NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo

Comment:Two commenters who favored removal of the counseling and shared decision-making visit requested that if CMS chose to retain the requirement, CMS should consider allowing the shared decision-making visit to occur in conjunction with the actual lung cancer screening exam ratherthan requiring a separate visit.Response:The NCD states that the counseling and shared decision-making visit must occur before the beneficiarys first lung cancer screening. The NCD does not prevent the SDM visit from occurring on the same day as the lung cancer screening exam or from occurring in conjunction with the actual lung cancer screening exam. As long as the counseling and shared decision-making visit occurs before the beneficiarys first lung cancer screening exam then it satisfies the NCD. As a reminder, this required counseling and shared-decision making visit is only required prior to the first LDCT screening.Comment:One commenter believes that patients current low level of screening may be caused by former smokers, who know they are at higher risk, being fearful of diagnosis, especially if they have loved ones who died of lung cancer. For this reason, they urge CMS to ensure that patients receive accurate, balanced, unbiased information on the benefits and risks of lung cancer screening.Response:We appreciate the comment. In addition to the importance of SDM addressing the benefits and harms of lung cancer screening, the counseling and SDM visit includes counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment; and counseling on the importance of maintaining cigarette smoking abstinence if former smoker; or the importance of smoking cessation if current smoker and, if appropriate, furnishing of information about tobacco cessation interventions. One underlying purpose of the counseling and shared decision-making visit is for the patient to have a complete and fully comprehensive discussion with the health care provider that thoroughly addresses all of the concerns of the patient.Furnished by Physician or Non-physician Practitioner (NPP)Comment:Commenters supported the removal of the requirement that the counseling and shared decision-making visit must be furnished by a physician or non-physician practitioner (NPP) while one commenter wanted to ensure that shared decision-making conversations still include a patients healthcare provider. This expansion allows other types of providers eligibility to furnish this service. Commenters acknowledged this expansion will ease the burden on physicians and NPPs and expand the number of providers who can deliver the counseling and shared decision-making visit. One commenter urged CMS to maintain that the shared decision-making visit should include a patients healthcare provider. While they acknowledge that health educators and others who are specifically trained to discuss the risks and benefits of LDCT and can spend more time with patients than physicians, they should not do so without the inclusion of healthcare professionals. They suggest that improving training for the shared decision-making conversations with the physicians and NPPs could be a possible solution rather than eliminating the requirement altogether.Response:We appreciate the support and understand the concern to include the beneficiarys healthcare provider. While we support the need for shared decision-making, we acknowledge that lung cancer screening with LDCT is no longer considered a new service. Professional societies and provider groups have noted that providers have gained considerable experience and expertise. We believe flexibility will reduce burden and therefore are removing the requirement that the counseling and shared decision-making visit must be furnished by a physician or NPP. This expansion can allow for this service to be furnished by auxiliary personnel incident to a physicians professional service. Therefore, there still exists a relationship between the physician or NPP and the auxiliary personnel furnishing the SDM visit as there are existing rules that apply. We believe this flexibility will enable a more streamlined process and broaden access to LDCT screening. We also support continued training for shared decision-making for all healthcare providers and encourage providers to consult with professional societies and provider groups for training opportunities.Decision AidsComment:Commenters generally supported the requirement that shared decision-making include one or more decision aids but cited the need for more specificity; while one commenter favored the requirement be removed. One commenter requested that the requirement specifically state that decision aids should provide patient education on the pros and cons of screening and another commenter suggested the decision aid include a checklist to be initiated by the patient to acknowledge the conversation took place. One commenter stated that inaccurate decision aids should be discarded and replaced with materials that provide timely and accurate information on benefits and risks of lung cancer screening. Another commenter reported that decision aids increase efficiency and ensure the key information is communicated. They informed us that the ACS-National Lung Cancer Roundtable is collaborating with the American Academy of Family Physicians to develop second-generation decision