Since the publication of the landmark NLST in 2011, many health care systems prepared to implement a lung cancer screening program. The NLST was the first randomized controlled trial to show a mortality benefit when screening high-risk populations for lung cancer with low-dose CT of the chest.1 At the time of NLST publication, the most updated guideline from the U.S. Preventive Services Task Force (USPSTF) cited insufficient evidence to recommend for or against screening for lung cancer.2 Similarly, the American College of Chest Physicians recommended screening only within the confines of a clinical trial.3
The University of Minnesota Health is an academic medical practice in the center of a large metropolitan area. Our health system affiliate, Fairview Health Systems, is one of several that provide care throughout the state. One advantage of this system is that any patient treated in the hospitals or clinics has a universal electronic health record (EHR, Epic). However, different physician practice groups provide services within the system. Imaging services are contracted to both University of Minnesota physicians and a large community radiology practice.
MATERIALS AND METHODS
Determination of Need and Assessment of Resources
In early 2013, we gathered a team, consisting of representatives from business development, thoracic oncology, radiology, thoracic surgery, and pulmonology, to design the program. Initial research included an assessment of available clinical resources, a market analysis, and a cost analysis to start the program. According to our estimates, approximately 94,634 people at high risk for lung cancer, based on smoking history, live in the metropolitan area. Only one other screening program was open in the area at the time of our program planning and launch.
A team of clinicians with lung nodule management expertise is an integral component of a lung cancer screening program.4 Our multidisciplinary thoracic oncology group was established in 2011 and includes board-certified thoracic surgeons, radiation oncologists, thoracic and interventional radiologists, interventional pulmonologists, and medical oncologists—all specializing in the care of patients with lung cancer. An experienced, specialized team contributes to optimizing outcomes of lung cancer screening by avoiding unnecessary diagnostic procedures and achieving the best possible outcomes for lung resection surgery.5 The multidisciplinary team reviews indeterminate lung nodules in a weekly lung nodule conference with diagnostic thoracic radiology to recommend a patient-specific plan for diagnosis and/or disease management. Minimally invasive diagnostic testing is available at our institution, including percutaneous lung biopsy, video-assisted thoracic surgery, and linear probe endobronchial ultrasound and guided bronchoscopy techniques (such as electromagnetic navigational bronchoscopy and radial endobronchial ultrasound). The team uses advanced diagnostic technologies with individualized attention to lesion characteristics, patient preferences, and medical comorbidities.
Establishing a workflow for ordering examinations, interpreting images, relaying results, and ensuring follow-up was a crucial phase of planning. The follow-up is driven by the guidelines by the National Comprehensive Cancer Network,6 American Association of Thoracic Surgery,7 and American College of Radiology (ACR).8 Implementation of the program required partnership with EHR builders, billing and patient financial services, and communications specialists.
Although self-referral for screening was initially considered, ultimately we required an order from a credentialed provider for screening. Subsequently released CMS requirements mandate an order and ordering provider, but health systems might elect to offer screening to patients with private insurance or those who would pay for services out of pocket. The anticipation of need for result follow-up influenced our decision to require all patients to have an ordering provider for lung cancer screening.
A unique EHR order was created specifically for lung cancer screening. The name of the order and associated search key words included “CT,” “lung cancer screening,” and “low-dose CT.” Initially the order had few mandatory responses related to eligibility criteria: patients’ symptoms suggestive of lung cancer, age, and smoking history. When this order is signed, providers are also prompted to include in the patient’s printed after-visit summary the “Lung Cancer Screening, Frequently Asked Questions and Resources to Help You Quit Smoking.” Subsequent CMS requirements changed the order to include the required elements for all patients.
Despite the limited screening interval and upper age limit of 75 reported in the NLST, we predicted benefit from continued annual screening. Hence, we added lung cancer screening to the health maintenance activity where other preventive health measures are tracked, including cancer screenings and vaccinations. The American Association for Thoracic Surgery also recommended annual screening for people age 55–79.7 Ultimately, the USPFTF and CMS released recommendations for both a broader age range and screening extending beyond three annual examinations. We educated primary care provider groups about screening eligibility and the process we developed.
After creating a new chest CT lung cancer screening order in the EHR, establishing a result workflow with radiology, and educating providers, our program launched on December 12, 2013. Because most insurance companies were not yet covering lung cancer screening examinations, we offered the service at $150, which was a fair market price at the time. Several insurance companies began covering screening throughout 2014, well before the updated USPSTF guideline.
At the time of screening, patients submit detailed information about their risk factors for lung cancer via a questionnaire (developed with collaboration from academic epidemiologists and clinical psychologists, subsequently adapted to match CMS registry data requirements). Imaging technologists enter the information into the EHR and share with the interpreting radiologist. The questionnaire assesses each patient’s risk profile including smoking history, radon and particulate exposures, family history of lung cancer, and personal medical history.
