related death among men and women in the US. The majority of people who are diagnosed with lung cancer will die from their

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Detterbeck, Frank Title: Professor and Section Chief, Yale Thoracic Surgery
Organization: Yale University School of Medicine
Date: 12/10/2014
Comment:

Date: December 10, 2014

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

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

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Borondy Kitts, Andrea Title: Lung Cancer Advocate and MPH Student
Date: 12/10/2014
Comment:

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

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

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Billings, Paul G. Title: Senior Vice President, Advocacy and Education
Organization: American Lung Association
Date: 12/10/2014
Comment:

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


December 10, 2014

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

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

Dear

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Bloomquist, Christine Title: Head of Policy & Executive Branch Advocacy
Organization: AstraZeneca Pharmaceuticals LP
Date: 12/10/2014
Comment:

December 10, 2014

BY ELECTRONIC DELIVERY

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

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

Dear Ms. Syrek Jensen:

On behalf of AstraZeneca, I am pleased to

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Brady-Copertino, Catherine Title: BSN, MS, OCN; Executive Director
Organization: DeCesaris Cancer Institute
Date: 12/10/2014
Comment:

8 December 2014

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

By Online Submission

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

Dear Ms. Syrek Jensen:

On behalf of the DeCesaris Cancer Institute, Anne Arundel Medical Center (DCI), we

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DeKay, Becky L. Title: President
Organization: Association of Community Cancer Centers (ACCC)
Date: 12/10/2014
Comment:

December 10, 2014

BY ELECTRONIC DELIVERY

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

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

Dear Ms. Syrek Jensen:

The Association of Community Cancer

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Ferkol, MD, Thomas Title: President
Organization: American Thoracic Society
Date: 12/10/2014
Comment:

December 10, 2014

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

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

Ms. Syrek Jensen:

The American Thoracic Society (ATS) and American College of Chest Physicians (CHEST) are the largest

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Ringen, DrPH, MHA, MPH, Knut Date: 12/10/2014
Comment:

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

Re: CMS Decision Memo on Medicare Lung Cancer Screening Coverage

We are writing as Principal Investigators of the occupational medical screening programs funded under the US

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Salner, MD, Andrew Title: Director, Helen & Harry Gray Cancer Center
Organization: Hartford Hospital
Date: 12/10/2014
Comment:

12/9/2014

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

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

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

More

Wimmer, Harold Title: National President and CEO
Organization: The American Lung Association
Date: 12/10/2014
Comment:

December 10, 2014

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

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

Dear Ms. Jensen:

The American Lung Association appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) proposed decision to

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

Dear Ms. Syrek Jensen,

As a Board Certified Registered Nurse and Certified Tobacco Treatment Specialist, I fully support CMS coverage for LDCT for the evaluation of high risk patients with a history of high tobacco use/dependence. Preventative care

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Steiling, Katrina Title: Assistant Professor of Medicine
Organization: Boston Medical Center
Date: 12/09/2014
Comment:

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

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

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Y- Talbot, Lucille Title: Public Health Consultant
Organization: Cancer Coalition
Date: 12/09/2014
Comment:
I am in support for this screening. As a public health professional and nurse I have seen too many people affected by lung cancer too late, including family members. We cannot ignore this advancement that should be available to those in need.
Stern, Eric Title: President
Organization: Washington State Radiology Society
Date: 12/09/2014
Comment:

December 10, 2014

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

By Online Submission

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

Dear Ms. Syrek Jensen,

The Washington State Radiology Society (WSRS) is greatly appreciative of the

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SWIDER, LYNN Date: 12/09/2014
Comment:

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

The proposed requirement for radiology imaging center eligibility requiring that the patient has participated in the past in lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging

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Khan, Nasir Title: Chairman Dept. Of Pathology and Lung Cancer Clinic
Organization: Ohio Valley Medical Center
Date: 12/09/2014
Comment:
It is already proven that LDCT will help save lives by early detection of lung cancers especially in the high risk population. But the restriction of: "Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening;" will inhibit facilities, mostly rural hospitals, who are currently not required to hold ACR accrediation status on their CT units

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Kotsen, PsyD, CTTS, Chris Title: Program Manager, Tobacco Quitcener
Organization: Steeplechase Cancer Cente, Robert Wood Johnson Hospital Somerset
Date: 12/09/2014
Comment:

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

1.

