ASCO in Action Podcast

Retiring ASCO Chief Medical Officer Dr. Richard L Schilsky gives a far-reaching interview with ASCO in Action podcast host ASCO CEO Dr. Clifford A. Hudis, who examines Dr. Schilsky's trailblazing medical career, his leadership in ASCO and indelible mark on its research enterprise, and what he sees for the future of oncology. ASCO's first-ever Chief Medical Officer even offers some friendly advice for Dr Julie Gralow, who starts as ASCO's next CMO on February 15, 2021. In a touching tribute, Dr. Hudis also shares what Dr. Schilsky's friendship and mentorship has meant to him personally, and suggests that Rich will still be supporting ASCO on critical priorities moving forward. Don't miss this exchange with one of oncology's greats! Transcript DISCLAIMER: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. CLIFFORD HUDIS: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. The ASCO in Action podcast is a series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. My name is Dr. Clifford Hudis. And I'm the CEO of ASCO and the host of the ASCO in Action podcast series. For today's podcast, I am especially pleased to have as my guest my friend, colleague, and mentor Dr. Richard Schilsky, ASCO's chief medical officer. Now, I am sure that many of our listeners have already heard that Dr. Schilsky will be leaving ASCO in February of 2021, retiring. However, I want to reassure everybody that even in retirement, he will continue to make contributions and provide leadership to all of us. And his illustrious and path-blazing career in oncology spanning more than four decades is not quite over thankfully. Rich is ASCO's first chief medical officer. And as such, he has made a truly indelible mark on all of us. He started with a proverbial blank piece of paper. The position had no precedent. It had no budget. It had no staff. But now after just eight years in the role, he has helped make the CMO a critically important position at the society. And I have to say that success is more than anything due to Rich's vision and his leadership. And that's some of what we'll be talking about today. So Rich, thank you very much for joining me today for what I hope is going to be a great casual but informative conversation about your amazing career, your unique role at ASCO, and maybe most importantly in the end what you see for the future of oncology not just in the United States, but around the world. Thanks for coming on, Rich. RICHARD SCHILSKY: Thanks, Cliff. It's great to be here today. CLIFFORD HUDIS: So with that, let's just dive right in and start at the very beginning. Rich, tell everybody why you decided to become an oncologist and maybe share a little bit about what those early days looked like for you and, in that context, what it was like to have cancer at the beginning of your career. RICHARD SCHILSKY: Well, I knew from an early age that I wanted to be a doctor. And in fact, I had written a little essay when I was in sixth grade as a homework assignment called My Ambition. And my mother had tucked that away in a scrapbook. And I found it a number of years ago. And on rereading it, it was quite amazing to me to see what I was thinking about even then. Because I said not only did I want to be a doctor, but I didn't think that was enough, that I wanted to be a medical researcher because I wanted to discover new information that would help people heal from whatever their diseases might be. And so it was never really any doubt in my mind that I would be a physician. I went to medical school at the University of Chicago. But I was living in New York City at the time having grown up in Manhattan. And the only year we had off in medical school, the only time we had off in medical school, was the summer between the end of the first year and the beginning of the second year. So during that time, I went back to Manhattan. And I was able to get a fellowship from the American College of Radiology that allowed me to essentially hang out in the radiation therapy department at New York University Medical Center, which was within walking distance of where I grew up. And so I would go over there every day. And I was taken under the wing of a young radiation oncologist. And of course, I wasn't really qualified to do anything at that point except to follow him around, talk and listen to the patients. But that turned out to be a really formative experience for me because we saw the whole gamut of cancer. We saw head and neck cancers. We saw lung cancer. We saw patients with breast cancer and prostate cancer. And in those years-- this is the early 1970s-- many of these patients have fairly locally far advanced disease and were quite debilitated by it. But listening to their stories, hearing about their hopes and their struggles, really demonstrated to me the human side of cancer. So I went back to school and thought about this in the context of my own personal experience, which dated back to when I was in college when my mother's mother, my maternal grandmother, was diagnosed with breast cancer. This was 1968. And as you well know, there were very few therapies available for breast cancer in the late 1960s, mostly hormone therapies. And my grandmother had the treatment that was considered standard of care at that time, which was extended radical mastectomy followed by chest wall radiation. And some years after that first mastectomy, she had a breast cancer that developed in the opposite breast and had a second extended radical mastectomy and chest wall radiation. And these were very traumatic and disfiguring procedures for her to go through. Anyway, long story short is after another few years, she developed bone metastases and then brain metastases. And there was really very little that could be done for her other than hormone therapies. And having observed her go through that illness and realizing how limited our treatment options were and then having the experience after my first year in medical school pretty well cemented for me that I wanted to be an oncologist. I thought actually about being a radiation oncologist. But then I did my internal medicine rotation in medical school, fell in love with internal medicine. And that sort of put me on the path to be a medical oncologist. The clinical challenge of caring for cancer patients, the emotional attachment to those patients, and, of course, even then, the unfolding biology of cancer was so intellectually captivating that I actually applied for oncology fellowship when I was a senior medical student. So even before going off to do my medical residency, I had already been accepted as a clinical associate at the National Cancer Institute to start two years hence. And that's how I became an oncologist. CLIFFORD HUDIS: So it's so interesting. Because, of course, the story I'm sure for many people interested not just in oncology, but even medical education, there are little things that don't happen nowadays that happened with you like that last little vignette about the early acceptance into an advanced training program before your fellowship among other things. Can you remind us about the timeline? Because I think one of the things that many of our listeners often can lose sight of is just how new oncology really is as a specialty. ASCO itself founded in 1964. And the first medical oncology boards were mid-'70s, right? So you were in med school just before that second landmark, right? RICHARD SCHILSKY: That's right. I graduated from medical school in 1975. I started my oncology fellowship in 1977. And I got board-certified in medical oncology and joined ASCO in 1980. And so that was the time frame at that point. CLIFFORD HUDIS: So the internal medicine was actually, if I heard you right, just two years, not the now traditional four. RICHARD SCHILSKY: Yeah. I was a short tracker. I did only two