Requirements for Effective Lung Screening Programs Coming Into Focus

Abbie Begnaud, MD

The 2016 American Society of Clinical Oncology (ASCO) Annual Meeting is taking place June 3–7 in Chicago. As part of this year’s coverage, today we are speaking with Abbie Begnaud, MD, assistant professor of medicine in the division of pulmonary, allergy, critical care, and sleep medicine at the University of Minnesota. At this year’s meeting, she will be speaking during an Education Session about the practical implementation of a lung cancer screening program in a healthcare system.

Cancer Network: Thank you for speaking with us today.

Dr. Begnaud: Good morning, thank you for the opportunity.

Cancer Network: Before we talk about screening programs, can you provide us some context. What are the current screening recommendations for lung cancer?

Dr. Begnaud: This is something that is relatively new but many people are now getting wind of. The US Preventive Services Task Force (USPSTF) issued their final recommendations-it’s been a little over 2 years now-for lung cancer screening. Individuals with a heavy smoking history, 30 pack-years is how we quantify that, between the ages of 55–80 years old should be screened. Any former smokers who have quit smoking more than 15 years ago are not included in that screening recommendation. The measurement pack-years is the equivalent of one pack of cigarettes a day for 1 year, so if a person smoked more or less than one pack a day, depending on how many years they smoked, they might still meet a 30 pack-year requirement.

As with all kinds of screening procedures, consideration of the patient’s other comorbidities and whether or not they have symptoms of cancer must be weighed. Of course, a person should be asymptomatic for signs of cancer before they get screened for cancer, and if they have other comorbidities that are severe enough that those are competing causes for mortality, then screening might not be a good option for that particular person.

Cancer Network: Tell us a bit about the lung cancer screening program at the University of Minnesota. When was it established and what is it designed to do?

Dr. Begnaud: Our program was established a couple of weeks before the final recommendations from the USPSTF, which was in December 2013. We had been in the works for quite some time, like many programs had been, as people saw that the National Lung Screening Trial showed mortality benefit to screening this population of people.

Our program was designed fairly early on. Since then, there have been quite a lot of changes and updates and implementation of compliance and regulatory requirements, as well as additional recommendations for what to do about screening and how to screen people. Many of those things are things that we started implementing well before they were considered required or best practices.

We are in a healthcare system which is somewhat unique, in that we have an academic practice in a university hospital and university clinics with university physicians embedded in a much larger community health system. In Minnesota, we have hospitals and clinics that are throughout many parts of the central state. We work with community practice doctors, private practice doctors, radiologists, imaging centers, and hospitals that are not part of the university. This has been a unique opportunity for us to reach out to the community while having the leadership of experts from the university guiding the program.

Cancer Network: What is unique about this program?

Dr. Begnaud: I think the layout of our healthcare system and our university’s role within the healthcare system is something that is unique and has provided unique opportunities and challenges for us, in that there are independent physician practice groups that we work with who we have had to collaborate with and get everybody on the same page with what we recommended for screening and what is required for compliance and best practices.

Another thing that is unique about us is that we were not a clinical site for the National Lung Screening Trial but we were a pretty early adopter. Subsequent to the initial USPSTF recommendations in 2013 there had been additional recommendations from the Centers for Medicare & Medicaid Services on the screening exam and eligibility criteria, follow-up, smoking cessation, participation in research, contribution to a registry, and specific requirements for the imaging centers, the CT protocol, and the radiologists, all of which have subsequently been recommended, implemented, and enforced, but those are things we were doing when we started our program in 2013.

One example would be the Lung-RADS, which is the scoring system that we use, similar to BI-RADS for mammography in breast cancer. Lung-RADS was introduced and proposed by the American College of Radiology in the spring of 2014, I believe. We were using something similar that we called U-Lung-RADS when we started the program in 2013. I think we were fairly insightful and forward-looking with what was ultimately going to be to be required, which has served us well because we were working on implementing those things way before they were required.

Cancer Network: What were some of the challenges you faced in setting up this program?

Dr. Begnaud: The changing landscapes over the last 2.5 years has been really challenging. Many of the things we foresaw coming and were preparing for them, but some we did not.