aids. The commenter who favored the removal of the requirement to use decision aids stated that since there is no designated, standard decision aid it creates more complexity and administrative burden for providers.Response:To reduce the burden of documentation paperwork for providers, we are removing the specifications for the components of the shared decision-making tools. As noted in the Analysis, several professional organizations and societies suggest the use of decision aids but do not specify the elements required as part of the shared decision-making tool. While we believe the tools and guidance have matured since the early inception of shared decision-making, we are continuing not to require the use of a specific decision aid. Eligible practitioners may select from various available decision aids designed for this purpose and recognized by national professional medical organizations. We appreciate and are encouraged by the information regarding the progress and development of decision aids.Counseling on the Importance of Adherence to Annual Lung Cancer LDCT ScreeningComment:A commenter requested we improve this requirement by making a slight modification to the wording. The request was to change, Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment to Counseling on the importance of adherence to annual lung cancer LDCT screening, impact of comorbidities and ability and willingness to undergo diagnosis and treatment. The commenter pointed out that it is both illogical and wasteful to perform a screening test if it is known beforehand that the beneficiary is unwilling.Response:We appreciate the commenter pointing out this wording. We note that the language of the NCD is consistent with the or used in the USPSTF Recommendation. We are not aware that this language is a cause of confusion for ordering practitioners or providers, therefore, to remain consistent with the wording of the USPSTF recommendation, we will retain the sentence as written.Reading Radiologist Eligibility CriteriaDocumented TrainingComment:Commenters supported the removal of the training documentation requirement. They believe training is basic and also included in Maintenance of Certification (MOC) for reading radiologists.Response:We appreciate the supportive comments. We believe removing this redundant requirement will reduce documentation burden on the provider.300 Chest CTs within the Past 3 YearsComment:Several commenters did not support the removal of the requirement for reading radiologists to document involvement in the supervision and interpretation of at least 300 chest computed tomography acquisitions in the past 3 years. They believe it is not a prohibitive requirement and it shows that the reading radiologist has some prior experience in screening images, ideally accompanied by mentoring. Two commenters mentioned that there are no provisions to require the American College of Radiology to mandate any certification or training for radiologists to read LDCT scans which would ensure a high-quality LDCT report.Response:LDCT screening, as we have stated elsewhere in this document, is a more mature service than when CMS first issued an NCD and it is no longer necessary for CMS to dictate experience as part of the NCD. We believe high quality reporting will continue as training, including formal training, is more readily available to radiologists. Imaging centers or professional societies may choose to adopt an experiential requirement but eliminating this issue from the NCD also reduces documentation requirements as part of coverage.CME RequirementComment:A commenter requested clarification as to why the documentation requirement for participation in continuing medical education (CME) in accordance with current ACR standards was retained within the Reading Radiologist Eligibility Criteria.  They state that the NCD does not specify any requirement for CME specific to lung cancer screening within the 75 CME credits required for Maintenance of Certification (MOC) and it is the same required documentation needed to submit to the ACR and ABR.Response:We appreciate the commenter identifying this discordance. We have more carefully reviewed the language in this requirement and have concluded that the requirement is not meaningfully contributing to the policy because it is unclear and nonspecific. Further, board certification currently requires continuing education leaving it unnecessary to maintain this separate requirement. We are removing this requirement in our final decision.Radiology Imaging Facility CriteriaRadiation DoseComment:Several commenters did not support the removal of the radiation dose criteria. They believe that eliminating this requirement could potentially cause confusion and no longer provide a distinction between low dose and regular dose screening protocols.Response:An important aspect of LDCT screening is reducing radiation exposure to as low as reasonably achievable especially given the annual screening frequency and likely follow-up diagnostic imaging tests.When the 2015 NCD was finalized, the acquisition parameters for low-dose CT were not explicitly defined in the imaging community, so the radiation dose requirement as part of the NCD was essential. Multi-society, multi-disciplinary organizations with extensive expertise in LDCT scans, such as the American College of Radiology, have published guidelines on