Implementing an LCS Program

All major medical organizations, including the United States Preventive Services Task Force (USPSTF) and the Centers for Medicare & Medicaid Services (CMS), recommend annual LCS for individuals at high-risk of developing lung cancer, with only one exception.1-9 There is near uniform consensus among these organizations that LCS is appropriate for the population studied in the National Lung Screening Trial (NLST), which enrolled healthy adults who were current and former (quit < 15 years) cigarette smokers aged 55-74 with at least a 30 pack-year smoking history. Many of these organizations including the USPSTF, CMS, American Association for Thoracic Surgery (AATS), and the American College of Chest Physicians (ACCP) now recommend expanding LCS coverage beyond the NLST criteria to capture others at high-risk of developing lung cancer (Organizational LCS Eligibility Recommendations).

Organizational LCS Eligibility Recommendations

 
Year
Age
Pack-Years
Quit
Other
AAFP1
2013
Ins. Ev.
Ins. Ev.
Ins. Ev.
None
AATS Tier 12
2012
55 - 79
≥ 30
No Limit
None
AATS Tier 22
2012
50-79
Over 20
No Limit
Cumulative 5% chance of developing lung cancer in next 5 years
AATS Tier 32
2012
Any
Any or None
No Limit
Personal History of Lung Cancer and 4 years NED
ACS3
2013
Over 50
≥ 30
≤ 15
“Relatively good health”
ACCP4
2017
55 - 77
≥ 30
≤ 15
None
ALA5
2017
55 - 80
≥ 30
≤ 15*
None
ASCO/ATS6
2015
55-74
≥ 30
≤ 15
None
CMS9
2015
55 - 77
≥ 30
≤ 15
None
NCCN Group 17
2017
55 - 74
≥ 30
≤ 15
None
NCCN Group 27
2017
Over 50
Over 20
No Limit
At least one additional lung cancer risk factor or at least 1.3% chance of lung cancer diagnosis within 6 years
USPSTF8
2014
55 - 80
≥ 30
≤ 15
None

AAFP = American Association of Family Physicians, AATS = American Association of Thoracic Surgery, ACS = American Cancer Society, ACCP = American College of Chest Physicians, ASCO = American Society of Clinical Oncology, ATS = American Thoracic Society, ALA = American Lung Association, CCO = Cancer Care Ontario, NCCN = National Comprehensive Cancer Network, USPSTF = United States Preventive Services Task Force, CMS = Center for Medicare and Medicaid Services

Year = year recommendation was published, Ins. Ev. = insufficient evidence to recommend for or against screening
Other = additional considerations for groups to screen beyond the core recommendation:
ALA – urges consideration of risk prediction, suggests standard criteria given insurance coverage,
* = not forced to exit screening after reaching 15 year quit mark

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Organizational LCS Eligibility Recommendations

Recommendations of ATS/ACCP policy statements on implementation of LCS

In addition to these clinical practice guidelines, the ACCP and American Thoracic Society (ATS) have issued policy statements to ensure that benefits of LCS outweigh harms as LCS advances from the clinical trial setting to implementation in real-world practice. Multiple other LCS implementation guidelines are available.7,10–12

