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Lung Cancer Screening Care Path Guide

Introduction

Clinical Judgment

The care path guide is intended to be broadly applicable, but it is not meant to substitute for clinical judgment. Clinicians and specialists should tailor processes and approaches to align with patient needs, abilities and care goals.

Lung Cancer: A Problem with a Solution

Lung cancer has been the leading cause of cancer-related mortality in the U.S. for more than 20 years.1,2 In 2018, more than 234,000 Americans received a new diagnosis of lung cancer, and more than 154,000 died from the disease.3 These figures have the potential to be greatly impacted by routine screening of eligible populations.

The estimated five-year survival rate for early stage lung cancer is well over 60%, but five-year survival drops to less than 5% if the cancer has metastasized.4 This discrepancy points to the urgent need to identify and treat lung cancers early. The National Lung Screening Trial (NLST) demonstrated a 20% relative reduction in mortality from lung cancer with three years of annual low-dose computed tomography (LDCT) screenings compared with chest radiographs.5 The more recently reported NELSON trial demonstrated a 26% reduction in mortality from lung cancer over six years of screening surveillance using LDCT in men, with even better results reported in women.6 Because screening leads to early stage detection and treatment, it is effective at reducing lung cancer mortality.

In Tennessee, where about 22% of adults smoke,7 lung cancer is a heavy burden. Each year, more than 4,400 Tennesseans die of lung and bronchial cancer,8 making these the leading causes of cancer deaths. In some areas, rates of lung cancer deaths are double the national average. This disease also poses an economic burden. Each year, tobacco use costs Tennessee an estimated $2.67 billion in direct healthcare costs alone—much of that due to lung cancer care.8

The Case for a Care Path Guide

Vanderbilt Health Affiliated Network care path guides are intended to reduce unnecessary variability in care. As such, they are tools for education, reporting, measurement and continuous improvement. Care paths are designed to standardize care to reduce variability and ensure a consistent level of quality for patients across time, venue and provider, combining workflow-friendly, evidence-based practice principles.

This care path guide offers a framework for an evidence-based strategy for reducing the number of lung cancer deaths through routine screening of high-risk patients who have the potential to benefit from treatment. The care path guide describes the screening process from identifying potential candidates through the management of findings.

Best Practice Advisory Tools

Vanderbilt Health Affiliated Network uses best practice advisories (BPAs) as decision-support guides through the EPIC EMR. When patients appear to meet eligibility criteria for lung cancer screening, a BPA will alert the clinician to discuss lung cancer screening for the patient and further determine whether patients are truly eligible for the screening. Providers are encouraged to use BPAs to ensure they discuss screening with all potentially eligible patients. Robust, standardized practices for collecting and recording data surrounding tobacco use and history can boost BPAs’ effectiveness at flagging patients who may be eligible for screening.

About This Care Path Guide

The Lung Cancer Screening Care Path was developed by an interdisciplinary team within Vanderbilt Health Affiliated Network to guide navigators, clinicians and specialists in an evidence-based approach to lung cancer screening. This resource is based on national and international research and the expert opinions of members of our network.

The objective of care paths is to provide a workflow-friendly summary of evidence-based guidelines in an effort to reduce unnecessary variability in the overall management of disease conditions by standardizing assessment, treatment and referral behavior. In so doing, overall quality is maintained or improved and costs invariably decrease.

This care path guide focuses on identifying patients who are eligible for lung cancer screenings, providing shared decision-making support for screening candidates, performing and reporting on screenings, and ensuring follow-up care. Lung cancer treatment is beyond the scope of this guide.

Screening Criteria

Eligibility

Determining eligibility for lung cancer screening represents a balance between the benefits and potential harms of screening. The NLST research team found that annual LDCT screening of patients who met all three of the following criteria led to a 20% reduction in mortality over three years of screening, compared with chest X-ray screenings:5

  • Ages 55 to 74
  • Smoking history of 30 pack-years or more
  • Current smokers, or former smokers who had quit within the past 15 years

The U.S. Preventive Services Task Force recommends yearly screenings for people ages 55 to 80 who have a smoking history of 30 pack-years or more and are either current smokers or have quit within 15 years.9 The Centers for Medicare & Medicaid Services (CMS) guidelines call for offering annual lung cancer screening to patients who meet all of the following criteria:

  • Are ages 55 to 77
  • Are current smokers OR have smoked in the past 15 years
  • Have a history of 30 pack-years of smoking
  • Do not have signs or symptoms of lung cancer
  • Have a written order from a physician

Recommended Lung Cancer Screening Centers

Vanderbilt Health Affiliated Network recommends that clinicians refer patients to a reputable lung cancer screening program.