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Wilson, Terri Title: Executive Director
Organization: Medical Imaging & Technology Alliance
Date: 12/09/2014
Comment:

December 9, 2014

BY ELECTRONIC DELIVERY

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

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

Dear Ms. Syrek Jensen:

The Medical Imaging & Technology Alliance (MITA) is pleased to submit comments on the

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Yester, Michael Date: 12/09/2014
Comment:

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

If wish to stick with the 1.5 mSv. then need to

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Pinsky, Paul Title: Acting Chief, Early Detection Branch, NCI
Organization: NIH, HHS
Date: 12/09/2014
Comment:

Clarifications/comments

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

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Jacobs, Ph.D., Paula M. Title: Associate Director, Division of Cancer Treatment a
Organization: Cancer Imaging Program, National Cancer Institute, National Institutes of Health
Date: 12/09/2014
Comment:

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

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

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

Dear Ms. Syrek Jensen:

The Cancer

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Johnson, Robert Date: 12/08/2014
Comment:

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

Anyone who fulfills the smoking requirement is going to have a

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Barry, Michael Title: Chief Science Officer
Organization: Healthwise
Date: 12/08/2014
Comment:

Healthwise is a nonprofit organization founded in 1975 with the mission of helping people make better health decisions. Healthwise develops and distributes accurate and unbiased health information and decision support tools, including patient decision aids. Healthwise materials are not developed with funding from drug or device companies. Distribution is primarily electronic through web portals, health plans, and health systems; including prescriptions by clinicians through their electronic

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Hazelrigg, Stephen Date: 12/08/2014
Comment:
The average age for lung cancer is around 70 thus the screening age seems too narrow. Would expand to 80yrs.
Requiring assymptomatic may be too rigid. Many have symptoms of COPD such as cough, shortness of breath etc that are simply due to their lung disease apart from cancer.
McGlothlin, Anita Title: Health Policy Analyst
Organization: American College of Radiology
Date: 12/08/2014
Comment:

December 8, 2014

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

By Online Submission

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

Dear Ms. Syrek Jensen:

The Lung Cancer Alliance (LCA), The Society of Thoracic Surgeons

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Fuortes, Laurence Title: Professor , MD
Organization: University of Iowa, College of Public Health
Date: 12/08/2014
Comment:
Dear Sirs
I would ask that you review several aspects of the proposed lung cancer screening program
First lung cancer incidence increases with age reflecting dose response and cumulative risk hence it does not make sense to exclude otherwise eligible persons who are surgical candidates older than 75 years go age
Second the issue of occupational and other risks such as pneumoconiosis and or pulmonary fibrosis as recognized lung cancer risks independent of tobacco smoking need to

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Fairobent, Lynne Title: Senior Manager for Government Relations
Organization: AAPM
Date: 12/08/2014
Comment:

American Association of Physicists in Medicine
One Physics Ellipse
College Park, MD 20740-3846
(301) 209-3350
Fax (301) 209-0862
http://www.aapm.org

Office of the President
John E. Bayouth, PhD
University of Wisconsin
K4/B55 – Box 0600
Clinical Science Center
600 Highland Avenue
Madison, WI 53792-0600
Phone: 608-263-9962       Fax: 608-890-3148
Email: bayouth@humonc.wisc.edu

December 8,

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Lee, David W. Title: GM and Head of Market Access
Organization: GE Healthcare
Date: 12/08/2014
Comment:

December 8th, 2014

BY ELECTRONIC DELIVERY

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

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

Dear Ms. Syrek Jensen:

GE Healthcare, a Division of General Electric Company,

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Butler, Elizabeth Title: Director of cardiac and thoracic surgery
Organization: St. Mary's Medical Group
Date: 12/07/2014
Comment:

To whom it may concern,

With regard to CMS lung screening and the Beneficiary Eligibility Criteria

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

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

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  • Calhoun, Royce Title: Director, Thoracic Surgery and Oncology
    Organization: Rideout Medical Associates
    Date: 12/07/2014
    Comment:

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

    1. Although the NLST cut off the study population at 74, the USPTF recommends a cutoff of 80 and I support at least that if not higher. I see patients every week in their late 70s, 80s who are physically and mentally robust, have been found to

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    Datta, Subhajit Date: 12/07/2014
    Comment:
    As a practicing thoracic surgeon, I respectfully request the following:
    Use the USPSTF age recommendation (55-80 years) rather than ages 55-74 as proposed.
    Revise the definition of asymptomatic to “symptoms suggestive of lung cancer” vs “no signs or symptoms of lung disease”.
    Remove the requirement that screening only be made available to current smokers or those who have quit smoking within the last 15 years.
    Retain the requirement that a patient receive a written order