years of internal medicine training rather than three. I did my training at Parkland Hospital and University of Texas Southwestern in Dallas with at that time a legendary chair of medicine, Don Seldin, who I had to get permission from him to leave the program prior to completing the third year of residency because I had already been accepted into fellowship at NCI. And he, Seldin, who was a brilliant chairman and a brilliant nephrologist, was not at all interested in cancer. And it took a bit of-- I was going to say arm twisting, but it really took bleeding on my part to get him to agree to allow me to leave the residency program to go to the NCI. But he eventually agreed. And in those years, the first-year clinical fellowship at the NCI was like being an intern all over again. There were about 15 of us. We were on call overnight in the clinical center once every two weeks. We cared for all of our inpatients as well as had a cadre of outpatients. We did all of our own procedures. We had no intensive care unit. So patients who were sick enough to require ventilator support, we cared on the floor in the inpatient service on our own with guidance from senior oncologists. It was a bit different from the way it is now. But, of course, it was fantastic on-the-job training because we just learned a ton and had to learn it very quickly. CLIFFORD HUDIS: So that's actually a great segue to the a

In the latest ASCO in Action podcast, ASCO CEO Dr. Clifford A. Hudis shares a quick preview of what's to come for the 2020 ASCO Advocacy Summit and Week of Action, which will take place September 14-18. Typically, ASCO volunteers from across the country gather in Washington, D.C. to advocate for policies that will improve access to high-quality, equitable care for people with cancer and ensure robust funding for cancer research through in-person meetings with their Members of Congress. Due to the COVID-19 pandemic, the 2020 ASCO Advocacy Summit will be a virtual event, but participants can expect the same important advocacy and education opportunities that the event provides every year. All ASCO members are encouraged to participate in the Congressional Week of Action by signing up with the ACT Network (through the Advocacy Center on ASCO.org). Subscribe to the ASCO in Action podcast through iTunes and Google Play.   Transcript Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Dr. Clifford Hudis: Welcome to the ASCO in Action Podcast, brought to you by the ASCO Podcast Network, a collection of 9 programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at "Podcast dot ASCO dot org" (podcast.asco.org) The ASCO in Action Podcast is ASCO's podcast series that explores the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for—people with cancer. I'm Dr. Clifford Hudis, CEO of ASCO and the host of the ASCO in Action podcast series. For this podcast, I wanted to share with listeners a preview of the 2020 ASCO Advocacy Summit and Week of Action taking place September 14-18. Typically, ASCO gathers volunteer advocates in Washington, D.C., in September for education sessions and in-person meetings with their Members of Congress. Due to the COVID-19 pandemic—like so many events scheduled to take place this year—the 2020 ASCO Advocacy Summit will be a virtual event, but that said, participants can expect the same advocacy and education opportunities that the event provides every year. ASCO volunteers will meet with Members of Congress and their staff by phone or video to advocate for policies that will improve access to high-quality, equitable care for people with cancer and ensure robust funding for cancer research. Advocacy Summit attendees will also attend webinars to receive education and training on lobbying Congress and the current political landscape. What is different this year is our online Week of Action, which will give all ASCO members an opportunity to advocate on critical issues of great importance to the cancer care delivery system in the United States. Participants in the Week of Action will amplify the Advocacy Summit's messages through email and social media messages to Members of Congress using ASCO's ACT Network. And, it's easy to get involved and make your voice heard. You just need to click on the link to the ACT Network in the Advocacy Center on ASCO.org and sign up to receive ASCO ACT Network emails. Then, you'll get all the information on the fastest and easiest ways to contact lawmakers delivered directly to your inbox. We hope you will participate as much as you can—the effort will take just minutes. Even one message a day by every ASCO member to your representatives in Congress will have a tremendous impact. During the virtual Advocacy Summit, which will be held in the middle of the Week of Action on September 16, ASCO volunteer advocates will have their virtual meetings with Members of Congress and their staff. The three issues or "legislative asks" that they will be discussing will be the same asks that ASCO members will contact their Members of Congress about during the Week of Action. One, we will ask Congress to support legislation—The CLINICAL TREATMENT Act, which will give all Medicaid beneficiaries coverage of routine costs when enrolled in clinical trials—coverage Medicare and private insurance plans already provide. The importance of improving health equity has become even more apparent during the COVID-19 pandemic, and this legislation takes us one step closer to that goal. Two, ASCO volunteer advocates will request lawmakers to co-sponsor the Safe Step Act, which will help protect patients from harmful step therapy protocols, which ASCO believes is never appropriate in the treatment of cancer. And three, we'll address the impact COVID-19 has had on cancer practices and research. Specifically, advocates will ask Congress to endorse maintaining reimbursement flexibilities for telehealth, as many oncology practices have rapidly transitioned to telehealth to ensure patients continued receiving treatment during the pandemic.  We'll also be asking Congress to provide emergency funding to the National Institutes of Health to mitigate disruptions caused to labs and clinical trials by COVID-19, and to restart research across the county. These are the same issues that participants in the Week of Action will be advocating for all week long in their outreach to Congress. The goals of the Advocacy Summit and Week of Action are to advance priority legislation, amplify the collective voice of the cancer care community on Capitol Hill, and to get ASCO members involved in advocacy initiatives. Members of Congress and their staff have grown accustomed to virtual constituent meetings, and personal stories continue to be the most effective form of advocacy, so the Advocacy Summit and Week of Action—even virtually—remain critical to ASCO's larger advocacy efforts. In addition to the meetings and messages between advocates and lawmakers, the ASCO Advocate of the Year and the Congressional Champion for Cancer Care will be named during the Advocacy Summit. In closing today, I encourage everyone listening today to follow the Advocacy Summit through social media by way of the hashtag ASCO Advocacy Summit (#ASCOAdvocacySummit) on Twitter AND to participate in the Week of Action through the ACT Network. A link to the ACT Network and all the information you'll need to participate in the Week of Action is available at ASCO dot org slash ASCO Action (www.asco.org/ascoaction). Until next time, thank you for listening to this ASCO in Action podcast and if you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts or wherever you listen and while you are there, be sure to subscribe so you never miss an episode. The ASCO in Action Podcast is just one of ASCO's many podcasts; you can find all of the shows at "Podcast dot ASCO dot org" (podcast.asco.org).

