This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.
The COVID-19 pandemic will change the structure and economics of clinical care and clinical trials in cancer, said Howard “Skip” Burris, president of clinical operations and chief medical officer of Sarah Cannon, the Cancer Institute of HCA Healthcare.
“The pandemic is going to create an opportunity to look at how oncology should be reimbursed and how a practice is not disadvantaged when they’re able to function electronically in some areas,” said Burris, who is this year’s president of the American Society of Clinical Oncology. “And then I think bigger picture, this pandemic will help us set some health care priorities for the population.
“I’m hopeful that after we get through the storm, there will be a real assessment and look at the data as you alluded to about the need to continue with appropriate cancer screening programs, mammography, colonoscopy, and appropriate CT scans.
“And hopefully, we won’t see too big of a disadvantage coming from procedures being delayed. The information during this time will help confirm what we thought for years—that early detection of cancer really leads to better outcomes. These few months here, I think, are going to greatly shape how we approach health care over the next few years.”
Burris spoke with Paul Goldberg, editor and publisher of The Cancer Letter.
Paul Goldberg: First of all, how are you?
Skip Burris: I’m doing well. We are staying fairly busy in continuing to care for our patients. Nashville had a lot of cases, but we have had a fairly low number of hospitalizations and an even lower number of deaths. So, we’ve been a little bit of an outlier as a state.
Nashville had a lot of cases early, but the hospitals have been relatively quiet in comparison to other states. The major hospitals here have been running inpatient COVID-positive numbers in the twenties, with a handful of patients in the intensive care unit.
How about your practice? How about Sarah Cannon?
SB: Our major practices are Tennessee Oncology and Florida Cancer Specialists, where we have the bulk of the patients on clinical trials. We also have research programs in Kansas City, Oklahoma City and Denver.
We have about a dozen COVID-19 positive patients across the practices, and have been fortunate that none have been critically ill. A few staff have been infected, exposed outside of our clinics, but again, nobody critically ill.
The Nashville clinic, where I practice, is relatively quiet, but we are continuing treatment. Surveillance visits have been moved out a few months, and we’re continuing to keep an eye on that timing. The benign hematology has also been moved out. The oral therapies are being handled with telemedicine and shipping the drugs to the patients.
The clinics across our network are steadily functioning, but not overly busy, including chemotherapy rooms. With the lower volume, we are able to successfully implement social distancing measures as well as all the safety precautions of masks, gloves, and hand washing.
What about the financial impact? Are you seeing any?
SB: There is an impact, but it’s a little early to do any calculations. The absolute visits are going to be dropping. We are starting to pick up the telemedicine visits, but it’s probably 50/50 on patients being comfortable with that approach versus simply wanting to push out their visit. The treatments have remained fairly steady in terms of those patients that are on intravenous treatments.
I think the financial impact is not going to be quite as devastating as we had first anticipated. The missed visits will never be made up.
It’s a little bit like the movies and the restaurant business—people are not going to have two dinners at the same place in the same night, or see two movies at the same time—patients are not going to come for two visits to our clinics in a week either. So, I think the financial impact is going to be substantial, but not catastrophic.
I do think it is different for large practices versus the smaller practices. I worry about some of the smaller practices, with a handful of physicians, and their ability to have staying power through this pandemic, as they may not have the ability to handle the decrease in volume.
What about impact on clinical trials, especially drug company trials? We’ve certainly written a lot about NCI trials, but drug company trials, I think haven’t been really gauged yet. What impact do you think this will have on approvals?
SB: It’s an interesting question. We have seen big pharma that are conducting global trials pause studies and put a hold on accrual. I think a part of that is making sure that they can get the data.
Also, it was easier to not make site-specific selections and just put a large trial on hold. So, we’ve seen most of the big pharma react that way.
We have seen a substantial drop in enrollment for phase II/III studies, resulting from at least a third of the clinical trial menu being put on pause.
The other part about the phase II/III side of the businesses is, in many of those scenarios, patients have an option. We have had so many approvals recently. Patients may have an off-study option that might require fewer visits or less travel. I suspect that is impacting accrual as well.
All of those will be detrimental in terms of slowing down trial completion, slowing down approvals.
On the other hand, on the phase I end of the spectrum, where I think the majority of the patients are seeking an investigational treatment and/or a treatment to match their mutation, we have not seen quite the level of decline.
And in particular, we have seen the smaller biotechs continue forward. Many of their phase I trials are at only a handful of sites, making any decisions site-specific.
