CMS to weigh coverage of CT scans for smokers

Dr. Barry Kramer once had doubts that using low-dose CT scans to detect early lung cancer is a good idea based on his research suggesting that a high rate of false-positive results could increase patient anxiety and harmful follow-up tests.

But in 2011, as an investigator on the National Lung Screening Trial, he found a 20% reduction in deaths among current and former heavy smokers over age 55 who were screened using CT scans versus those screened using chest X-rays. Since then, Kramer, now director of the National Cancer Institute's Division of Cancer Prevention, has been an advocate of CT screening for the estimated 9 million Americans between 55 and 80 who have a smoking history of 30 years averaging a pack a day.

“In my estimation, the benefits outweigh the harms,” he 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 and past heavy smokers. The panel will make a recommendation by the end of the meeting. The CMS expects to release a proposed decision memo in November and a final national coverage determination by February 2015.

Last December, the U.S. Preventive Services Task Force recommended such annual screenings for current or past heavy smokers ages 55 to 80. Under the Patient Protection and Affordable Care Act, that recommendation means private insurers are required to cover the screening on a first-dollar basis for their non-Medicare members. The test costs $300 to $400.

Many experts 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's Lung Cancer Screening Committee.

Others raise concerns about potential negative effects on patients, including the cumulative effect of annual radiation exposure from the scans. The American Academy of Family Physicians in January concluded that the evidence is insufficient to recommend for or against the screening. It urged a shared decisionmaking discussion between doctors and patients regarding the benefits and potential harms of the screening.

Medicare's coverage determination for lung cancer CT scans for smokers comes after 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 by HHS for its coverage policy—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.

Smoking-related lung cancer kills about 130,000 Americans each year. The five-year overall survival rate for lung cancer patients in the U.S. is 16.8%. That low rate has been attributed to the late stage of diagnosis for the disease. The preventive services task force estimated that if its recommendation was fully implemented, it could save as many as 20,000 lives annually.

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.

A Milliman actuarial analysis published in Health Affairs in 2012 concluded that covering CT lung cancer scans for smokers ages 50 to 64 would save lives at a cost of under $1 per insured member a month. 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 smoking cessation counseling 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, Boston, who has studied Medicare coverage decisions. “Since they did it for these, I would not be surprised if they did it 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 unlikely to assess cost because that is too controversial politically and because no other screening test is equally effective in detecting lung cancer.

A CMS spokesman said the agency has no plans to consider cost in making its coverage decision.

Follow Virgil Dickson on Twitter: @MHVDickson