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Commentary: CMS should use caution when implementing lung cancer screening
A strategy that limits CMS coverage of lung cancer screening to certified and comprehensive centers may be preferable to widespread coverage due to the potential harms associated with screening and a lack of data specific to the Medicare population, according to a commentary published today in Annals of Internal Medicine.
“It is essential that low-dose CT screening programs have the proper infrastructure in place to ensure standardized interpretation and reporting of CT results, a protocolized evaluation process for screen-detected nodules, and a coordinator to ensure patients receive evaluation in a timely and appropriate fashion,” Renda Soylemez Wiener, MD, MPH, assistant professor of medicine in The Pulmonary Center of the Boston University School of Medicine, told HemOnc Today. “Through a process of certification of screening programs, CMS can ensure that Medicare beneficiaries undergoing low-dose CT screening have it done in a way that maximizes benefits and minimizes harms from lung cancer screening.”
Renda Soylemez Wiener
Benefits vs. risks
The US Preventive Services Task Force issued a guideline in December recommending annual lung cancer screening with low-dose CT for adults aged 55 to 80 years who have a 30 pack-year smoking history. The guideline — which covers individuals who currently smoke or who quit smoking within the past 15 years — is based largely on results from the National Lung Screening Trial (NLST), which showed annual screening with low-dose CT reduced risk for lung cancer mortality by 20%.
Under the Affordable Care Act, those who meet the eligibility criteria for screening will be covered by their private insurers until age 64. However, those in the Medicare population account for 70% of patients with lung cancer, according to commentary recently published in The Wall Street Journal.
CMS is considering whether to authorize Medicare coverage for lung cancer screening. A proposed decision is expected by November, and a final decision is expected by February 2015.
In April, the Medicare Evidence Development & Coverage Advisory Committee expressed low to intermediate confidence that the benefits of lung cancer screening outweigh the potential harms.
Medicare beneficiaries may be particularly susceptible to these harms, Wiener wrote.
“While the vast majority (95%) of [detected pulmonary nodules] will turn out to be false-positive results, the evaluation process can expose patients to harms including anxiety over whether the nodule is malignant, radiation exposure from serial CT scans to monitor the nodule for growth, and physical complications such as bleeding, collapse of the lung or even death for those undergoing invasive testing or surgery,” Wiener said. “An additional potential harm that can arise during nodule evaluation is the risk of loss to follow-up, which can cause delays in the diagnosis and treatment of cancer if the nodule turns out to be malignant.”
Although the NLST included more than 53,000 adults, data specific to Medicare beneficiaries was limited, Wiener wrote. Only 25% of the study population was aged 65 years or older, and adults aged older than 74 years were not eligible for the trial.
“In the ideal scenario, there would be another randomized controlled trial that studied low-dose CT screening for lung cancer specifically among the older adults who were not well represented in the NLST — ie, those aged 65 to 80 years,” Wiener said. “However, it is extremely unlikely that such a trial will ever take place due to expense and a changing standard of care. Yet, I do not believe Medicare coverage should wait for further research, which would delay the potential benefits of lung cancer screening for Medicare beneficiaries.”
A registry to follow the outcomes of patients after they have been screened would be particularly important for this patient population, Thomas J. Lynch, MD, director of Yale Cancer Center and a HemOnc Today Editorial Board member, said in an interview.
“The evidence is very strong that there is a benefit in this setting, and I very much would like to see screening covered by Medicare,” Lynch said. “It’s reasonable to require tracking of outcomes and the consequences of screening through the incidence of toxicities and the false-positive rate in the older population, but to reject screening reflects a bias that people have against lung cancer patients. There’s this attitude that, ‘You smoked, so you deserve lung cancer and you deserve to die.’ I think that’s absolutely absurd.”
Cost is another significant subject of debate surrounding Medicare coverage of lung cancer, Wiener wrote.
In a study recently presented at ASCO, Roth and colleagues determined that if 50% of adults eligible for screening under the USPSTF criteria actually underwent screening, the cost to Medicare would reach $9.3 billion in 5 years. That figure — which includes follow-up and additional work-up, as well as estimated costs of treatment for those diagnosed with lung cancer — would equate to a $3 monthly premium increase per Medicare member.
Options for coverage
In her commentary, Wiener noted CMS may decide to deny lung cancer screening coverage for Medicare beneficiaries or delay coverage for evidence development. However, offering coverage only within certified facilities may be the optimal situation, she wrote.
Lung cancer screening programs in such facilities should include rigorous procedures to identify appropriate high-risk patients, shared decision-making prior to screening and smoking cessation services. As Lynch suggested, a registry to track screened patients and follow-up research also are vital components to these programs, Wiener wrote.
Certified facilities may include small or community-based centers, Wiener said. The Veterans Health Administration’s eight-site demonstration project, as well as the screening program of Lahey Hospital in Burlington, Mass., can serve as models for smaller facilities, she said.
Yet, only offering covered screening in certain facilities may impact access to care, Lynch said.
“The idea of offering screening only in certain facilities is self-serving to those facilities,” Lynch said. “We happen to have a great certified screening program [at Yale Cancer Center], but I know my screening program can’t be offered to everyone who is eligible.”
In a recent addition to the debate, 130 lawmakers urged CMS to cover low-dose CT lung cancer screens in a letter last week.
“Americans pay into Medicare throughout their working lives and deserve to have access to potentially life-saving evidence-based screening that can prevent further health costs down the road,” the letter said.
“Those lawmakers are responding to the concerns of their constituents in a very positive way,” Lynch said. “This isn’t always the best way to decide medical policy, but I think it’s very positive that Congress is getting behind coverage.”
For more information:
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Roth JA. Abstract #6501. Presented at: 2014 ASCO Annual Meeting; May 30-June 3, 2014; Chicago.
Thomas Lynch, MD, can be reached at Yale Cancer Center, P.O. Box 208028, 333 Cedar St., WWW 205, New Haven, CT 06520-8028; email: thomas.lynch@yale.edu.
Renda Soylemez Wiener, MD, MPH, can be reached at The Pulmonary Center,
Boston University School of Medicine, 72 East Concord St., R-304, Boston, MA
02118; e-mail: rwiener@bu.edu.
Disclosure: Wiener reports grants from the NCI and VA HSR&D QUERI during the conduct of the study. Lynch serves on the board of directors of Bristol-Myers Squibb.