American College of Radiology (ACR)-accredited screening programs follow the CMS guidelines outlined above. The state of Tennessee has 29 such programs. A searchable database can be found at acraccreditation.org.

The GO2 Foundation designates Lung Cancer Screening Centers of Excellence based on criteria set by the ACR, National Comprehensive Cancer Network and International Early Lung Cancer Action Program (I-ELCAP).10 A list of the eight Screening Centers of Excellence in Tennessee can be found at go2foundation.org.

Women and Underrepresented Minorities

Providers should make efforts to ensure women and minorities who may be eligible for screening do not slip through the cracks.

Several physicians surveyed in the American Thoracic Society and American Lung Association Lung Cancer Screening Implementation Guide found that minority populations often lacked access to screening, were not aware of screening recommendations or were deterred by a lack of cultural connection with providers.11

Women, who have been shown to benefit more than men from screening CT,6 may be more concerned about breast cancer and overlook their lung cancer risk. Only 6.3% of eligible women reported having had LDCT lung cancer screenings,12 compared with more than 65% of women who report having had mammograms.13

Outreach to Women

Lung screening, overall, has shown greater effectiveness in women. In an effort to reach more women and minorities who qualify for lung cancer screening, Vanderbilt Health Affiliated Network actively recruits these populations for research.

 

Ineligible Patients Who Wish to Be Screened

Patients who do not meet the lung cancer screening criteria may wish to be screened because they are current or former smokers who fall outside the recommended screening range or believe they may be at high risk for lung cancer from other sources, such as radon exposure in the home or workplace hazards. When a clinician thinks a patient would benefit from lung cancer screening, even if the patient does not meet eligibility criteria, the clinician may refer the patient to a screening center and advise him or her to find out if the screening is covered by health insurance. The majority of programs offer self-pay options for uninsured patients or those whose health insurance provider does not cover a clinician-referred screening. Patients may also seek clinical trials that would cover the cost of the scan.

Patients who show signs or symptoms of lung cancer should be referred for diagnostic testing instead of an LDCT screening. These patients may return to yearly lung cancer screenings when symptoms resolve without evidence of lung cancer, when they have not had a diagnostic CT for a year or more, or when any diagnosis of lung cancer is at least five years in the past and they are not undergoing imaging surveillance for other types of cancer.11

Screening Referral

    Instructions for Referral to a Lung Screening Program

    If patients meet the eligibility criteria outlined above, they may be referred for a lung screening. At Vanderbilt Health Affiliated Network, criteria are built into the EMR standard order for screening so the referring clinician can confirm the patient is eligible before ordering the screening consultation.11 A clinician at the lung screening location will conduct a shared decision-making conversation with each patient and make the final determination about whether to conduct the screening.

    Screening Program Components

      Because LDCT screening for lung cancer is still being implemented in many locations, identifying a quality program for referral may be challenging. A good program should include the radiology personnel, facilities and equipment that meet the standards below. It should include a tobacco-cessation component. It should also offer shared decision-making or provide materials to referrers so those clinicians can confidently perform shared decision-making conversations in-house.

      The following criteria should also aid facilities wishing to establish a screening program.

