In 2011, researchers published the results of the National Lung Screening Trial, comparing two ways of detecting lung cancer—low-dose helical computed tomography (CT)—often referred to as spiral CT—and standard chest X-ray.
The results were unequivocal: Individuals who underwent low-dose CT had a 20% lower risk of dying from lung cancer than those undergoing regular chest X-Ray. Despite the fact low-dose CT lung screening was not covered by Medicare or most private insurers, many providers—prompted by the apparent benefits of lung screening—began ramping up screening programs.
Atlantic Medical Imaging has 10 imaging centers in southern New Jersey and was quick off the mark when it came to offering low-dose CT screening, starting a program almost immediately after the results of the NLST were published. “We started in December of 201 and really ramped up in January,” says David Kenny, DO, medical director of Atlantic Medical’s Egg Harbor Township center. “This wasn’t a covered service, but we felt it was something we needed to offer to the community,” he continues.
“And we offered it for free from 2011, with an appropriate prescription, until 2015.”
CT lung screening is offered at eight of the Atlantic Medical Imaging’s 10 locations. From the start, one concern was whether Atlantic Medical Imaging could replicate the NLST experience and results at the community level. “Doing it in the real world as opposed to an academic setting is challenging,” he points out.
For example, Kenny says, in an academic center, a screening program will involve a multidisciplinary team that includes the radiologists who read the studies, as well as oncologists, pulmonologist and thoracic surgeons who become involved with positive results. “So the concern is how do you replicate this in a community when referring physicians have different referral patterns,” he says.
AMI has screened more than 2,000 people since the program started, and Kenny reports that the program is exceeding the expected benefits. The 2,000 screening exams have resulted in the diagnosis of 10 early-stage cancers, which translates to about 1.6 lives saved per 320 persons screened. (In the NLST, 320 individuals needed to be screened to save one life.)
Those 10 early-stage cancers (stages 1 and 2) account for 67% of the total number of cancers detected through screening, which closely mirrors the results of the NLST results, for which 70% of detected tumors were either stages 1 or 2.
“With lung cancer, most patients are diagnosed at stage 3 or stage 4,” he adds. “Diagnosing a cancer at stage 1 or stage 2 is a potential life saved because it’s a cancer that can be removed
surgically. Statistics indicate that more than 230,000 people are diagnosed with lung cancer every year and 160,000 will die. It’s a huge problem, but with lung screening, we find these cancers earlier. That will help reverse those statistics.”
While Kenny believes the benefits to lung cancer screening are clear, he acknowledges drawbacks to screening as well. “There is the theoretical risk of radiation exposure,” he notes, adding that both the dose and the risk is small. He points out that a low-dose lung cancer screening CT exposes a patient to about 1 mSv, “a fraction of the amount of background radiation a person receives living at sea level.”
Stress and anxiety also are involved when a patient gets a positive scan. “Our false positive rate is 37%, which is high,” Kenny says. “But if you follow the American College of Radiology’s algorithm on what to do with positive results and small nodules, patients aren’t being scanned or biopsied unnecessarily. In our database, we have not come across anyone who has had a negative result from an unnecessary biopsy.
“I think the emotional risks associated with false positives might be overstated. If you educate patients appropriately, they understand the context in which they are given results.”
Kenny points out that a high number of patients will have lung nodules. “We’ll tell them that lung nodules are very common—more common in some parts of the country than others. We tell them that the chances of having lung cancer from a small nodule is very, very low.”
The NLST trial determined that out of 230 detected nodules that were less than or equal to 5 mm, just three turned out to be malignant, less than 2%. “We assure them that this is common, and that we will follow up according to ACR guidelines,” he says. “To be honest, we haven’t come across anyone who has had a difficult time with that.”
A community hospital jumps in
It is a curious fact that in the United States current cigarette smoking rates are highest in the Midwest. According to the Centers for Disease Control and Prevention, about 21% of adults in the Midwest smoke—well above the 17% national average.
Indiana’s smoking rate is one of the highest in the nation—and Elkhart County’s population of smokers is among the state’s highest at 23.4%.
With this high population of smokers comes a correspondingly high rate of lung cancer.
According to Allison Lamont, MD, a radiologist at Elkhart General Hospital, the state of Indiana also has an overrepresented number of lung cancers diagnosed compared to the rest of the United States, “and that’s probably because we have so many smokers.”
Around the time that the NLST results were published, it became clear that CT lung cancer screening could be helpful in an area with a high rate of lung cancers, says Lamont’s colleague, Albert Cho, MD.
A number of other actors and factors contributed to the decision to implement a CT lung screening program at Elkhart General. For example, in 2011, the Elkhart County Community Health Assessment identified smoking as a significant health concern impacting the area’s population. In addition, Cho adds, the hospital’s thoracic oncologists and cardiothoracic surgeons were aware of the promising results from lung screening trials and were “interested in getting an early start on lung cancers.”
“So we looked at [CT lung cancer screening] and thought that this was a place we could make a big difference,” Lamont says. “We were doing well with colorectal and breast cancers. We wanted to see if we could address the smoking issue in our population.”
One of the first steps in developing a program was putting the infrastructure in place that could support it. This included the development of a multidisciplinary Thoracic Oncology Clinic—which comprises staff from thoracic surgery, radiology, pathology, medical oncology, radiation oncology, and pulmonology—and meets regularly to assess diagnostic exams and guide the management of each case.