ASCO President Lori J. Pierce, MD, FASTRO, FASCO, joins ASCO CEO Dr. Clifford A. Hudis in the latest ASCO in Action podcast to discuss how her childhood inspired her to become an oncologist and how the theme of her presidential year, "Equity: Every Patient. Every Day. Everywhere." is more important than ever as the country responds to a healthcare pandemic that is disproportionately impacting people of color. "Every patient, no matter who they are, deserves high-quality care and every patient has the right to equitable care," says Dr. Pierce. "We have to get to the root causes to understand the barriers that patients face if we're going to really make a difference, so it's important to me that equity be front and center of everything that we do." Subscribe to the ASCO in Action podcast through iTunes and Google Play.   Transcript  Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.  The ASCO in Action Podcast is ASCO's series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for--people with cancer. My name is Dr. Clifford Hudis. And I'm the CEO of ASCO, as well as the host of the ASCO in Action Podcast series.  Today I'm really pleased to be joined by Dr. Lori J. Pierce, ASCO's president for the 2020-2021 academic year. Dr. Pierce is a practicing radiation oncologist. She is a professor and vice provost for academic and faculty affairs at the University of Michigan. And she is the director of the Michigan Radiation Oncology Quality Consortium.  Dr. Pierce, thank you so much for joining me for this podcast. My hope today is that our conversation will give our listeners a better idea of who you are, what and who has had important impact and influence over your life, and what your professional career and path as a radiation oncologist has looked like. I also hope to highlight what you hope to accomplish during your presidential year.  Dr. Lori Pierce: Thank you, Dr. Hudis. I'm glad to join you today. Before we get started, I just want to note that I have no relevant financial relationships to disclose.  Dr. Clifford Hudis: Now before we start to discuss the details of your presidential theme and your current role at ASCO, I think our listeners will be really interested to learn how your childhood inspired you to become a radiation oncologist. And I hasten to add ASCO staff were really excited by the stories that you shared when you gave an all staff presentation a few weeks back. So, can you talk a little bit about your childhood summers in North Carolina, how they were informative for you, and how they inspired your career?  Dr. Lori Pierce: Sure. I'm happy to. So first of all, I'm originally from Washington D.C. But my father's family, which is quite large, is from a small town in North Carolina called Ahoskie. And that's in the north eastern part of the state, maybe about 30 minutes just beyond Virginia. And I have tons of relatives. I used to love to go visit them every summer because I would get spoiled.  But that was in the south in the '60s. And in retrospect there was significant segregation there. And I again would have a great time going to visit my family. But I noticed--and it was something you noticed and you put in the back of your head--that when there were health care issues, there was one doc that my family could use. And he was great. Doc Weaver, he did it all.  He was the one who would come to the homes, deliver babies, take care of all the medical issues--he did at all. And so, people just revered him because he always seemed to help people. And that stuck in my mind. That was actually when the first times that I thought about possibly becoming a physician because he always seemed to make people better.  But then also the experience as I got older made me acutely aware that there was indeed segregation in Ahoskie and that there was inequity in care. Even Doc Weaver seemed to be a great doctor for someone--I was 5 or 6 at the time. And to my eyes, he was great. Clearly there weren't choices in terms of care. And that was my first exposure to inequity in terms of health care.  Dr. Clifford Hudis: Well that's interesting, of course. And obviously we're going to circle back to this. But before we get to that, one of the things that I always point out to Nancy Daly--who's the CEO of Conquer Cancer--is that all roads lead through Philadelphia in medicine. You proved that true, right?  Dr. Lori Pierce: Yes. So, I went to the University of Pennsylvania. I got my degree in engineering. I should say at that time I clearly was planning to go into medicine. But I was going to go into radiology. And so biomedical engineering was a great area to pursue. I majored in biomedical engineering and minored in chemical engineering from the University of Pennsylvania.  And so, then I applied to Duke for medical school. I was accepted. But I decided to defer my admission. And so, I worked for a while before going into medicine.  Dr. Clifford Hudis: Well that's interesting. And when you deferred your admission, was this because you had something you wanted to do, or you needed to essentially to save money in order to go to medical school? What did you do in that break?  Dr. Lori Pierce: Yeah. So, it was very much the latter. My parents were absolutely wonderful people. And they focused very much on education from my sister and me--for us to go to the best possible colleges. My parents never had an opportunity to go to college. And so, they very much wanted the best colleges for my sister, Karen, and I.  But we had a ground rule in our family. And that was that if my sister or I decided to go and pursue education beyond undergraduate degree that we would need to pay for that. And so, I knew that. And even though I was very fortunate to get quite a bit of scholarship from Duke, there was still going to be a lot that I was going to have to pay.  And so, I made a decision, instead of taking out a lot of loans, that I was actually going to work. At that time--probably now as well--being an engineer brought a very good salary. And so, I elected to defer my admission for medical school and take the offer that gave me the most money.  And that ended up being a job in Round Rock, Texas, which is just outside of Austin. And I have to tell you this was back in 1980. And it's not at all what Round Rock is like now. I hear Round Rock--since industry is there now--is really just a suburb of Austin. But at that time, Round Rock was a sleepy town I-35 from Austin. So, I can live in Austin and work in Round Rock.  And it was a very interesting experience. I worked for McNeil Consumer Products. I was the second shift supervisor. And it was an interesting time because here I was fresh out of undergrad, green behind the ears, and an African-American woman, as a supervisor to people who were generally in their 40s through 60s, most of whom had never been out of the state of Texas, and you look at that and you say, oh my gosh. How did I get here? Why am I here? Why did I decide to do this?  And you think about how different people are. But when you start to work with people, you realize that there are common threads. And you find those common denominators. And you learn that even though we may look different on the outside, there are a lot of things that are similar in the inside.  And I think the lessons that I learned as that second shift supervisor have served me well in medicine because you can always find a common denominator with patients, even when apparently at first look, it looks like you're very, very different. So, they were very good lessons I think that I learned that I wouldn't have done had I not chosen that path.  