evekhm/cms_iom_500 huggingface dataset:
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
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.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
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 System
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
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 Interventions
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
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.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
In order to avoid any further misunderstanding, we have revised and clarified the language used in the analysis. Specifically, we have removed the word appropriate from the final decision memorandum Section IX (CMS Analysis, Smoking Cessation) and replaced it with required, indicating (as we have noted), that as a policy requirement for low dose CT screening NCD, a smoking cessation intervention is not a radiology imaging facility eligibility criterion. The sentence now reads as, it is not required for Medicare beneficiaries to receive smoking cessation interventions for current smokers within the setting of a radiology imaging facility. It remains critically important to provide information about tobacco cessation or cigarette smoking abstinence to the patient at touchpoints between provider and patient along the clinical pathway.CMS-Approved RegistryComment:Some commenters did not support the removal of the requirement for radiology imaging facilities to submit data to a CMS-approved registry for each LDCT lung cancer screeningperformed. Commenters noted that the registry provides guidance for required and optional fields, facilitates additional research, aids in quality audits, quality improvements and establishes best practices. They are concerned that removing this requirement will likely result in lower overall quality of lung cancer screening. One commenter agreed with the original purpose of the registry as outlined in the proposed DM, but believes the three published studies reinforced the purpose of the registry rather than fulfilled it.Other commenters supported the removal of the registry requirement stating that it creates a financial disincentive to small radiology imaging facilities and a barrier to overall lung cancer screening, particularly for rural and minority populations. They point out that the only CMS-approved lung cancer screening registry requires that providers pay a fee to input their data into the registry. The commenters believe by removing this requirement it will expand access by encouraging more providers to offer lung cancer screenings.Response:We appreciate the comments. The primary purpose for requiring the submission of data to a CMS-approved registry, as stated in the 2015 Decision Memo, was to document compliance with the coverage criteria that are not evidenced on the health care claim. The registry will help ensure that only eligible beneficiaries will receive this screening service since only beneficiaries that meet the eligibility requirements will benefit from such screening.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
In addition, the most recent 2021 USPSTF recommendation statement changed from encouraging the development of a registry in 2014 to having no comment on the need for a lung cancer registry. Since the published studies, using data from the LCSR, fulfilled the purpose as outlined in the previous NCD, it is no longer necessary to mandate data collection through this NCD. This will also reduce the administrative burden on providers and institutions.Comment:Several commenters supported the development of a free lung cancer screening registry.Response:We agree that a registry that would be free to access would aid in eliminating the financial burden for smaller providers. We are aware of a proposed bill in Congress (H.R. 107-The Lung Cancer Screening Registry and Quality Improvement Act of 2021) that if passed would provide grant funding for the development of free lung cancer screening registries and encourage the development of quality measures in lung cancer.Comment:Two commenters suggested CMS make the Lung Cancer Screening Registry (LCSR) data publicly available.Response:The LCSR is maintained by the American College of Radiology (ACR). We encourage our commenters and any interested party to reach out directly to the ACR for more information about data access.Additional CommentsComment:The American Cancer Society (ACS) and the National Comprehensive Cancer Network (NCCN) requested we update their respective sections within the Decision Memorandum (DM). ACS informed us that their 2013 guideline is currently being updated and has been taken down from their website. They provided interim language and asked that we replace our language in the final DM. NCCN provided us with the most recent version of the NCCN Guidelines and requested we update the risk assessment image in the final DM.Response: We thank ACS and NCCN for advising us of the current information. We updated the ACS and NCCN sections within the Evidence-based Guidelines section of the DM to reflect their requests.Comment:Several commenters advocated that lung cancer screening be added to hospital performance and quality measures in such reporting systems such as the Healthcare Effectiveness Data and Information Set (HEDIS), Merit-based Incentive Payment System (MIPS), and National Quality Forum (NFQ).Response:We thank the commenters, but quality measures are beyond the scope of this NCD.Comment:One commenter raised concerns regarding the April 30, 2014 Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting.
