When Will Enough Ever Be Enough?

Abstract

Imagine—A 20% reduction in lung cancer mortality in long-term smokers, the highest risk group for our nation's largest cancer killer. Imagine—A randomized multicenter controlled trial conclusively demonstrating that early detection of lung cancer, before patients become symptomatic, can save more lives than the decades of work spent on new methods of treating the disease. Imagine—A trial so robust that the National Cancer Institute's Data and Safety Monitoring Board for the study stopped the study before its scheduled completion so that all patients in the study could realize the benefits of lung cancer screening [1National Cancer Institute. Statement concerning the National Lung Screening Trial. Available at: http://www.cancer.gov/PublishedContent/Files/images/DSMB-NLST.pdf. Accessed May 30, 2014.Google Scholar]. Imagine—Having a tool that actually achieves many of the goals of the $200 billion 1998 Tobacco Master Settlement Agreement between the tobacco companies and the states. Well, of course, we don't have to imagine it. These are the outcomes of the National Lung Screening Trial (NSLT) [2The National Lung Screening Trial Research TeamReduced lung-cancer mortality with low-dose computed tomographic screening.N Engl J Med. 2011; 365: 395-409Crossref PubMed Scopus (6622) Google Scholar], a study sponsored by the National Cancer Institute and the National Institutes of Health and conducted by ACRIN™ and the Lung Screening Study group. The NLST conclusively demonstrated that screening for lung cancer in high-risk individuals with low-dose CT (LDCT) would save lives—10,000 to 20,000 lives [3de Koning H.J. Meza R. Plevritis S.K. et al.Benefits and harms of computed tomography lung cancer screening strategies: a comparative modeling study for the US Preventive Services Task Force.Ann Intern Med. 2014; 160: 311-320Crossref PubMed Scopus (346) Google Scholar], each and every year.With a cohort of more than 53,000 patients enrolled at 33 trial sites, the NLST is the most robust lung cancer screening trial to date and was the basis for the US Preventive Services Task Force's (USPSTF) decision to recommend annual lung cancer screening in high-risk individuals. In reaching its recommendation, the USPSTF relied heavily on a modeling study by de Koning et al [3de Koning H.J. Meza R. Plevritis S.K. et al.Benefits and harms of computed tomography lung cancer screening strategies: a comparative modeling study for the US Preventive Services Task Force.Ann Intern Med. 2014; 160: 311-320Crossref PubMed Scopus (346) Google Scholar], which found that “annual lung cancer screening of individuals with a smoking history of at least 30 pack-years from ages 55 through 80 years offers substantial benefits…there would be a 14% overall lung cancer mortality reduction and a 25% reduction in those eligible for screening, with relatively limited harms.” The recommendation of the USPSTF is significant because the Patient Protection and Affordable Care Act of 2010 requires that private insurers provide preventive services recommended by the USPSTF as a covered benefit, which is necessary for the widespread implementation of screening programs.So all that is left to complete this story is for CMS to provide coverage for screening the 65- to 80-year-old group of high-risk individuals. Although the Patient Protection and Affordable Care Act requires private insurers to follow USPSTF recommendations, for some reason, CMS is not held to this same standard, but on the basis of amendments to the Social Security Act as of January 2009, CMS is allowed to add coverage of “additional preventive services” through the national coverage determination process if the USPSTF grades the service A (strongly recommends) or B (recommends) and it meets certain other requirements [4Centers for Medicare and Medicaid Services. National coverage analysis tracking sheet for lung cancer screening with low dose computed tomography (CAG-00439N). Available at: http://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=274. Accessed May 20, 2014.Google Scholar]. On February 10, 2014, CMS initiated a national coverage analysis. The final decision is expected by February 2015. As part of that process, CMS held a meeting of a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to review available evidence. On the basis of the available evidence, as well as the recommendation of the USPSTF, it is difficult to imagine that CMS would not provide coverage for LDCT for lung cancer