Dr. Clifford Hudis: So, I think that some of what you learned will no doubt pop up as we talk in greater detail now about your presidential theme. Let me just start by saying for me personally, this is one of the highlights of the year for me each year, when our president comes on board in a sense and begins to present their vision for their theme and what they hope to see us achieve over the year they serve as president.  And it's amazing because of course the wide range of background experiences as well as aspirations that different people bring. And you certainly I think came into this with a very clear vision of equity for every patient every day everywhere. Can you expand I think--I wouldn't say speak on this because you've already begun to touch on it--but can you expand on what you were hoping to see accomplished through this theme and what motivated you to focus on it specifically in your role as ASCO president?  Dr. Lori Pierce: A multitude of things. It's hard to really pick out one. But certainly, I think we all are acutely aware of the different outcomes for people of color. In terms of almost any industry you look at, the outcomes are less favorable, significantly so for people of color. And you look at those numbers and you know that there are reasons to explain this.  And it's not just biology, which is what a lot of people propose. And quite often it's not biology at all, that clearly these patients are lower socioeconomic status. The majority of these patients are poor. Late diagn

American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Piyush Srivastava, the past chair of ASCO's Clinical Practice Committee, in the newest ASCO in Action Podcast to discuss the recently released ASCO Special Report: A Guide to Cancer Care Delivery During the COVID-19 Pandemic. Dr. Srivastava was instrumental in developing the report, which provides detailed guidance to oncology practices on the immediate and short-term steps that should be taken to protect the safety of patients and healthcare staff before resuming more routine care operations during the COVID-19 public health crisis. Subscribe to the ASCO in Action podcast through iTunes and Google Play.   Transcript  Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Dr. Clifford Hudis: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.  This ASCO in Action podcast is ASCO's series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer.  I'm Dr. Clifford Hudis, CEO of ASCO. And I'm the host of the ASCO in Action podcast series. I'm really pleased to be joined today by Dr. Piyush Srivastava, the past chair of ASCO's Clinical Practice Committee. Dr. Srivastava is also a practicing gastrointestinal oncologist, the regional medical director of the End of Life Options program, and the director of Outpatient Palliative Care at Kaiser Permanente Walnut Creek Medical Center in California.  Today, we're going to talk about the recently released ASCO Special Report: A Guide to Cancer Care Delivery During The COVID-19 Pandemic.  Dr. Srivastava was instrumental in developing the report. And we'll speak today about the guidance that the report provides for oncology practices as they return to more routine care delivery. Piyush, thank you so much for joining me today.  Dr. Piyush Srivastava: Thank you, Dr. Hudis for taking the time to speak with me. Just before we start, I just want to say that I do not have any relationships to disclose. So, thank you.  Dr. Clifford Hudis: Thank you very much for joining us today. Now, just to provide some context, today as we speak, we're approaching month five of the COVID-19 public health crisis in the United States. We've had more than 2.15 million confirmed cases of the virus and well over 100,000 deaths.  In fact, as we record this today, several of the largest population states in the United States-- California, Texas, and Florida-- are just reporting their largest single-day increases in cases and the health care systems in some of their big cities are approaching the kind of near breaking point that we saw earlier in New York. So, the problem is still very much with us.  When the outbreak began, oncology practices nationwide immediately began making operational changes designed to protect the safety of patients and the safety of staff. This meant adjusting to resource shortages that were unfolding and complying with national and state restrictions on elective procedures, among many other things.  Today, communities across the country are in varying states of recovery. And as I just described, some of them actually are probably pausing their recovery right now. Either way, they are facing a real transition in terms of oncology practice. And some are returning to something more like routine care while continuing to be acutely attuned to protecting the health and safety of both patients and staff.  So, Dr. Srivastava, could you start us off and tell our listeners just a little bit about what's happening in your own practice and how you have been adapting to the changing circumstances?  Dr. Piyush Srivastava: Of course. I would be very honored to share my experiences at Kaiser Permanente in Northern California. So, at the start of the pandemic, we were very fortunate to be nicely set up to provide care remotely. We've had a very strong existing telehealth structure. So, we were quickly able to adapt to the pandemic situation.  Initially, we nearly went 100% remote, with doing all of our new consults and chemo checks via video visits and telephone visits. If a patient needed some more attention, to be seen by a care practitioner, many times that we would coordinate with the on-call physician on site, who would see the patient on the chemotherapy infusion chair.  We also looked as an institution which services we could provide remotely and take off site and so that we didn't need to bring the patients into the cancer center. For example, we activated our home health nursing team to be able to provide port flushes in the home setting.  We also made a very conscientious effort to see what treatments and what procedures that we could postpone or actually decrease the frequency or increase the timing in between events. For example, bisphosphonate administration and port flushes, which we increased to do every three months.  What was extremely eye opening and inspiring to me is a large organization such as Kaiser Permanente was extremely nimble and flexible and was able to respond to the outside pressures. I believe, when I speak to my colleagues across the country, that many people experienced the same things with their institutions. And their institutions responded very flexibly to the ongoing pandemic.  Dr. Clifford Hudis: Thanks very much. It's really interesting, I think for me, and I'm sure for many of our listeners, to hear how you adapted but also to compare that with their own experiences. It sounds to me like some of the key features were clear eye on the safety of patients and staff but also having a structure that respected the needs of the clinicians from the beginning. And then, of course, understood that the flexibility overall was a key attribute. And I just think that's something that many people will be reflecting on.  As we hit it from that one in a sense, forgive me, but anecdote, which is how one center, one operation adapted, I wonder if you could talk a little bit about ASCO's role in providing the more general guidance that you helped to develop. Why did this society feel it was necessary to provide guidance at that level?  