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    Moritz, Troy Title: Director of Lung Cancer Screening Program
    Organization: Pinnacle Health System
    Date: 12/06/2014
    Comment:
    Use the USPSTF age recommendation (55-80 years) rather than ages 55-74 as proposed. Make the mandatory data reporting, optional for one year to assist small and rural hospitals in implementing programs. Require a pulmonary nodule clinic as a requirement for a lung cancer screening center approval.
    Taylor, Derek Date: 12/05/2014
    Comment:
    I am wondering about the accreditation requirements. Our CT department is accredited by the ACR, however, we do not have the newer lung screening designation through ACR, we only have the overall CT accreditation. Will the specific lung screening accreditation be required or will the blanket ACR accreditation in my CT department be enough?
    Peper, William Title: Thoracic Surgeon
    Organization: William A. Peper, M.D. P.A.
    Date: 12/05/2014
    Comment:

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

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    Major Issues with CMS’ Beneficiary Eligibility Criteria

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

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

    2) REQUEST TO CMS:

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  • Nieszczur, Gina Date: 12/05/2014
    Comment:
    The following proposed requirement: Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening; Will limit the number of healthcare entities that will qualify to provide these screening exams. Consideration should be given to the demand and ability to provide. Limiting the number of locations will not ensure equal opportunity for

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    Boatfield, Chris Date: 12/05/2014
    Comment:
    The language in this comment: "Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening;" will inhibit facilities, mostly hospitals, who are currently not required to hold ACR accrediation status on their CT units. The above mentioned "advanced diagnostic imaging center" verbiage resembles that in the MIPPA act which pertains to IDTFs. The

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    Otto, Madeline Title: Director, Federal Government Relations
    Organization: Group Health Cooperative
    Date: 12/04/2014
    Comment:

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

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

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    Fenton, Joshua Title: Associate Professor
    Organization: University of California, Davis
    Date: 12/04/2014
    Comment:

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

    The requirement that PCPs use a decision aid during the dedicated visit is

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    Caligiuri, Michael Title: Director and CEO
    Organization: The Ohio State Univ Comp Cancer Center - James Cancer Hosp
    Date: 12/04/2014
    Comment:

    Dear Secretary Burwell,

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

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    Pedulla, Diane Title: Director, Regulatory Affairs
    Organization: American Psychological Association
    Date: 12/04/2014
    Comment:

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

    APAPO strongly recommends that psychologists participate in the shared decision making visit to help individuals understand the

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    Hewgley, Robert Title: Radiologist
    Organization: Mcminn Medical Imaging
    Date: 12/04/2014
    Comment:
    ACR Guidelines address physician qualifications very thoroughly. Additional requirement for board certification is unnecessary, and may result in limitation of the service.
    Rousou, Laki Title: Thoracic Surgeon
    Organization: Mercy Medical Center
    Date: 12/04/2014
    Comment:

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

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

    2) REQUEST TO CMS: Revise the definition of asymptomatic to “symptoms suggestive of lung

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    Hofer, Bradley Title: Partner
    Organization: CCVSA.COM
    Date: 12/03/2014
    Comment:

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

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

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

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    AZOURY, FOUAD Title: Cardiothoracic Surgeon
    Organization: St-john Hospital and Medical Center
    Date: 12/03/2014
    Comment:
    As a Thoracic surgeon , I am puzzled by the proposition of not including asymptomatic patient in lung screening. I also believe based on median age of lung cancer diagnosis that the age should be increased to at least 80 .
    Thank you for allowing me to comment.
    Freeman, Richard Title: Director of Thoracic Surgery
    Organization: St Vincent Health
    Date: 12/03/2014
    Comment:
    Lung cancer Is the leading cause of cancer death for men and women in the US. Discovered early, there is a high rate of cure. However, most patients are not diagnosed until the late stages of the disease. Low dose CT screening has been extensively studied and found to reduce lung cancer mortality by the same amount as mammography. This screening technique also compares favorably to number of patients screened to cancers found for other screening tests such as colonoscopy. It is essential that

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    Parkyn, Jessica Date: 12/03/2014
    Comment:
    Currently, only 15% of people will present with potentially curable, early stage lung cancer. LDCT is proven to detect lung cancer early and save lives. This would be a step in the right direction.
    Kohman, Leslie Title: Medical Director, Upstate Cancer Center, Professor
    Organization: Upstate Medical University
    Date: 12/03/2014
    Comment:
    As a thoracic surgeon involved with clinical trials for lung cancer since 1999, I applaud CMS decision to approve lung cancer screening by low-dose CT for eligible high-risk persons. I request that the definition of eligibility be changed from "no signs or syptoms suggestivbe of lung disease" to "no signs or symptoms suggestive of lung cancer." Many of these participants have lung disease of various kinds due to decades of smoking, and they should be included, not excluded. Emphysema

