AJMC®tv Interviews, April 2019

Ben Jones, Vice President, Government Relations and Public Policy, McKesson Specialty Health

What are some recent policies that are having the biggest impact on cancer care delivery?

A number of policies have really taken shape over the past 18 months and significantly transformed community oncology and cancer care in general. One of them is around site-of-service parity; that is establishing a level reimbursement field for certain services on a go-forward basis and even in the last round of rulemaking for clinic office visits. Changes to 340B have had an impact on community cancer care and cancer care in general.

But by and large, the biggest proposals are those that are pending. The president has released his drug pricing blueprint that contained a number of changes—seismic shifts—in policy for [Medicare] Part B reform. They include step therapy, a relaxing of protected classes, but also a new international index model, the International Pricing Index Model, that would completely change the way Part B drugs are acquired, stored, and administered to patients. I really think this could lead to a lot of disruption in access to timely care for practices across the country.

Are there unique challenges that community practices face regarding reimbursement?

In 2015 the Bipartisan Budget Act instituted site neutrality on a go-forward basis for off-campus outpatient facilities. Since then, there’s been an expansion to clinic office line visits, and that could go further. But by and large today, there’s still a big disparity in reimbursement, where a hospital practice or a hospital-based cancer care center will receive twice as much as the outpatient facility for the exact same service. And this is incentivizing hospitals to consolidate, and we will have situations in which a community cancer center changes nothing but the sign on the door, and then all of a sudden, the patient’s out-of-pocket costs go up and the cost of Medicare goes up.

Allen Lichter, MD, FASCO, Senior Partner, TRG Healthcare

The administration—HHS Secretary Alex Azar and President Donald Trump— have indicated that they want to look into this. They made a proposal in the last physician fee schedule. They want to explore site neutrality for drug administration services; that was included in the drug pricing blueprint. And this is also something that Congress is becoming well aware of in trying to figure out how they can expand what they passed in 2015, to try to come to some sort of parity in reimbursement without disrupting access to care in hospital or community-based settings.How is telehealth allowing community oncologists to reach more patients and improve care?

I think today telehealth is present in oncology in specific areas. Obviously, our imaging colleagues use telehealth to transport images all around the world, and if you go to an emergency department at night, your image is often read in another part of the world, where it’s daylight. Our pathology colleagues are using telecommunications to transmit images. Our patients are sometimes sending images—I certainly sometimes let my dermatologist take a look at certain things on my skin to save me a trip to the office.

Another area is patient engagement, trying to keep using technology—often an app or a synthetic conversational agent, called a chatbot—to ask the patient how they’re doing, to check up on symptoms, and to allow patients to tell us much earlier about something that’s going on and head it off at the pass and not react to it as a crisis. But the future is going to have so much more. We’re going to have remote sensors. We’re going to be able to monitor physiologic processes. We’re going to be able to diagnose and eventually provide therapeutic interventions remotely.

Another area that oncology touches with telehealth is the second-opinion process. Many major institutions and cancer centers will do second opinions through telemedicine versus having the patient travel for hundreds or thousands of miles.

There’s a presence now, but the future is extremely interesting.

Toby Campbell, MD, MSCI, Professor of Medicine, University of Wisconsin Carbone Cancer Center

The concept that as patients, the only way [you and I] can have an interaction with the healthcare system is to drive to an office or a hospital, wait in the waiting room, go back, get into a gown, and wait for the healthcare provider to come into the room—that’s certainly the paradigm that I grew up in and is the paradigm that predominates in medicine today, but there are so many ways to deliver effective healthcare. It doesn’t necessarily involve that face-to-face interaction. And believe me, I think face-to-face is the essence of medicine. But sometimes we need to expand our capacity and to be more convenient and fit into the patient’s life better. That’s where I see us making strides.When should end-of-life care discussions take place with patients with a cancer diagnosis? Are they happening at the right time?

End-of-life care discussions should happen with patients well before you’re at that point. Just imagine that you’re an oncologist, and you’re working with a patient—maybe you’re working with them for months or a few years—and you have a discussion about, “Hey, you’ve got this cancer, and here’s a treatment.” And then, “Oh, there’s bad news, but I have another treatment.” At some point, you run out of treatment options. And then you face a discussion about talking about end-of-life care. Well, that’s an awfully big discussion, and it’s a really impactful and momentous one.

I think that the strategy that makes the most sense is to walk yourself back to the beginning when you identify that a patient has a disease that cannot be cured. At those early moments, before you even face any crucible moments, you start to introduce it. And then you introduce it again at any time of progression. And that way, when you reach that point, where you do not have any additional treatment options that make sense, [it’s a less difficult conversation]. The patient is likely already aware, but it might sound something like, “You know how we’ve been talking over time that at some point we were going to reach a place where I didn’t have any additional treatment options? You know, we’re there.”

And odds are that conversation if you imagine the one that you might have had to have without having any preparation versus that, it really alters the arc of the whole thing. But it starts—the inflection point can be modest, can be mild, months or years earlier, as opposed to a giant inflection point if you wait until the end.

