Dr. Barry Kramer, director of the National Cancer Institute's Division of Cancer Prevention, once had doubts that using low-dose CT scans to detect early lung cancer
is a good idea.
In 2009, he co-authored a study that found one in three people who undergo frequent CT scans to spot lung cancer received false-positive results that could lead to potentially harmful follow-up tests and unnecessary patient anxiety.
But in 2011, as an investigator on the National Lung Screening Trial, which studied 53,454 current and former heavy smokers over 55 over a three-year period, he found a 20% reduction in deaths among the group screened using CT scans versus those screened using chest X-rays. Since then, he has been a vocal advocate of CT screening for the estimated 9 million Americans who are between 55 and 80 and have a smoking history of 30 "pack years," defined as averaging a pack a day for a year.
“In my estimation, the benefits outweigh the harms,” Kramer said.
That will be the central issue on April 30 when the CMS convenes a meeting of the Medicare Evidence Development and Coverage Advisory Committee to decide if Medicare
will cover annual screenings for lung cancer with low-dose CT scans for current or past heavy smokers. The panel will make a national coverage recommendation by the end of the meeting. The CMS expects to release a proposed decision memo on Nov. 10, and, after taking public comments, plans to release a final national coverage determination by Feb. 8, 2015.
, the U.S. Preventive Services Task Force gave a Grade B recommended rating for offering such screening annually to current or past heavy smokers ages 55 to 80. The USPSTF recommended
annual screening for lung cancer with low-dose CT scans in adults ages 55 to 80 who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. Under the Patient Protection and Affordable Care Act, the task force recommendation means that private insurers are required to cover the screening on a first-dollar basis for their non-Medicare insured members. The test typically costs $300 to $400.
Many experts, but not all, support Medicare covering CT scans for smokers. “Lung cancer is the leading cause of cancer death among both men and women and without screening we can make no headway,” said Dr. Ella Kazerooni, chairwoman of the American College of Radiology Lung Screening Committee. “The fact is, we're trying to reduce mortality and this is the only cancer we don't screen for today.” The total cost of covering CT scans would be relatively modest because of the limited size of the eligible Medicare population, she added.
Others raise concerns about potential negative impacts on patients. “It would be a mistake for CMS to extend coverage for this screening recommendation at this time,” said Dr. Kenneth Lin, an associate professor of family medicine at Georgetown University. The task force recommendation “could potentially mean that a patient who never stops smoking could be exposed to 25 annual CT screenings, with the resulting radiation and false positive results… It could very well lead to over diagnosis and overtreatment.”
The American Academy of Family Physicians in January concluded that the evidence is insufficient to recommend for or against the screening. The academy urged a shared decisionmaking discussion between doctors and patients regarding the benefits and potential harms of the screening. It noted that while the annual CT screening would be covered by private insurers with no cost sharing, any follow-up testing would be subject to regular patient cost sharing.
Medicare's coverage determination for CT scans for lung cancer in smokers follows controversial recommendations from the U.S. Preventive Services Task Force several years ago that women under 50 with an average risk of breast cancer should not receive routine mammograms—the recommendation was not adopted—and from the American Urological Association raising questions about the value of routine prostate-specific antigen tests for men. In both cases, the groups said the potential harms may outweigh the benefits.
Advocates say it's important for Medicare to cover CT scans to screen for lung cancer among smokers because more than two-thirds of Americans diagnosed with lung cancer are 65 or older, according to estimates from the National Institutes of Health. The preventive services task force estimates that if its recommendation was fully implemented, it could save as many as 20,000 lives each year.
Smoking-related lung cancer kills about 130,000 Americans each year. Over half of those deaths are former smokers, according to the American College of Preventive Medicine. The five-year overall survival rate for lung cancer patients in the U.S. is 16.8%, research shows. That low rate has been attributed to the late stage of diagnosis for the disease.
On the other hand, some groups have urged the CMS to put protections in place to safeguard Medicare beneficiaries from excessive radiation exposure and misdiagnosis. In a comment submitted to the agency, America's Health Insurance Plans said the CMS should issue a guidance on evidence-based guidelines for ordering CT scans for lung cancer. It also said the CMS should encourage primary care providers to engage in shared decision-making with patients about whether to order the scans.
To make sure the new coverage is having a positive impact, a patient registry should be mandated, recommended Dr. Jo-Anne Shepard, director of thoracic radiology at Massachusetts General Hospital.
There has been discussion about whether the CMS will or should consider cost-effectiveness in making its decision. The 2008 Medicare Improvements for Patients and Providers Act authorized the Medicare program to consider cost in making coverage decisions about preventive screening services. Section 101 of the law said the HHS Secretary can consider “the relation between predicted outcomes and the expenditures” for screening services and “may take into account the results of such assessment in making such determination.” A Milliman actuarial analysis published in Health Affairs in 2012 concluded that covering CT scans for lung cancer for smokers ages 50 to 64 would save lives at a cost of under $1 per insured member per month. The cost per life-year saved would be lower than screening for cervical and breast cancer and comparable to the cost per life-year saved of screening for colorectal cancer, the study found. A separate study published in the Journal of Thoracic Oncology in 2011 found cost-effectiveness numbers for CT lung cancer screening that were less favorable than those for breast cancer or colorectal cancer screening. But it also found that combining CT screening with discussing smoking cessation with patients could significantly improve the cost-benefit ratio.
The CMS previously has taken cost into consideration in making positive coverage decisions on screenings for depression, HIV, and obesity screening and counseling, said James Chambers, an assistant professor of medicine at Tufts Medical Center's Institute for Clinical Research and Health Policy Studies, who has studied Medicare coverage determinations. “Since they did it for these, I would not be surprised if they did for proactive CT scans of lungs in heavy smokers,” he said.
But Dr. Barry Straube, a former CMS chief medical officer who now is director of healthcare consulting for the Marwood Group, said the CMS is not likely to assess cost in its determination on CT scans for lung cancer, for two reasons. The first, he said, is that the CMS would only consider cost if two or more screening tests were equally effective, which is not the case in detecting lung cancer. Second, explicitly considering cost in coverage decisions is hugely controversial politically. “There will be strong political pressure to not use cost alone, if at all, in this decision,” he said.
A CMS spokesman said the agency has not made any coverage decisions based on costs and that it has no plans to do so. Follow Virgil Dickson on Twitter: @MHvdickson