Yesterday, February 10, the Centers for Medicare and Medicaid Services (CMS) announced finalized and significant modifications to its National Coverage Determination (NCD): Screening for Lung Cancer with Low Dose Computed Tomography (LDCT). In doing so, CMS:

• lowered the starting age of eligibility from 55 years to 50 years
• decided against (pending further evidence) increasing the stopping age of eligibility from 77 years to 80 years
• lowered the pack-year smoking history from 30 pack-years to 20 pack-years
• made clear that LDCT screening studies can be performed in independent diagnostic testing facility (IDTF) settings

Medicare pays for lung cancer screening, counseling, and shared decision-making visits, and for an annual screening for lung cancer with low dose computed tomography as a preventive service benefit under the Medicare program. CMS first issued an NCD in 2015 initiating this screening benefit, but stakeholders have observed that many of the features of the initial NCD served as a barrier to the effectiveness of this screening program. The revised NCD makes numerous improvements to this program and eliminates many of the barriers to qualified patients’ ability to gain access to important LDCT lung cancer screenings.

This action arises from a formal joint request to reconsider the NCD submitted in May 2021 to CMS by the GO2 Foundation for Lung Cancer and the American College of Radiology.  In response, CMS published a proposed new NCD in November 2021. During the 30-day comment period following the release of the proposed decision memorandum, CMS received 49 comments from various individuals and organizations including the American College of Radiology, American Association for Thoracic Surgery, American Cancer Society, American Lung Association, a joint comment from The American Thoracic Society and American College of Chest Physicians, Association for Quality Imaging, Medical Imaging &Technology Alliance, National Comprehensive Cancer Network, and Radiology Business Management Association.

The updated NCD adopts several of the 2021 updated recommendations from the US Preventive Services Task Force (USPSTF). Individuals who are current smokers or who have quit smoking in the past 15 years and who are asymptomatic of cancer can be referred for the LDCT screening following a “shared decision-making visit” with their provider. Shared decision-making includes counseling on the importance of adherence to annual lung cancer LDCT screening, the impact of comorbidities, and ability or willingness to undergo diagnosis and treatment. Additionally, the counseling focuses on the importance of maintaining cigarette smoking abstinence for former smokers, the importance of smoking cessation for current smokers, and the furnishing of information about tobacco cessation interventions.

The NCD retained the eligibility criteria for the reading radiologist to include board certification or board eligibility with the American Board of Radiology or equivalent organization, but it removed the eligibility criterion that the reading radiologist must have documented participation in CME in accordance with the American College of Radiology standards. The NCD observed that CME is already part of the American Board of Radiology’s Maintenance of Certification (MOC) Part 2 that requires radiologists seeking board re-certification to attain 75 CME credits every three years.

Also removed is the requirement for written orders for the initial and subsequent annual lung cancer screenings with low dose CT. Electronic orders are accepted for the initial order, and an order is not required for the annual screening.

The new NCD no longer requires imaging facilities to participate in a data registry. CMS states that lung cancer screening with LDCT is now a mature technology that no longer requires the criteria established early in its inception.  

To address health disparities in the access to lung cancer screening tests, CMS encourages shared decision-making between patients and practitioners that is culturally sensitive and understandable by those of different cultural backgrounds. And CMS also encourages the use of tobacco cessation and abstinence programs that address differences in cultural beliefs, language, and literacy.

Finally and significantly, CMS eliminates the radiology imaging facility eligibility criteria that imaging facilities make available smoking cessation interventions for current smokers. This criterion in the initial NCD had been the reason that the various Medicare Administrative Contractors (MACs) refused to allow IDTFs to participate in the program. MACs stated that IDTFs were unable to perform LDCT lung cancer screening due to the perceived belief that making available smoking cessation interventions constituted a “therapeutic intervention.” Since IDTFs are enrolled for the purpose of performing tests and restricted against performing therapeutic services, the MACs deemed IDTFs ineligible to perform LDCT scans pursuant to the NCD. 

Stakeholders requested CMS to be transparently clear on IDTFs' eligibility. In response, CMS said, "While smoking cessation services are important for patients, we are not making it a requirement that imaging centers furnish the service because it would prevent IDTFs from furnishing LDCT screening." Eliminating this barrier is welcome news!

The NCD was effective on February 10, 2022, the date the final decision memoranda was posted.