A CMS panel today rejected the concept of national Medicare coverage of annual lung cancer screening for high-risk individuals.
The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) conducted a daylong hearing during which several clinicians and members of the public testified about the benefits and risks of lung cancer screening with low-dose CT.
Several medical organizations are asking CMS to provide full national coverage for high-risk patients, but MEDCAC members did not make such a recommendation.
Following the hearing, the committee expressed low to intermediate confidence that the benefits of annual screening with low-dose CT outweighed those potential risks.
“It is our obligation to do no harm,” said committee member Curtis A. Mock, MD, MBA. “I didn’t hear the evidence to support that there is benefit beyond harm.”
The committee’s decision comes 4 months after the US Preventive Services Task Force recommended annual low-dose CT screening for adults aged 55 to 80 years with a 30 pack-year smoking history who either still smoke or have quit within the prior 15 years.
The USPSTF guidelines were based largely on results of the National Lung Screening Trial (NLST), which included more than 53,000 adults aged 55 to 74 years who were at high risk for lung cancer. Researchers randomly assigned participants to annual low-dose CT or single-view posteroanterior chest radiography for 3 years.
Results showed annual low-dose CT was associated with a 20% (95% CI, 6.8-26.7) reduction in lung cancer mortality. Researchers have suggested that if a similar screening approach was implemented for the estimated 8.6 million American adults who meet eligibility criteria, more than 12,000 lung cancer deaths could be prevented each year.
Yet, others in the clinical community have emphasized that the benefits of lung cancer screening must be weighed against risks, such as the potential for overdiagnosis and a high frequency of false-positive results, both of which are associated with additional workup, patient anxiety and unnecessary treatment.
Of the 24.2% of scans found positive for lung cancer during the NLST, a majority ultimately were reclassified as false positives (96.4%). In addition, a modeling study conducted by the USPSTF projected 10% to 12% of lung cancers detected were overdiagnosed, meaning the nodule detected during screening never would have progressed to the point where it posed a threat.
MEDCAC members were asked to vote on a scale of 1 to 5 whether they were confident that evidence adequately showed the benefits of lung cancer screening with low-dose CT outweighed the harms in the Medicare population. The mean score of the vote was 2.222, equating to low to intermediate confidence.
When asked to express their confidence that the harms of lung cancer screening with low-dose CT would be minimized if implemented in the Medicare population, the mean score of the committee’s vote was 2.333, again equaling a vote of low to intermediate confidence.
Many committee members said they believed there is a subset of individuals who would benefit from annual screening with low-dose CT, but that current evidence doesn’t go far enough to show who would benefit most.
Committee member Stephen H. Woolf, MD, MPH, cited the “very tenuous risk–benefit ratio” of screening. He also questioned whether clinicians would follow the appropriate screening schedule, noting recommended intervals often have “a slippery slope.”
Several committee members expressed concern about placing too much emphasis on the results of one randomized, controlled trial. They also questioned whether results of the NLST can be extrapolated to the Medicare population.
“The [NSLT] trial is unlikely to be repeated, and it is unlikely there will be a better trial,” countered committee member Gerald A. White Jr., MS, FAAPM, FACR. “I don’t think there is ever going to be something that is more adequate.”
“I worry we may be setting the threshold so high that no new technology could pass it,” added committee member David Howard, PhD.
For more information:
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Moyer VA. Ann Intern Med. 2013;doi:10.7326/P14-9009.