      Radiology
      Facilities and Equipment

      Technical specifications for screening facilities and LDCT equipment are provided by the American College of Radiology (ACR) and the Society of Thoracic Radiology.The CT scanner should meet the ACR-SCBT-MR-SPR Practice Parameter for the Performance of Thoracic Computed Tomography. The scanner should also, at minimum, meet these guidelines:14

      • Gantry rotation of 0.75 seconds or less
      • Slice thickness of a preferred 1.0 mm, or at most 2.5 mm
      • 16 or more detector rows

      Facilities and practices should be designed to follow ACR best practices to keep radiation exposure as low as reasonably achievable. Best practices include the use of automated or manual dose reduction technologies to maximize image quality while minimizing radiation dose. A qualified medical physicist should monitor the facility and radiation exposure in accordance with ACR technical standards.14

      Credentialing
      All clinical personnel who perform lung cancer screenings should be trained in a standardized reporting system, for example, Lung-RADS or ELCAP. Radiologists should be board certified and receive training in completing lung cancer screenings according to standard practice.11 Training in LDCT screening may be obtained via the ACR. For instance, this CME from ACR is designed for practitioners wishing to begin LDCT screening for lung cancer. For more about  LUNG-RADS, the Lung Cancer Screening Registry, obtaining accreditation as a designated Lung Cancer Screening Center and more consult this library of resources.

      Insurance and Reporting Requirements
      The Lung-RADS structured reporting system is most commonly used to communicate screening findings to patients and referring clinicians. Finding classifications are as follows:15

      • Score: 0. Finding: Incomplete; further screening or comparison to prior CT needed.
      • Score: 1. Finding: No nodules and definitely benign nodules.
        • Continue with annual screenings.
      • Score: 2. Finding: Benign appearance or behavior.
        • Continue with annual screenings.
      • Score: 3. Finding: Probably benign; includes nodules with a low likelihood of becoming active cancer.
        • Follow-up screening in six months.
      • Score: 4A. Finding: Suspicious; additional diagnostic testing recommended.
        • Follow-up screening in three months; PET-CT for solid nodules equal to/larger than 8 mm.
      • Score: 4B. Finding: Very suspicious; additional testing and/or sampling recommended.
        • Chest CT, PET/CT and/or biopsy.
      • Score: “S” modifier. Finding: Non-lung-cancer significant or potentially significant findings.

      For screenings to be reimbursed by Medicare or Medicaid, screening data must be collected and reported using a standard reporting system.

      Outreach and Education of Referring Clinicians

      Vanderbilt participated in the NLST, and the Vanderbilt Lung Screening Program has enrolled more than 2,000 patients and performed over 3,000 screening examinations.16 These early numbers represent only a small fraction of potential screening patients in our area—middle Tennessee’s smoking and lung cancer incidence rates are among the highest in the nation.17 The Lung Screening Program provides outreach and education to both encourage referrals and enable other institutions to create lung screening programs of their own.

      Our outreach strategy includes:

      Our website at vumc.org/radiology/lung

      Clinician brochures at vumc.org/radiology/lung under “Additional Resources”

      My Southern Health articles

      Banners in clinics

      Before Screening

        Patients may be identified as potential screening candidates through flags in the EMR based on criteria match, conversations with clinicians or self-referral. Because not all smoking behavior is captured in the EMR, primary care providers are encouraged to discuss smoking history with patients and initiate conversations about lung screening as appropriate.

        Shared Decision-Making

        Participants in lung cancer screenings covered by Medicare, Medicaid or private insurance are required to undergo shared decision-making conversations before being enrolled in the screening program. The purpose of these conversations is to:

        • Confirm that the patient is eligible for a lung cancer screening. While a clinician will have referred the patient based on eligibility criteria, this will be reconfirmed at the time of the screening. Patients who are found to be ineligible may decide to proceed with a self-pay screening.
        • Provide information about the purpose of screening, what will happen and the range of possible results.
        • Provide information about the benefits and harms of screening. Research has shown that annual screening may provide a lung cancer mortality benefit of at least 20% with reduction in overall mortality of close to 7%.5 Potential harms include a small radiation exposure (less than annual background radiation), the potential for false positives and the possibility for overdiagnosis of benign disease.
        • Determine whether the patient is willing to undergo additional testing and treatment if he or she has a suspicious finding.
        • Obtain informed consent for screening.
        • Provide tobacco cessation counseling.
        • Offer opportunity for patients to ask questions and collaborate with medical providers in the decision-making process.

