Baptist Health South Florida, a six-hospital system in South Florida, implemented a multidisciplinary low-dose CT lung cancer screening program in July of 2014, spearheaded by 72-radiologist practice Radiology Associates of South Florida, Miami, and Juan Batlle, MD, director of the program. Initiated prior to the era of reimbursement for the service, eligible patients were required to pay just $35 for the study.
As Batlle puts it, “We went from zero to sixty fairly quickly, and we had to adjust to that.” The program, which institutes a standardized approach across the system with one database, screened between 700 and 800 patients in year one and is on track to screen 1500 this year.
While there are many operational decisions that must be made in developing a lung cancer screening program, many of the key clinical decisions revolve around nodule management. “Images were being performed at outpatient facilities across Miami Dade and Broward, as far north as Cold Springs and as far south as Homestead Hospital,” he explains. “We really had to create a virtual system for a nodule clinic.” In a recent interview with Radiology Business Journal, Batlle describes how the program handles nodules.
How prevalent are nodules in the screening population?
Batlle: Lung screening is something that has been happening academically for more than 20 years. That screening has been happening in very heterogeneous populations, that is non-smokers, heavy smokers and everyone in between.
The numbers that you get for “false positive” rates range from 5%-10% all the way up to 30%.
With the National Lung Screening Trial, it was somewhere in the 20% to 25% range, but subsequent use of the ACR’s Lung-RADS™ structured reporting system dramatically lowered the false-positive nodule detection to the 10% to 15% range. We find that our “false positive” nodule-detection rate is somewhere in the 10% range—fairly low, and it’s usually lower than 10%. What ACR’s Lung-RADS did to push that number down was the creation of category 2, a benign category, with no need to follow up, just return to annual screening. That included all nodules up to 6 mm in size. If you find a nodule, and the average of two perpendicular measurements is smaller than 6 mm, then that nodule can be called a Lung-RADS 2 and it can be followed conservatively.
What that means is that these tiny nodules which were frequently found and over-called on previous exams no longer require any follow-up whatsoever apart from the annual CT exam. That eliminates 15% to 20% of patients who otherwise would have been called positive, and would have been called back for a follow-up scan and no longer are. We adhere strictly to that.
How are nodules assessed?
Batlle: I make sure I measure the nodules faithfully: a long nodule that measures 7 mm but is only 1-mm wide is not a 6–plus-mm nodule. The average of tdhose measurements is below 6 mm.
It’s important to make sure that you are measuring accurately, and that you faithfully go through the entire record to see if you can find a previous CT scan that includes that area to try and clear that nodule as benign and stable. I attempt to look for other signs of benign nature, like central calcification or complete calcification of the nodule, fat within the nodule, or characteristic features that may help
you attribute it to an infection, like other small clustered nodules in the area. These are all things I go through to make sure that when I call a nodule back, one that needs a six-month follow-up scan, that is done very rarely, less than 10% of the time.
The other thing that is useful from the ACR Lung-RADS perspective is that in its Lung-RADS 3 category, what they recommend is one additional 6-month scan. If a person is getting their scan January 1, 2016, and they are due to have the next scan in January 2017, the only extra scan they are going to get is July 2016. Then they go back to a yearly schedule: July 2017, July 2018. That “false positive” creates just one additional low dose CT scan.
I think it’s a very straightforward, streamlined, economical way that the ACR has helped develop to help us make decisions for patients that don’t overly worry them. The vast majority of our patients, 90% or more, are told come back in a year.
Which nodules are biopsied?
Batlle: Again, we follow the ACR’s Lung-RADS. Once the nodule gets to 8-mm or more, we look to characterize it with a PET scan and see if there is metabolic activity. If there is metabolic activity