SummaryOn Feb. 10, CMS opened a national coverage analysis (NCA) on the use of lung cancer screening with Low-Dose Computed Tomography (LDCT) devices.
Currently, there is no national Medicare coverage policy for lung cancer screening, meaning the outcome of this NCA is likely to establish a standardized policy across all Medicare contractors.
Two prominent stakeholders in the oncology space requested the NCA: (1) Dr. Peter Bach of Memorial Sloan-Kettering Cancer Center and (2) the Lung Cancer Alliance. Their requests come only a few months after the United States Preventive Services Task Force (USPSTF) issued a Grade B recommendation for LDCT scans of asymptomatic individuals at high-risk of developing lung cancer. In its announcement of the NCA comment period, CMS noted it is specifically interested in receiving evidence to “inform the identification of patients eligible for screening; the appropriate frequency and duration of screening; facility and provider characteristics that predict benefit or harm; precise criteria for test positivity and the impact of false positive results and follow-up tests or treatments.”
The implications of this development are threefold: CMS is soliciting public comments on the NCA until March 12 and will host a MEDCAC meeting on April 30 to review the available evidence on this topic. CMS will post the draft coverage decision on Nov. 10. Additionally, the American College of Radiology (ACR) is currently developing a comprehensive screening protocol, including practice guidelines and appropriateness criteria for lung cancer screening. CMS is likely to consider these protocols as part of the evidence base once they are released.
- USPSTF Recommendation Will Play a Dominant Role in the Coverage Decision: Under the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008, CMS received authority to extend coverage for preventive services meeting certain requirements, including USPSTF Grade A or B recommendations. Since the passage of MIPPA, CMS has issued six NCDs on screening services and has largely aligned its coverage decisions with USPSTF’s recommendations, indicating that the USPSTF Grade B recommendation will figure prominently into CMS’ coverage decision on LDCT.
Concerns Regarding Practical Implementation of USPSTF’s Recommendation May Lead to Additional Conditions for Coverage: Dr. Bach and other key opinion leaders expressed concern over USPSTF’s recommendations. Specifically, they emphasized the importance of appropriately identifying asymptomatic and high-risk patients and ensuring physicians have the expertise necessary to perform screening in the least harmful and most beneficial way possible. In his NCA request letter, Dr. Bach states that coverage should be limited to centers of excellence and a screening registry should be mandated leveraging CMS’ Coverage with Evidence Development (CED) program to ensure that benefits, harms, and administrative best practices are logged and further evaluated. Dr. Bach also recommends screening only up to age 74, in contrast to the USPSTF recommendation’s of up to age 80.
Important Engagement Opportunity for Life Science Companies: Life sciences companies with LDCT scanners should submit evidence-based comments to CMS; they should also consider providing public testimony at the forthcoming Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting on this topic.
To learn more about the NCA and its comment opportunity, click here.