More than 60 medical organizations and patient advocacy groups are now pleading with Medicare to cover low dose computed tomography (LDCT) screening for beneficiaries at high risk for lung cancer. Decision day comes in November. Will CMS do the right thing in the eyes of those in favor of screening?

The voice count topped 60 on Sept. 26, when a coalition led by the American College of Radiology, the Society of Thoracic Surgeons and the Lung Cancer Alliance sent CMS a 43-page letter. The letter urges CMS to adopt the December 2013 recommendation from the U.S. Preventive Services Task Force (USPSTF) on LDCT lung cancer screening for heavy smokers, including relatively recent quitters, between 55 and 80 years old. The document follows numerous prior calls from various groups dating to 2012, and it goes into quite granular detail suggesting specific measures and describing appropriate-use conditions.

Ella Kazerooni, MD, chair of the ACR’s lung cancer screening committee, took questions from Radiology Business on the import of, and expectations for, the new letter.

RadiologyBusiness.com: What is new, or newly persuasive, in the Sept. 26 letter?

Kazerooni: We reinforce two points, starting with our belief that Medicare should cover LDCT lung cancer screenings for Medicare-age beneficiaries who meet the USPSTF criteria. That’s very important, because the way things are right now with that grade B recommendation from the preventative services task force, all third-party payors starting January are required to cover this until a person hits age 65—and then all of a sudden they would lose the covered benefit just as they are going into their highest risk years for lung cancer.

The second point was to reinforce that we believe there should be a decision on coverage with evidence for other high risk populations that the National Lung Screening Trial didn’t study and for whom there will never be a randomized trial. Somebody who maybe smoked less but has three first-degree relatives with lung cancer, somebody who has been exposed to high levels of radon or asbestos, which we know are risk factors for lung cancer—to not have something for those people moving forward because there won’t be a randomized trial puts them in limbo, essentially. If Medicare were to come forward with a decision on coverage with evidence, those people could be enrolled in screening in a more research-like practice where their data would be collected in a very serious, clinical, trial-like manner with serious audits of data for validity to see if we can draw conclusions to determine whether those people should or should not be covered in the future.

So those are the two key points in the new letter. But I think the part that gives it tremendous substance is some of the new evidence and infrastructure that has been put in place to help support quality screening. One of the things the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) clearly voiced was, what is the infrastructure for doing this? How do we know it’s going to get rolled out with attention to quality and safety, and that the appropriate people are going to get screened, and that we are not going to do lots of inappropriate tests? I think those are reasonable concerns. And I think we do have a substantive infrastructure for doing it well.

RadiologyBusiness.com: When you speak of infrastructure, I assume you are referring to information infrastructure—registries and quality/outcomes databases and so on.

Kazerooni: Yes, pretty much. Radiologists have been screening for breast cancer for at least three decades now, and we have a strong infrastructure in place for asking, in a very structured manner: Who is it appropriate to screen? How do we screen them? How do we interpret the tests? What do we recommend? We have taken that 30-year experience with mammography and BI-RADS, in the last year, compressed down our timeline and developed the same structure for lung cancer screening.

The ACR is also committed to a lung cancer screening clinical registry on which sites would collect their data as defined in Lung-RADS, submit to the registry and then receive back individual physician performance metrics, practice metrics and regional and national benchmarks so they know where they’re performing. That’s something that was not in place when mammography started, and only evolved over many years of practice and federal legislation.

So we’ve developed a lot of the resources and tools to make sure that this could be done well.

RadiologyBusiness.com: What will be the coalition’s response if, come CMS’s Nov. 10 decision deadline, the agency gives your recommendations a thumbs-down?

Kazerooni: I think there will be widespread and extensive complaints from not just professional societies but also patients and patient-advocacy groups. I think folks in Washington are watching this very, very closely. There was a House letter and a Senate letter that went in, signed by all members of the health finance committees of both chambers of Congress. We had close to half the Senate and at least a third of the House, which are huge numbers of sign-on to any letter to ever go to Medicare. So there is a lot of support in Washington and a lot of people watching. The last time we met with CMS in the early summer, they were very well aware that people in Washington were watching. It was one of the first things they said, that they have gotten these letters from the House and the Senate and they are very well aware of the political pressure.

So I think that, coming from so many directions, it’s hard to imagine them not coming forward with a favorable decision. It’s almost impossible to imagine.

Almost impossible—Kazerooni did say “almost.” Preparing for disappointment may be wise, as the current issue of JAMA features a “Viewpoint” article titled “Should CMS Cover Lung Cancer Screening for the Fully Informed Patient” and an editorial, “Implementing Lung Cancer Screening Under Medicare: The Last Chance to Get It Right.” Taken together, the two pieces would seem to suggest that the forthcoming decision is not yet a slam-dunk for any stakeholder.