Dr. Piyush Srivastava: Yes. So, as we are all extremely aware, many individual health care professionals, institutions, and health systems look to ASCO for mentorship when it comes to oncology care. So, this current pandemic was no different. I believe ASCO felt a strong duty and a responsibility to partner with the oncology world to ensure the highest quality and efficiency of cancer care and delivery through this pandemic.  Also, the beginning of the pandemic, there was a lack of really clear guidance from federal and state agencies. So, cancer care providers and administrators looked to ASCO to help develop their plans of providing care during the pandemic. Now, also opening and ramping up as well, they're looking to us.  Dr. Clifford Hudis: I see. So, as we think about staff at ASCO headquarters, it's really pretty straightforward on a daily basis. Our decisions to open headquarters, for example, or not are predicated, number one, on the safety of our staff. So, when you look at the Special Report, what would you say was the one or the several overarching goals that drove the development of the Special Report?  Dr. Piyush Srivastava: So, when constructing the report, we did very much realize that there are so many varied practices across the country, really around the world, right? For example, we have small rural practices. We have medium-sized private practices. We have academic centers, and we have hospital systems. And all these organizations look to ASCO for cancer guidance and guidance to cancer care delivery.  By no way were we going to be able to solve individual operational care delivery issues for each practice. So, the Special Report is made to serve, if you will, as a starting point or a launching pad for individual institutions to develop their own policies and operational adjustments.  So, what I would like to do now is maybe just dive a little bit deeper into some of the specific policies and practices that were outlined in the report. And as I look at it, it was really broken down into stages of patient care.  So, for example, before a patient even arrives on site, many practices are in a sense pre-screening them or triaging them. What are some of the methods that you have seen put into place and that have been effective that we should recommend to practices just getting open?  So, the Special Report lists out very clearly sequential steps to consider in safely bringing patients into cancer centers. And I'll highlight a few of them, which I feel is extremely important. The first step is to actually reach out to the patient well before their scheduled visit to the cancer center. So, if we can call these patients and family members well before their visit, we can educate them as to the process that they'll experience when they come into the cancer center.  Allow them to ask questions and to give the reasoning behind or the why to we are doing this. I think that will go a long way. So transparent communication, I think, will reduce anxiety and fear.  I also believe an effective second step was to do a quick check in, anywhere from 12 to 48, 72 hours prior to the actual visit, de

In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Jonathan Marron, incoming Chair of ASCO's Ethics Committee and a lead author of the new Ethics and Resource Scarcity: ASCO Recommendations for the Oncology Community During the COVID-19 Pandemic.  In this episode they discuss ASCO's recommendations, why ASCO developed this guidance, and what patients, families, and the entire medical community need to know about allocating limited resources during the COVID-19 Pandemic.   Subscribe to the ASCO in Action podcast through iTunes and Google Play.    Transcript Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content that offers enriching insights into the world of cancer care. You can find all of our shows, including this one, at podcast.asco.org. The ASCO in Action podcast is ASCO's podcast series, where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer. My name is Dr. Clifford Hudis, and I'm the CEO of ASCO. And I'm proud to serve as the host of the ASCO in Action podcast series. Today, I'm very pleased to be joined by Dr. Jonathan Marron, incoming chair of ASCO's Ethics Committee and a lead author of ASCO's recent recommendations for the oncology community on ethically managing scarce resources during the COVID-19 pandemic. Dr. Marron is also a bioethicist at Boston Children's Hospital, a pediatric oncologist at Dana Farber Cancer Institute, and he is on the Center for Bioethics teaching faculty at Harvard Medical School. Today, we're going to talk about those recommendations. And I'll note that they were published just recently as a special article just in early April in the Journal of Clinical Oncology. We'll focus specifically on the reasons that ASCO took this step and what it is that oncologists, patients, families, and the entire cancer care community need to know about this issue. Dr. Marron, thank you so much for joining me today. Dr. Jonathan Marron: Thank you so much, Dr. Hudis. It's really a pleasure to be speaking with you, and an honor as well. Before we get started, I do want to just point out that I have no conflicts of interest to disclose. Dr. Clifford Hudis: Well, that's great. Now, just to provide some context as we start this discussion, it's the middle of May as we're recording this. In the United States, the COVID-19 public health crisis bubbled up to awareness a little bit in January, became seemingly near threat in February, and seemed in the public's eye, I think, to breach our shores at the beginning to middle of March. So, we're about four months, more or less, into this public health crisis. The US has had now about a million and a half-confirmed cases of the virus. And I think this week, we crossed the 90,000 number in terms of deaths from the virus. From the very early days, there was-- and we all remember this-- an extraordinarily emotional and widespread concern that medical resources, and especially ventilators, but also medications, as well as space, critical and intensive care beds-- those three things, that they would be stretched, that some communities would be especially hard hit, and that, as a consequence, access to those resources might be limited. And when that arose as a concern, what followed, especially for people who work in this field, and bioethicists in general, as well as everyday clinicians, was the very real possibility that they would be forced to make some painful and difficult choices. And I'll say some of our members wrote about these experiences as well in ASCO Connection and elsewhere. So, can you now maybe help our listeners understand why ASCO in particular thought that this situation needed to be addressed and why we decided to provide the very specific guidance that you took part in creating in the form of these recommendations? Dr. Jonathan Marron: Absolutely. So you really highlighted a couple of the main questions and concerns that we had that we wanted to do our best to address, in the sense that at the outset of the pandemic, it was really difficult to tell what direction things were going to go and just how bad everything was going to get. Seeing the experience in China and seeing the experience in Italy, there was significant concern that, as you mentioned, our health care system would not be able to support the critical care needs that we would have. There is a long history of people thinking about how to utilize and best utilize resources like this in the setting of scarcity. One