The Medicare Evidence Development & Coverage Advisory Committee (MedCAC) convened today and representatives from organizations such as the American College of Radiology and the Lung Cancer Alliance went before the committee to contend for national Medicare coverage of low dose CT (LDCT) screening for patients who are at a high risk for lung cancer.
While the Centers for Medicare and Medicaid Services (CMS) will not post a draft coverage decision until November, the MedCAC panelists at today's meeting did not have high confidence that current evidence supports the notion that the benefits of LDCT lung cancer screening in the Medicare population would outweight the harms.
Last December, the U.S. Preventive Services Task Force (USPSTF) recommended that annual screening with LDCT be provided to asymptomatic adults between the ages of 55 and 80 who have a 30 pack-year history of smoking and currently smoke or have quit within the last 15 years. According to the recommendation, screening should be discontinued once a patient has ceased smoking for 15 years or develops a health problem that drastically limits his or her life expectancy or willingness to undergo curative lung surgery. This recommendation was designated grade “B,” meaning that private insurers must cover the procedure without a co-pay under the Affordable Care Act. However, the healthcare reform law does not force Medicare to provide full national coverage for the recommendation.
Paul Pinsky, MD, of the National Cancer Institute and National Institute of Health in Bethesda, Md., began the meeting’s featured speaker section by discussing the design of the National Lung Screening Trial (NLST), which played a large role in the 2013 USPSTF recommendation regarding LDCT screening. Pinksy noted that while LDCT demonstrated efficacy for lung cancer screening with a 20 percent mortality benefit, there was extreme variability in the radiologists’ false-positive rates. The false-positive rates ranged from 10 percent to as high as 50 percent, and most of the centers involved in the study were academic. Significant abnormality was higher in the older population at 8.7 percent versus 6.9 percent for those between the ages of 55 and 64. “Models that extrapolate benefit must be taken with caution,” Pinksy remarked.
“This genie certainly won’t be able to be stuffed back into the bottle if we don’t deal with this now,” said Peter Bach, MD, MAPP, of the Memorial Sloan-Kettering Cancer Center in New York City, in reference to the current lack of Medicare coverage for LDCT screening. Bach branched off of Pinksy’s points about the NLST’s design by bringing attention to the underrepresentation of people in the older age band. Moreover, about only 25 percent of the subjects were in the Medicare eligible age group, and most participants were overeducated in relation to the typical population of tobacco users. Thus, Bach argued, the population was not correctly represented.
In addition to the trial’s study population, Bach also focused on the atypical care settings involved, which included those with particular expertise at academic medical centers. These factors made the situation appear to be more efficacious to the community, said Bach. Additionally, fewer than 12 percent of the subjects were over the age of 70 at the time of study entry and none were older than 74. This is especially problematic, as the risk of lung cancer rises with age, he said. Bach then pointed to the reality that every guideline recommends shared decision making, and asked Medicare to consider this truth when moving forward in making their decision.
Laurie Fenton Ambrose, President and CEO of the Lung Cancer Alliance in Washington D.C., then took the podium, pledging to ensure that the people behind the numbers are heard. She emphasized the Lung Cancer Alliance’s support for national coverage for lung cancer screening in the Medicare population, as 27.5 percent of all cancer deaths are attributed to lung cancer. Ambrose emphasized that the vast majority of lung cancer cases are detected at late stages and continue to occur in people over the age of 65. “There is no other proven way to detect lung cancer than screening,” she said.
Ambrose pointed to the rigorous testing and review of lung cancer screening that has taken place over the past 30 years, which is far more than any other screening method. She emphasized key elements of responsible screening, which she listed as educating those at risk, implementation of best practices and supporting quality improvement with the collection of data and analysis through established registries.
“The Affordable Care Act makes lung cancer screening an essential benefit,” said Ambrose. “Coverage with evidence will not lead to any additional information that will fundamentally change the elements and the practice of responsible lung cancer screening for our seniors. But what it will do, make no mistake, is cost time, money and their lives.”
If screening is limited only to large academic medical centers or National Cancer Institute-designated cancer centers, people in areas with high risk will face significant barriers to access, Ambrose further argued. “If restricted, the very community hospitals that are leading the way and saving lives right now will be disenfranchised,” she said.
“For too long, a black cloud of despair and indifference has hovered over this community, yet now we have a convergence of solid evidence and best practices that bring tangible hope for their survival,” Ambrose said. “There is no need to create any additional barriers to this life saving benefit that would result in a patchwork system for our Medicare population.”
A representative of the American Academy of Family Physicians (AAFP) discussed the organization’s position on LDCT screening coverage. Doug Campos-Outcalt, MD, MPA, of the University of Arizona College of Medicine in Tucson, explained that while the AAFP rarely disagrees with USPSTF recommendations, they did disagree with their guideline for lung cancer screening. He cited the organization’s five largest concerns: that the recommendation was based largely on one study; that the conditions of the National Lung Screening Trial are unlikely to be replicated in community setting; modeling; the possibility of a current smoker undergoing 25 annual CT scans and the lack of cost benefit analysis.
The AAFP therefore chose the “I statement”—insufficient evidence—as they felt that there was not enough evidence available to assess the harms of screening and they are not confident that the benefits in the community settings would equal those of the National Lung Screening Trial. TAAFP recommends that the USPSTF restrict the recommendation to clinical settings that have a high rate of diagnostic accuracy using LDCT, enact appropriate follow-up protocols for positive results, provide clear criteria for performing invasive procedures and have low complication rates from invasive procedures. “Betterment of risk and benefit patient profiling should be considered to minimize the number of CT scans performed,” said Campos-Outcalt.
Following public comments and questions, the MedCAC panel voted on a preset group of questions, and largely expressed low confidence in the merits of covering LDCT screening. They gave an average confidence score of 2.22 (out of 5) to the question of whether there is adequate evidence to determine if the benefits outweigh the harms of lung cancer screening with LDCT in the Medicare population. Likewise, they expressed concern that there are evidence gaps regarding the use of LDCT for lung cancer screening in Medicare beneficiaries outside of the clinical trial setting.
A draft coverage decision will be posted on November 10.