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    Frederiksen, MD, James Title: Research consultant
    Organization: Duke Universtiy School of Medicine
    Date: 12/03/2014
    Comment:
    The purpose of this message is to recommend that CMS change its Proposed Decision Memo outlining its coverage of Screening for Lung Cancer with Low Dose Computed Tomography (LDCT). CMS should (1) use the USPSTF age recommendation (55-80 years) rather than ages 55-74; (2)remove the requirement that screening only be made available to current smokers or those who have quit smoking within the last 15 years. (3)retain the requirement that a patient receive a written order for the initial screen

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    Cohen, Neri Title: Chief, Division of Thoracic Surgery
    Organization: GBMC Healthcare
    Date: 12/03/2014
    Comment:

    Major Issues with CMS’ Beneficiary Eligibility Criteria

    1. REQUEST TO CMS: Use the USPSTF age recommendation (55-80 years) rather than ages 55-74 as proposed.
      The age restriction 55-74 contradicts the recommendation from the United States Preventive Services Task force (USPSTF recommendation).
      Since 70 is the median age for lung cancer diagnoses, there is a strong concern that 74 is a relatively young age to cease screening.
    2. REQUEST TO CMS: Revis

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    Martin, Sarah Date: 12/02/2014
    Comment:

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

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

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    Hamlin, John Title: Diagnostic Radiologist and Lawyer
    Organization: Diagnostic Imaging Group
    Date: 11/30/2014
    Comment:

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

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    rone, steve Date: 11/28/2014
    Comment:
    Please do NOT use my tax money to pay for smokers' ct scans. They all took their risks, so let them cover their losses i.e, they can pay for their own ct's!! Thanks for viewing my concerns. Steve Rone
    Ayers, Michael Title: Director, Interventional Bronchoscopy
    Organization: Geisinger Medical Center
    Date: 11/28/2014
    Comment:

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

    I have one issue regarding the inclusion criteria. Although any screening test is designed for "asymptomatic" patients, I believe in the case of lung cancer screening the requirement for "no evidence of lung disease" will exclude many potential patients that may benefit from Lung Cancer Screening. In the case of lung cancer, many patients have associated COPD/Emphysema and will likely exhibit

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    Metcalf, Ann Title: Administrative Director of Imaging Services
    Organization: Mercy Hospital - Springfield
    Date: 11/28/2014
    Comment:

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

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

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

    Campbell, Greg Title: Attending Pulm Crit Care
    Organization: Asheville Pulmonary
    Date: 11/28/2014
    Comment:

    I would advocate for the removal of the clause pertaining to "lung disease". This would exclude a large proportion of my patients with COPD from this opportunity. These patients were not excluded in the original trial.

    Thank you

    Speice, Donald Date: 11/26/2014
    Comment:
    It appears only logical that yearly screening under the proposed guidelines would be medically advantageous to medicare recipients and financially beneficial to the medicare program. Such screening should be included as a preventive measure covered by Medicare/medicaid.
    Ogburn, Nicholas Date: 11/26/2014
    Comment:
    I applaud the use of screening CT scanning for early detection of lung cancers in high risk patients. Our best results come from early detection and unfortunately most of our lung cancers are found in later stages with poor outcomes. Your screening population criteria seem very appropriate. The use of multidisciplinary thoracic oncology clinics will fit very well into this scenario.
    Fowler, John Date: 11/25/2014
    Comment:

    As a pulmonologist I see every day the ravages of incurable lung cancer. The evidence is clear: screening saves lives.

    Low-dose CT screening should be a covered service under Medicare, the population at highest risk of premature death from the commonest cause of cancer death in the United State.
    Chay, MD, Christopher Title: MD
    Organization: Cancer Care of WNC
    Date: 11/24/2014
    Comment:
    To whom it may concern,
    I would like to voice my support for coverage of spiral CT for lung cancer screening. I am an Oncologist and understand the importance for screening in this high risk population. Studies have shown definitively that there is a clinical benefit and patients deserve to have this covered to improve the curative benefits we have from surgery, chemotherapy, and radiation. If coverage is not met, I would have to question the motives of CMS as to better the proven