As you said at the beginning, in terms of approvals, certainly many of the phase II/III studies are going to be slowed substantially. It is also important to note that some of the big academic centers, typically accruing many patients, are in cities hit the hardest by COVID-19, such as New York City, Boston and some of the cities in Europe, which is impacting trials.
You would think that some patients would have to be censored out, because with time to progression, the radiographic metrics, you would pretty much have missed the opportunity to gauge it; right?
SB: Correct. I think it’s going to be complex within the phase II/III trials. I was reading The Cancer Letter with Matt Ong’s interview with Don Berry [The Cancer Letter, April 24, 2020], thinking about how individuals will need to come in and really think about how we pool that data and analyze it. But you’re exactly right.
The NCI has been great in encouraging taking deviations related to COVID-19 needed to keep the patient on study. We have made a number of operational adjustments including remote data monitoring, shipping pills to keep people on oral therapies, and implementing telemedicine visits.
Certainly, in the phase II/III area, with time to progression studies, there will be an impact, and there will be some complexities in how we analyze that data.
How are academic cancer centers affected?
SB: Probably a lot depends on where they are located geographically. In talking to our colleagues at centers in New York, Boston and New Haven, we know many of those centers have had to stop clinical trial accrual. We are seeing the same thing in much of the East Coast and parts of the West Coast.
Also, there is a tertiary referral travel population. We have seen, at all of our centers, patients being much more hesitant to travel for treatment. I think it will substantially impact analyzing the data from those centers and getting those trial programs up and running.
Some of the academic medical centers have had a higher volume of COVID-19 positive patients. I know I’ve had some patients that have gone back and forth to MD Anderson, where they are now encouraging patients to stay there in Houston, and not travel for their safety.
This recommendation gets into socioeconomic issues about who can do this relocation and who cannot.
What impact do you think it will have financially on the academic cancer centers?
SB: I think you have to look at an academic medical center as part of a larger hospital. We can break this into different buckets—small community practices will be hit differently than larger community practices that have more synergies.
Larger practices may have better staying power, and, of course the CARES program allows the hospitals to help in some ways. There are some waivers with regard to Stark concerns, and then the ability for some of these practices to participate in the PPP programs for loans and for advanced Medicare payments.
When you think about the hospitals right now, they are essentially doing emergency room care, which has dropped, COVID-19 care that’s ongoing, and then cancer care that needs to be done.
The other services generating revenues have slowed down because many of the procedures, such as orthopedics and cardiovascular can be pushed out a few months. We have seen across the country health systems and hospital systems beginning to furlough individuals and take other actions with regard to employment.
I think that this environment is going to be tough for the academic medical centers. Hospitals have multiple sources of revenue, and many of these sources have really been scaled back as patients choose to defer coming in or there are simply not the resources for routine health care.
So, there is redistribution, but is it a net loss?
SB: It will be interesting to see how some of that care comes back. While patients will never make up that cancer visit, the patients who need a hip replacement will schedule their surgery.
The individuals who need a valve replacement will get their cardiac procedure. I think in other specialties there will be a backlog, and it will be interesting as we go through the summer and the fall to see how that is handled. There is some short-term pressure in terms of just how much routine health care has paused or slowed down.
It has been interesting to see the articles talking about all the patients who used to come into the emergency room or the urgent care centers for aches and pains, and how much that has dropped. And then we are going to wonder going forward, will patients be more hesitant to utilize the health care system? Will they think once or twice before coming in?
As you have alluded to, we also have the economic side: we are seeing the unemployment numbers go up, which may have short-term impact as well. We have many Americans, unfortunately, uninsured or with less health insurance than they have had in the past.
What about the impact on community hospitals and for-profit hospitals?
SB: Sarah Cannon’s parent company is HCA Healthcare, and they have committed to not laying off anyone through this crisis. HCA Healthcare is a large company, with the financial strength to support pandemic pay programs that will aid employees.
County hospitals or rural community hospitals are impacted on a different level. They already were under economic pressures. I suspect we may see some consolidation and closures of hospitals in rural settings or in places that are geographically disadvantaged.
That issue is going to be a stressor to the system. We already were trying to figure out how to do rural health care before the pandemic, and this crisis has certainly exacerbated the challenge.
Hospitals that do not have a large system to help alleviate some of the stress are going to be struggling to get through the near term.
I was just looking at what seems to be happening in the adjuvant care. There seems to be a shift to neo-adjuvant—because of COVID. Is there data to support this in terms of safety and efficacy?
