Proponents cite ROI of early detection, reduced mortality
Perhaps it is only appropriate the Centers for Medicare & Medicaid Services is scheduled to announce its highly anticipated coverage decision for low-dose computed tomography (LDCT) lung cancer screening in November. After all, this is officially ‘National Lung Cancer Awareness’ month.
For proponents of using the diagnostic imaging study for early detection, the cost/benefit analysis is simple … LDCT saves lives in a cost efficient manner among a targeted, high-risk population. Medicare already covers broad-based screenings for colon, breast and prostate cancers. According to the American Cancer Society Cancer Facts & Figures 2014, the combined estimated annual deaths from those three types of cancer is still significantly less than deaths from lung cancer (120,220 vs. 159,260).
One of the most vocal supporters for extending coverage to Medicare beneficiaries is Ella A. Kazerooni, MD, MS, FACR, associate chair for Clinical Affairs and division director for Cardiothoracic Radiology at the University of Michigan. “I firmly believe that screening for lung cancer with CT saves lives,” she stated. An expert in the field, Kazerooni’s long list of credentials includes serving as a trustee on the American Board of Radiology, chair of thoracic imaging for the American College of Radiology’s Commission on Body Imaging, chair of ACR’s Committee on Lung Cancer Screening, vice chair of the National Comprehensive Cancer Network’s Lung Cancer Screening Panel, and past president of the American Roentgen Ray Society.
“Medicare received two formal requests for a national coverage decision,” she explained of actions taken earlier this year precipitating the CMS determination. “They statutorily have until Nov. 10 to post their draft coverage decision,” Kazerooni continued, noting a final decision was expected in February 2015 following a comment period.
The Science
While CMS will complete the coverage decision process in a 12-month period, proponents say the science supporting CT scans for diagnosing lung cancer goes back several decades. Considering the current poor survival rates, this delay in integrating the scientific research into routine practice has been particularly frustrating for providers.
Kazerooni said more than three-quarters of lung cancers are found in a late stage when the disease has spread, making surgical intervention ineffective or impossible. Patients are typically asymptomatic until the disease has progressed, which contributes to dismal survival rates. Currently, more than 90 percent of those diagnosed annually with lung cancer will die from the disease.
Research from the International Early Lung Cancer Acton Program (I-ELCAP), which was formed in 1992, has shown annual CT screening to be an effective tool. In the original study, more than 1,000 high-risk, asymptomatic patients were screened. Of those who received a lung cancer diagnosis, more than 80 percent were at a clinical Stage 1.
Subsequently, findings from a much larger international pool were published in several publications in 2006 after long-term follow-up of more than 31,000 asymptomatic study participants. While less than 2 percent of those screened received a lung cancer diagnosis, 86 percent were found in Stage 1 with an overall cure rate of 80 percent.
Similarly, the National Lung Screening Trial (NLST), one of the largest and most expensive clinical trials ever undertaken in the United States, evaluated the impact of screening methods on survivability. The trial, which ran from 2002-2010 and included more than 53,000 participants, compared outcomes when screening with standard chest x-ray vs. LDCT. The results published in 2011 in the New England Journal of Medicine demonstrated a 20 percent reduction in lung cancer mortality for those screened by LDCT.
In both arms of the trial, more than 94 percent of positive screening results turned out to be false positives upon further testing, which is one of the arguments against annual screening. It should be noted, however, that the false positive difference between LDCT and conventional x-ray was less than 2 percent, yet decreased mortality with LDCT was 20 percent.
The available science led the United States Preventive Services Task Force (USPSTF) to assign a grade of B to lung cancer screening among high-risk patients —current or former heavy smokers, ages 55-80, with a smoking history of at least 30 pack-years. The USPSTF website defines the evidence behind a grade of B as being strong enough to recommend the service be provided.
The task force isn’t the only organization to support LDCT screening for high-risk patients. In fact, Kazerooni said most every major clinical healthcare professional society, including the American Medical Association, has stepped up to voice support for CMS adopting coverage.
“There’s overwhelming professional support,” Kazerooni said. “We also have a lot of support from the House and Senate,” she added, noting congressional support is bipartisan.
The Decision
The irony, Kazerooni continued, is the USPSTF recommendation led to a screening inclusion in the federally mandated Affordable Care Act requiring third party payers cover LDCT for those at high risk of developing lung cancer. “It’s not a ‘recommended;’ it’s not a ‘they should;’ it’s a ‘must,’” Kazerooni said of the screening becoming a covered benefit beginning Jan. 1, 2015.
If CMS doesn’t reverse current policy, then those who have received annual screenings for as much as a decade will abruptly lose the benefit when they hit 65 and qualify for Medicare coverage.
“The average age of lung cancer diagnosis is 70 so to not offer lung cancer screening as they enter their peak years of risk would be a tragedy,” Kazerooni stated.
Among the issues being weighed by CMS are patient safety, frequency of testing, impact of false positive results, consistent quality across screening facilities, evidence-based data to identify eligible patients and inform follow-up and treatment, and cost of screening in relation to improved outcomes.
Kazerooni noted CMS is undertaking the normal due diligence that goes into releasing a national coverage analysis decision. She and colleagues across a number of medical specialties have provided information and parameters for the screening. For example, she noted, the American Association of Physicists in Medicine has created specific exam protocols. The ACR, which is one of three bodies that accredits CT facilities, has developed a practice standard for the screening. Proponents, she stressed, are specifically calling for low-dose, rather than standard dose, scans to improve the safety profile. Providers also agree smoking cessation counseling should be part of the overall professional intervention for all high-risk individuals who qualify for screening.
As for cost, Kazerooni said, “Low-dose CT screening is at least as cost effective, if not more so, than breast cancer screening. When you’re talking about breast cancer screening, you’re talking about every woman of a certain age. Even though CT scans are more expensive, we’re targeting resources to a smaller, high-risk group.”
Bolstering that assertion, a study published in August in American Health and Drug Benefits found LDCT to be cost effective in the Medicare population. The researchers found implementing the screening cost less than $20,000 per life-year saved, which is less than the costs associated with cervical and breast cancer screening.
Kazerooni is favorably encouraged CMS will follow suit with private payers and cover LDCT screenings for those with the necessary inclusion criteria who are not suffering from another medical condition that would significantly limit life expectancy. However, she added, she is interested to see what conditions CMS attaches to approval.
“It’s hard to believe they would do anything else but cover it,” she concluded of CMS. “There is a huge need for this, and we want to see it brought forward to benefit individual patients and the public at large.”