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    Mauro, MD, MMSc, Christine Title: Medical Director, Advanced Surgical Technologies
    Organization: Covidien
    Date: 11/24/2014
    Comment:
    As a surgeon and medical director for Covidien, I support the proposed coverage of lung cancer screening for high risk individuals. This coverage will likely lead to earlier diagnosis for many individuals, making them better candidates for surgery and improving their chances of complete cancer resection. Patients whose lung cancer is found earlier will have better outcomes overall. Please proceed with the planned coverage.
    Walker, Ronald Title: Professor of Clinical Radiology
    Organization: Vanderbilt University Medical Center
    Date: 11/24/2014
    Comment:

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

    I am a radiologist and a nuclear medicine physician at an academic medical center. I have been the imaging director for an NCI-funded lung cancer screening trial for 4+ years, and can directly attest to the effectiveness of the latest data that show reduction in unnecessary biopsies and false-positives, as shown in

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    Kuri, Jamie Title: Market Development Representative
    Organization: Dignity Health
    Date: 11/23/2014
    Comment:

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

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    Khandhar, Sandeep Title: Medical Director, Thoracic Oncology
    Organization: Inova Health System
    Date: 11/23/2014
    Comment:
    This is an important step for progress toward improved survival in this devastating disease. Lung cancer incidence is similar to other cancers yet the mortality is staggeringly high. Recommended ages for screening likely need to be broadened to include ages 50-80.
    Bohl, Michael Title: CEO
    Organization: Radiology Group, PC, SC
    Date: 11/23/2014
    Comment:

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

    CAG-00439N

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

    I encourage you to:

    1. Retain this

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    Binns, Oliver Organization: Asheville Heart
    Date: 11/22/2014
    Comment:
    After 13 years in practice as a board certified Thoracic surgeon I commend CMS for endorsing lung cancer screening with LDCT. Despite advances in treatment, mortality rates are essentially unchanged since 1975. It has become clear that the only way to impact lung cancer mortality is to shift the stage at diagnosis. LDCT will accomplish this with appropriate multidisciplinary review of findings. Coupled with smoking cessation, we can dramatically decrease lung cancer mortality rate in the

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    Fox, Stewart Title: MD
    Organization: Long Island Thoracic Surgery PC
    Date: 11/22/2014
    Comment:
    As a Thoracic surgeon involved with the ELCAP studies for the past 7 years, I can attest to the fact that numerous asymptomatic patients were identified and treated for early stage lung cancer. These patients have a cure rate of 85%, as opposed to the 3% cure rate if their disease had progressed to the point that it became symptomatic. I firmly believe in the proposal before you.
    Stumacher, Richard Date: 11/22/2014
    Comment:
    LDCT has the same grade recommendation as mammograms. It is unfair that CMS would not pay for a screening test that is considered as valuable as mammograms. If the problem is cost for performing the CT scans, it should be passed on to the Tobacco Industry
    Lynch, May Title: Radiology Manager
    Organization: Deborah Heart and Lung Center
    Date: 11/20/2014
    Comment:

    Do hospitals need to obtain advanced imaging accreditation if they are already accredited by Joint Commission?

    For radiologist eligibility: What types of chest CT exams count towards the "300 chest CT" done within the past 3 years?

    Smith, Anita Title: Lung Cancer Navigator
    Organization: Piedmont Healthcare
    Date: 11/20/2014
    Comment:
    First of all, I am so glad Medicare has decided to potentially cover the CT Lung Screening for their patient population. However, I do have a couple of comments.
    1) I would like to propose that the age cap of 74 years be reconsidered and that the "cap" be based on health status instead of age, like the NCCN Guidelines recommend. They word it as patients should "consider annual LDCT until patient is no longer eligible for definitive treatment". In other words until their health is such

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    Tarnoff, Michael Title: Corporate Chief Medical Officer
    Organization: Covidien
    Date: 11/20/2014
    Comment:

    November 20, 2014

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

    Dear Ms. Syrek Jensen:

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

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    Inyart, Patricia Title: Clinical Research Manager
    Organization: Good Samaritan Hospital
    Date: 11/20/2014
    Comment:
    I believe this is definitely a step in the right direction in order to address the overwhelming evidence that supports lung screening and I applaud CMS for recognizing that data. Our facility is acreditited by ACR for chest CT but I would like to see CMS clarify the specifications for an "accredited advanced diagnostic imaging center." Also, I agree with others who have stated that measurement of "effective" dose should be made clear, whether that be as stated in "mSv" or the more common CT

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    Finelli, Daniel Date: 11/20/2014
    Comment:
    Though the mean CTDI in the NLCST was @ 1.5 mSV, the current ACR recommendations are

