With reimbursement for low-dose CT lung cancer screening assured, radiology will be called on to play an important role in the development and operation of screening programs.
When it comes to lung cancer, the numbers tell a grim tale.
It is the second most common cancer in both men (behind prostate cancer) and women (behind breast cancer) and accounts for about 13% of all new cancers.
Even more discouraging is the fact that lung cancer is decidedly lethal. According to the American Cancer Society, lung cancer accounts for about 27% of all cancer deaths making it by far the leading cause of cancer death among both men and women.
It’s a “silent killer” pointed out William Way, MD, chief medical officer of Wake Radiology, a practice with more than 50 radiologists in 20 locations in the Raleigh, N.C., area. “It’s an aggressive malignancy that presents late after it has metastasized, so early detection is a huge advantage.”
Which is precisely why many radiologists have become strong advocates of low-dose CT (LDCT) lung cancer screening and its potential for significantly reducing lung cancer mortality.
One of the largest clinical CT lung screening programs in the country has been implemented by Lahey Hospital & Medical Center in Burlington, Mass. For Lahey, says Brady McKee, MD, a radiologist at Lahey and co-founder of the hospital’s “Rescue Lung, Rescue Life” CT lung screening program, the tipping point for CT lung screening came when the National Lung Screening Trial (NLST) was halted in 2010. That trial was stopped after early results showed that screening heavy smokers with LDCT reduced lung cancer deaths by 20% compared to screening with chest x-ray.
“We really took notice of that result, and we started to think about having a program at Lahey and how that would take shape,” McKee says.
According to McKee, while Lahey’s radiology department and Cancer Center were the primary drivers behind the program, it became a multidisciplinary effort. “And that’s probably why were able to be successful,” he adds. “We really didn’t try to drive it out of radiology, because we knew there were lots of other people who had to be involved.”
As at Lahey, the NLST was the event that truly galvanized thinking about the possibility of a CT lung screening program at OhioHealth, a network of 11 hospitals, 50-plus ambulatory sites, hospice, home-health, medical equipment and other health services spanning 40 counties in Ohio.
“Now, for the first time, we had a major study that actually showed there was an ability to reduce mortality when you screened at-risk patients,” says Tom Buse, MD, medical director of radiology, Riverside Methodist Hospital in Columbus.
There was some initial hesitation, however, particularly since the United States Preventive Services Task Force (USPSTF) and the Centers for Medicare and Medicaid Services (CMS) had yet to weigh in on the subject. “We didn’t know whether anyone would even order the exam since no insurance company was going to pay for it and Medicare wouldn’t cover it,” Buse adds. “A lot of these high-risk patients can’t afford CT imaging, so what good would a [LDCT screening program] do?”
Since there was no reimbursement available for screening, “we didn’t want to launch our program too soon and have no patients come,” Buse continues, but OhioHealth was still being proactive. “We formed a small steering committee at Riverside Methodist—our flagship hospital—because we wanted to be ready when the results came out,” Buse said. “When those results came out, we increased the urgency to get a program together.”
Taking the first step
The initial step was to set up a multidisciplinary task force on CT lung cancer screening that included radiologists, thoracic surgeons, pulmonologists, oncologists and radiation oncologists. According to Buffy Jansak, system program director for lung and prostate cancer for OhioHealth Cancer Services in Dublin, Ohio, this multidisciplinary approach involved interaction with dozens of departments within OhioHealth.
“I think I counted more than 65 different departments I had to work with, such as our legal, revenue cycle, patient access service, and billing departments,” she said. “So there were a lot of other meetings going on outside of that [task force] that had to occur to make sure we had our ducks in a row.”
The program was launched at three OhioHealth sites on July 22, 2013, (a week before the USPSTF issued its decision recommending LDCT screening) using guidelines established by the National Comprehensive Cancer Network (NCCN).
An important step in establishing the program was the addition of nurse navigators. Any good program has to have continuity, said Buse, which means that nurse navigators are the “glue” that hold OhioHealth’s program together.
Nurse navigators are a key component of the OhioHealth program, first screening patients for eligibility and then scheduling and coordinating imaging, biopsy if needed, follow-up care and smoking cessation.
The use of nurse navigators is part of a three-pronged approach to lung cancer screening at OhioHealth that also includes screening and smoking cessation, says Buse. “We want to be a comprehensive program that sees the patient all the way from referral to screening, through treatment and palliation if cancer is detected, and through graduation [if they are too old for screening guidelines or have quit smoking for more than 15 years and are disease free]. It’s an approach that has given us a high success rate at finding cancers and minimizing interventions.”
Role of radiology
It wasn’t until the first set of CT lung cancer guidelines were issued by the National Comprehensive Cancer Network that Lahey’s program really got off the ground, McKee reports. “NCCN really came out with some great information and it was exactly what I knew was the missing piece to start our program.”