Other staff members also participate in the clinic, including a nurse practitioner who helps drive the process. The idea, says Lamont, is to create a process that moves patients seamlessly from lung screening to appropriate follow-up and treatment, if necessary.
As far as the aspects of the program pertaining specifically to lung screening, patients at Elkhart General are imaged using a low-dose CT protocol. Smokers or former smokers between the ages of 50 and 79 and meet the high-risk criteria for developing lung cancer are encouraged to get screening.
Once a patient undergoes screening, an advanced practice nurse will, within five days of the CT scan, contact the patient, discuss the results of the scan, as well as the appropriate follow up scan. Smoking cessation counseling is also offered at this time.
Follow-up is a key element of the program, Cho says. “We want to make sure the patient doesn’t get lost to follow-up.” In the case of Elkhart, a decision was made to follow the National Comprehensive Cancer Network lung cancer screening guidelines concerning recommended follow-ups.
The advanced practice nurse makes sure an appointment is made for the next scan and that the information is entered into a computer database so that the patient is flagged if he or she misses that follow-up appointment. Reports are sent to the patient’s primary care physician or other physicians as designated by the patient.
As far as reporting the scan results, radiology has developed a structured reporting format it calls L-RADS (similar to the breast imaging reporting system BI-RADS) where Cho essentially took the complex NCCN algorithm for follow-up of lung nodules based on the size of the lesion and turned it “into a digestible and distilled algorithm.”
As of December 2015, Elkhart General Hospital had scanned 443 unique patients with more than 750 studies and registered a cancer detection rate of 1 in 32. In the event of a suspicious finding, the advanced practice nurse follows up with the patient’s referring physicians and coordinates biopsy or PET/CT scan and refers the case to the multidisciplinary thoracic oncology clinic.
Buying into the program
“What we found is that people really got excited about the program as it progressed,” Cho reports. “It really started out with the cardiothoracic surgeons, but the cardiologists jumped on it very early and started referring patients, and it expanded out to the pulmonologists. And when the primary care physicians started getting the reports, they began ordering the exams, so now it’s pretty widespread.”
“We’re lucky that we got buy-in very early,” Lamont adds, noting that one of the first proponents of CT lung cancer screening was a medical student who started peppering cardiologists about it and got them interested.
She also noted that this early buy-in on the part of specialists like cardiologists and cardiothoracic surgeons is probably lacking in one of Elkhart General Hospital’s sister institutions, which is having trouble getting its lung cancer screening program off the ground.
One of the major challenges the hospital faced in setting up the program was establishing a price for the exam. The program got underway before the United States Preventive Services Task Force gave low-dose CT lung cancer screening a B grade, and prior to CMS’s coverage decision for high-risk individuals.
“We spent a lot of time thinking it through,” Lamont says. “We though about doing it for free, but decided against that. We finally decided to charge $199, which is the rough equivalent of an unenhanced CT chest reimbursement from Medicare, so it’s in that ballpark.” That also is the approximate cost of a 1.5 pack-per-day cigarette habit for one month, Lamont observes.
She acknowledges concerns both that pricing the scan too high would be a barrier to entry to the program, and pricing it too low would lead to inappropriate utilization, or even de-legitimize the procedure. “We have a group in the area that has its lung cancer studies priced substantially less than we do, and they are having a tough time getting referrals,” she says. “You have to find a price that is just right to have it both valued and respected.”
There were some challenges related specifically to the community hospital setting that might not exist at a major academic center. Lamont notes that getting a team of physicians to collaborate at the community hospital level is not an easy thing to do.
“That kind of collaboration is a wonderful thing, but it’s a big commitment for those physicians,” she says. “Those of us in radiology and pathology are used to being told to show up to a conference. But to get the oncologists in the room with the cardiothoracic surgeons and the pulmonologists is no small feat.
“In our case, everyone across the oncologic world bought in on this, and it’s been great,” she adds. “I think they are used to this kind of collaboration at academic medical centers, but pushing this to other institutions could be challenging. It’s going to be much harder with private practices where every hour not practicing is uncompensated time.”
New to the program
Unlike Atlantic Medical Imaging and Elkhart General Hospital, Huntington Hill Imaging Center in Pasadena, California began its program after CMS’s coverage decision was announced. Its low-dose CT lung cancer screening program was launched in January 2015, and according to Cathy Vesolowski, Hill Medical Corporation’s vice president of operation, Huntington Hill continues to fine-tune operational details.
Getting a program started is not as simple as it might appears, she says. One hurdle to engaging referring physicians is the relative complexity of qualifying a patient for a scan.
In the case of Huntington Hill, referring physicians and their patients must follow the follow very specific guidelines to qualify a patient for lung cancer screening (see sidebar, page ).
There’s also the issue of setting up a program for follow-up care. “What do you do if the scan is normal? What do you do if it’s a Lung-RADS (the ACR Lung Imaging Reporting and Data System) 1, 2, 3, or 4? There’s a lot of work behind it,” she points out.
Tracking patients so they aren’t lost to follow-up can also be a challenge for a program just getting started, Vesolowski reports. In Huntington Hill’s case, tracking is being done manually, simply because of the low volume of patients who are being screened. Veselowski adds that as the numbers increase, she is staring to look at different electronic tracking programs.
Huntington Hill screened about 130 patients in 2015. “Not a huge number,” Veselowski says, “but we’ve had a few that have gone to surgery, and the referring physicians who experienced this thought it was fantastic.” Veselowski hopes that kind of success will hopefully lead to more patients entering the screening program in the future.