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    DeWoody, Chuck Date: 11/18/2014
    Comment:
    Please consider increasing the age from 74 to 78-80. As we know it does take time for lung cancer to develop in former smokers.Stopping at 74 leaves a lot of people susceptible to the start of lung cancer at age 75-on.The additional expense for EXTENDING screening to 78-80 will pick up small cancer growths EARLY,while still localized;treatment and cure rate will cost a lot LESS for Medicare,compared to treating AFTER it spreads.Thank you for your consideration of this idea....CD.
    Holland, Jonathan Title: Administrator
    Organization: RapidSound, Inc
    Date: 11/18/2014
    Comment:
    I am an administrator for a diagnostic imaging center, and we fully support this initiative. This NCA will make strides towards detecting and treating lung cancer.
    Knoth, Maeve Date: 11/18/2014
    Comment:
    I am so discouraged that pressure from interest groups and non-medical personnel is being considered in relation to covering lung cancer screening. The MEDICAL board responsible for looking at the science and studies related to effectiveness and harm done by lung cancer screening has judged that more harm than good is done by these screenings. Why can't Congress listen to them? Just about everyone else who is weighing in has something to gain from approving the screenings- radiography

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    Livingston, Cat Date: 11/17/2014
    Comment:
    CMS criteria should mirror USPSTF recommendations, as well as ACIP. Nonalignment is in conflict with the ACA's intent of USPSTF A and B preventive services being offered without cost-sharing.
    Clair, Gary Date: 11/17/2014
    Comment:
    I smoked a pack of cigarettes a day for thirty years. I quit 20 years ago. I should have known better, but I was a fool to start smoking. [PHI Redacted] My doctor says that my Medicare coverage will not cover a CAT scan to see if my lungs are pre- cancerous. I would like to nip a potentially big problem in the bud right away. Please allow for this procedure.
    Thank you
    11-17-14
    Kronmal, Kathy Title: Manager of Oncology and Research
    Organization: UW Medicine Northwest Hospital and Medical Center
    Date: 11/17/2014
    Comment:
    To whom it may concern,
    Thank you for the proposed coverage determination, it is truly a huge step that will have a tremendous impact of the overall health of the American public.
    As an oncology coordinator for a 281 bed acute care facility, I am concerned about the length of time involved in implementing a registry to meet the requirement. Our hospital already has an active program screening about 25 patients per year, but would need to stop offering this service until both the

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    Batlle, Juan Title: Chief of Thoracic Imaging
    Organization: Baptist Health
    Date: 11/17/2014
    Comment:

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

    In the current decision memo, it is required that the

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    Sheehan, Patty Date: 11/17/2014
    Comment:
    As a hospital CT department who sees outpatients, does our hospital's Joint Commission Accreditation fulfill the accreditation of advanced diagnostic imaging center or would a separate accreditation from ACR or IAC be required in order to offer lung cancer screenings?
    Nelson, James Title: Professor of Radiology emeritus
    Organization: University of Washington School of Medicine
    Date: 11/14/2014
    Comment:
    As a rare, smoking radiologist I just paid for my screen, which I consider a great value.
    Jenson, Erica Title: Registered Nurse
    Date: 11/14/2014
    Comment:
    Look at the data... 67% of people diagnosed with lung cancer die of lung cancer which could have been prevented with earlier detection. Lung cancer is the #1 Cancer of Women and causes the most deaths of cancers per year. Most people who get diagnosed with lung cancer are diagnosed too late because there is NO preventive screening. This NEEDS to change. And No, these people are not just smokers and lung cancer is not just caused by smoking. The death numbers keep escalating each year. This

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    Munn, Samson Title: Vice Chair, Radiology; Vice Pres., Medical Staff
    Organization: Tufts Medical Center
    Date: 11/14/2014
    Comment:

    With regard to low-dose lung cancer screening CT:

    • With respect to the discussed pre-CT clinic visit, eligible for coverage by CMS, who is responsible to perform/arrange/conduct the visit? One would expect not the radiologist; but, is this understood/agreed? If not, why not?
    • Regarding radiologist qualifications, what is a “chest CT?” Would chest CT angiograms count? Would cardiac CTs count?
    • Also regarding radiologist qualifications, what is