Registry participation, which is required by the Centers for Medicare & Medicaid Services, and is something that I think is really important and I am glad that they chose to require that, but that requirement has been a challenge to get set up. Many of the requirements and recommendations that surround screening are the things that you want to do in order to make a screening program robust to help maximize the benefit-to-risk ratio, but are the things that are somewhat challenging to do. Many other screening programs and screening recommendations just don’t have all of those additional requirements.

Another example is the requirement for what Medicare calls a counseling and eligibility visit. For Medicare patients, in order to be reimbursed for screening, they have to not only meet the eligibility criteria that we discussed, but prior to having an order for low-dose CT for lung screening, they have to have a face-to-face visit with a credentialed provider who talks about the risks and benefits of screening, who confirms the patient’s eligibility for screening, and who explains to the patient a little bit about the screening process.

The screening process is not just a one-time CT, it’s a CT and follow-up of any findings, which might mean annual follow-up of CT, or might be something more soon than annual, and it might mean additional diagnostic testing. Patients should affirm with the ordering provider that they are willing to comply with those things in order to maximize the potential benefit of screening. That is something that is really unprecedented in terms of being a documentation requirement for screening.

In theory all screening programs should have some degree of that shared decision-making engagement with the patients and the provider. If you have a very elderly person with comorbidities, screening them for cancer is maybe not reasonable to do. For lung cancer screening, it is required to have a documented visit, face to face, to have a discussion before screening is undertaken. Without that, it will not be reimbursed. That has been a real challenge, to educate our providers to try to minimize the barrier for patients who want to get screened and are eligible, but can’t get into the doctor’s office in a reasonable time frame or it is inconvenient for them physically to get into the doctor’s office, or any number of reasons why that is an additional barrier.

Cancer Network: What sort of tips or advice would you have for a healthcare system looking into starting a lung cancer screening program?

Dr. Begnaud: The first set of things are basic business development things, assessing the market, how many potential eligible persons do you think you have in your healthcare market, and comparing that with how many other programs are available.

In our area, for example, we are in a large metropolitan area, and there are several large healthcare systems who offer a variety of tertiary care treatment options. There are actually several screening programs in our city. If you are just thinking about starting a screening program and there are already several in your area, you may be a little bit behind in terms of that and you may find that there are not an adequate number of patients to have a robust screening program.

At the same time, as this is a new recommendation, I am sure many places who don’t have screening programs will want to try to have one to provide that to their patients. If that is the case, then the most important thing is to assess and assemble your team.

The initial team members that you will need are quite a few people. You will need radiology, both administration radiology and radiologists, and probably people who are in the lines of technical support or information technology, as well as people who are clinical, nurses who are providing patients with results notification, and people who send letters to patients. You will need compliance and billing members-people who work in your billing and coding departments who can help you with the shared decision-making component, making sure that all requirements are met in order to get the bill submitted. You will also need some kind of a solution to contribute to registries or to build your own registry, which is an option, which again requires a piece of information technology. There are some proprietary software programs out there to help make registry participation and some of the other requirements a little bit easier to do. If you have means and inclination, those are things you might need to look into before starting a program.

Primary care involvement is a really important part. Even though radiology is a core part, it is not all about radiology. You need partners in primary care who can help you with front-end things like shared decision-making and identification of eligible patients, and then you also need people who are experienced in dealing with back-end things, like the findings. Many patients are going to have findings like nodules, as well as other findings not related to lung cancer but that may be significant, like coronary artery calcification, thyroid nodules, and liver nodules. Our team consists of a pulmonologist, thoracic surgeon, interventional pulmonology, interventional radiology-a whole multidisciplinary team of people who are equipped and have some expertise in dealing with pulmonary nodules and the appropriate management of nodules.

The good news for someone looking to start a program now is that although I anticipate that things will continue to change over time, many of the murky elements of starting a program are at least clarified for the time being. The USPSTF has issued a recommendation about the eligibility requirements for screening. The Centers for Medicare & Medicaid Services have published exhaustive reports and instructions for how to implement screening, how to read the radiology reports, how to participate in registries-all things necessary for reimbursement, which are things that have not always been there. At least now there is an outline or guideline for what needs to be done.

You would certainly want to review all of those things, all of those documents and requirements, before getting started, and make sure that you can meet all of those requirements before you start screening people because you may find that if you start screening people before looking into details, there are lots of patients getting screened who will not get reimbursed for screening.

Cancer Network: This gave us a great summary of the experience at the University of Minnesota. Thank you again for taking a few minutes to speak with us about this.