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
Response:We thank the commenters, but quality measures are beyond the scope of this NCD.Comment:One commenter raised concerns regarding the April 30, 2014 Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting.Response:The 2014 MEDCAC meeting is not part of this reconsideration. Details regarding this meeting are summarized in the 2015 DM. A MEDCAC meeting was not convened for this reconsideration.Comment:One commenter requested to include ICD-10 diagnosis codes for smoking in remission.Response:Coding guidance is outside the scope of this national coverage analysis.Comment:One commenter asked when the changes are effective.Response:All NCDs are effective on the date the final decision memoranda are posted.Comment:One commenter urged CMS to work with appropriate federal and state stakeholders to address additional barriers that exist for both providers and patients, including ensuring private insurance plans include lung cancer screening as a routine screening for eligible patients; including eliminating LCS as a cost-sharing benefit and to urge the American Academy of Family Physicians (AAFP) to acknowledge the importance of lung cancer screening in eligible patients, thus raising their grade on lung cancer screening to A from its current ranking of B.Response:While CMS does not have direct authority to influence these changes, we agree that continued stakeholder engagement is important. The updated NCD may contribute to opportunities for continued stakeholder engagement to address additional barriers to access to lung cancer screening.IX. CMS AnalysisNational coverage determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act ( 1869(f)(1)(B)). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. CMS is authorized to cover "additional preventive services" if certain statutory requirements are met as provided under  1861(ddd) of the Social Security Act. Regulations at 42 C.F.R.  410.64 provide:
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
(a) Medicare Part B pays for additional preventive services not described in paragraph (1) or (3) of the definition of preventive services under 410.2, that identify medical conditions or risk factors for individuals if the Secretary determines through the national coverage determination process (as defined in section 1869(f)(1)(B) of the Act) that these services are all of the following:(1) Reasonable and necessary for the prevention or early detection of illness or disability.(2) Recommended with a grade of A or B by the United States Preventive Services Task Force.(3) Appropriate for individuals entitled to benefits under part A or enrolled underPart B.(b) In making determinations under paragraph (a) of this section regarding the coverage of a new preventive service, the Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such services and may take into account the results of such an assessment in making such national coverage determinations.When making national coverage determinations, it is important to consider whether the evidence is relevant to the Medicare beneficiary population. In considering the generalizability of the results of the body of evidence to the Medicare population, it is necessary to consider at least the age, race and gender of the study participants.Due to the natural history of lung cancer, the burden of lung cancer is high in older adults. In this analysis, we will evaluate specific criteria of screening tests as described by Cochrane and Holland (1971) in addition to the hierarchical framework of Fryback and Thornbury (1991). We will utilize the hierarchical framework of Fryback and Thornbury (1991) in our analysis of low dose CT screening tests for lung cancer. As Cochrane and Holland (1971) noted, evidence on health outcomes, for example, evidence that screening can alter the natural history of disease in a significant proportion of those screened," is important in the consideration of screening tests since individuals are asymptomatic and "the practitioner initiates screening procedures." We will look for sound human clinical evidence that shows that changes in the eligibility criteria for a  screening test has clinical utility since lung cancer screening with low dose CT has been shown to improve health outcomes, including lung cancer mortality, which benefits Medicare beneficiaries.Evidence Review Summary:For this reconsideration of the NCD on lung cancer screening with low dose CT, CMS focused on three questions:
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
Evidence Review Summary:For this reconsideration of the NCD on lung cancer screening with low dose CT, CMS focused on three questions:Question 1: Is the evidence sufficient to determine that screening for lung cancer with low dose computed tomography is recommended with a grade of A or B by the United States Preventive Services Task Force?In 2021, [t]he USPSTF recommends annual screening for lung cancer with LDCT in adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery. (B recommendation) (USPSTF, Krist; 2021). This recommendation replaces the 2013 USPSTF statement that recommended annual screening for lung cancer with LDCT in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years (USPSTF, Krist; 2021).Question 2: Is the evidence sufficient to determine that screening for lung cancer with low dose computed tomography is reasonable and necessary for the prevention or early detection of illness or disability?The human empiric evidence was assessed to determine whether changes in the beneficiary eligibility criteria for age and smoking history when screening with low dose CT show benefit for Medicare beneficiaries in the prevention or early detection of lung cancer by lowering lung cancer mortality.Randomized Controlled Clinical Trials
NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo
Randomized Controlled Clinical TrialsThe evidence base for this reconsideration of low dose CT for lung cancer screening has a primary focus on randomized controlled clinical trials of the effect of screening with low dose CT on the outcome of lung cancer mortality. Ten randomized controlled clinical trials involving human subjects were included in the evidence: the Continuous Observation of Smoking Subjects trial (COSMOS; Rampinelli, 2017), the Danish Lung Cancer Screening Trial (DLCST; Wille, 2016), the Detection And screening of early lung cancer with Novel imaging Technology and molecular assays trial (DANTE; Infante, 2015), the Italian Lung Cancer Screening Trial (ITALUNG; Paci, 2017), the Lung Cancer Screening Intervention trial (LUSI; Becker, 2020), the Lung Screening Study (LSS; Doroudi, 2018), the Multicentric Italian Lung Detection study (MILD; Pastorino, Silva, Sestini, 2019), the National Lung Screening Trial (NLST; National Lung Screening Trial Research Team [NLST], 2019), the NederlandsLeuvens Longkanker Screenings Onderzoek trial (NELSON, which is the Dutch acronym; de Koning, 2020), and the United Kingdom Lung Cancer Screening pilot study trial (UKLS; Field; May, 2016). In subsequent discussions, each randomized controlled trial will be referred to by its acronym.