the radiation dose that should be emitted by the low dose CT scan. The guidelines also appear to support the effort to standardize the protocol for administering the low dose CT scan. Given that there are readily available evidence-based guidelines and LDCT screening is now a mature technology, we are removing the radiation dose requirement from the NCD. This also allows guidelines to adapt, as needed. Requirements in an NCD remain static and could become outdated. Thus, we are not adopting the commenters suggestion and will remove this requirement from the NCD as proposed.Lung Nodule Reporting SystemComment:Some commenters did not support the removal of the requirement for utilization of a standardized lung nodule identification, classification and reporting system. They noted that Lung-RADS is an example of a system that is deemed appropriate by the lung cancer screening community and generally the one most used. The commenters believe that removing the standardized reporting system could impact the quality of lung cancer screens and affect patient management and care by increasing ambiguity in follow up and clinical management recommendations made to ordering providers. They stated that Lung-RADS provides clear and consistent communication between the radiologist and the ordering providers by helping ordering providers decide on appropriate follow-up for suspicious results. Another commenter was concerned that this will provide opportunity for home-grown reporting systems and entrepreneurial efforts by competing groups, and undermine the efforts of everyone using a common  system.Response:After considering the public comments, we did not finalize our proposal to remove the requirement for utilization of a standardized lung nodule identification, classification and reporting system as part of the radiology imaging facility eligibility criteria. We believe that utilizing a standardized lung nodule identification, classification and reporting system is likely to standardize low dose CT screening and the evaluation and management of abnormal lung nodule findings and to provide clear and consistent communication between the reading radiologist and the ordering providers. Additionally, the USPSTF notes in their low dose CT lung cancer screening recommendation that data suggest that the use of Lung-RADS may decrease the rate of false-positive results in lung cancer screening (USPSTF, Krist; 2021). Therefore, after further review, utilization of a standardized lung nodule identification, classification and reporting system, such as Lung-RADS, will remain a requirement for a radiology imaging facility.Smoking Cessation InterventionsComment:Some commenters did not support removing the requirement for smoking cessation interventions for current smokers from the radiology imaging facility criteria. They state that it is appropriate and essential to receive smoking cessation interventions at every touchpoint in the lung cancer screening process. They believe that CMS is being contradictory by stating that smoking cessation interventions are vitally important at every touchpoint between the provider and patient along the clinical pathway for lung cancer screening, yet we are removing the requirement from the radiology imaging facility criteria. Other commenters did not agree with CMS stating that it is not appropriate for Medicare beneficiaries who are current smokers to receive smoking cessation interventions within the radiology imaging facility setting and therefore removing it as a requirement. A few commenters provided specific examples of smoking cessation interventions that CMS could require of the radiology imaging facilities.Other commenters supported the removal of this requirement and applauded CMS for streamlining the process to allow independent diagnostic testing facilities (IDTFs) the ability to perform and receive reimbursement for lung cancer screening. Since IDTFs are enrolled as a facility for the purpose of performing diagnostic tests and smoking cessation interventions are considered therapeutic interventions, they did not satisfy the NCD criteria and were unable to receive reimbursement for the lung cancer screening service. Commenters believe the removal of this requirement expands access to lung cancer screening by increasing accessibility to screening sites.Response:CMS strongly supports all opportunities to provide appropriate smoking cessation services to beneficiaries. It was not our intent to convey a message that implied otherwise. Removing the requirement for imaging facilities to furnish smoking cessation services was not intended to downplay the importance of this intervention but rather to expand the availability of LDCT screening. There are separate rules and regulations that determine the services that are legally able to be furnished in certain Medicare recognized settings. We determined that while smoking cessation services are of critical importance we have a need to balance the accessibility of LDCT screening. While smoking cessation services are appropriate for patients, we are not making it a requirement that imaging facilities furnish the service because it would prevent IDTFs from furnishing LDCT screening. We have updated the language in the analysis section in order to correct any misunderstanding that may have implied that CMS was not supportive of smoking cessation services.