screening.Now imagine the unimaginable: In a 1-day meeting on April 30, 2014, the MEDCAC panel assigned to make Medicare coverage recommendations for lung cancer screening concluded that there is not enough evidence to recommend Medicare coverage for lung cancer screening. The MEDCAC decision, although not binding on the CMS coverage group, was very disappointing because it seemingly discards the available high-level evidence and relies more on the biases of the panel members. The ACR, the Society of Thoracic Surgeons, and the Lung Cancer Alliance [5American College of Radiology. Collaborative comments to MEDCAC on lung cancer screening. Available at: http://www.acr.org/∼/media/ACR/Documents/PDF/News/LCS%20Consensus%20stakeholder%20document_FINAL%20logo.pdf. Accessed May 20, 2014.Google Scholar] submitted collaborative comments outlining the data supporting coverage of LDCT for lung cancer screening. Several ACR representatives attended and presented at the MEDCAC panel meeting, including Ella Kazerooni, the chair of the ACR's Committee on Lung Cancer Screening. By all accounts, our specialty and position were incredibly well represented, but despite our comments, comments from hundreds of other stakeholders [6Centers for Medicare and Medicaid Services. View public comments for lung cancer screening with low dose computed tomography. Available at: http://www.cms.gov/medicare-coverage-database/details/nca-view-public-comments.aspx?NCAId=274&ExpandComments=n&NcaName=Lung+Cancer+Screening+with+Low+Dose+Computed+Tomography&MEDCACId=68. Accessed May 30, 2014.Google Scholar], and extensive testimony at the hearing, the panel concluded that there was not enough evidence to determine that the benefits of lung cancer screening outweigh the harms. The votes of the panelists can be found on MEDCAC's website [7Centers for Medicare and Medicaid Services. MEDCAC meeting 4/30/2014—lung cancer screening with low dose computed tomography. Available at: http://www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=68#agenda. Accessed May 20, 2014.Google Scholar]. In response to the question, “How confident are you that there is adequate evidence to determine if the benefits outweigh the harms of lung cancer screening with LDCT in the Medicare population?” the MEDCAC panel on average answered 2.2 out of a possible confidence score of 5. Despite the results of the NLST and the recommendation of the USPSTF, 3 of 5 was the highest score recorded, and one-third (3) of the panelists voted 1 of 5.On the basis of the reports of the ACR attendees, reports of other attendees [8Gannis F. CT lung screening meeting: a travesty of public health policy. Available at: http://www.auntminnie.com/index.aspx?d=1&sec=sup&sub=imc&pag=dis&ItemID=107339&wf=1. Accessed May 30, 2014.Google Scholar], and the recorded video [9Centers for Medicare and Medicaid Services. 2014 Apr 30th, MEDCAC - lung cancer screening with low dose computed tomography (morning session). Available at: http://www.youtube.com/watch?v=xlCaTHxleqM. Accessed May 20, 2014.Google Scholar, 10Centers for Medicare and Medicaid Services. 2014 Apr 30th, MEDCAC - lung cancer screening with low dose computed tomography (afternoon session). Available at: http://www.youtube.com/watch?v=qG3NAPVzkTk. Accessed May 20, 2014.Google Scholar] of the meeting, some panelists cited the potential harms of lung cancer screening as a reason for not supporting coverage. One panel member stated that studies with false-positive results would cause “thousands of iatrogenic deaths,” even though there was not a single documented death in the NSLT as a result of a complication from screening. And although the panel considered only high-level evidence from randomized trials, its members frequently cited the theoretical risk for developing cancer from radiation exposure on the basis of modeling studies from atomic bomb data rather than any study confirming that theory. I cannot imagine how they could compare this theoretical risk, which would be particularly low in Medicare-aged patients, with the risk of not undergoing screening.Most disconcerting was the panel's general dismissal of the compelling evidence for lung cancer screening provided by the NLST. The MEDCAC panel challenged the statistical validity of the NLST, as well as the quality of the evidence, suggesting that the NSLT is only one trial and that decisions cannot be based on only one trial. Is the panel suggesting that the NSLT needs to be repeated? Two important pieces of legislation from Congress, the