This article is more than 5 years old. Information may no longer be current.
CMS supports Medicare coverage of lung cancer screening
The CMS today issued draft guidance that supports Medicare coverage of annual lung cancer screening with low-dose CT for individuals who meet specific criteria.
The guidance applies to individuals aged 55 to 74 years who are asymptomatic for lung cancer, have at least a 30 pack-year smoking history, either currently smoke or have quit in the past 15 years, and receive a written order from a physician or qualified non-physician practitioner.
“This is wonderful news for patients,” Roy S. Herbst, MD, PhD, Ensign professor of medicine (medical oncology), professor of pharmacology and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven, told HemOnc Today.
Roy S. Herbst
Before screening, beneficiaries must undergo a lung cancer screening counseling and shared decision-making visit that addresses the benefits and harms of screening; the importance of adherence to annual screening; and the importance of smoking cessation for current smokers or continued tobacco abstinence for former smokers.
“We believe the proposed decision strikes an appropriate balance between providing access to this service and ensuring, to the best extent possible, that the benefits outweigh the harms when implemented in the Medicare population,” a CMS press release stated.
The CMS will accept public comment on the draft guidance for 30 days, and it is expected to issue its final guidance by Feb. 8, 2015.
About 85% of lung cancers are detected at advanced stages, and more than half of those diagnosed with the disease die within 1 year, according to the American Lung Association.
As part of an effort to reduce lung cancer mortality, several entities — including the American Cancer Society, National Comprehensive Cancer Network and American Lung Association — have recommended some form of screening with low-dose CT for those at high risk for lung cancer.
The US Preventive Services Task Force (USPSTF) followed suit in December 2013, recommending annual low-dose CT screening for adults aged 55 to 80 years with a 30 pack-year smoking history who either still smoke or have quit within the prior 15 years.
The USPSTF based its guideline primarily on results of the National Lung Screening Trial (NLST), which included more than 53,000 participants aged 55 to 74 years at high risk for lung cancer based on age and smoking history.
Researchers randomly assigned participants to annual low-dose CT or annual single-view posteroanterior chest radiography. Screenings continued for 3 years.
The results, published in 2011 in The New England Journal of Medicine, showed annual low-dose CT was associated with a 20% (95% CI, 6.8-26.7) reduction in lung cancer mortality and a 6.7% (95% CI, 1.2-13.6) reduction in all-cause mortality.
A subsequent study by Ma and colleagues — published in 2013 in Cancer — suggested that if a similar screening approach was implemented for the estimated 8.6 million American adults who met NSLT eligibility criteria, more than 12,000 lung cancer deaths could be prevented each year.
However, some clinicians have emphasized that the benefits of lung cancer screening must be weighed against risks. These risks include the potential for overdiagnosis and a high frequency of false-positive results, both of which are associated with additional workup, patient anxiety and unnecessary treatment.
A modeling study conducted by the USPSTF determined 10% to 12% of lung cancers detected were overdiagnosed, meaning the nodule detected during screening would not have progressed to the point where it posed a threat.
“While there is some risk of overdiagnosis, it is outweighed by the mortality benefit that has been demonstrated with screening targeted groups of high-risk patients,” Charles Powell, MD, chief of pulmonary, critical care and sleep medicine at Mount Sinai Hospital, said in a press release. “Thoughtful implementation of lung cancer screening with strict attention to monitoring of screening program adherence to standards for centers of excellence and with routine utilization of smoking cessation and multidisciplinary management will help to maximize the benefits and minimize the harms of screening.”
Further, 24.2% of scans in the NLST yielded positive results for lung cancer, but 96.4% of those ultimately were reclassified as false positives.
Yet, additional analyses of data from the NLST — published by Gareen and colleagues this year in Cancer — showed false-positive results were not significantly associated with patient anxiety or worse quality of life.
The cost-effectiveness of lung cancer screening also has been a concern.
A study by Black and colleagues, published in The New England Journal of Medicine, indicated lung cancer screening would cost $81,000 for each quality-adjusted life-year gained. The researchers also found the cost was highly variable based on patient characteristics and how screening is implemented.
NLST eligibility was capped at age 74 years, but the USPSTF extended the age limit for its recommendation to 80 years based on results of modeling studies that suggested a correlation between older age and increased benefit.