of the concerns that comes up whenever you have to make these difficult or realistically impossible choices is how you're going to do so. And so really, that's where we came, as oncologists and as the ASCO community, to try to figure out how we could best represent the oncology community and to ensure that cancer unto itself was not going to keep a given patient from having a fair chance to access these potentially lifesaving resources, even in the setting of a public health crisis like this, even in the setting of scarce resources. Dr. Clifford Hudis: So, I remember as this was being developed having conversations with, I think, you and other members of the panel. I'm going to push a little bit on at least one of the areas that I think is really a concern but can be misunderstood. And that is this high-level statement you just made that people with-- if I understood correctly-- that people with cancer might find themselves discriminated against in these moments of triage, fundamentally. There's one ventilator. There are three patients at need. And God forbid we're ever in this situation-- how do you decide who gets it. On the one hand, of course, there's a fairness doctrine. But on the other, there is a medical reality. And cancer is not one thing. So, could you just talk a little bit about what we mean when we say protecting the cancer patients? And let me be clear. We're not saying that cancer as a diagnosis, stage, prognosis should be ignored exactly, right? Dr. Jonathan Marron: Absolutely. And I think what you said there really is one of the most, if not the most, important aspects here, that there are a couple of different ways that you can go about trying to take, as the example that you had of the three patients, and decide which of those three will get the ventilator. If not the perhaps fairest way would be simply to make a choice at random and say each of those three individuals has an equal chance at it, and we'll flip a coin or do some other random way of deciding who will get it. That's certainly fair. But some people would say, you know what? They may not be equal in all ways. And if we're trying to maximize our resources and maximize the potential outcome benefits of these scarce resources, we want to do something more than just do something-- choose randomly. And we've actually learned in the past from work with community groups that people don't love the idea of randomly choosing things like this, in a public health emergency or otherwise. And so then-- the question, then, is OK, so how are you going to make that choice. If we're trying to maximize health care outcomes, and which you usually think about that being survival, we want to use medical information. But then the question is, what is the information that should be used. So, one of the concerns is that there could be certain disease processes, cancer or otherwise, that would be seen as exclusion criteria. That's to say, OK, we have these three patients. We have one ventilator. Patient one has cancer, so therefore we're going to not even give them a chance at that ventilator. And that's really where this comes in. That's not the way to do this. Cancer absolutely should come into the consideration. But that patient's specific cancer-- their diagnosis, their prognosis, the medical information-- the best medical information that we have, the best evidence-based medical information that we have about their specific disease so that we can make an informed decision, or at least a maximally informed decision about who is the most likely to survive if they are given access to the ventilator or ICU bed or whatever it might be. Dr. Clifford Hudis: Yeah, I think this was one of the areas that you had to read somewhat carefully and be patient to understand the context, because if I understand correctly-- and with no disrespect to our colleagues outside of oncology-- one concern is that in the ER, a patient who once had cancer might just be, in a blanket way, discriminated against. But look, I was a breast cancer doc for 30 years. Most of my patients were, frankly, cured. And the fact that they had breast cancer in 1996 is of essentially no meaningful relevance to any medical decision, almost. I'm oversimplifying it here, rather. But our concern, I think, was that in the front lines, under duress and pressure, that mistaken judgments might be made, and we wanted to advocate for that. Is that-- I may not have said that so elegantly. But is that-- that was one of the concerns in the other direction, right? Dr. Jonathan Marron: Absolutely, yeah. And it's certainly conceivable that somebody, in a very well-intentioned way, would think that OK, this patient currently has cancer or at some point in the past had cancer. And as wonderful as the electronic record is, sometimes it can be difficult to

In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by Dr. Ray Page, Past Chair of ASCO's Clinical Practice Committee and President of the Center for Cancer and Blood Disorders, to discuss the benefit of drug repository programs solely for oral medications that are maintained within a closed system. These programs can play an important role in helping patients afford their treatment and can reduce the financial toll on the cancer care delivery system, provided that important guardrails are implemented to keep these programs safe. Subscribe to the ASCO in Action podcast through iTunes and Google Play.   Transcript  Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. The ASCO in Action podcast is an ASCO series where we explore the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer.  My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series. For today's podcast, I am really pleased to join once again Dr. Ray Page. Dr. Page is a past chair of the American Society of Clinical Oncology's Clinical Practice Committee, he is the President of the Center for Cancer and Blood Disorders where he also serves as a medical oncologist and hematologist, and he's a great and good friend of ASCO's.  Earlier this year, ASCO released a position statement on state drug repository programs outlining the society's support for such programs solely for oral medications and provided that they are maintained within a closed system. ASCO's statement also makes recommendations to help ensure that these programs are implemented appropriately with sufficient patient protections in place.  Today, Dr. Page and I will discuss the important role that these programs can play in helping our patients afford their treatment while reducing the financial toll on the cancer care delivery system as a whole. We will discuss the important guardrails that are needed to keep these programs safe. And with that, I want to welcome you, Dr. Page, and thank you for joining me today.  Dr. Ray Page: Thank you very much, Cliff, for having me for this conversation today. And I just want to let you know that I have no disclosures for this conversation.  Dr. Clifford Hudis: Thanks again for joining us today, it's a real pleasure to talk with you once more. And I want to get to today's subject. First and foremost, what are state drug repository programs? How do they work and what's the purpose?  Dr. Ray Page: In its simplest definition, a drug repository program is basically a legal process that allows unused drugs that have been prescribed to patients to be able to be donated and reused rather than thrown away or set aside if it's no longer needed. Its purpose is to offer a practical way to increase access of prescription drugs for patients. And often, this process can offer more timely access to drugs with a negligible financial impact for the patients. And this was a program that has managed at the state level, and it's subject to individual state laws and State Department of Pharmacy rules and procedures.  