American Recovery and Reinvestment Act of 2009 and the Patient Protection and Affordable Care Act of 2010, set the agenda for public funding of medical research. These laws specifically provide public funds dedicated to comparative effectiveness research to achieve the goal in health care reform of spending health care dollars on the services that provide evidence-based health benefits and eliminating spending on services that do not. In its “100 Initial Priority Topics for Comparative Effectiveness Research,” the Institute of Medicine placed “Compare the effectiveness of imaging technologies in diagnosing, staging, and monitoring patients with cancer including positron emission tomography (PET), magnetic resonance imaging (MRI), and computed tomography (CT)” in the top quartile [11Institute of Medicine. 100 initial top priorities in comparative effectiveness research. Available at: http://www.iom.edu/∼/media/Files/Report%20Files/2009/ComparativeEffectivenessResearchPriorities/Stand%20Alone%20List%20of%20100%20CER%20Priorities%20-%20for%20web.pdf. Accessed May 30, 2014.Google Scholar]. The NSLT is a prime example of comparative effectiveness research in action. The NSLT was a tremendous investment of public resources. The National Cancer Institute spent more than $240 million in tax dollars, and researchers spent more than 8 years to complete the trial. The results speak for themselves. To dismiss the validity of the NSLT as “only one study” seems to be a travesty of the public trust. If there is such a bias against screening that positive outcomes will never be accepted, if the bar is set higher than what is deliverable by the research community, and if the cost of providing optimal care will be deemed too high, why make the investment in the first place? So I am left to imagine, when will enough ever be enough to overcome the biases we faced with the MEDCAC panel?Fortunately for our patients, the MEDCAC recommendation is only one piece of information CMS will consider in making its final coverage determination. The ACR will continue to work with CMS as well as other stakeholders and policymakers to promote Medicare coverage for lung cancer screening because there is indeed enough evidence to warrant coverage, and the time for CMS to act is now. Imagine—A 20% reduction in lung cancer mortality in long-term smokers, the highest risk group for our nation's largest cancer killer. Imagine—A randomized multicenter controlled trial conclusively demonstrating that early detection of lung cancer, before patients become symptomatic, can save more lives than the decades of work spent on new methods of treating the disease. Imagine—A trial so robust that the National Cancer Institute's Data and Safety Monitoring Board for the study stopped the study before its scheduled completion so that all patients in the study could realize the benefits of lung cancer screening [1National Cancer Institute. Statement concerning the National Lung Screening Trial. Available at: http://www.cancer.gov/PublishedContent/Files/images/DSMB-NLST.pdf. Accessed May 30, 2014.Google Scholar]. Imagine—Having a tool that actually achieves many of the goals of the $200 billion 1998 Tobacco Master Settlement Agreement between the tobacco companies and the states. Well, of course, we don't have to imagine it. These are the outcomes of the National Lung Screening Trial (NSLT) [2The National Lung Screening Trial Research TeamReduced lung-cancer mortality with low-dose computed tomographic screening.N Engl J Med. 2011; 365: 395-409Crossref PubMed Scopus (6622) Google Scholar], a study sponsored by the National Cancer Institute and the National Institutes of Health and conducted by ACRIN™ and the Lung Screening Study group. The NLST conclusively demonstrated that screening for lung cancer in high-risk individuals with low-dose CT (LDCT) would save lives—10,000 to 20,000 lives [3de Koning H.J. Meza R. Plevritis S.K. et al.Benefits and harms of computed tomography lung cancer screening strategies: a comparative modeling study for the US Preventive Services Task Force.Ann Intern Med. 2014; 160: 311-320Crossref PubMed Scopus (346) Google Scholar], each and every year. With a cohort of more than 53,000 patients enrolled at 33 trial sites, the NLST is the most robust lung cancer screening trial to date and was the basis for the US Preventive Services Task Force's (USPSTF) decision to recommend annual lung cancer screening in high-risk individuals. In reaching its recommendation, the USPSTF relied heavily