We implemented a structured reporting system for results called U-Lung-RADS, which was modeled after Bi-RADS and was very similar to the system ultimately released by ACR in April 2014 (Table 1).9 In addition to a numeric score based on the likelihood of cancer, additional modifiers indicate the presence of incidental or suspicious findings. We implemented the ACR Lung-RADS 1.0 immediately after it was released.
Lung-RADS Version 1.0 Assessment Categories
Our results follow-up team is comprised of a call center, certified nurse specialists, and a physician. The team monitors semiweekly and monthly reports for screening examination results. All patients who were screened receive a letter describing the results of the screening CT and the next steps for follow-up in plain language. The follow-up team also helps facilitate orders for follow-up scans and appointments and verifies that they are performed. The team also notifies the primary care physician of any incidental findings. Incidental findings unrelated to lung cancer were found in 7.5% of patients in the NLST,10 therefore a mechanism for management is imperative. Patients who have Lung-RADs 1 or 2 (no suspicious findings) and meet eligibility for screening have the lung cancer screening topic added to their health maintenance modifier. The health maintenance activity is visible to all providers, and, when overdue, an alert appears in the patient’s chart. For any positive findings (Lung-RADS 3 or higher), the certified nurse specialist or physician is notified immediately so that the patient can be discussed in multidisciplinary team conference to establish a plan for follow-up or diagnostic procedure. A unified EHR allows multidisciplinary chart and image review as requested by ordering providers for externally performed screening examinations with abnormal findings.
Improving examination ordering rates.
The number of orders for screening has been less than expected relative to the estimated eligible population. Several identifiable barriers are likely responsible. First, adoption of new recommendations usually grows over time.11 Adoption is almost certainly limited by provider awareness of screening availability and eligibility, as well as the time required to incorporate yet another preventive care service into patient interactions. Secondly, uncertainty regarding insurance coverage may discourage health care providers from ordering a screening. As we expand to new regions in the state, we offer educational sessions to primary care practices served by those centers. Furthermore, systemwide educational events have been held in the form of grand rounds at multiple sites and lunch webinars for primary care providers.
An effective method of improving adoption of guidelines for lung cancer screening may be to use the EHR’s best practice alert (BPA) functionality. A pop-up alert prompts a health care provider about a clinical topic, including eligibility for preventive care activities. Activating an alert for lung cancer screening CT orders for all of our patients who meet the criteria would probably improve ordering rates and awareness among our ordering physicians. However, implementing alerts like these must balance patient care and health care provider information overload and alert desensitization.12 Moreover, in order for a BPA to be useful, patients must have a very detailed smoking history recorded in the EHR.
Improving examination completion rates.
Even as examination orders increased, many went unscheduled and were not performed. We believe this low completion rate to be primarily due to reimbursement uncertainty and out-of-pocket payment for the examination. Because several national private insurance companies added lung cancer screening coverage prior to the USPSTF recommendation, we eliminated the self-pay approach and began reviewing orders for insurance eligibility. If an eligible patient’s insurance did not cover screening, they could receive the screening examination under a local grant for this purpose. Thus, we were able to remove a cash price barrier and offer the procedure to all eligible patients as an insurance-neutral screening examination. We notified providers about the grant and elimination of the self-pay option using an internal newsletter. We also sent letters that explained the benefits of screening and offered examination with insurance or grant coverage to all patients with orders that had not been completed. Finally, our imaging centers do not proactively schedule ordered examinations; rather, patients are asked to initiate the scheduling process. Proactive scheduling of ordered examinations by radiology would likely improve completion rates as well.
Improving result reporting.
Streamlining result reporting also was an initial challenge. We believe it is important to deliver results to patients in a way that minimizes anxiety about abnormal findings. We envisioned an experienced certified nurse specialist to deliver abnormal results along with a treatment recommendation to the patient. However, early examination results follow-up by the ordering provider was generally not in accordance with national guidelines. When this happened, we contacted the providers to notify them of the service we intended to provide and revised any misinformed recommendations. As providers learned to trust that we would handle results follow-up, the process became more streamlined. Primary care physicians are informed of all patient communication and recommendations. As a service to patients and providers who scheduled at a non-university-affiliated imaging center in the health system, we added an opt-in question to the imaging order in September 2015. Ordering providers who opt-in transfer nodule follow-up to the centralized results team.
Smoking Cessation Program
The effect of screening for lung cancer on smoking rates is not fully known13 but thought to be most favorable when smoking cessation assistance is offered with screening.14 Moreover, smoking cessation is an important part of preventive health and cost-effective lung cancer prevention.15 We use a variety of tools to help patients quit smoking. A pharmacist provides pharmacologic assistance in medication therapy management for smoking cessation, and smoking cessation tools are incorporated in the lung cancer screening ordering process in the EHR. Furthermore, our institution is a site for a National Institutes of Health–funded smoking cessation trial, with participation offered to smokers who are being screened. Therefore, we consolidated available institution resources within a website to provide centralized access to smoking cessation assistance. We incorporated smoking cessation resources in our lung cancer screening FAQs, which was given to patients at the time of order placement. Although many barriers to ideal provision of smoking cessation assistance exist,16,17 it is unequivocally recommended to accompany lung cancer screening.4
Adapting to New Guidelines and CMS Requirements
Professional society guidelines.