Most insurers follow USPSTF recommendations and authorize coverage of specified services. However, questions about whether Medicare would follow suit for lung cancer screening had been unanswered until today.
The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) — a CMS advisory panel — rejected the concept of Medicare coverage for lung cancer screening.
MEDCAC conducted a daylong hearing April 30, at which several clinicians, members of the public and representatives of medical organizations testified. After the hearing, the committee expressed low to intermediate confidence that the advantages of annual screening with low-dose CT outweighed the potential risks.
For more information:
- Aberle DR. N Engl J Med. 2011;365:395-409.
- Black WC. N Engl J Med. 2014;371:1793-1802.
- Gareen IF. Cancer. 2014;120:3401-3409.
- Ma J. Cancer. 2013;119:1381-1385.
- Moyer VA. Ann Intern Med. 2013;doi:10.7326/P14-9009.
Perspective
Back to Top
I’m very pleased and happy that CT screening for the appropriate at-risk individuals will be covered as part of the preventative health Medicare service. It has taken several decades for us to find a screening test in the lung cancer community. We need to further study other molecular diagnostics to complement the already-established CT scans. The specific eligibility criteria need to be integrated into our guidelines and pathways, and health care providers need to be clear on the eligible patient population, which is consistent with the NLST population.
Perspective
Back to Top
This is fantastic news! We make a difference in the lives of patients we see in small ways every day. A few times in a professional career, you have the opportunity to make an impact on a population. Helping to bring lung cancer screening to high-risk smokers and reduce mortality from this fatal disease has been an amazing journey. I hope to see the face of lung cancer look far different in 20-some years when I retire than what it looks like today because of bringing screening CT to practice.
Perspective
Back to Top
Stimulated by the technologic advances in CT scanning that made it possible to image the lungs in a single breath, the Early Lung Cancer Action Project (ELCAP) was developed in 1992 to assess the benefit of annual CT screening for lung cancer. The study design provided both a low-dose chest CT and a chest radiograph to participants at high risk for lung cancer to obtain diagnostic information on the frequency of nodule detection and that of diagnosed lung cancers on both imaging modalities, as well as prognostic information on predictors of cure, and ultimately the estimated cure rate of lung cancers diagnosed under screening – the screen-diagnosed cases as well as the symptom-prompted cases of lung cancer that come to attention prior to the next round of annual repeat screening.
Critical to the diagnostic and prognostic performance is the regimen of screening (“how to do the screening”), which specified the required imaging technique, definition of a positive result, clinical workup and its timing for positive results, and the pathologic confirmation of the diagnosis.
The baseline results of ELCAP were widely publicized and stimulated renewed public debate about the merits of screening for lung cancer. ELCAP expanded to a trial of 6,295 participants involving 12 institutions in New York state, and then to the International ELCAP of 66,000 participants following a common protocol. It also led to the development and funding of the National Lung Screening Trial (NLST). Ultimately, the goal of the ELCAP design was to provide quantitative estimates of relevant diagnostic and prognostic parameters, and it has consistently shown in its publications that some 80% of the cancers can be diagnosed in stage I and that the overall lung cancer cure rate is 80%.
Finally, this life-saving screening is being made available to older smokers who are at high risk for lung cancer with the announcement by the CMS, which also recognized the importance of a regimen of screening and quality assurance measures.
Claudia I. Henschke, PhD, MD
David F. Yankelevitz MD
Icahn School of Medicine at Mount Sinai
Disclosure: Henschke and Yankelevitz report no relevant financial disclosures.
Perspective
Back to Top
I am very pleased with the proposed decision memo from the Centers for Medicare & Medicaid Services. It supports CT screening for lung cancer conditional on its being performed properly. The requirement for a written order will help ensure that only eligible patients are offered screening and that they are empowered to make an informed decision. The requirements for the radiology imaging center will help ensure that the screening exam is properly performed and interpreted. The creation of a registry will enable review of real-world screening process and outcomes and opportunities for future improvements.
Perspective
Back to Top
This decision is a major win for men and women aged over 55 years who smoked cigarettes. It will allow them to receive effective screening that will reduce the death rate from lung cancer. Moreover, the connection to a structured screening program with smoking cessation tied to this is a significant advantage.