SB: That is a great question, and I say that because I have asked the same question. In certain settings, such as HER2 positive breast cancer, there are a number of patients who would likely benefit from neoadjuvant therapy, as well as some triple-negative or locally advanced tumors.
There are likely other subsets of breast cancer and other diseases where neoadjuvant therapy makes sense. But by and large, you are correct, that during this COVID-19 crisis, many think it is better to put patients through chemotherapy versus surgery. And that has been greatly debated.
We already were trying to figure out how to do rural health care before the pandemic, and this crisis has certainly exacerbated the challenge.
CMS came out with guidelines that put cancer surgery in the Tier Three category, and that seems reasonable. Our motto at Sarah Cannon has been that we are going to stay safe and stay the course.
We have seen a number of surgeries put off, but I do not think I have ever said to a patient with invasive cancer that their surgery is elective. Some are more urgent than others.
The system has made a quick shift to thinking that neoadjuvant therapy is the safest thing to do or the best thing to do, but there is not a lot of data to back that up in many settings. We have never really had clinical trials that showed that hormonal therapy was a great neoadjuvant treatment for the hormone-positive breast cancer. It is a real judgment call to put patients through chemotherapy, with myelosuppression and more in this setting.
There were some broad-based recommendations made from several societies that I found interesting, without a lot of data to back them up.
Will we learn from this, or will this be one of those societal experiments that we will never know the impact of?
SB: I hope we can learn from it. We have talked about this topic at ASCO. Under Dr. Richard Schilsky, the CMO, and in conjunction with the leadership, we have launched the ASCO Survey on COVID-19 in Oncology Registry [The Cancer Letter, April 17, 2020] to try to track the patients within our practices that have tested positive.
We are hoping that as we gather data, we can also get some insights to the overall changes in care that took place. CancerLinQ should also provide some of that information as its database has been growing.
You bring up some points that are going to be to key in this issue. Are some of these delays appropriate and what sort of delays are we seeing? Then, on the screening side, we have seen a marked decrease, both from health systems deciding not to have screening clinics open for mammography and colonoscopy, and also the patient population being unwilling to come in. It will be interesting to track that data.
We should be able to get some large looks at information across the country as we are seeing patients not come in for what are well known and data-proven screening mechanisms that are appropriate for certain cancers.
Is there any insight about immunotherapy versus chemotherapy in patients who are at risk for COVID?
SB: No, we do not have any data, but it’s been a question that is going to be asked and looked at with great interest. We had the initial group of data that came out of China and Northern Italy where lung cancer group seemed to do poorly. We do not have the next level of data in terms of immunotherapy and chemotherapy in some of those populations.
I think the most interesting data will be the U.S.
We are hoping within the ASCO registry that we gather a large amount of information and will be able to sort out whether we see a difference between immunotherapy and chemotherapy.
And then, specifically in some other populations, such as the bladder cancer group or some of the other diseases where immunotherapy is used more often.
Theoretically, the checkpoint inhibitors should have been an attractive treatment choice in the COVID-19 setting and one would hope that patients were not disadvantaged by taking those types of therapies.
This sounds like a good real-world evidence question.
SB: Absolutely. We will be aggregating the data as we go. This question might be one place where electronic medical records and the aggregation of data and platforms like CancerLinQ hopefully will really yield some insights.
I think we are going through the sprint phase right now. I’m no expert in infectious diseases, but one would think that now we will move into more of the marathon phase of COVID-19 where we will continue to see pockets of the virus and what happens during the upcoming fall season.
I suspect this virus will be with us for a while at least until we get some vaccines that are effective. So, these early learnings will be very helpful as we think about taking care of patients later in 2020 and then as we move into 2021.
What role have oncologists played—or have the science behind oncology played—in development of treatments? Are you seeing a kind of a merging of oncology with, say, virology with rheumatology?
SB: It is an excellent topic. Because of our research infrastructure and the rapid initiation of a number of COVID-19 trials, Sarah Cannon has been brought to the table to help with the infrastructure support around some of these clinical trials.
Our involvement has quickly led to more conversations, one being convalescent plasma. Our blood cancer doctors and experts that have been doing apheresis and transfusions and infusions for years have been brought in to help operationalize that and work with the Red Cross.
That therapy has been a place where we have seen the hematologists and oncologists brought to the table. Then we have also seen an abundance of potentially helpful therapies in the anti-inflammatory group. We have had some mixed news over the last few days about the IL-6 monoclonal antibodies that we’ve been using to help cytokine release syndrome.