And these kind of programs are of exceptional importance to cancer patients who are constantly challenged today with getting affordable access to vital drug treatments for their disease, and these issues are described very well in ASCO's 2017 position statement on the affordability of cancer drugs. And this has all been on the radar of ASCO's State Affiliates Council in recent years where our state society presidents and their executive directors have shared model state legislation to advance these kinds of drug donation programs in their individual states.  Dr. Clifford Hudis: So, Ray, before we go any further, can you tell me, what does this actually mechanically in practical terms look like at the level of a practice or from the perspective of a patient or a pharmacy? What actually happens physically with product in the context of a repository?  Dr. Ray Page: It really varies from practice to practice and state to state, but Cliff, I can tell you that I see this in my own practice absolutely every day in my doctor-patient interaction. And this is really what's gotten me personally intensely interested in pursuing and establishing laws in Texas to allow for pill donation. Because ideally, we would like to have that transaction between the doctor and the patient of being able to get unused drug for those patients where the drug's not used anymore  And so there's many reasons why in the office, these people don't need the drug anymore. They could have progression of disease that requires new drug, or alternatively, they could have completed their treatment regimens that may have resulted in a cure. But oftentimes there can be interval dosage adjustments due to side effects and toxicities where they just need a new prescription.  And lastly, I just have to mention a little bit about the negative impacts of the pharmacy benefit managers in this world, and I'll refer our listeners to our previous podcast that we did together a few months ago just understanding the global concerns of the PBMs, but however, I'll just say that their drug distribution process oftentimes contributes to the tremendous cancer drug wastage that we have in the United States.  Dr. Clifford Hudis: Well, I mean, picking up on that, if readers take a look at ASCO's position statement, they'll see that we identify there the fact that appropriately-implemented drug repository programs can help address some of the cancer drug waste, And if I remember correctly, this was quantified by researchers in New York at Memorial Sloan Kettering Cancer Center. I think they found an estimate of about $3 billion annually.  The question is, exactly what causes this waste? And you alluded to the fact that you see this in your practice as well, but I just want to be really clear and in a practical sense, this waste is that a patient is dispensed-- I'll say, for argument's sake, 60 pills, and has progression of disease or a toxicity-based dosage adjustment and comes back for a routine office visit and still has, for argument's sake, 20 of the pills leftover. And the goal here is to essentially recycle those pills back into the supply, is that right?  Dr. Ray Page: That is correct. And so that's the basic mechanism. And as practicing physicians we see this issue all the time, where for the reasons that I explained, there's always unused pills that we don't need anymore. And if there is a mechanism by which we can safely transfer that drug to somebody that can actually use it and need it, there can be substantial positive impact with that for our patients.  Dr. Clifford Hudis: And is it only a financial benefit, Ray? Or are there non-financial benefits as well that this repository programs can somewhat mitigate?  Dr. Ray Page: Yeah. Well the financial impact of this is huge. The Americans are paying over $61 billion a year in out-of-pocket expenditures for drugs, and drug abandonment can have serious effects on a patient's health leading to hospitalizations, extensive health care cost, and even death. And the British Medical Journal reported an estimated $3 billion in leftover cancer drugs are discarded in the United States every year, and that's truly a tragic impact on our society.  But also, outside of financial, in 2015 the Environmental Protection Agency estimated that about 740 tons of drugs are wasted just by nursing homes every year, and obviously this can't be good for our environment, and we've all heard reports about many of these discarded drugs ending up in our water systems. So redistribution and enabling access to these unused drugs can help alleviate some of these problems that go outside the finances.  Dr. Clifford Hudis: Well thank you for that. I mean, high out-of-pocket expenses have been for a long time a serious concern for us at ASCO, and you've I think touched on how this can help reduce them. My question is, are there any pushbacks from patients or providers with regard to these programs? I mean, I can imagine that there might be some bureaucratic overhead that might represent a challenge for small practices or maybe there's some risk associated with it, but I'm just guessing. Is there any clear objection to these that we should be thinking about and possibly working to mitigate?  Dr. Ray Page: In general, in my interactions with my patients, most everyone has negligible concern about getting a donated drug for immediate use. There should be informed consent and disclosure, obviously, but the patients generally trust their physicians recommendations and are truly interested in just getting the opportunity to get access to the drugs. From a patient's perspective, I generally think that their greatest concern are just getting quick access to the oral drugs so they can get started on their cancer therapy as soon as possible, often to alleviate active symptoms that they're having, and to alleviate some of the fear of just not getting access to beneficial drugs.  And the physicians I think share that same sentiment of the patients, but in addition, physicians have concern and

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis provides an update on a new initiative, the ASCO Survey on COVID-19 in Oncology Registry (ASCO Registry), which aims to help the cancer community learn more about the pattern of symptoms and severity of COVID-19 among patients with cancer, as well as how the virus is impacting the delivery of cancer care and patient outcomes. "We have an urgent need to learn more about how COVID-19 is directly and indirectly affecting the people with cancer who we serve. In times of crisis, it's especially important that we learn from every patient so that we can refine our approaches and continue to provide the highest quality care," said Dr. Hudis. Subscribe to the ASCO in Action podcast through iTunes and Google Play.   