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    Pugh, Denise Title: Medical Imaging Manager
    Organization: Joint Township District Memorial Hospital
    Date: 11/14/2014
    Comment:
    If our facility is ACR accredited in CT what specific training and experience in LDCT lung cancer screening is required?
    Mathena, Susan Date: 11/13/2014
    Comment:
    This test should be covered 100% as a preventative service. it does save lives!!
    IBARRA, JULIO Title: Chief of Pathology
    Organization: MemorialCare
    Date: 11/13/2014
    Comment:
    I am in support of CMS' approval of screening for Lung Cancer with LDCT. Research shows, and the practice in our community bears out, that LDCT is effective in detecting lung cancer at its earliest, most treatable stage.
    Reich, Jerome M Title: MD
    Organization: Earl A Chiles Research Institute, Thoracic Oncology Section
    Date: 11/13/2014
    Comment:
    My colleagues and I have completed an investigation into long-term survival of post-lobectomy persons which demonstrated a 7-year reduction in disease-free survival. This unfortunate penalty is acceptable for persons who would otherwise die of lung cancer. However, it will prove harmful for screen-identified persons who are overdiagnosed, offsetting, to an undetermined extent, the benefit of screening. Notably, this deficit in survival took place largely after 6-years. I would be more than

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    Trask, Jeffrey Date: 11/13/2014
    Comment:

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

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

    Radiology imaging center eligibility criteria:
    For purposes of Medicare coverage of lung

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    Foster, Janet Date: 11/13/2014
    Comment:
    I urge you NOT to extend FREE coverage for CT lung scans to smokers. Smokers have been overconsumers of policy holders' and tax payers' dollars for decades. I am a critical care nurse (for 40 years), advanced practice nurse, and supporter of most tenants of the Affordable Care Act but NOT this. Obviously, smokers can afford to pay for the CT scan; at least the cost of a carton of cigarettes. This is a waste of tax payer dollars that can be channeled into other good health care

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    McKee, Helen Title: Chaplain
    Organization: Danville Regional Medical Center
    Date: 11/13/2014
    Comment:
    This is such an excellent idea and would help to prevental many unneccesary deaths. By screening and identifying problems earlier, and then following up to determine need for treatment is the most logical approach to decreasing deaths from cancers.
    Grischy, Sandra Title: RN. Lung Cancer Navigator
    Date: 11/13/2014
    Comment:
    I am so encouraged that this screening will allow lung cancer to be seen as a disease and not a stigma.
    To reduce the mortality of this disease is a humane and cost saving decision.
    Feinberg, Lawrence Title: Professor, Department of Medicine
    Organization: University of Colorado School of Medicine
    Date: 11/12/2014
    Comment:
    Medicare should only reimburse higher risk patients who meet NLST criteria. At least 20% of persons who meet NLST criteria have an unfavorable benefit-risk profile; CT screening would represent low value care. Medicare is right to endorse and reimburse this new screening method, but should take a proactive, discriminating, safety-conscious approach and deny reimbursement for lower risk patients. Specifically, the analysis by Kovalchik, et al (NEJM, 2013) reveals that > 5000 patients in the

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    Kursman, Nancy Date: 11/12/2014
    Comment:

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

    I am writing to you to urge the Centers for Medicare and Medicaid Services Coverage and Analysis Group to mandate for Medicare recipients annual screening for lung cancer with low-dose computed tomography (LDCT) in adults ages 55 to 80 years who have a 30 pack-year smoking history and

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    Bacon, Randy Title: Imaging Manager
    Organization: The Aroostook Medical Center
    Date: 11/12/2014
    Comment:
    The first requirement for facilities to be eligible to perfrom LDCT is ambiguous and unreasonable. The requirement states that the facility is one that "Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening". The requirement does not specify what constitutes "accredited" or "advanced". A straightforward list of unambigous requirements

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    zigmund, beth Title: Dr.
    Date: 11/12/2014
    Comment:
    Considering the strong evidence for mortality reduction from lung cancer screening and the USPSTF recommendation in favor (mandating coverage by private insurers under the ACA), it is clear that CMS should cover LDCT screening. To do otherwise would be discriminatory against the medicare population and would be to ignore the evidence.
    Johnson, Kirk Title: Manager Imaging Services
    Organization: Orange Coast Memorial Medical Center
    Date: 11/12/2014
    Comment:
    I am in support of CMS' approval of screening for Lung Cancer with LDCT. CT Exposures are As Low As Reasonable Acceptable using the ALARA Principle with the application of the ASIR (adaptive statistical iterative reconstruction). This ASIR algorithm enhances patient safety with by using the lowest radiation dose feasible for this CT application. Coupling patient safety and historically effective findings with the use of LDCT, patients are well served by engaging with this type of service for