Howard Burris III, MD, FACP, FASCO, President, Clinical Operations and Chief Medical Officer, Sarah Cannon Research Institute

So I don’t think that oncologists have this conversation as often as they could. We certainly have some data that suggest patients have a poor understanding of whether their disease is curable. So it certainly suggests that we could be doing this earlier.As next-generation testing becomes more important, with a growing number of approved targeted therapies, what is needed from a policy perspective to ensure access to these tests?

Access to these tests and getting the various stakeholders together [are what is needed]. If I were a payer at an insurance company, my question wouldn’t be whether I approve the testing; it would really be how you could be prescribing this new therapy, this relatively expensive therapy, without having a molecular profile on the patient. I think much as we’ve had legislation regarding access to clinical trials, this sort of national education that [patients with] cancer should have [access] to getting a test performed would be key.

Basit Chaudhry, MD, PhD, Founder, Tuple Health

A good first step has been the FDA approving some of these tests and then Medicare providing reimbursement. So I feel optimistic that we’re moving in a direction where we’re going to begin to get policymakers across the country, the physicians across the country, to understand this is a critical piece of information [patients with] cancer should know.With results from the Oncology Care Model (OCM) performance period 3 (PP3) now out, did you see improvement over performance periods 2 and 1?

It’s interesting. In PP3, 33% of practices were able to achieve a shared savings. I think that was somewhat concerning because that has stayed stable since PP2. In PP2, 33% of practices [also] achieved a savings. In PP1, it had been 25%. So between PP1 and PP2, we saw a growth or improvement. I personally was hoping that we’d continue to see aggregate improvement in performance in terms of achieving a shared savings. That, unfortunately, didn’t happen, so that aspect of performance leveled out.

The other important thing about the results from PP3 is that we’ve gotten additional data on what has happened in the true-up period. Medicare claims can be sent in about a year after a service is provided and in performance-based models, you continue to look at what happens as claims roll out or into Medicare. So for PP1, the number of practices that retained a shared

savings went from 25% to 20%. For PP2, it went from 33% to 25%. There are 2 trends, I think, that is concerning with the results of shared savings. One is that we’ve leveled out in terms of the proportion of practices that have achieved a shared savings, and then [with] the true-up process, we’re seeing a regression of the results.

Now, from what we understand from Medicare, different practices are getting shared savings at different times. So overall, from what they’ve said, from the start of the program, around 50% of all the participants have achieved at least 1 shared savings. I feel like that’s progress in certain respects, but in aggregate, I think there’s still concern over where practices are. The other thing I think is how you look at performance versus the benchmark. The benchmark doesn’t take into account the amount that’s provided from the MEOS [Monthly Enhanced Oncology Services] payments or the 4% discount, which is supposed to neutralize that. So practices are doing better with respect to the benchmark; about three-quarters of practices, from what we understand, are under benchmark. But there’s still a concern there on how people are doing with respect to performance-based payments, and the upshot of it is that if practices are going

Katie Goodman, BSN, RN, CCRP, Director, Clinical Research, Florida Cancer Specialists & Research Institute

to stay in the OCM, a good proportion most likely would need to go to a down-sided risk model.How is community oncology poised to shape the future of cancer care regarding clinical trials?

Community oncology practices are where most patients receive their treatment. So if we need patients to participate in clinical trials to get the answers, to move the needle on the science, to know whether this next treatment will be effective, we have to bring the trials to where those patients are being treated. We also know that patients aren’t going to participate in a clinical trial if it’s too much of a burden on them. They have to travel great distances to participate. [Patients with] cancer are usually in the clinic once a week at the very least, if not more, and that is too great a burden on a patient. We want the answers, we want the science, and the only way we can really do that is to bring the trials to the patients where they live. So it is very important

Lee Schwartzberg, MD, FACP, Executive Director, West Cancer Center

to us in the practice that I work at that, we continue to offer clinical trials in the community setting.Liquid biopsies have shown promise in lung cancer and most recently in breast cancer. Do you think use of these biopsies will become more prevalent in the future?

I think liquid biopsies are going to be very important in the precision oncology world of tomorrow. I just returned from AACR [American Association for Cancer Research Annual Meeting], and there were many presentations in 2019 about liquid biopsies. The technology is developing very quickly. The idea that tumors shed both cells and circulating tumor DNA, as well as some other subcellular molecules like microRNA and proteins into the bloodstream, means that the blood is a rich source [for] understanding the dynamics of how tumors grow and shrink. So as the technology improves, and as the studies are done to show concordance against tissue biopsies, we’re going to see liquid biopsies used in multiple directions.

Right now, they’re good for when you don’t have a tissue biopsy available or there’s a limited sample or not enough to do next-generation sequencing; for example, we can get those results from a liquid biopsy. I think in metastatic cancer, it’s going to be very useful to monitor patients to see what happens because tumors, unfortunately, change over time. They can find resistance mechanisms to get around some of the medicines we use. And of course, there’s a lot of interest in early diagnosis using liquid biopsies, and many companies are working on tests that can be used broadly to screen patients for cancer when they have no symptoms. So we’re very excited about the entire spectrum of liquid biopsies. There’s a lot of work that needs to be done. There are a lot of clinical trials to show the clinical utility, but the validation—technical validation and the clinical validation—has already largely been done.