Now that so many recommendations are in place—such as those from the USPSTF and CMS—programs don’t have that issue, anymore. “It’s going to be driven more from the top down now,” McKee says, “where administrators are going to start looking at their radiology departments and ask, ‘What’s the status of our lung screening program?’”
At this point, McKee adds, while it’s going to be “absolutely critical” to have a strong multidisciplinary team in place and assembled, radiology must take the initiative in monitoring the day-to-day operations of the program.
The multidisciplinary team is important in overseeing the structure of the program and “as a place to go where you have suspicious findings, which typically happen in just 4% of cases,” McKee says. “But you need someone in radiology who is responsible for the other 96% and is a resource for staff that have been assigned to enroll a patient [in the program], keep track of the findings and schedule the appointments.”
In addition to having a multidisciplinary team in place, strong support from primary care is necessary as well, McKee adds. “It’s really a group effort, but it can’t happen without radiology. Radiology can’t do it on its own, but so much is required on a day-to-day basis that I don’t see how a well-run, highly functional program can work without it.”
What do radiologists and radiology departments need to know about CT lung screening?
In the March Issue of the Journal of Thoracic Imaging, McKee and his colleagues from Lahey describe the essentials of a lung-screening program. Radiologists who regularly read CT chest images should be capable of reading CT lung screening exams “with a modest investment in time to become familiar with current guidelines, recommendations and dedicated structured reporting.”
They also suggest that programs providing CT lung screening should consider establishing an internal credentialing process. At Lahey, for example, radiologists must read a pre-selected list of publications about CT lung screening and review a series of lectures covering specific topics such as reporting with Lung-RADS (Lung Imaging Reporting and Data System), a classification system that scores patients based on nodule presence, size and suspicion of malignancy.
The radiologist has to achieve a score greater than 80% on a multiple choice test based on the publications and lectures. In addition, once a radiologist has been credentialed, he or she must interpret at least 150 screening cases per year to maintain their credentialing.
Establishment of an internal credentialing process also can “help ensure the radiologists interpreting the exams have acquired the knowledge necessary to use the structured reporting system and ensures the radiology reports generated can be audited and used to derive quality metrics,” McKee and his colleagues explain in the Journal of Thoracic Imaging article.
The American College of Radiology (ACR) has also initiated a CT lung screening center accreditation process in which a scanner in an accredited center that performs LDCT lung screening programs must have an active ACR chest module accreditation, In addition, the CT lung screening protocols must be within exposure ranges specified by the ACR to insure low dose radiation exposure to patients.
Other ACR requirements include an integrated smoking cessation referral mechanism, internal quality control process and use of a structured reporting system such as Lung-RADS.
Getting the word out
Primary care providers are going to be the key players in determining whether or not at-risk patients undergo LDCT lung screening, McKee says: “This is a discussion that really needs to be happening at annual well visits for patients at high risk. That’s the future of lung screening.”
Primary care physicians have knowledge of their patients overall health, McKee explains, and are best positioned to help patients decide on the appropriateness of preventive care interventions like lung cancer screening. “We strongly feel that you need a physician order for all patients before screening,” he says. “You need to have a point person a patient can go to before the exam to discuss whether it’s appropriate, and after the exam as well to talk about the pulmonary end of the study.”
There’s probably going to be some resistance from primary care providers regarding the effectiveness of any kind of screening program. “I’m not sure we’re ever going to resolve that debate,” McKee says. “But for those people who believe screening does work, it’s a matter of putting the lung screening evidence in some perspective so that they can see how it compares—and we feel the evidence is strong, that it’s something that is beneficial for the specific patient population that’s at high risk.”
Consequently, Lahey mounted an extensive local continuing medical education campaign to provide its primary care physician community with information about the results of the NLST; to describe the way in which the LDCT program was being run at Lahey; and answer questions about the risks and benefits of screening. As a result of this effort, most patients are referred to the program through Lahey’s PCP network, McKee says.
OhioHealth decided to go with a “soft launch” approach when it started its program in 2013. “We anticipated we would go with a louder launch once the program began, but we really didn’t know how much volume we would get and how many people would support the program,” Jansak says. “We really needed to educate our primary care physicians because there was still a lot of discussion going on about whether or not the risks of screening outweighed the benefits. Some of our primary care providers are family practitioners, and a lot of them are still not 100% supportive of lung cancer screening.”
The point of the soft launch was educational. Jansak and her colleagues attended primary care staff meetings and regional campus meetings with the goal of explaining why OhioHealth was launching the program, who was eligible to be screened, and to whom the primary care providers would be referring.
