How to Implement a Lung Cancer Screening Program

Low-dose chest CT, a useful and effective screening tool for patients at high risk for developing lung cancer, has recently been approved for coverage by Medicare. Until recently, only private payers have been covering the procedure, excluding a significant number of people who could benefit from such screening. Now, because of the increased demand from patients who will be eligible through Medicare coverage, more health systems will be introducing lung cancer screening programs.

Diagnostic Imaging spoke with Ella Kazerooni, MD, MS, associate chair for clinical affairs and division director of cardiothoracic radiology at the University of Michigan Health System, about the implementation of their lung screening program.

How did the University of Michigan Health System program starte and what was involved in getting it off the ground?
Like a lot of places, we had a small fledgling program, but we’ve been planning for this latest development for the past 18 months, hoping for a good outcome [from CMS]. I chair the ACR Lung Cancer Screening Committee and there were many efforts involved in putting together CT Accreditation Programs, developing Lung-RADS, and building the registry, all things that I’ve been working on ahead of the effort.

As the process moved along, I’ve been making sure that our practice is ready for coverage. We did things like build a better order in our electronic medical record, so we could meet all of the documentation details that are required for coverage reimbursement. These are things like smoking cessation requirements, good decision making, making sure that people are the right number of pack-years, and more.

We have a group that includes our IT folks, both from EPIC and from radiology. We need all the data elements that are going to be required for the registry. We need to extract the data from electronic medical systems and to be able to export them to the ACR’s Lung Cancer Screening Registry with as little human interaction as necessary.

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One thing a lot of people might not have been doing yet in their practices is looking at smoking histories. We started looking at the smoking histories in our EMR a little over a year ago. It turns out that while meaningful use requirements include documenting smoking as “yes” or “no,” we don’t do so well on documenting pack-years. As a health system, we met the “yes” or “no” documentation across all of our clinics, but if you’re going to have that data to support appropriateness of screening, you need pack-years in your EMR.

We started running reports of when people entered “yes” for smoking and if pack-years were documented. We found documentation of pack-years was in the low 40%. So, we had to do some educational efforts. We worked with our entire ambulatory care system here at the university to educate the clinic leaders, both physicians and management leaders, as well as the medical assistants about why pack-year documentation was important, how to do it, and where to do it in the EMR. Now, we track quarterly the pack-year documentation in order to get that information back to the clinics to see how well they’re doing.

When do you see this program being fully available?
I think right now we’re on the precipice from that switch. All the things line up. The recommendation from USPSTF in December 2013 has meant that third party payers are required to cover the screening with no copay under the Affordable Car Act terms. The CMS decision brings us the next large wave of people, because they were not covered under the Affordable Care Act-USPSTF required coverage. So, that CMS has now come forward is huge.

We know there are other large health care systems, like the VA system, that have been doing a pilot at many of its centers, and they will soon roll out nation-wide coverage across the VA system to veterans. So, all of these things are just starting to come into play. This is the year where practices really need to ramp up their lung cancer screening programs, to look at the requirements for coverage and reimbursement, so that they can bring it to patients and providers. This is really a big year for education.

Has past experience with screening for other cancers helped with developing lung cancer screening programs?
I speak with my breast imaging colleagues a lot about their journey with breast screening and the lessons learned over the last 30 years. I think that lung cancer screening can be fast forwarded much quicker because of what we learned from the breast cancer screening, and also because we now have electronic vehicles of communication, whether it’s the Internet, the Web, or the electronic medical records that prompt physicians in their office. We have a lot of advantages now that they didn’t have 30 years ago with mammography.

For example, we have the have the best practice alert. If an older individual comes in for a clinic visit appointment in the fall, a best practice alert comes up and says, “Consider Pneumovax for your patient,” or when a parent brings in a child for a well-baby visit, the alert says, “These are the vaccines that are needed.” We can set up our EMRs to fire best practice alerts for lung cancer screening. We do have one set up based on age and smoking history so our physicians and our offices don’t have to think about this, as well as all the dozens of other things that they have to think about with patients. This makes things as easy as possible.

Why is such a screening program so important now?
Lung cancer is the leading cause of cancer death in the United States for both men and women. It surpassed breast cancer mortality in women a long time ago.

So, now we finally have something to combat the leading cancer killer, which is lung cancer screening. What I think this is going to do is that 10 to 20 years from now, the face of lung cancer is going to look a lot different. When people start to think about getting lung cancer screening the way they think about coming for mammograms, we’re going to be picking up cancer earlier, and earlier, and earlier for the next couple generations. Right now, lung cancer is essentially a death sentence. When people hear “lung cancer,” they think, “Oh my goodness, I’m not going to be alive in three to five years.” That is fundamentally going to be different in 10 to 20 years, by the time I retire.