Core LCS domain13
Policy recommendations & metrics for high-quality LCS programs13
Implementation strategies6
Who is screened, how often, and for how long?
Policy recommendation:
  1. LCS programs should collect data on all enrolled subjects related to the risk of developing lung cancer.
Associated quality metrics
  • The LCS program must confirm that there is a policy about who will be offered screening. While this is up to each individual program, insurance agencies will often mandate that they are in keeping with USPSTF recommendation.
  • At least 90% of all screened subjects must match the programss stated policy, excluding those enrolled in clinical trials.gov registered screening research protocols.
  • The LCS program must confirm that there is a policy about the frequency and duration of screening that is in keeping with the recommendations.
  • Education of referring clinicians on eligibility criteria
  • EMR-based clinical reminders
  • Human review (e.g., LCS coordinator)
  • Targeted feedback to PCPs who repeatedly refer patients for LCS who do not meet eligibility criteria
How the CT is performed
Policy recommendations
  1. A low dose LCS CT should be performed based on the ACR-STR technical specifications.
  2. LCS programs should collect data to ensure the mean radiation dose is in compliance with ACR-STR recommendations
Associated quality metric:
  • The LCS program must confirm that there is a policy about the technical specifications for performing low dose CT screening that is in keeping with the ACR-STR technical specifications and credentialing criteria
  • Protocols for CT technician
  • Training of CT technicians
Structured reporting
Policy recommendations
  1. LCS programs should use a structured reporting system, such as Lung-RADS™.
  2. LCS programs should collect data about compliance with the use of the structured reporting system.
Associated quality metrics
  • The LCS program is using Lung-RADS™ as their structured reporting system, or uses a structured reporting system with similar elements (communication tool, identification of positive findings, lung nodule management recommendations).
  • The selected structured reporting system is being used for at least 90% of the CT screen reports.
  • Use of templated structured reporting system (e.g., Lung- RADS™)
  • Training of radiologists in use of reporting system
Lung nodule management algorithms
Policy recommendations: LCS programs must:
  1. Include clinicians with expertise in the management of lung nodules and the treatment of lung cancer,
  2. Have developed lung nodule care pathways,
  3. Have the ability to characterize concerning nodules through PET imaging, non-surgical and minimally invasive surgical approaches,
  4. Have an approach to communication with the ordering provider and/or patient,
  5. Have a means to track nodule management, and
  6. Collect data related to the use of, and outcomes from, surveillance and diagnostic imaging, surgical and non-surgical biopsies for the management of screen detected lung nodules.
Associated quality metrics:
  • The LCS program has designated clinicians with expertise in lung nodule management, the performance of non-surgical biopsies and minimally invasive surgical biopsies, and lung cancer treatment. The following specialties should be represented: radiology (diagnostic, interventional), pulmonary medicine, thoracic surgery, medical oncology, radiation oncology.
  • The LCS program has designated an acceptable lung nodule management strategy, such as the use of available published evidence-based algorithms and/or care pathways.
  • The LCS program can describe the lung nodule communication and nodule management tracking system being used by their program.
  • The LCS program must be capable of reporting on:
    • the number of surveillance and diagnostic imaging tests,
    • non-surgical and surgical biopsies that are performed for malignant and benign screen-detected nodules,
    • the number of cancer diagnoses, and
    • the number of procedure-related adverse events (e.g. hospitalization, death)
  • Formation and regular meetings of multidisciplinary LCS steering committee with clear leadership structure
  • Multidisciplinary lung cancer tumor board to advise on evaluation of nodules at high risk of malignancy
  • Adoption of nodule evaluation algorithm
  • Clear allocation of responsibility for nodule evaluation between primary care and specialists, via EMR or direct communication
  • LCS coordinator to oversee and coordinate nodule evaluation between primary care and specialists
  • Registry of LCS patients, used to track nodule evaluation and other quality metrics
Smoking Cessation
Policy recommendations
  1. LCS programs must be integrated with a smoking cessation program.
  2. LCS programs should collect data related to the smoking cessation interventions that are offered to active smokers enrolled in screening.
Associated quality metrics
  • The LCS program has integrated smoking cessation services.
  • The LCS program will report on the portion of active smokers who are offered, and who participate in, a smoking cessation intervention.
  • Written materials with links to smoking cessation resources
  • Evidence-based interventions: nicotine replacement, pharmacotherapy, counseling
  • Interventions at multiple time points (before, after LCS)"
Patient and provider education
Policy recommendations
  1. LCS programs should educate providers so that they can adequately discuss the benefits and harms of screening with their patients.
  2. LCS programs should develop or use available standardized education materials to assist with the education of providers and patients.
  3. LCS programs are responsible for the oversight and supplementation of provider-based patient education.
Associated quality metrics
  • The LCS program will list the educational strategies used to educate ordering providers about the key components of LCS.
  • The LCS program demonstrates the availability of standardized patient and provider educational material.
Provider education:
  • Grand round presentations
  • Audit and feedback to individual providers
Patient education / shared decision-making:
  • Designate who will conduct shared decision-making (e.g. referring clinician, LCS coordinator)
  • Patient decision aids (generic or personalized) available at point-of-care, or mailed to patients in advance"
Data Collection
Policy recommendations
  • LCS programs must collect data on all enrolled patients related to the quality of the program, including those enrolled in registered clinical research trials. Data collection should include elements related to each of the other 8 components of a LCS program (as above). In addition, data collection should include the outcomes of testing (complications, cancer diagnoses), and a description of the cancers diagnosed (histology, stage, treatment, survival).
  • A review of the data and subsequent quality improvement plan should be performed at least annually.
  • An annual summary of the data collected should be reported to an oversight body with the authority to credential screening programs. Standards set forth in the above policy statements should be used by the oversight body to judge areas of compliance and deficiency.
Associated quality metrics
  • The LCS program must collect data related to each component of a LCS program, the outcomes of testing, as well as the cancers diagnosed, and report this data annually to an oversight body.
  • The LCS program should respond to concerns from the oversight body in order to maintain accreditation.
  • LCS registry to facilitate data collection
  • LCS coordinator tasked with maintaining registry
  • Regular feedback of quality metrics data to LCS steering committee
  • Regular feedback of quality metrics data to referring providers
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Recommendations of ATS/ACCP policy statements on implementation of LCS