Lung Cancer Screening: The Time Has Come
The ACR responds to recent trial results and the USPSTF.
Screening studies, such as mammography, prostate-specific antigen testing, and EKGs, are under attack. The opponents of these tests claim they are too costly and that there are too many misses and false positives.
Patient anxiety is also considered a harm by some. However, there is heartening news that the government may soon decide that high-risk patients should have access to a lung cancer screening benefit, which could be instrumental in saving the lives of countless patients.
Between August 2002 and April 2004, a multicenter study enrolled 53,454 people to determine if screening with low-dose CT could reduce mortality from lung cancer. This National Cancer Institute (NCI)–sponsored trial was a joint effort of ACRIN (through protocol ACRIN 6654) and the NCI’s Lung Screening Study Group. In August 2011, the National Lung Screening Trial (NLST) research team reported in the New England Journal of Medicine that the results of the trial “demonstrated a relative reduction in mortality from lung cancer with low-dose screening of 20 percent.”1 Study participants were asked to undergo three annual screenings with low-dose CT or chest radiography. Those who underwent CT were shown to be less likely to die of lung cancer.
William C. Black, MD, professor of radiology at Dartmouth-Hitchcock Medical Center in Lebanon, N.H., has written that the NSLT results were “published backwards.” He wrote, “What usually happens with screening studies is that as they progress, the relevant information is released, so the first paper might be on the design of the study, the next would relate what happened during the first screening, and the next on subsequent screenings. Finally the last paper would reveal the final results as they relate to mortality.”2 But in this case, the final results were judged to be too important to wait to disseminate to the public, so the final paper came out before any of the intermediary papers. In fact, the NSLT was halted early when the benefit from CT screening became apparent.
According to a recent ACR release on the topic, “The cost of $72,916 per quality adjusted life year (QALY) saved by LD-CT was far less than the $100,000 QALY that public health officials typically need to justify the widespread application of a screening exam.”3
In August of 2013, the United States Preventative Services Task Force (USPSTF) issued a Grade B draft recommendation for low-dose CT lung cancer screening for asymptomatic individuals 55–79 years of age (the NLST trial enrolled study participants ages 55–74) who had a smoking history of at least 30 pack years (calculated by multiplying the number of packs smoked per day by the number of years smoked).
Medical applications that earn a Grade B from the task force qualify for the list of minimum benefits provided by insurance plans approved by the Affordable Care Act. The public is provided with a 30-day comment period before the USPSTF announces its final decision. Once the task force makes its formal recommendation, the next step is for Medicare to define the coverage of the new benefit. CMS will look at the entirety of the issues included in a screening benefit, including the qualifications of the physician interpreters, the frequency of the scans, the issue of incidental findings, and questions around physician payment. The normal time frame for CMS making a national coverage decision is six to nine months, but the process could take longer. So whether you are for or against Obamacare, a positive response by the USPSTF and a decision on how CMS defines the covered benefit will most likely result in required reimbursement for lung cancer screening for high-risk patients.
Some institutions have already set up CT screening programs for lung cancer using low-dose CT. One example is the Lahey Clinic in Boston. Under the lead of Brady J. Mckee, MD, Andrea B. Mckee, MD, and Christoph Wald, MD, PhD, the clinic began a screening program in January 2012.
Lahey did not charge for initial or annual follow-up screenings, but workups of any positive findings, clinical assessments, or interventions were billed to the patient’s insurance in the usual fashion.4
What is the ACR doing in response to these activities, which date back to 2002? “Lung cancer screening guidelines and standards must take into consideration the potential for false positives, incidental findings, and other consequences that might negatively impact patients,” says Ella A. Kazerooni, MD, FACR, a thoracic radiologist at the University of Michigan. Kazerooni is chair of the ACR Thoracic Imaging Committee, and I have appointed her to chair the newly formed ACR Committee on Lung Cancer Screening, where she will work with others, including but not limited to Debra L. Monticciolo, MD, FACR, chair of the ACR Commission on Quality & Safety, James A. Brink, MD, FACR, chair of the ACR Commission on Body Imaging, Mark R. Armstrong, MD, chair of the ACR Committee on CT Accreditation, Geraldine B. McGinty, MD, MBA, FACR, chair of the Commission on Economics, and Pamela A. Wilcox, RN, MBA, ACR assistant executive director for quality and safety. The College is already working on a practice guideline and an ACR Appropriateness Criteria®. An accreditation module is under consideration.
In addition, facilities will need to work in multidisciplinary teams with radiologists, pulmonologists, and thoracic surgeons to provide efficient and effective care. Kazerooni and her Lung Cancer Screening Committee will form work groups and will also look at a standardized reporting system and lexicon for lung cancer screening, similar to BI-RADS®, patient educational materials, and issues of economics and government relations.
There’s lots to do. Now is the time!
By Paul H. Ellenbogen, MD, FACR, Chair
1. National Lung Screening Trial Research Team. “Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening.” N Engl J Med 2011 Aug 4:365(5);395–409.
2. Lowry F. NLST Reveals Details of First Round of Lung Cancer Screening. Available at http://bit.ly/ACRMScape. Accessed Nov. 26, 2013.
3. ACR. ACR Seeks Comprehensive CT Lung Cancer Screening Policy for Medicare. Available at http://bit.ly/ACRScreening. Accessed Nov. 26, 2013.
4. McKee BJ, et al. “Initial Experience With A Free, High-Volume, Low-Dose CT Lung Cancer Screening Program.” JACR 2013:10:586–592.