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CMS draft guidance allows access to lung cancer screening, requires safeguards
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The CMS took a “responsible approach” when it issued its draft guidance for Medicare coverage of lung cancer screening for individuals who meet age and smoking history criteria, according to the primary requestor for the national coverage determination.
“The benefits for high-risk individuals, as well as the potential risks, were well documented and — I think — broadly agreed upon,” Peter B. Bach, MD, MAPP, physician, epidemiologist and director of the Center for Health Policy Outcomes at Memorial Sloan Kettering Cancer Center, told HemOnc Today.
“I had hoped in my request that I had given [the CMS] a roadmap for doing this in a way that would minimize the chance that the balance of benefits and risks would go the wrong way,” Bach said. “I think they went pretty far to try to create a way where there would be access, but there would also be safeguards.”
‘A major win’
The CMS is expected to issue its final guidance on Medicare coverage of lung cancer screening with low-dose CT by Feb. 8.
The draft guidance — released Nov. 10 — supports coverage of annual screening for individuals aged 55 to 74 years who are asymptomatic for lung cancer, have at least a 30 pack-year smoking history, and either currently smoke or have quit in the past 15 years.
Before their first screening, Medicare beneficiaries would need to undergo a 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.
“This decision is a major win for men and women aged older than 55 years who smoked cigarettes,” said Thomas J. Lynch, MD, director of Yale Cancer Center, physician-in-chief at Smilow Cancer Hospital at Yale-New Haven and a HemOnc Today Editorial Board member. “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.”
During their counseling visit, beneficiaries would be required to obtain a written order for screening from a physician, physician assistant, nurse practitioner or clinical nurse specialist. Beneficiaries also would be required to obtain a written order for subsequent screenings, but the draft guidance indicates those orders could be obtained from a physician or qualified non-physician practitioner during “any appropriate visit,” such as an annual wellness visit or tobacco cessation counseling session.
In addition, the draft guidance establishes eligibility criteria for radiologists and radiology imaging centers, and it requires screening facilities to collect and submit data to a CMS-approved national registry to allow monitoring of outcomes and quality of care.
“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,” William C. Black, MD, chest radiologist at Dartmouth-Hitchcock Norris Cotton Cancer Center and professor of radiology at Geisel School of Medicine at Dartmouth College, told HemOnc Today. “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 processes and outcomes, [allowing] opportunities for future improvements.”
NLST results
Only 15% of lung cancers are detected at early 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 US Preventive Services Task Force (USPSTF), American Cancer Society, National Comprehensive Cancer Network and American Lung Association — have recommended screening with low-dose CT for those at high risk for lung cancer. ASCO and the American College of Chest Physicians also released an evidence-based guideline, with input from the American Thoracic Society.
The USPSTF based its recommendation — released in December 2013 — 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.
In the NLST, 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. 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.
“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.”
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.
Potential benefits must be maximized
Based on the NLST results, the USPSTF recommended annual low-dose CT screening for adults aged 55 to 80 years who have the same smoking history outlined in the CMS draft guidance. The USPSTF raised the upper age limit from NLST eligibility criteria due to results of modeling studies that suggested a correlation between older age and increased benefit.
Under the Affordable Care Act, private insurers are required to cover evidence-based services that receive an “A” or “B” rating from the USPSTF, and annual lung cancer screening with low-dose CT falls into that category.
Medicare, however, is exempt from that provision in the health care law and can make its own coverage determination.
Early indicators were not positive, as 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.
Less than 7 months later, the CMS expressed the opposite opinion in its draft guidance.
“I think ‘relieved’ is the best way to characterize my reaction,” Bach said. “The MEDCAC votes, obviously, were pretty bad. CMS was not required by law to cover it. They were within their authority to say, ‘We’re not convinced the benefits are there’ … and that would have been a really unfortunate outcome.”
Bach said he hopes the overwhelmingly positive reaction to the draft guidance from clinicians and advocacy groups helps ensure that the final guidance from the CMS is “in the same zone” as the draft guidance. Even if that happens, he outlined three key efforts that would maximize the potential of lung cancer screening:
- Stakeholders must “thoughtfully improve” how they follow up on screen-detected findings and also continue to evaluate the appropriate spacing of CT screening (eg, should it be annual or every other year).
- Screening criteria should be re-evaluated based on risk criteria.
“We won’t be able to get 9 million people screened every year, so we need to figure out how to target this to people for whom the risk–benefit tradeoff is the greatest,” Bach said. “Over the next few years, I’d like to see the task force try to make the criteria more risk-based. These age and pack-year cutoffs are a move in the right direction, but we know vastly more than that to help determine who is likely to benefit.”
“Less invasive surgical approaches are promising but they haven’t been well studied. There have been problems with accruals and randomized trials,” Bach said. “If we’re going to start finding these stage I lung cancers, we can’t persist at a 30-day mortality rate of 3% to 4%. From a public health perspective, that is a huge hole we have to get out of in order to really have a benefit from early detection.” – by Mark Leiser and Alexandra Todak
References:
Aberle DR. N Engl J Med. 2011;365:395-409.
Black WC. N Engl J Med. 2014;371:1793-1802.
CMS. Proposed decision memo for screening for lung cancer with low-dose computed tomography. Available at: www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=274. Accessed on Nov. 13, 2014.
Gareen IF. Cancer. 2014;120:3401-3409.
Ma J. Cancer. 2013;119:1381-1385.
Moyer VA. Ann Intern Med. 2014;160:330-338.
For more information:
Peter B. Bach, MD, MAPP, can be reached at Memorial Sloan Kettering Cancer Center, 1275 York Ave., New York, NY 10065; email: bachp@mskcc.org.
William C. Black, MD, can be reached at Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH 03756; email: william.c.black@dartmouth.edu.
Ella A. Kazerooni, MD, MS, can be reached at University of Michigan Radiology, Cardiovascular Center, Floor 5, Room 5482, 1500 E Medical Center Drive, SPC 5868, Ann Arbor, MI 48109; email: ellakaz@umich.edu.
Thomas J. 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.
Disclosure: Bach, Black, Kazerooni and Lynch report no relevant financial disclosures.
Perspective
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Edward S. Kim, MD
After testing for several decades, we finally have a screening test to identify people who may have lung cancer. I am very pleased and happy that CT screening for the appropriate at-risk individuals will be covered as part of the preventive health Medicare service. This will be a big first step for the lung cancer community. Engagement of primary care physicians will be needed in order to recommend appropriate folks for CT screening. Follow-up of any suspicious findings needs to be coordinated through the appropriate pulmonary/oncology teams. We need to continue further studies of molecular diagnostics to complement the established CT scan screening so that further risk-based populations can be identified, perhaps even those patients with lung cancer who had minimal past smoking histories. 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.Click Here to Manage Email Alerts