on a modeling study by de Koning et al [3de Koning H.J. Meza R. Plevritis S.K. et al.Benefits and harms of computed tomography lung cancer screening strategies: a comparative modeling study for the US Preventive Services Task Force.Ann Intern Med. 2014; 160: 311-320Crossref PubMed Scopus (346) Google Scholar], which found that “annual lung cancer screening of individuals with a smoking history of at least 30 pack-years from ages 55 through 80 years offers substantial benefits…there would be a 14% overall lung cancer mortality reduction and a 25% reduction in those eligible for screening, with relatively limited harms.” The recommendation of the USPSTF is significant because the Patient Protection and Affordable Care Act of 2010 requires that private insurers provide preventive services recommended by the USPSTF as a covered benefit, which is necessary for the widespread implementation of screening programs. So all that is left to complete this story is for CMS to provide coverage for screening the 65- to 80-year-old group of high-risk individuals. Although the Patient Protection and Affordable Care Act requires private insurers to follow USPSTF recommendations, for some reason, CMS is not held to this same standard, but on the basis of amendments to the Social Security Act as of January 2009, CMS is allowed to add coverage of “additional preventive services” through the national coverage determination process if the USPSTF grades the service A (strongly recommends) or B (recommends) and it meets certain other requirements [4Centers for Medicare and Medicaid Services. National coverage analysis tracking sheet for lung cancer screening with low dose computed tomography (CAG-00439N). Available at: http://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=274. Accessed May 20, 2014.Google Scholar]. On February 10, 2014, CMS initiated a national coverage analysis. The final decision is expected by February 2015. As part of that process, CMS held a meeting of a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to review available evidence. On the basis of the available evidence, as well as the recommendation of the USPSTF, it is difficult to imagine that CMS would not provide coverage for LDCT for lung cancer screening. Now imagine the unimaginable: In a 1-day meeting on April 30, 2014, the MEDCAC panel assigned to make Medicare coverage recommendations for lung cancer screening concluded that there is not enough evidence to recommend Medicare coverage for lung cancer screening. The MEDCAC decision, although not binding on the CMS coverage group, was very disappointing because it seemingly discards the available high-level evidence and relies more on the biases of the panel members. The ACR, the Society of Thoracic Surgeons, and the Lung Cancer Alliance [5American College of Radiology. Collaborative comments to MEDCAC on lung cancer screening. Available at: http://www.acr.org/∼/media/ACR/Documents/PDF/News/LCS%20Consensus%20stakeholder%20document_FINAL%20logo.pdf. Accessed May 20, 2014.Google Scholar] submitted collaborative comments outlining the data supporting coverage of LDCT for lung cancer screening. Several ACR representatives attended and presented at the MEDCAC panel meeting, including Ella Kazerooni, the chair of the ACR's Committee on Lung Cancer Screening. By all accounts, our specialty and position were incredibly well represented, but despite our comments, comments from hundreds of other stakeholders [6Centers for Medicare and Medicaid Services. View public comments for lung cancer screening with low dose computed tomography. Available at: http://www.cms.gov/medicare-coverage-database/details/nca-view-public-comments.aspx?NCAId=274&ExpandComments=n&NcaName=Lung+Cancer+Screening+with+Low+Dose+Computed+Tomography&MEDCACId=68. Accessed May 30, 2014.Google Scholar], and extensive testimony at the hearing, the panel concluded that there was not enough evidence to determine that the benefits of lung cancer screening outweigh the harms. The votes of the panelists can be found on MEDCAC's website [7Centers for Medicare and Medicaid Services. MEDCAC meeting 4/30/2014—lung cancer screening with low dose computed tomography. Available at: http://www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=68#agenda. Accessed May 20, 2014.Google Scholar]. In response to the question, “How confident are you that there is adequate evidence to determine if the benefits outweigh the harms of lung cancer screening with LDCT in the Medicare population?” the MEDCAC panel on average answered 2.2 out of a possible confidence score of 5. Despite the results of the NLST and the recommendation of the USPSTF, 3 of 5 was the highest score recorded, and one-third (3) of the panelists voted 1 of 5. On the basis of the reports of the ACR attendees, reports of other attendees [8Gannis F. CT lung screening meeting: a travesty of public health policy. Available at: http://www.auntminnie.com/index.aspx?d=1&sec=sup&sub=imc&pag=dis&ItemID=107339&wf=1. Accessed May 30, 2014.Google Scholar], and the recorded video [9Centers for Medicare and Medicaid Services. 