Screening Process—Standardizing

SR/BM: We use a fixed milliampere (mA) for all LCS exams. For very large patients we increase the mA by 10 and for small patients we decrease the mA by 10. This decision is at the discretion of the technologist performing the exam.

EMH: We screen at multiple sites using a variety of CT equipment. We use both fixed mA and variable mA approaches to minimize patient dose, depending on the site and equipment used. The most important thing is that all sites adhere to the dose limitations required by CMS, optimizing for individual patient size as needed.

KK/CCT: Many programs utilize radiology databases for tracking orders and results. Transferring data into other management systems for surveillance is also a method to ensure tracking orders and completion of orders. Manual review of the database is often required to ensure this occurs. EHR systems can be programmed to create critical results for lung nodules that are sent to the ordering provider and the multidisciplinary team managing lung nodules at the institution. In our program we have a critical result reporting function, a notification to the nodule program, and a movement of these patients into a registry for management by the team. If a patient does not show for a follow-up or an order is not completed, the navigator can follow-up to ensure its completion or the reason why it was not followed if not clinically indicated. The team manages the removal of patients from the registry when follow-up is no longer indicated or a diagnosis is made.

SR/BM/CCT: We have two order codes that are specific to LCS. One order is for the initial and annual screening exams and has the G0297 CPT code attached to it. The second is for follow-up low-dose CTs that stem from screening exams and has the 71250 CPT code attached. These exam codes fall onto a work queue in our EHR to be reviewed, pre-authorized, and scheduled; they also migrate into our LCS patient database.

MG: Screening exams are tracked in the Radiology Information System by using unique exam codes.

Structured Reporting

CF: Our radiologists use Lung-RADS™. There was some resistance at first due to lack of familiarity with format. This was overcome by education by the LCS program (run by pulmonary at our practice), providing a template in radiology reporting software, and current need for this format for data submission to an approved registry (required for reimbursement by CMS).

CCT/RSW/KS: Our program reports findings of all LCS studies in a structured reporting system utilizing Lung-RADS™. Results are then tracked by the navigator of the program.

EMH: LCS studies are reported in a standardized fashion using the ACR Lung- RADS™ classification system to categorize results and recommended follow up. We currently use institutionally developed tracking systems but are in the market for a commercial system to be shared among all regions.

EJ: CT scans are interpreted using Lung-RADS™ within 25 minutes to allow for same day review of the results with patients.

MKG: Most exams are interpreted by general radiologists, using a standardized template that conforms to Lung-RADS™ categories. Follow-up is arranged by the ordering provider.35

EMH: This will be local practice specific; the radiologist should provide direction to the ordering provider though, especially if that person is an APN/PA/PCP.

SR/BM: In our program, all patients with a Lung-RADS™ 4 lesion are recommended to be seen by a pulmonologist. It is important to note that these patients remain in the screening program, as the majority of them will end up back in the screening cycle. Patients are followed until they are no longer a Lung-RADS™ 4 (i.e., either downgraded due to imaging stability or benign pathology and returned to annual screening, or found to have lung cancer), and during this time all appointments related to the abnormal finding are tracked (i.e., specialist consults, PET/CTs, percutaneous/trans bronchial/excisional biopsies, etc.).

CCT: All Lung-RADS™ 4 cases in our program are called to the ordering provider and the nodule program for referral to a pulmonologist in the program within 24 working hours. The navigator then discusses this option with the ordering provider whom either calls the patient themselves with the appointment information (the typical course of action) or asks our program to call the patient. The patient is then tracked within the program and their care navigated. If a work up is completed and the patient is no longer a Lung-RADS™ 4, they are returned to the screening population.

RSW/KS: For patients with findings suspicious for lung cancer, (Lung-RADS™ 4A, 4B, 4X), the LCS Program Coordinator notifies the referring provider directly, and the referring provider communicates these.

CF: All screened individuals with Lung-RADS 4A/B/X are seen in consultation by a pulmonologist to develop a plan for further evaluation as indicated.

SR/BM/CCT: Regardless of short-term stability, if a solid or part-solid nodule has documented growth in comparison to older prior exams, it is suspicious and will result in an overall exam assessment of Lung-RADS™ 4 in our program until such time that it is resolved, resected or treated. Non-solid nodules of any size will have annual surveillance recommended until development of a solid component is suspected.

EMH: The answer to this depends on whether the initial result was Lung-RADS™ 4A or 4B. If it was a 4A, the new result becomes a Lung-RADS™ 2 (by Lung-RADS™ definition) and the recommendation becomes a return to screening in 12 months. If it was initially a 4B, we would likely discuss the case at multidisciplinary conference for a consensus opinion on next action.