        Shared decision-making conversations must be documented for CMS reimbursement code G0296: counseling visit to discuss need for lung cancer screening using LDCT scan (service is for eligibility determination and shared decision-making). Scans must be documented using G0297: LDCT scan for lung cancer screening.

        Low-Dose CT Lung Screening: Costs for Patients

        Medicare, Medicaid and all Affordable Care Act-compliant private insurance plans cover LDCT lung screenings for patients who meet the CMS criteria (see Page 4).

        Patients who are uninsured or do not meet those criteria but would still like to be screened will have to pay for the screening out of pocket. The majority of LDCT lung screening programs offer self-pay options for these patients. Costs vary facility to facility. At Vanderbilt University Medical Center, for example, a self-pay screening costs $145.

        Decentralized Programs

        In decentralized programs, shared decision-making conversations are conducted by the referring physician or a staff member in the referring physician’s office. Advantages include ease of access for patients, familiarity between the patient and his or her medical team, and the clinician’s ability to integrate this conversation into larger discussions about topics such as smoking cessation or environmental health concerns.

        On the other hand, primary care clinicians may feel they lack the time and training to conduct these conversations. Also, some patients may decide to schedule a screening but fail to follow through. Decentralized programs will need to provide local clinicians with decision aids and informational materials to help them introduce lung cancer screening to patients and conduct conversations in a complete, standardized manner. The patient’s historical data for registry compliance must then be collected again by the imaging facility for reporting.

        Centralized Programs

        In centralized programs, lung screening personnel routinely conduct shared decision-making conversations, so they become familiar with presenting the information to patients. Screening personnel at centralized programs can also answer patients’ questions about the specifics of the screening and possible outcomes. Additionally, screenings are generally conducted immediately following the shared decision-making visit and procurement of informed consent, eliminating the possibility of patients missing scheduled screenings.

        However, centralized programs require patients to travel simply to have a conversation that may not result in a screening. This could possibly deter some patients from scheduling.

        Decision Aids

        Tools for shared decision-making include informational pamphlets and brochures, videos, and step-by-step conversation guides. Decision aids should be provided in the patient’s native language and should include, at minimum:

        Smoking Cessation Tools

        The shared decision-making appointment is just one opportunity for clinicians to discuss smoking cessation. Tobacco cessation resources for clinicians are available through the Agency for Healthcare Research and Quality. Smoking cessation has been shown to be more effective when coupled with annual lung screening.

        Clinicians who wish to be accredited as Tobacco Treatment Specialists can do so through the Council for Tobacco Treatment Training Programs.

        Opportunities for Research

        Patients who wish to obtain a LDCT screening may be able to participate in a research opportunity. Some research hospitals offer access to trials open to community members, such as the Nashville Lung Cancer Screening Trial.

        After Screening

          A board-certified radiologist should read and interpret all LDCT scans and assign a classification score to each. Depending on the score, the patient may be scheduled for additional testing or returned to annual screening.

          Lung-RADS scores of 1 or 2 (negative or benign) result in an appointment for a regular 12-month screening. Lung-RADS scores of 3 (probably benign) result in a follow-up CT scheduled for six months. Lung-RADS scores of 4 result in immediate navigation of additional imaging or consultation with specialists.

          Communicating Findings

          As a best practice, findings should be communicated to patients within 48 business hours. If a patient has negative, benign or probably benign findings, he or she should receive a phone call and a letter to relay results within one week, and the referrer should be notified by EMR or fax.

          If the findings are suspicious, the referring provider should be contacted directly. Depending on the ordering clinician’s preference, either the lung screening program or the referring provider should notify the patient within 48 business hours of his or her results.

          Incidental findings should be reported to the patient within 48 hours, and the referring physician should be contacted by EMR or phone.

          Patient Education and Resources

            Marketing and Outreach Resources

            Vanderbilt Health informational video: Lung Cancer Screening Saves Lives

            American Lung Association Lung Cancer Risk Quiz

            Shared Decision-Making

            University of Louisville LuCa (Lung Cancer) National Training Network

            Tobacco Cessation

            Tools and resources can be found at the Agency for Healthcare Research and Quality.

            Tobacco Treatment Specialist accreditation criteria and resources can be found at the Council for Tobacco Treatment Training Programs.