There is a mix of data about the role of inflammation in COVID-19 analysis. We are seeing conversations about some of the other drugs that are out there such as selinexor, the new myeloma drug and acalabrutinib, the lymphoma drug, those being potentially efficacious in helping with an inflammatory response. So, we are seeing the oncologist being brought to the table to discuss how those therapies might work, how they might be utilized.
It is nice to see our specialists being able to contribute in that regard. Because at the practice level, we have been worried about the cancer patients being a vulnerable population.
So, at our facilities, the cancer doctors have been asked to not go to the hospital, to allow the hospitalist to take care of our patients and to really try to protect the oncologists from being exposed and potentially transmit to our patient population.
But academically, scientifically, intellectually, it has been good to see the conversations ongoing.
What will oncology look like when it’s over? Will there be a rebound? So, how will it work? What will it look like?
SB: Being a clinical researcher and involved in drug development throughout my career, I think one positive is going to be what we talked about in terms of modernizing the clinical trial process.
In regard to some types of visits, we know now that we can handle some with telemedicine, which may decrease the burden on the patient. The remote data monitoring has gone very well for our centers.
Decreasing the number of visits, sending out the pills for patients, and using local laboratories are some elements to modernizing the clinical trial process that I think will be attractive.
For some patients who live an hour or so away, and travel is burdensome, I think the idea of decreasing the number of visits will be attractive.
But having oral therapies shipped is going to create some pressure on what the payment model should be. We don’t envision a decrease in the need for nurses as they provide critical education and contact for our patients.
The pandemic is going to create an opportunity to look at how oncology should be reimbursed and how a practice is not disadvantaged when they are able to do some things remotely or electronically. And then I think bigger picture, this pandemic will help us set some health care priorities for the population.
I’m hopeful that after we get through the storm, there will be a real assessment and look at the data as you alluded to about the need and benefit to continue with appropriate cancer screening programs, mammography, colonoscopy, and appropriate CT scans.
And hopefully, we won’t see too big of a disadvantage coming from procedures being delayed. Hopefully, the information during this time will help confirm what we thought for years—that early detection of cancer really leads to better outcomes.
These few months of the COVID crisis are going to greatly shape how we approach health care over the next few years.
Let’s look at their rebound. If it actually happens, you won’t have a full rebound, probably, because adjuvant care that’s not delivered now is not going to be needed. But there would be a rebound. If there is a rebound, will the same institutions that are now furloughing people be trying to hire them back?
SB: It’s interesting to think about how that’s going to go. I’m glad that at Sarah Cannon we have not had to furlough anyone.
We’ve actually had a number of our staff move to a work from home setting to socially distance and create space in the clinical area, and that has actually gone fairly well.
You are right. There are certain segments that we will never catch up on with regard to visits and therapies. I think we will get back to business as it was in terms of volumes.
Now, I think there might be some things that are done remotely and through telehealth. We might see a real shift in the workforce assessment. I know that many of these hospitals and many of the cancer centers and health care systems in general are finding out that some of these individuals can work from home. And so, do they all need to be in the office?
So, I think we will see some changes in terms of how the workforce is deployed as well. Patients are still living longer. Our generations have been healthier or seen the continued need for health care as patients are moving into the older ages. We are certainly a long way from having cured cancer.
The number of younger people being affected by cancer continues to be real and continues to be growing. So, I think the need is going to be there.
Is there anything we missed? Anything we’ve overlooked?
SB: I think you have hit the big points. It has been interesting being involved with ASCO during this time, to see the thirst for information and the connectivity across the country and across the globe.
Our ASCO.org resources have received an incredible number of page views. We went from a few thousand to a 100,000 to 250,000 over the past week. Patients are desperately looking for information and concerned about where they are in their care and the treatment.
We have also been looking at, and it kind of goes to the workforce question, how often do we need to get together and meet? I think people love the big annual ASCO meeting in Chicago. I know I am particularly sad that we will not be gathering this year. It might be that we see fewer in-person meetings overall. We will certainly see how these virtual meetings go over the next couple months.
It might be that we see fewer in-person meetings overall. We will certainly see how these virtual meetings go over the next couple months.
We might see a real shift here in terms of how education is done. Even just from this past month, we have gone from being uncomfortable being seen on video to accepting them as part of life.
And we’re a very adaptable society, and I think most people are technologically savvy. It’s been interesting to see just what has changed over the last 4-6 weeks. We’ve seen a seen a real culture shift in terms of the willingness to do something via video.
Thank you so much for talking with me.