SR/BM: We recommend a formal pulmonary consultation for suspicious exams and allow the pulmonologist to determine based on that consultation if a PET-CT is needed and be available to help the patient interpret the findings on the PET-CT once it is performed. Using this method, 50 percent of patients in our program with suspicious findings undergo PET-CT, more than half of which (54 percent) are eventually diagnosed with lung cancer.

CCT: All suspicious nodule findings are referred to the nodule program and the ordering provider is notified. The ordering provider can decide not to refer the patient, which is a very rare occurrence. The pulmonologist then decides whether a PET CT or other evaluation is warranted.

EMH: For some Lung-RADS™ 4 nodules, yes. It is the interpreting radiologist’s discretion as to what to recommend based on their assessment of the identified nodule.

CF: As above, all patients with Lung-RADS 4A/B/X are seen by a pulmonologist with plans for further evaluation and management determined at that visit.

Incidental Findings

SR/BM: In our program, significant incidental findings are unexpected findings which are either new or unknown and require some form of clinical or imaging investigation before the next recommended LCS study. Coronary artery calcifications and emphysema are highly prevalent, expected findings in this population and should be reported on every exam separate from this category. The rate of significant incidental findings in the NLST was 10.2 percent at baseline and 7.5 percent overall31 and as such could not have regularly included either coronary artery calcifications or emphysema of any level based on the prevalence of these findings in this patient population.

EMH: Significant incidental findings in NLST were left to the discretion of the radiologist, and so undoubtedly did include some degree of emphysema and coronary artery calcification (CAC), although only in select patients. This is quite a complex issue and will vary by radiologist depending on their own unique sensitivity/ specificity, and their need for certainty (follow-up) on specific items. We also report all emphysema and CAC routinely (as well as aortic calcification, another predictor of downstream cardiovascular risk); however, if a 55-year-old has what looks like a 3000 CAC score, we’ll make that an S and recommend noninvasive cardiovascular risk assessment (like Framingham) if it hasn’t been done before. Similarly, emphysema disproportionate to age and smoking history will generally get called out for specific follow-up. We are using the ACR thyroid white paper to minimize thyroid evaluations; kidneys are the biggest problem issue we see, due to noise.

JM: At Rush the presence of moderate to severe coronary calcification is reported. The frequent finding of coronary artery calcification in the screening setting has been widely reported and discussed and findings from the NHLBI MESA studies and other sources suggest that preventative interventions such as enhanced smoking cessation efforts, diet and life style intervention, statin directed therapy should be considered. In regard to COPD, there is no uniform opinion in the radiological community as to a how the findings of coronary artery calcification or emphysema, both representative of smoking-related disease, identified on LCT should be interpreted. Most commonly these are interpreted as incidental findings; alternatively these can, and some believe should, be viewed as opportunistic findings.36,37 The importance of the reporting of emphysema may also lead to the earlier identification, diagnosis, and treatment of COPD; for example, because COPD may be underdiagnosed in up to 80 percent of patients who meet diagnostic criteria for airway obstruction on spirometry, the reporting of emphysema on LCT may lead to an earlier investigation for COPD than otherwise sought. For example, one study demonstrated that although 31.6 percent of patients who underwent LCT screening were diagnosed with COPD, a higher percentage of patients demonstrated emphysema and bronchial wall thickening, at 50.6 percent and 39.4 percent, respectively. This earlier identification of incidental findings may lead to an earlier diagnosis and subsequent treatment with smoking cessation and inhaled bronchodilators with or without inhaled corticosteroids. This may ultimately result in less exacerbations and hospitalizations for COPD, greatly reducing the burden to society and the healthcare system.36

CF: Significant findings are defined as those that require further evaluation or treatment prior to the next scheduled screening exam.

CF: For scans with other significant findings (S) the PCP is contacted directly by LCS program to confirm they are aware of scan results.

CCT/RSW/BM: Incidental findings are documented in the radiology report. Concerning incidental findings that would fall into criteria for an unexpected or urgent finding are reported with a flag in the EHR and if there is a significant concern it is called personally to the ordering physician.

EMH: Incidental findings are flagged in the report. Potentially significant unexpected or urgent findings are communicated directly to the ordering provider.

PM: Incidental findings are reported in the structured radiology report. We have partnered with specialists in fields relevant to the most commonly identified incidental findings (e.g., thyroid nodules, coronary artery calcification) to develop algorithms for management of these findings. Our program navigator will follow these algorithms in guiding patient management. These results and the evaluation plan are communicated to the referring providers within the EMR or directly by phone. We have found that approximately one in seven patients require additional testing related to incidental findings, and one in eight require a specialty consult. Approximately half of the payment to the institution in the year following the initial screen has been related to management of incidental findings.