In late 2014, the American College of Chest Physicians and the American Thoracic Society jointly published a statement that outlined the key components of a high-quality lung cancer screening program (Table 2).4 Guidelines are also available for lung cancer screening from the ACR, Society of Thoracic Radiology,8 and the American Association of Thoracic Surgeons.7 Our program had already been built with these best practices in mind and required no modifications to meet the guidelines.
Recommended Components of High-Quality Lung Cancer Screening Program4
CMS Decision Memo.
The CMS Decision Memo was released in November 201418 and incorporated many of the elements of a high-quality screening program previously recommended (Table 3). In addition, a credentialed provider must conduct a shared decision-making visit with the patient when ordering the initial screening examination, document eligibility and discussion of risks and benefits of screening, and offer smoking cessation if applicable. The screening order itself should also include eligibility criteria.
CMS Lung Cancer Screening Eligibility Criteria19
To render an interpretation that will be reimbursed by CMS, radiologists must be board certified, experienced in chest CT, and participate in continuing medical education. Imaging centers eligible for reimbursement of lung cancer screening must have experience with low-dose CT lung cancer screening and be accredited as an advanced diagnostic imaging center. In addition, effective radiation dose of reimbursable examinations must be less than 1.5 mSv, and data must be collected and submitted to a CMS-approved registry for each screening examination. Although an extensive list of data elements was initially proposed, the final Decision Memo included 10 data elements pertaining to the ordering provider, interpreting radiologist, patient smoking history, and CT scanner.
Adapting EHR tools.
To facilitate compliance with CMS requirements, we modified the EHR tools. In addition to making modifications to the lung cancer screening imaging order, we created a SmartSet, which is a bundle of orders and documentation related to a topic. The SmartSet guides clinicians on patient eligibility, required billing codes, suggested wording for the shared decision-making visit, orders for smoking cessation tools, and the imaging order. When signed, the SmartSet outputs patient instructions with screening FAQs and scheduling information. A BPA was created to direct the ordering provider from the stand-alone order to the SmartSet, as many providers had become accustomed to using the order laone.
Lung cancer screening is a relatively new preventive health care service (secondary prevention). As such, developing and implementing new processes can be guided by national leaders but must also be customized to meet the needs of local and regional health care systems. We began implementing a screening program before current regulatory requirements were released.
Approximately one-third of the orders were for patients whose eligibility for screening could not be confirmed. Eligibility was unconfirmed due to insufficient documentation of smoking history, documented smoking intensity less than 30 pack-years, or quit more than 15 years prior to examination. Our health system has had some success but continues to optimize EHR tools to facilitate compliance with recommended eligibility. Most patients did report smoking history on prescreening questionnaires that was adequate for lung cancer screening eligibility. We believe that infrequent and inaccurate recording of smoking history by clinicians to be responsible. Furthermore, the EHR tool for recording smoking history is inadequate to fully capture the variability in smoking intensity over time that describes many smokers’ habits. A tool that more specifically captures light smoking, heavy smoking, and quit periods can help record an accurate account of smoke exposure. In addition to improving EHR tools and utilization, confirmation of eligibility prior to screening using low-dose CT will likely be needed to reach perfect compliance with eligibility requirements.
Early orders had a low completion rate, which we believe to be due to the absence of insurance coverage and the self-pay cost of the examination ($150). After the CMS final Decision Memo, examination orders quadrupled, supporting our notion that uncertainty about reimbursement drove initial low uptake. Feedback from providers suggests that anxiety prevents patients from scheduling examinations despite having the information to do so. Furthermore, in most clinics, patients are asked to schedule examinations themselves rather than having examinations scheduled for them. Completion rates continue to improve, despite having a patient-initiated scheduling system.
Our findings suggest that reimbursement-driven enforcement of patient eligibility as required by Medicare is necessary to apply screening to the high-risk groups who are most likely to benefit. We also concur with the need for continued monitoring of screening outcomes through national registries to further refine screening eligibility and utility.
This article demonstrates our experience implementing a lung cancer screening program outside of a federally supported clinical trial. Future trends will be greatly shaped by outcomes reported from national registries and by experience with pervasive screening in a climate of reimbursement for eligible patients. As diagnostic radiology technology improves and adjunctive methods of early detection of lung cancer become available, the risk–benefit ratio for screening for lung cancer will continue to evolve and, ideally, improve.