When low-dose CT screening for lung cancer got the thumbs down by a panel looking into Medicare coverage Wednesday, the pulmonology community was shocked and indignant.
The Centers for Medicare and Medicaid national coverage determination advisory group voted low confidence on evidence of a net benefit and on potential to minimize risk for the Medicare population.
Arguments by professional organizations at the meeting largely centered on what would be appropriate limitations on the screening criteria and requirements for screening centers seeking reimbursement, confident in the 20% lung cancer mortality reduction and nearly 7% overall survival boost in the pivotal National Lung Screening Trial (NLST) and recommendation of the U.S. Preventive Services Task Force (USPSTF).
“It was a pretty stunning surprise,” Douglas Wood, MD, chief of cardiothoracic surgery at the University of Washington in Seattle, told MedPage Today after his presentation at the meeting.
“Medicare has the ability to decide how it is rolled out. None of us were thinking it should be a blanket approval with no qualifications,” said Wood, past president of the Society of Thoracic Surgeons.
“My impression is that the majority of panelists had decided what they wanted to do because it appeared from questions and panel discussion that they did not take anything from the presentations.
The level of frustration building among invited speakers as the question and answer period wore on was palpable.
Arguments were batted back and forth about the definition of overdiagnosis, whether further rounds of screening would raise or lower false positive risks, the meaning of the nonsignificant 65 and older subgroup analysis in NLST, and how well radiology and other groups could really police themselves.
Perhaps indicating one reason for the advisory committee approach, panelist Jo Carol Hiatt, MD, MBA, of Kaiser Permanente, explained:
“The instructions to the jury, so to speak, this morning were that we were to assume there would be no real conditions on these questions — there wouldn’t be registries, there wouldn’t be coverage with evidence, and that sort of thing. So I read this question as not necessarily having all the quality and certification controls imposed by the ACR and other institutions, that we wouldn’t necessarily limit to certified sites.”
Frustration was a common thread among responses to the panel’s decision by experts contacted by MedPage Today as well:
“Screening high risk patients with a low dose CT scan has a number needed to treat of 320 to save a life. … I await the full rationale behind the CMS decision, but this ruling would seem an unfortunate decision that will impact a huge number of at-risk patients.” — Michael A. Nead, MD, PhD, director of the Pulmonary Nodule Clinic at New York’s University of Rochester Medical Center
“By denying coverage for screening among those at higher risk for the development of lung cancer, we do a potential disservice to a large number of people who may benefit from this life-saving intervention.” — Patrick Nana-Sinkam, MD, director of the lung cancer screening program at the Ohio State University Comprehensive Cancer Center in Columbus
“The U.S. Preventive Services Task Force gave this a B recommendation, meaning that it does save lives in the long run … It’s a tremendously missed opportunity by Medicare.” — James Jett, MD, a pulmonologist in the oncology division at National Jewish Health in Denver
“The barrier always was we have the ability to screen for lung cancer and we have no ability to pay for it. The test was expensive enough that it was prohibitive, except for a few patients who could pay for it on their own.” — D. Kyle Hogarth, MD, director of the Bronchoscopy and Upper Aerodigestive Cancer Risk Clinic at the University of Chicago
“There has been no recent intervention other than smoking cessation that has shown such a positive impact in lung cancer. There is no data in breast cancer that is more convincing than presented in lung cancer. It confirms concerns that have been reiterated in the community that the standard is different for lung cancer than it is for other cancers … because of stigma attached to the linkage to cigarette smoking.” — Charles Powell, MD, chief of pulmonary, critical care, and sleep medicine at Mount Sinai in New York and chair of the American Thoracic Society’s thoracic oncology assembly.
A reversal before the final determination early in 2015 might still be possible, Lung Cancer Alliance president and CEO Laurie Fenton Ambrose suggested.
“We are confident as part of the coalition of leading experts in lung cancer screening that we can provide CMS with the evidence and data that proves full coverage for lung cancer screening for our high risk seniors based on USPSTF guidelines is the right thing to do,” she said.
But Wood wasn’t hopeful that much more could be done to answer concerns of the CMS advisors.
“The data exist and was ignored,” he told MedPage Today. “I don’t think there’s some data mining that solves this. NLST was a superb study and is never going to be repeated.”
Registry data aren’t likely to add anything more informative than that, although a few smaller randomized trials from Europe due out soon could help, Powell added.
What could make a real difference is if physicians and others who disagree with the advisory panel opinion speak out, Powell argued, pointing to the power of public opinion in reinstating mammography for women in their 40s after a negative decision from the USPSTF.
Crystal Phend joined MedPage Today in 2006 after roaming conference halls for publications including The Medical Post, Oncology Times, Doctor’s Guide, and the journal IDrugs. When not covering medical meetings, she writes from Silicon Valley, just south of the San Francisco fog.
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