AM: No, our program does not at this time manage incidentally discovered nodules. We are looking into how to best assist primary care, pulmonary medicine and radiology with this functionality. Some centers will refer high risk individuals to their screening program after an incidental nodule is discovered on non-screening CT, to then formally enter these individuals into the screening program.

DTC: An incidental nodule would necessitate a diagnostic CT scan, and is not part of the scope of our lung cancer screening program.

CL: Outside of the screening program the incidental pulmonary nodules are managed based on radiology recommendations and practice patterns of ordering physicians. Primary care or emergency room physicians, where imaging identifies the incidental nodules, will often refer to pulmonary for further evaluation.

CCT: When our program was established, the oversight committee decided to proactively manage and conduct surveillance on all nodules detected regardless of the study detecting the nodule. In this way, nodules found on a diagnostic CT are funneled into the same clinical care pathway as those detected on a lung cancer screening study and the nodule program is notified through the EHR. The nodule is automatically reported to the nodule program for either work-up or surveillance depending on nodule characteristics. Data on clinical evaluation and therapy is collected in the same manner as those detected on LCS studies and cases are discussed in our multi-disciplinary team meetings. Those found on lung cancer screening are reported and tracked according to reporting requirements. This is essential, as is a program that tracks follow-up with the annual screening CT. In recent survey data, there is very poor compliance with annual follow-up and poor mechanisms to track patients following initial enrollment. Creating a parallel program for surveillance of nodules found (both incidental and those on screening), as well as tracking completion of follow-up imaging is an important component of providing safety net systems for imaging. These were included due to the large number of cancers found incidentally and the risk of loss to follow-up.

CF: No

CF/RSW: All of the above. We pull as much of the data as we can from our EHR but most of the required data for CMS submission is entered manually by the program navigator. The LCS program navigator has been given access to the radiology software (a separate system) and pulls needed data from there. In addition to our EHR, data is retrieved from local hospital EHRs with respect to procedures, pathology and treatment, and manually entered into low dose screening program database.

CCT: Some data regarding types of studies, nodules, follow-up can be collected by radiology at the point of care; others such as smoking cessation, shared decision making can be collected by the EHR where hard stops can be created at the point of ordering. Others, such as process measures of the program itself are often manually tracked in another IT platform by a data coordinator or navigator. Information to populate these areas can be gleaned from the EHR.

GM: Many groups have created work-arounds within their EHR to help collect and easily extract data.

DTC: The program coordinator and the radiology manager of medical diagnostics informatics collect quality metric information. This includes the data variables that are imputed into the registry. Data that are discussed during the monthly task force meeting include distribution of Lung-RADS™ scores, age, which scanners at what sites are being used, dose, smoking information, etc. If a patient has been screened that does not fit USPSTF or CMS criteria, then a root cause analysis is performed.

CCHS: Currently manually. Looking into software to implement.

SR/BJM: Coronary artery calcifications and emphysema of varying degrees are expected in this patient population. We qualitatively reporting of the presence and extent of both findings using a four-point scale: none, mild, moderate, marked.

SR/BM/EMH/CCT: Patients with LungRADS2 results have two potential indications for their next exam in 12 months: 1) asymptomatic patient meeting high-risk criteria for lung cancer screening, and/or 2) follow-up of benign-appearing nodule(s). Therefore, patients meeting CMS/USPSTF high-risk criteria would have their next exam in 12 months as a screening exam (CPT code G0297). However, patients not meeting CMS/USPSTF high-risk criteria don’t have that first indication, so their scan in 12 months is a diagnostic follow up (CPT code 71250) of the benign-appearing nodule(s).

EMH: Great question that I have seen inconsistent information about. Since the follow up exam is a discrete event, if the Lung-RADS 3 nodule was stable at 6 months, it becomes a Lung-RADs 2 (by Lung-RADS definition) and the recommendation becomes a return to screening in 12 months

SR/BM/CCT: LungRADS recommendations are based on each unique exam result. Therefore, if the patient has a follow-up exam as a result of a positive baseline scan, and the result of that follow up exam is Lung-RADS™ 1 or 2 with a next recommended date in one year, that would be one year from the follow up exam and it would be considered an annual screening exam.

EH: Interval scans performed for acute symptoms would not generally be interpreted using Lung-RADS criteria. However, if such as scan serendipitously occurs at the recommended interval as specified in the original LCS report, the result may reclassify the initial Lung-RADS result, which should be included in the final report of the interval scan. An example would be a patient with a Lung-RADS 3 nodule who is involved in a car wreck 6 months later and has a chest CT for trauma, prior to their recommended follow up exam. If the Lung-RADS 3 nodule identified initially is stable, the trauma exam can be used to reclassify the patient into Lung-RADS category 2, with a return to screening in 12 months. This is not an issue as long as we explain it correctly in the report to the referring physician and to the patient.

SR/BJM/CT: We try to catch these ahead of time whenever possible, but in a case where that isn’t possible, the exam is passed along to one of our radiologists credentialed in reading lung screening exams to determine how that interval CT affects the patient’s next CT in the screening program. These interval CTs are not read using LungRADS; however, they can impact when the next screening exam will be.

Our program management system has a patient level score which takes into consideration the most recent information available in the patient’s medical record not simply the result of the last CT lung screening exam. For example, if the patient’s last exam was a LR4 but a biopsy of a suspicious lesion is negative for malignancy the patient level score should be changed from LR4 (the most recent CT lung screening exam score) to LR2 reflecting the fact that the finding which triggered the LR4 score was, in fact, benign. Results of PET/CT exams and CT exams performed for non-lung screening indication. For example a trauma CT of the chest abdomen and pelvis could also result in the patient level score in the program management system deviating from the result of the last CT lung screening exam.

SR/BJM/CT: In cases in which another area was imaged (i.e. cervical spine) that scanned through nodule, the exam is directed to a credentialed lung screening radiologist to determine the impact on the next screening exam.

GM/CCT: In order to be an accredited program through CMS you need to be >90% compliant with CMS guidelines. This includes submitting patients to the registry and >90% compliance with their eligibility criteria. Our center has interpreted this as we need to submit all patients to the registry.

DTC: We submit all patients that undergo CT screening into the registry. This allows for transparent retrospective review.

AM: For the most part, the answer is no. The American Association of Thoracic Surgeons (AATS), however, recommends annual screening for individuals who carry the highest risk for lung cancer, namely those with a personal history of lung cancer regardless of smoking status. In these individuals, the risk for developing a second primary lung cancer is 24% per year compared with the Tammemagi calculated risk for NLST participation of 1.6% risk over six years.24

An Example of the Rate of S Positives from Lahey Medical Center

Percentage of S Positive Findings

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Appendix II: An Example of the Rate of S Positives from Lahey Medical Center

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