By Deborah Borfitz
December 9, 2019 | Most patients, as well as most primary care physicians, consider lung cancer to be highly lethal. That’s because early-stage disease tends to be discovered by accident rather than intentionally through screening. In the absence of screening, nearly three-quarters of patients are diagnosed at stage III or IV of the disease when outcomes are uncertain, says Andrea McKee, M.D., chairman of radiation oncology at Lahey Hospital & Medical Center in Burlington, Massachusetts. Once the cancer has spread to other organs, the survival rate in only about 6%. But if caught early, the cure rate with surgery or radiation oncology can be as high as 90%, she says.
Doctors interested in screening their high-risk patients—guidelines from the National Comprehensive Cancer Network (NCCN) rank risk based on patient age, smoking history, and other factors—might be dissuaded by misinformation still circulating in the medical literature, McKee adds. “We’ve documented over 100 peer-reviewed articles that cite the false-positive rate for lung cancer screening as 96%, which isn’t true [that’s the false discovery rate]. The false positive rate in clinical practice is about 10%, which is the same as for mammography.”
Currently, only about 4% of the at-risk population in the U.S. is being screened for the nation’s top cancer killer, says McKee. That’s in stark contrast to the high-volume CT lung cancer screening program she helped develop at Lahey, which is scanning about 65% of the eligible population with impressive results.
As detailed in an article published in Managed Care, 70% of cancers detected by Lahey’s screening program in 2017 were stage I compared with the national average of 25% in the absence of screening. The proportion of stage IV cancers were also markedly lower—7% versus 57%. The early detection figure has since bumped up to 85%, McKee notes. More than 6,000 high-risk patients have been screened since 2012, about 325 of which have had a suspicious finding and about 235 have been diagnosed with lung cancer.
Lahey was the first facility to receive accreditation by the American College of Radiology (ACR) as a lung cancer screening center and remains one of the largest such programs in the country, says McKee. It has provided free, hands-on consultations with many hospitals setting up screening programs, including doing grand rounds with their primary care physician group. Many people have also made site visits to Lahey to see its program in action.
Rescue Lung Rescue Life
McKee says she believes healthcare facilities everywhere are obliged to provide this “proven, life-saving” service to the communities they serve. She is president of the recently launched nonprofit Rescue Lung Rescue Life (RLRL) Society whose mission is to eliminate the barriers to CT lung screening adoption.
The RLRL Society is comprised primarily of physicians, in addition to scientific researchers and patient advocates, and will host its first conference next May in Boston that is expected to attract an even broader audience, says McKee. “Lung cancer screening is a multidisciplinary endeavor, and the other conferences out there usually don’t have all of the disciplines together”—a team that includes radiologists, pulmonologists, thoracic surgeons, radiation oncologists, medical oncologists, pathologists and primary care as well as patient navigators.
“We have this sense of urgency about helping other people to screen because lives are at stake,” says McKee. “Nine million people in the U.S. are at high risk and 2% of them have lung cancer. If they don’t get screened, it’s going to be late-stage lung cancer.”
Next steps for the nonprofit include launching a dedicated periodical, “reflecting the uniqueness of lung cancer screening” and a robust accreditation program for screening centers that includes on-site surveys and chart reviews, she says.
Screening Benefits
Not all family physicians are in favor of preventive screenings, believing they cause more harm than good or represent wasted effort, and this is being played out across every disease type, says McKee. Lung cancer screening, being “very new,” has the added disadvantage of unfamiliarity.
As a screening advocate, McKee points to the value of targeting high-risk individuals. Failure to diagnose lung cancer at an early stage is often deadly and, while survival rates are improving, the cost of delayed detection can be exorbitant.
Accountable care organizations on the hook for the quality and cost of care need to take notice, says McKee. Results of the landmark National Lung Screening Trial (NLST) suggest that CT lung screening costs less than $100,000 per quality-adjusted life years, but the calculation is based on 2009 pricing before people with stage IV cancer were kept alive for several years on immunotherapies and targeted therapies. “That is something that has completely changed the cost of delivering care for late-stage lung cancer.”