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What is the process then for the patients? Will they know enough to ask for this screening?
No. I think it’s incumbent upon health care systems, radiologists, pulmonary med physicians, and so on, to educate patients about the need for the lung cancer screening. We really need to get into the business of a public awareness campaign to benefit our patients.

Patients who learn about it can certainly bring this up when they come to see their physicians, whether they’re seeing a primary care physician or one of their specialists. They can ask if lung cancer screening is right for them.

What kind of responses have you had about this program? What have people been saying about it?
There’s tremendous amount of enthusiasm for being able to finally move forward systemically with lung cancer screening CT. We’ve had hundreds of sites that have applied to ACR for the Lung Cancer Screening Designation. With the CMS final coverage decision, we are fielding lots of calls and emails from people who want to know, “So how do I meet the terms of CMS so I can offer it to my patients? Fill me in on the details so I can do this right.” So, the response has been overwhelming from the radiology community.

Has there been any resistance from people who may be afraid of over diagnosis and over treatment?
April 30^th last year, there was the MEDCAC Panel in Baltimore where CMS convened the panel to investigate whether or not lung cancer screening with CT should be covered. Every question they were asked, they basically voted down. What I took away from this was that there were concerns that this could be done in a large scale with attention to quality and safety, that low radiation dose would be used for these scans, instead of standard radiation dose for a chest CT, and that the right people would be screened.

What was your response?
To address the concerns, we basically tackled each one with the programs that ACR rolled out. So, regarding the radiation dose issue, the American Association of Physicists in Medicine (AAPM) has on their website low-dose chest CT protocols to use for screening, for over 30 makes and models of CT scanners that are available in the U.S. today. The protocol parameters are on their website, and they’re free and public access, so there’s no excuse for not being able to get a low-dose CT protocol for your CT scanner.

With respect to quality and safety, this is why the ACR rolled out the Lung Cancer Screening Designation under the CT Accreditation Program – just to specifically look at radiation dose, appropriateness of screening, and managing test results. This is why we developed Lung-RADS, which is the BI-RADS for lung cancer screening. I looked at how BI-RADS was developed and has been used for mammography, and I said, “We need this for lung cancer screening.” So we rolled out Lung-RADS. With this, when radiologists do see abnormalities, they know what the standard and appropriate recommended work up is.

We defined positive and negative screens. That seems like it should be pretty straight forward, but different people saw different things. “Is it a 4 mm nodule? Is it a 6 mm nodule? Is it an 8 mm nodule?” So, Lung-RADS defines what’s a positive and what’s a negative screen. And for each type of abnormality that is found, it says, “What’s the next work up? Is it that you’re really worried about it, and you need to go to a more aggressive match management scheme, like biopsy or PET scan? Is it a milder degree of suspicion, where they should get a three-to-six month follow-up CT to check on the stability of the nodule before they go back to their annual screening calendar?”

So Lung-RADS clearly spells out the recommendation. You see something a little bit bigger, and then the recommendation is a little more escalated. We really tried to systematically hit all of the concerns that were raised by the MEDCAC Panel: appropriateness, down-stream test utilization, and radiation dose. And I think by doing this and being able to show CMS what we’re able to do, that it really weighed strongly in coming forward with a positive coverage decision.

One other thing that I think weighed heavily with Medicare is the registry requirement. Thirty years ago, when breast cancer screening came out, there were no reporting requirements. Historically in imaging, when a new test came along, as long it fit under an existing CPT code, you started doing it. Nowadays, the demand for value and showing benefit in health care is much different. You can’t just do a new test or add something under an existing CPT code without people paying attention. Had it not been for having a clinical practice registry requirement under the CMS coverage decision, I don’t think Medicare would have come forward and that will really give us a check on quality and safety.

What advice do you have for other facilities that want to develop a similar program?
We put together something called the ACR Lung Cancer Screening Resource Webpage. If you just type into your favorite search engine, “ACR Lung Cancer Screening Resources,” it’s the first hit you’ll find. 

On this page, we tried to put resources to help practices that want to get started or enhance what they’re already doing. So, we have AAPM protocols, the ACR Lung Cancer Screening, the registry list of elements, and requirements on there. We have the Accreditation Program there, as well. We have one or two tobacco consultation programs. If somebody doesn’t have one locally in their practice, there are resources that they can drive to from national organizations that do have resources available.

So, we’re trying to put on that webpage resources that practices would find useful in setting up their lung cancer screening programs. We’re trying to supplement it with information and guidance about the coverage decision from CMS, and what practices should be doing if they want to start doing it with respect to getting coverage from CMS for their practice.

What’s the strongest message you would give to radiologists reading this article?
I would say that lung cancer screening with CT is one of the most significant advances in thoracic imaging and thoracic disease that I’ve seen in my 22 years as a thoracic radiologist. The time is now to become educated and to set up programs in whatever environment they’re in, small or large, to bring this to patients.