The past 13 months have been full of highs and lows for lung cancer screening advocates. In December 2013, we hit an important milestone with the USPSTF awarding low-dose CT (LDCT) lung cancer screening a “B rating.” In the months thereafter, however, MEDCAC recommended against CMS coverage for lung cancer screening in high risk individuals.
With CMS’s decision last night to cover lung cancer screening, at-risk patients with private and public insurance will have access to this lifesaving exam. The ability to detect lung cancer in its infancy represents a paradigm shift in the fight against the number one cancer killer. As always, we are here to provide our analysis and explain what has changed since CMS released its proposed decision memo last year.
Related: The Lung Cancer Screening Program Toolkit
CMS expands patient eligibility criteria
The table below looks at the evolution of the eligibility criteria for lung cancer screening patients. CMS not only expanded the age criteria, but also changed the wording of what constitutes an asymptomatic patient to account for patients with COPD, asthma and smoker’s cough that might have been excluded under the previous wording.
CMS maintains its position that patients must undergo shared decision making from a qualified medical professional prior to receiving a written order for the exam. CMS will still require that patients receive a written order for all subsequent LDCT lung cancer screenings and leaves open the possibility for clinicians to engage in further shared decision making conversations during these visits.
CMS broadens imaging facility eligibility criteria in response to stakeholder concerns
One of the most frequently asked questions following the proposed decision centered on which imaging facilities would be eligible to receive reimbursement from Medicare. When we spoke with CMS we were assured that the final rule would provide clarity and indeed it does. CMS will no longer require that a facility “Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening.” This decision further increases patient access to this service as the previous language would have excluded many providers from eligibility.
The new rule also includes modified language around radiation dose and radiologist requirements that are consistent with stakeholder comments, but do not fundamentally change the standards.
CMS adds more detail on criteria for participating data registries
CMS also provided additional detail on the necessary capabilities of participating data registries. These requirements include:
- Establishment of a steering committee and a governance board for oversight of the registry
- Registry management plan, including identification of key personnel
- Operational plan and framework that describes mechanisms for collection and submission of data from imaging facilities to the registry
- Registry catchment area
- Mechanisms for the submission of registry data to CMS electronically
- Mechanisms to collect information (e.g.; HICN) in order to permit linkage of registry data with external databases (e.g. Medicare claims data sets)
- Description of data management and data quality review methods, including validation
- Use of CMS-approved standardized data dictionary
- Mechanisms for submitting a list of facilities participating in the registry to CMS
- Quality assurance plan
CMS has not yet identified which registries are approved, and plans to post this information on its website.
Good news for patients, advocates, and providers
While the past 13 months have seen multiple milestones in the move towards coverage for LDCT lung cancer screening, this is a moment years in the making. Notably, the Lung Cancer Alliance, American College of Radiology, and Society of Thoracic Surgeons have spearheaded a coalition of advocates pointing to the clinical benefits of this exam.
Now the challenge for providers is to ensure that their screening programs are high quality, evidence-based, and ready to handle the increased demand. Our lung cancer screening toolkit contains 30 best practices and tools to help providers act on this important mandate.