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    Hotra-Shinn, Erin Date: 11/12/2014
    Comment:
    I am in support of CMS' approval of screening for Lung Cancer with LDCT. Research shows, and the practice in our community bears out, that LDCT is effective in detecting lung cancer at its earliest, most treatable stage.It's very unfortunate that we see many late stage lung cancers diagnosed at our hospital that have poor prognoses, as a result of not being diagnosed earlier. Thank you for your consideration.
    Clark, Noelle Title: MSN, RN, OCN
    Organization: Seton Healthcare
    Date: 11/12/2014
    Comment:
    I believe the age limit should be 55-80. Giving an arbitrary cut off age of 74 because "we" would not treat these patients with chemotherapy is incorrect. A patient's performance status and overall health status is more telling of being able to handle chemotherapy treatment than age. Plus the fact that early stage lung cancers are going to be easier to treat than more advanced cancer. I believe the age question needs to be looked at from an ethical view as to are we going to deny coverage

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    Sterne, Sylvia Organization: 1933
    Date: 11/11/2014
    Comment:
    Please provide information regarding why the cut off age is 74 and not 80 or 85. I smoked a pack a day for about 45 years and quit smoking in July, 2000 (14+ years). I am 81 years old and healthy now. People are living to be 95-100. Why would you deny this service to people over 74.
    Randle, Emily Title: Chief Operating Officer
    Organization: Orange Coast Memorial Medical Center
    Date: 11/11/2014
    Comment:
    I am in support of CMS' approval of screening for Lung Cancer with LDCT. Research shows, and the practice in our community bears out, that LDCT is effective in detecting lung cancer at its earliest, most treatable stage.
    Heath, William Title: Corporate Director of Imaging Services
    Organization: Baptist Health Care Corporation
    Date: 11/11/2014
    Comment:
    This is the right thing to do for our aging population, many of which are at high risk for Lung CA
    Stewart, Kevin Title: Director of Environmental Health
    Organization: American Lung Association of the Mid-Atlantic
    Date: 11/11/2014
    Comment:

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

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    Munn, Samson Title: Vice President, Med. Staff; &Vice Chair, Radiology
    Organization: Tufts Medical Center
    Date: 11/11/2014
    Comment:
    If each of the medical criteria is indeed met and documented, and if the order is placed formally, then why would the "lung cancer screening counseling and shared decision making visit" also be necessary? In that setting, the main effects it would have would be a) to delay the screening lung CT, b) to entail an additional visit for busy patients and busy doctors, really just for documentation of elements that could have been documented already or without a clinic visit, and c) the additional

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    Powell, John Date: 11/11/2014
    Comment:
    I support the Lung Cancer Screening!
    Powell, Dan Date: 11/11/2014
    Comment:
    [PHI Redacted] it is absolutely critical for this new screening to be approved. So, many lives can be saved with this new program. If it can be caught at stage 1 or 2 the person has a good chance of survival. I wouldn't wish stage 4 Lung Cancer on my worst enemy.
    Wu, Christopher Date: 11/11/2014
    Comment:

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

    Can the CMS age range be brought into line with the USPSTF guidelines? Insurers will need to cover A and B grade recommendations of the

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    Yoshiwara, Kim Date: 11/11/2014
    Comment:
    Medicare should not be prolonging lives but making lives comfortable; not welfare for medical companies. At age 55+ we have made our beds and should not expect to be saved from all our past actions.
    Kay, Carolyn Organization: www.ManyYearsYoung.com
    Date: 11/11/2014
    Comment:

    Wouldn't it be cheaper and just as effective, with fewer potential side effects, to use breath temperature measurement (http://bit.ly/1EoJAm5) to screen for lung cancer?

    And there's at least one other breath test (http://bit.ly/1EoKa3k).

    flynn, michael Title: MD, retired physician, former B reader
    Date: 11/10/2014
    Comment:

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

    The National Cancer Institute says: " Many studies have shown that the combination of smoking

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    Nease, KARL Date: 11/10/2014
    Comment:

    This is an outrageous proposal! The message it sends to smokers is "don't worry—smoke your entire life then let the taxpayers fund your screening and care for your self-inflected cancer".

    Medicare refuses to fund skin cancer screening yet is willing to pay for idiots who intentionally cause their poor health.

    What next—Medicare will pay for cigarettes if you only smoke one pack per day?

    Quit enabling smokers!

    RODGER, CINDY Title: Office Mgr
    Organization: SCOTT A RODGER MD, PRIMARY CARE
    Date: 11/10/2014
    Comment:
    Will Primary Care Physicians be paid a "G" code for counseling prior to ordering the LDCT?
    eitel, dolores Title: Retired Family/Adult Nurse Practitioner
    Date: 11/10/2014
    Comment:
    Absolutely agree with screening. Early detection early cure and or increased quality of life.