The Centers for Medicare and Medicaid Services (CMS) is proposing significant and important modifications to its National Coverage Determination (NCD): Screening for Lung Cancer with Low Dose Computed Tomography (LDCT). 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 issued its 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 proposed 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.

Last year, a formal joint request to reconsider the NCD was submitted to CMS by the GO2 Foundation for Lung Cancer, The Society of Thoracic Surgeons, and American College of Radiology (ACR), and CMS received numerous comments from various stakeholders, including from the Association for Quality Imaging. This new proposed NCD is in response to that request and the comments from stakeholders.

The proposed NCD adopts the updated the 2021 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 helps the current or former smokers understand the importance annual LDCT screenings and the  “impact of comorbidities and ability or willingness to undergo diagnosis and treatment.” Shared decision-making sessions also include smoking cessation counseling.

The CMS proposed determination modifies the existing NCD by:

  • lowering starting age of eligibility from 55 years to 50 years
  • changing the stopping age of eligibility from 77 years to 80 years
  • lowering pack-year smoking history from 30 pack-years to 20 pack-years

Additionally, the proposed NCD:

  • simplifies requirements for the counseling and shared decision-making visit;
  • removes the restriction that the shared decision-making visit must be furnished by a physician or non-physician practitioner;
  • modifies the eligibility criteria for the reading radiologist to include board certification or board eligibility with the American Board of Radiology or equivalent organization and documented participation in continuing medical education in accordance with current ACR standards;
  • removes the requirement for written orders for subsequent annual lung cancer screening with low dose CT;
  • eliminates the radiology imaging facility eligibility criteria that imaging facilities make available smoking cessation interventions for current smokers; and
  • states that imaging facilities are no longer required to participate in a data registry.

Quite significant is the elimination of the radiology imaging facility eligibility criteria that imaging facilities make smoking cessation interventions to current smokers. This criterion was the reason that the various Medicare administrative contractors (MACs) refused to allow independent diagnostic testing facilities (IDTFs) to participate in the program. MACs stated that IDTFs were unable to perform LDCT lung cancer screening due to 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. Eliminating this confusion is welcome news.

CMS is seeking comments on it proposed NCD, and the agency indicates that it will respond to public comments in a final decision memorandum.

Reed Smith will continue to track developments related to this NCD and its impact on the industry.  Please reach out to the health care attorneys at Reed Smith if you have any questions about this NCD or any related inquiries.