Tools of the trade
Jansak said a prescription tear pad was developed, which was distributed to the primary care community so that the logistics of a screening referral were “super easy.” On the front of each paper was information about the criteria for the program and the three sites physicians could refer to at OhioHealth (the program has now been extended to more sites). On the back was the prescription with ICD-9 codes that just required a physician’s signature.
“So we really targeted our marketing around education and that worked really well,” Jansak said. “Our volumes were much more robust than anticipated.”
In fact, according to Buse, to date OhioHealth has screened about over 600 patients.
“Every single one of those 600 have met with a nurse navigator, watched our program video, and been offered smoking cessation counseling, whether they are a current or former smoker,” Buse said. “And we’re getting about 40% of these patients coming back for a second year of screening, which we think is pretty good. There isn’t a whole lot of data letting us know how other places are doing, but we’re pretty happy that patients are coming back in the second year, which speaks to the benefit of the program and the relationship with the nurse navigators.”
That’s despite the fact that up until February of this year, Medicare wouldn’t pay for LDCT screening. Instead, OhioHealth charged a fee of $99, which covers the CT scan, the video, a meeting with the nurse navigator, and a smoking cessation referral. The current assumption, Buse says, is now that Medicare is covering screening exams, the patient return rate will increase.
An early economic model
At Lahey, the decision was made to offer free screening—at least until CMS and commercial insurers established reimbursement on a broad scale—to encourage persons at high risk to get screened, regardless of socioeconomic status.
As described in a study in the August 2013 issue of the Journal of the American College of Radiology, Lahey determined that in the first two years of its screening program, 60% to 80% of the revenue available to offset costs would come from treating lung cancer, while in later years revenue from interval low dose CT follow up of small pulmonary nodules and lung cancer treatment would also be important revenue sources.
Jansak makes a similar point about the LDCT screening program at OhioHealth—that the downstream revenue gained from the program should more than offset the costs associated with screening. “We have not lost any money on this program,” she asserts.
Of the first 600 patients screened at OhioHealth, 16 were sent for biopsy after screening. Biopsy resulted in 10 cancers detected—nine of which were early-stage cancers—and six false positives. There were no complications reported from any of the biopsies, according to Buse.
“We’re very disciplined in our program,” Buse says, meaning that any cases that are troubling will go before a multidisciplinary task force—the same one set up four years ago at the start of the CT lung screening program—for a recommendation.
“If a patient has a high-risk lesion, he is going to be referred to a specialist,” he says. “We were concerned about the patient with the 1.5 cm nodule. They could go straight to biopsy, while some of these don’t have to be biopsied. In those cases, you can do surveillance imaging and see whether it grows, and if doesn’t, you [haven’t subjected the patient] to an unnecessary biopsy. But a high suspicion lesion then gets referred to a specialist—a pulmonologist or a thoracic surgeon.
“It’s this multidisciplinary approach that leads to fewer false positives, better compliance with recommendations, and more patients coming back the next year,” he said.
One radiology practice’s experience
At Wake Radiology, a practice with a significant outpatient-imaging center footprint, the practice’s body imaging section began looking at lung CT screening shortly after the results of the NLST came out. “We saw the value in this, but the problem was that from a reimbursement standpoint this wasn’t a covered service,” Wake Radiology’s CMO William Way, MD, says.
One step that Wake took was to begin developing its own internal imaging protocols. “Anytime we begin a new endeavor like this, we organize a team of people who are interested and we save the cases and review them so that the group at large is happy with the protocols, the reconstructions and the interpretations,” Way explains. “In that way, we are able to develop internal standards on how we are going to do this.”
The first lung CT scan was performed in January 2012, so the group is three years into doing CT lung cancer screening. “But it hasn’t gotten a whole lot of traction because it wasn’t a covered service,” Way says.
Also, the group was hesitant to jump willy-nilly into a screening program. “We entered into this with some trepidation,” Way explains. “We’ve all read many CTs, and we’ve seen a lot of chest CTs with a lot of nodules. We wanted to be very cautious about inadvertently taking people down a labor intensive, expensive and dangerous diagnostic pathway that could be unnecessary. There were internal concerns about the real utility of this.”
Way says that it will take some time to educate primary care physicians about CT lung cancer screening. He also points out that the cost of providing the screening exam is not insignificant and could lead to downstream costs.
At the same time, Way says, healthcare providers are being told to do more while holding costs down. “So they are stuck between a rock and hard place if they really want to push this [lung cancer screening] because the message is antithetical to what they’re being told.”
That said, Way believes LDCT lung screening will be a successful program that will detect cancers earlier and save lives, particularly in a state like North Carolina where tobacco is a major industry and a sizeable portion of the population smokes.
Ultimately, radiology practices must come to consensus around how to proceed on this new population-health management pathway. As McKee says, without the involvement of radiology, a lung-cancer screening program is unlikely to succeed.