The latest "State of Lung Cancer" report issued by the American Lung Association (ALA) gives lung cancer screening a large share of the credit for the dramatic 26% improvement in the five-year survival rate over the past decade, from 17.2% to 21.7%. Massachusetts, Vermont, New Hampshire, and Kentucky were the only top-tier screening states, scanning between 9% and 12.3% of the high-risk population.
New England was well represented both because of the “crosstalk” between the three states and replication of a free screening program developed at Lahey before reimbursement was available from the Centers for Medicare & Medicaid Services (CMS), says McKee. Eligibility for the community benefit program was tied to guidelines of the NCCN, which included category 1 screening recommendations (55 to 77 years of age with a 30 pack-year history who still smoke or have quit within the last 15 years) and the category 2A group (aged 50 years and older with a 20 pack-year smoking history and at least one additional lung cancer risk factor) backed by a similarly high level of evidence.
Nationwide, the lung cancer death rate could be reduced by up to 20% by doing low-dose CT screening on the category 1 individuals, according to the ALA report. This is also the group for whom screening is commercially reimbursed. The ALA estimates close to 48,000 lives could be saved if everyone currently eligible were screened.
The reduction in lung cancer mortality was demonstrated in 2011 by the NLST, says McKee. Specifically, three rounds of CT scans over two years are prescribed.
Program Evolution
McKee and Brady McKee, M.D. (her husband), section head of thoracic imaging and cardiac CT, were the driving force behind Lahey’s CT lung cancer screening program. “Radiology is pretty much where the bulk of the work is being done,” she says.
“A very small percentage of patients have a finding on a CT scan that requires a referral to a pulmonologist or thoracic surgeon,” McKee continues. “In our program, only patients with a Lung-RADS [Lung CT Screening Reporting & Data System] category 4 finding—or about 4% of the at-risk population—get referred to a specialist.”
Lung-RADS was developed by radiologists at Lahey before the first patient was screened and the system has since been handed off to the ACR, says McKee. It provides structured reporting and the ability to code exams as well as monitor program quality, and is akin to the National Committee for Quality Assurance’s HEDIS measure for breast cancer screening.
Screening was a community benefit program at Lahey until late 2015, after CMS clarified how to bill for the exam, says McKee. From the beginning, Lahey has had a rigorous process for ensuring patients qualify for screening. But CMS added a new layer of requirements, including shared decision-making, offering smoking cessation interventions and entering data into a national registry.
Since CMS restricts reimbursement to screens done on NCCN category 1 individuals, the exam is currently available only as a self-pay option ($125 per scan) to those in the NCCN 2A category, says McKee. “For compliance reasons, if you’re going to charge for the exams at all you have to charge everybody.”
The fact that one group has coverage while the other does not—despite having an identical risk of developing lung cancer and rate of false-positives—is one of the obstacles to lung cancer screening adoption, says McKee. Doctors are understandably frustrated that medical decisions are being made based on payer reimbursement policies rather than what is indicated by science and they believe is in the best interests of patients.
McKee says she believes payer policies will eventually be updated given mounting evidence supporting expanded coverage. Since the NLST published, additional studies have reported an even larger mortality benefit by broadening screening to a younger population and over a longer period.
Results from NELSON, the largest European lung cancer screening trial, showed a reduction in lung cancer mortality of 26% when four rounds of CT scans were used over 5.5 years in current and former heavy smoking men at high risk between the ages of 50 and 74 years. Similarly, the Multicentric Italian Lung Detection (MILD) trial showed a 39% reduction of mortality at 10 years in current and former smokers between the ages of 49 and 75 years.
In the MILD study, the long-term benefit of screening beyond five years was a 58% reduced risk on lung cancer mortality. “That’s really very unusual to see that in screening studies,” says McKee.
Screening Eligibility
The article in Managed Care specifically lists 11 obstacles to lung cancer screening adoption, including restricted screening capacity in high-need areas, limitations of screening criteria and the stigma associated with smoking. Evidence suggests the criteria used to identify high-risk individuals are still not inclusive enough for former smokers and African-Americans. Future studies are needed to assess if vaping should be added to the list of eligibility requirements, McKee says.
The lag between the initiation of cigarette consumption and the onset of lung cancer is 20 years, says McKee, but with vaping lung injuries are occurring much earlier. The U.S. Centers for Disease Control and Prevention has documented more than 2,000 deaths cases of vaping-related illnesses and over 40 acute deaths since starting its investigation in August, naming vitamin E acetate as the primary culprit.