2014 Apr 30th, MEDCAC - lung cancer screening with low dose computed tomography (morning session). Available at: http://www.youtube.com/watch?v=xlCaTHxleqM. Accessed May 20, 2014.Google Scholar, 10Centers for Medicare and Medicaid Services. 2014 Apr 30th, MEDCAC - lung cancer screening with low dose computed tomography (afternoon session). Available at: http://www.youtube.com/watch?v=qG3NAPVzkTk. Accessed May 20, 2014.Google Scholar] of the meeting, some panelists cited the potential harms of lung cancer screening as a reason for not supporting coverage. One panel member stated that studies with false-positive results would cause “thousands of iatrogenic deaths,” even though there was not a single documented death in the NSLT as a result of a complication from screening. And although the panel considered only high-level evidence from randomized trials, its members frequently cited the theoretical risk for developing cancer from radiation exposure on the basis of modeling studies from atomic bomb data rather than any study confirming that theory. I cannot imagine how they could compare this theoretical risk, which would be particularly low in Medicare-aged patients, with the risk of not undergoing screening. Most disconcerting was the panel's general dismissal of the compelling evidence for lung cancer screening provided by the NLST. The MEDCAC panel challenged the statistical validity of the NLST, as well as the quality of the evidence, suggesting that the NSLT is only one trial and that decisions cannot be based on only one trial. Is the panel suggesting that the NSLT needs to be repeated? Two important pieces of legislation from Congress, the American Recovery and Reinvestment Act of 2009 and the Patient Protection and Affordable Care Act of 2010, set the agenda for public funding of medical research. These laws specifically provide public funds dedicated to comparative effectiveness research to achieve the goal in health care reform of spending health care dollars on the services that provide evidence-based health benefits and eliminating spending on services that do not. In its “100 Initial Priority Topics for Comparative Effectiveness Research,” the Institute of Medicine placed “Compare the effectiveness of imaging technologies in diagnosing, staging, and monitoring patients with cancer including positron emission tomography (PET), magnetic resonance imaging (MRI), and computed tomography (CT)” in the top quartile [11Institute of Medicine. 100 initial top priorities in comparative effectiveness research. Available at: http://www.iom.edu/∼/media/Files/Report%20Files/2009/ComparativeEffectivenessResearchPriorities/Stand%20Alone%20List%20of%20100%20CER%20Priorities%20-%20for%20web.pdf. Accessed May 30, 2014.Google Scholar]. The NSLT is a prime example of comparative effectiveness research in action. The NSLT was a tremendous investment of public resources. The National Cancer Institute spent more than $240 million in tax dollars, and researchers spent more than 8 years to complete the trial. The results speak for themselves. To dismiss the validity of the NSLT as “only one study” seems to be a travesty of the public trust. If there is such a bias against screening that positive outcomes will never be accepted, if the bar is set higher than what is deliverable by the research community, and if the cost of providing optimal care will be deemed too high, why make the investment in the first place? So I am left to imagine, when will enough ever be enough to overcome the biases we faced with the MEDCAC panel? Fortunately for our patients, the MEDCAC recommendation is only one piece of information CMS will consider in making its final coverage determination. The ACR will continue to work with CMS as well as other stakeholders and policymakers to promote Medicare coverage for lung cancer screening because there is indeed enough evidence to warrant coverage, and the time for CMS to act is now.