Last week’s decision by CMS to cover low-dose CT for lung cancer screening was widely hailed by medical associations that have a dog in the fight. Rooters included the ACR, the Lung Cancer Alliance and the American Thoracic Society. But critics quickly weighed in—from both sides of the debate.
On one side were those who said the coverage criteria for patients and facilities are overly restrictive. Douglas Wood, MD, immediate past president of the Society of Thoracic Surgery, told MedPage Today that CMS had stopped too short, “rather than extending the age for screening beyond that of the enrollment criteria of the National Lung Screening Trial (NLST)—as the U.S. Preventive Services Task Force had done based on modeling—and including risk factors beyond age and smoking pack-year history.”
On the other side were those who amplified the thinking of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), which last April voted against recommending the coverage. “The benefits of this have been overestimated, and the harms have been underestimated,” said Russ Harris, a professor of medicine at the University of North Carolina, as quoted in several outlets.
Count Reginald Munden, MD, in the first camp. “It’s a win-lose,” the chair of radiology at Houston Methodist and NLST principal investigator told RadiologyBusiness.com. “There are some parts that may hinder or prevent people from getting screened, but it’s better than not funding at all.” He then took a few additional questions.
RadiologyBusiness.com: How will the decision affect the screening program you’ve set up at Houston Methodist?
Munden: It really hasn’t made a difference to our screening program whether you are insured or not insured, 55 or 70 years old. We screen according to NLST criteria, which is basically what CMS adapted. The only thing I think we will have to adjust to is do more government paperwork. We probably will have to dump more stuff onto our coordinator personnel to make sure we put the data into the database, for example.
RadiologyBusiness.com: Do you serve a substantial Medicare population?
Munden: We do not, really. We probably are average for most nonprofit hospitals in large cities. We have two county hospitals, and we have regional hospitals that have a higher population of Medicare and Medicaid patients. I would guess we’re pretty much average. It’s going be interesting to see how this plays out in more regional areas rather than the larger cities.
RadiologyBusiness.com: What are your concerns with the particulars of the decision?
Munden: First, I think it’s fantastic that they agreed to pay for lung cancer screening. We’ve been fighting to get this through CMS, particularly since the MEDCAC ruling. So this is great for patients and great for those of us in the lung cancer prevention business, trying to make a dent in this disease. Because the only thing that’s had any real benefit against lung cancer, other than smoking cessation, is screening. Obviously, if people didn’t smoke we wouldn’t even be talking right now. But that’s not been successful so far.
As far as specific concerns, my concern has always been requiring a patient or participant to get an order to be screened. In most states you can’t refer yourself; you have to have a physician’s order. Self-referral, to me, is very important for screening. You can do it in mammography, but we can’t do it in lung cancer screening. I suspect there are several reasons for this. One is the fear of the radiation from the CT, but that’s not really a concern nowadays with the low dose and everything else. And CMS speaks to that, saying you have to have a less than 1.5 mSv [scanner], although I don’t know anyone who’s doing any more than that anyway. That’s an appropriate response to a legitimate concern, and industry and our profession responded to it.
And then on the shared decision-making, I’ve been involved in that and I’ve actually worked with some of my former colleagues over at M.D. Anderson [Cancer Center of the University of Texas]. We’ve developed an educational videotape presentation on shared decision-making that has been very well received. So I think shared decision-making is an important part of this. Whether that needs to be done at a different office or can be done when you walk in to get your screening, I think, is part of the issue. The wording in the CMS decision is that, if you have to go to another physician’s office and have a consultation and a visit and get your order, and then you have to walk over to come see me for your screening CT—frankly, few of us have a lot of spare time in our lives. It’s hard enough to get into a physician’s office when you’re sick, because of the shortage of physicians. So I do think the shared decision-making piece creates a barrier.
RadiologyBusiness.com: What about the piece that, in effect, penalizes people who do the right thing by quitting and ‘staying quit’ for more than 15 years?
Munden: After about 15 years, your risk of developing lung cancer from smoking is almost down to baseline. You never go all the way back to as if you had never smoked, but your risk of developing lung cancer from your smoking after 15 years is very, very low. So I don’t think that’s a big penalty; I think it’s actually pretty reasonable.
The other thing is that there is some debate about using 74 years of age as a cap. When we designed the NLST, we had to design a trial that had limitations in order to answer a specific question. We used 55 years old and 30 pack years because that was a higher risk population. We capped it at 74 because, in order to do a survival of a cancer, you need average life expectancy to be five more years. At that time, life expectancy was around 79 or 80. So to screen someone whose life expectancy is under five years, and they die within three years of the screening, you don’t know whether or not their death had anything to do with lung cancer. I know there is debate. The Preventive Services Task Force used 80 years of age. Again, I come back to the fact that 55 to 74 is better than nothing.
RadiologyBusiness.com: Do you think there’s now a better chance for lung cancer screening with low-dose CT to move in the direction of mammography, where self-referral is widely accepted?
Munden: Well, that’s my hope. And frankly, I don’t mind contributing to a registry [as stipulated by the CMS criteria]. In fact, maybe doing a registry in this population is a good idea. It’s going to take a little more resources. But one of the comments I’ve seen made by several people, and I’ve had the same question, is that the NLST—and all screening trials—were done in very controlled, academic kind of environments. Do those results translate out to the general population? I think they do, but we don’t know for sure. So this registry is going to be really the only system that will look at the effectiveness of lung cancer screening in the general public. Although if it works in the Medicare population, it’s likely to work in the other population.
So doing a registry for a period of time, and getting data so it may be in five or even 10 years, we can have an analysis showing that it works. And if we get to that point, I hope we do away with [denying screens to] self-referrers. I do not think we should do away with the shared decision-making process, because that’s also an opportunity to do smoking cessation, which is more important to this than anything. Mammography doesn’t have that issue. There is genetic counseling and all that, but that’s a different story. So there always has to be some component where there is a consultation of some kind going on. And I think smoking cessation should be a very important part of any screening program. But the resources to do that have to be allocated; otherwise, you shouldn’t be screening. And I think there is doubt that that will be done in the general population, frankly.
Basically, this [CMS green light] is exciting for anyone who’s been touched by lung cancer or the threat of it. My parents were ex-smokers, so I’ve been down this road in many ways. I think this is wonderful. I hope it’s implemented; I guess it’s February before the comment period is over and the final decision comes out. We look forward to that. I don’t think anything is going to dramatically change for us, but we will be ready.
Editor’s note: To comment on the CMS decision before the window closes on Dec. 10, click here.