The lung injury commonly seen in vaping patients is like the lung damage caused by mustard gas, says McKee. “In my mind there is no question that vaping will cause lung cancer due to that injury we’re seeing,” she says. An association has already been demonstrated in mice models.
What It Takes
Countering misinformation about lung cancer screening is part of the mission of the RLRL Society, says McKee, and it builds on a collaborative initiative between Lahey and Genentech to raise screening awareness and reduce the stigma associated with lung cancer. Those educational materials are freely available online and have been downloaded by over 700 screening centers around the country.
Healthcare executives also need to understand what it takes to run a high-quality screening program, says McKee, including a dedicated software system and a patient navigator. Approximately one navigator per 1,500 actively enrolled patients is required to manage the database, schedule patient appointments and “help develop quality metrics the steering committee can review.”
The value of screening needs to be holistically viewed across all service lines at a hospital, which is “not something we are all that good at in medicine,” says McKee. CMS reimbursement for CT lung cancer screening is modest, so making the business case often means treating the cancers that are detected. It is feasible to run a screening program and refer out positive findings, she adds, but it could take a few years to break even.
Radiology training is key. ACR practice guidelines indicate recent experience in reading chest CTs, typically ordered because of chest pain or pneumonia, is enough to qualify a radiologist to do CT lung screening. But McKee and her colleagues at Lahey believe more specific training should be required on using the Lung-RADS system and scanning high-risk but asymptomatic patients.
Working with MeVis AG, Lahey developed a lung cancer screening simulation environment, called the LungAcademy, to help train radiologists to read actual exams using Lung-RADS, McKee says. The training is mandatory for all radiologists and radiology residents and requires scored reviews of over 100 cases, plus a quiz based on included reading material and video lectures. “We also overread their initial exams and do some random audits to ensure radiology quality within our CT lung screening program.”
Top Challenges
In McKee’s experience, three related challenges typically beset new lung cancer screening programs—no tracking system, no navigator, and disengaged primary care physicians. Without a tracking system, patient management falls to an already overwhelmed primary care base that immediately disengages, says McKee. “They need help and that is what the lung cancer screening is meant to do. Their job is to identify high-risk patients,… conduct shared decision-making, and talk to them about smoking cessation.”
About 48% of Lahey’s screening population are current smokers, McKee says. The program has served as a “teachable moment” to improve smoking cessation rates to three times the national average. “And these are all heavily addicted, longstanding smokers…. We may not get them to quit in year one but if they stick with the program year over year more of them are quitting.”
Lung cancer screening requires a physician’s order, usually but not necessarily from a primary care doctor, because someone must manage any unexpected, significant incidental findings, says McKee. “But that doesn’t happen very often.”
Primary care physicians are otherwise not burdened with figuring out what to do next with patients once they’re screened, McKee notes. “They refer patients and we take it from there. We identify the ones who come back next year and take care of getting them back in and sending them reminder letters.”
For the 4% of the screened population with a finding suspicious for lung cancer, radiologists also let referring primary care physicians know a pulmonologist or thoracic surgery consultation is the next step, she adds. “Our reports never recommend a PET/CT or a biopsy, as the reading radiologist is not familiar enough with the patient to decide if that is appropriate. At that point, the patient needs a specialist.”
Lahey conducted an extensive outreach campaign with primary care physicians prior to the launch of its lung cancer screening program to explain its purpose and their role, as well as screening risks, benefits, myths and controversies to inform their conversations with patients, says McKee. Referring doctors were also introduced to Lung-RADS, whose reporting features purposefully mimic those used in mammography, and the community of players within the program—both of which helped to build trust.
Primary care physicians now receive report cards detailing how they’re doing relative to their peers in referring patients to the program and helping patients quit smoking, how many of their patients were diagnosed with cancer and at what stage, and which patients were referred but never presented for screening.
The two main lung cancer screening sites within Lahey Health (now part of Beth Israel Lahey Health) are its hospitals in Burlington and Peabody, Massachusetts, says McKee. Screening appointments typically take less than 10 minutes to complete with the actual exam lasting less than six seconds. “There are no needles involved and patients usually do not have to change their clothes. It is one of the quickest, easiest and most effective screening exams available.”