CMS established evidence-based coverage criteria, including data collection and standardized lung nodule identification, classification and reporting system to facilitate continuous improvement in screening techniques, and protocols to help reduce false-positive results.
—Patrick Conway, MD
Lung cancer doggedly remains the leading cause of cancer-related death in the United States. This grim mortality figure is due, in part, to a lack of early detection methods; more than half of all lung cancers have metastasized at the time of diagnosis. For decades, lung cancer advocates lobbied for low-dose computed tomography (CT) screening programs that would help promote early detection and reduce mortality. In 2011, the National Lung Screening Trial, sponsored by the National Cancer Institute, demonstrated that screening with low-dose CT reduces lung cancer mortality.
Based on this large trial, the U.S. Preventive Services Task Force issued a report giving low-dose CT in lung cancer a grade B recommendation, which garnered coverage by the Centers for Medicare & Medicaid Services (CMS). However, translating science into policy is difficult. To shed light on the challenge, The ASCO Post spoke with a principal administrator at CMS, Patrick Conway, MD.
Background and Current Role
Please describe your medical background and a bit about your position at CMS.
I am currently the acting principal Deputy Administrator of CMS, and I also serve as its Chief Medical Officer. I lead the Center for Clinical Standards and Quality and the Center for Medicare and Medicaid Innovation.
I am a pediatrician by training and, before joining CMS, served as Director of Hospital Medicine and Associate Professor at Cincinnati Children’s Hospital. In that role, I was also Assistant Vice President for Outcomes Performance, responsible for leading measurement, including the electronic health record measures, and facilitating improvement of health outcomes across the health-care system. I attended Baylor College of Medicine and completed my pediatrics residency at Harvard Medical School’s Children’s Hospital Boston.
Age Cutoff for Screening
Please talk about the difference in age cutoffs for low-dose CT screening coverage between the U.S. Preventive Services Task Force (80 years) and CMS (77 years). Certain advocacy groups were critical of the CMS decision.
The age range of 55 to 77 years for Medicare coverage is based on data from the National Lung Screening Trial and is within the age range of the [U.S. Preventive Services Task Force’s] grade B recommendation. The [U.S. Preventive Services Task Force] used modeling with potentially unrealistic assumptions to extend the age range. However, we found no empirical data to support screening in adults aged 78 to 80 years, as the [National Lung Screening Trial] did not enroll or have follow-up data on these individuals. Therefore, we have not included these ages.
Other Eligibility Criteria
Is CMS confident that eligibility criteria such as a patient’s smoking history can be assessed with accuracy?
We recognize the importance of accurate ascertainment of smoking history and have created a specific shared decision-making visit to allow a careful calculation of pack-years, in addition to an interactive discussion of the potential risks and benefits of screening. If calculated carefully and systematically, we believe smoking history can be assessed as well as it was in the [National Lung Screening Trial].
High-Quality Screening Availability
The National Lung Screening Trial was conducted in large facilities with the resources to execute standardized low-dose CT testing and data collection. Is CMS confident that widespread low-dose CT screening can be done in controlled high-quality settings across the nation?
In 2014, the Medicare Evidence Development & Coverage Advisory Committee also expressed concerns about the implementation of this service outside a controlled trial. CMS established specific evidence-based criteria such as beneficiary eligibility, radiologist training, imaging center requirements, and data collection to increase the likelihood of obtaining true positive results and to ensure that the benefits of screening outweigh harms for the Medicare population.
Benefits vs Harms
Is CMS comfortable that the harms associated with true false-positive results will be kept to a minimum, so that they are outweighed by the benefits of low-dose CT?
CMS established evidence-based coverage criteria, including data collection and standardized lung nodule identification, classification and reporting system to facilitate continuous improvement in screening techniques, and protocols to help reduce false-positive results. With these criteria, we believe the number of false-positives will be minimized and show recognized benefits over harms of screening.
We also included a shared decision-making visit between the clinician and beneficiary to discuss the potential risks and benefits. Finally, in the future, screening programs will improve as appropriate data are collected. ■
Disclosure: Dr. Conway reported no potential conflicts of interest.