Transcript Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy, should not be construed as an ASCO endorsement. Dr. Clifford Hudis: Welcome to the ASCO in Action Podcast, brought to you by the ASCO Podcast Network, a collection of 9 programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org ("Podcast dot ASCO dot org") The ASCO in Action Podcast is ASCO's podcast series that explores the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for—people with cancer. I'm Dr. Clifford Hudis, CEO of ASCO and the host of the ASCO in Action podcast series. For this podcast, I wanted to provide a quick update about one of ASCO's newest initiatives, the ASCO Survey on COVID-19 in Oncology Registry, which we've launched in response to the COVID-19 pandemic. It's clear that the COVID-19 pandemic poses a threat to people all across the globe. Since the worldwide outbreak of the coronavirus, we've learned that certain populations – including individuals with cancer – are more likely to be vulnerable to the worst outcomes from COVID-19. However, there's still so much that we do not understand. We have an urgent need to learn more about how COVID-19 is directly and indirectly affecting the people with cancer who we serve. In response, ASCO recently announced the new ASCO Survey on COVID-19 in Oncology Registry or ASCO Registry for short. This exciting new initiative was developed under the leadership and vision of ASCO's Chief Medical Office Dr. Richard Schilsky, with support from a dedicated team of professional staff who work for our Center for Research & Analytics (CENTRA). The ASCO Registry was established so that we can learn more about the pattern of symptoms and severity of COVID-19 among patients with cancer, as well as how the virus is impacting the delivery of cancer care and patient outcomes. We're not just looking at point-in-time data on patients with cancer. The ASCO Registry will capture longitudinal data on how the virus impacts patient care and outcomes throughout the COVID-19 pandemic and into 2021. We hope that longer-term look will tell us if the virus resulted in specific complications for patients, delayed patients' ability to get a specific type of treatment, or if certain approaches resulted in better outcomes for patients. Once we have sufficient data in the Registry, we plan to release periodic reports to the cancer community and the broader public on key learnings. These reports might include details like the characteristics of patients with cancer most impacted by COVID-19, estimates of the severity of disease among patients with cancer, changes or delays to treatments, and the implementation of telehealth in a cancer care setting. We also hope to be able to report on the clinical outcomes among patients with cancer during the pandemic. And, we might even learn that certain unconventional approaches might allow us to deliver care more efficiently or safely without jeopardizing patient outcomes. The ASCO Registry is open to all U.S. oncology practices. That includes physician-owned, academic, hospital or health system-owned practices, and hospitals themselves. Participating practices will be asked to complete a baseline data capture form on each patient with cancer who has a confirmed diagnosis of COVID-19. Later, practices will be asked to provide follow-up information on each patient's status, treatment, and outcomes. Data will also be collected on practice-level changes, such as new screening procedures, implementation of telehealth in the practice, and changes to clinical trial enrollment procedures. The ASCO Registry will securely collect limited patient identifying data – such as zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities. By collecting this type of data, it will be possible for us to conduct longitudinal analysis. Data from practices participating in the registry will be collected and securely stored on the CancerLinQ® platform. We're not alone in our work to better understand the impact of COVID-19 on the cancer care system and the patients we serve. Other registries, including the COVID-19 and Cancer Consortium (CCC19) and the American Society of Hematology (ASH) Research Collaborative COVID-19 Registry for Hematologic Malignancy have already been launched, and other multi-site registries are in development. We are encouraging all oncology practices to participate in one or more registries based on their specific needs and to reflect the patients they serve. Each of these registries has a different focus and timeline, so participating in multiple registries will not compromise our efforts or prevent all organizations from working together. We are actively looking for opportunities to collaborate with our colleagues on these initiatives. The ASCO Registry is part of our ongoing efforts to provide the most current information and resources the virus to our members and the larger oncology community. We've developed a wide variety of COVID-19 resources to support clinicians, the cancer care delivery team, and patients with cancer. Some of those resources include patient care guidance for oncologists treating patients with cancer during the COVID-19 pandemic; guidance for practices on how to adjust their policies in response to the virus; and updates on federal activities to respond to this crisis. We're also co-hosting a weekly webinar series with the Oncology Nursing Society on COVID-19. Each webinar examines a range of issues to help clinicians care for people with cancer during the COVID-19 pandemic. You can find all of these resources and more at asco.org. Patient-focused information is also available at cancer.net. We invite all of our listeners to learn more about the ASCO Registry on asco.org. In times of crisis, it's especially important that we learn from every patient so that we can refine our approaches and continue to provide the highest quality care. Until next time, thank you for listening to this ASCO in Action podcast and if you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts or wherever you listen and while you are there, be sure to subscribe so you never miss an episode. The ASCO in Action Podcast is just one of ASCO's many podcasts; you can find all of the shows at podcast.asco.org.

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis is joined by Dr. Jason Westin, member of the Government Relations Committee of the Association of Clinical Oncology, to discuss CAR T-cell therapy, a groundbreaking and lifesaving cancer treatment that comes with significant side effects, a jaw-dropping price tag, and limited locations where treatment is currently available. "This is potentially home run therapy for patients who have decades of life left to go," says Dr. Westin.  While he stresses that CAR T is a major step forward in ridding the world of cancer, Dr. Westin worries about the high cost of the treatment, which "is an incredible amount put upon the system."   Subscribe to the ASCO in Action podcast through iTunes and Google Play.   Transcript  Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience and conclusions. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.  Dr. Clifford Hudis: Welcome to the ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org.  The ASCO in Action podcast is ASCO's podcast series where we explore the policy and practice issues that impact oncologists, the entire cancer-care deliver team and the individuals we care for--people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO as well as the host of the ASCO in Action podcast series.  For this podcast I am really pleased to have Dr. Jason Westin as my guest. Dr. Westin is a member of the Association for Clinical Oncology's Government Relations Committee. And he is the director of lymphoma clinical research in the Department of Lymphoma Melanoma within the Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center.  Today Dr. Westin and I will discuss chimeric antigen receptor, or CAR T-cell therapy. Two years ago, ASCO named CAR T-cell therapy as our advance of the year in our annual Clinical Cancer Advances Report. CAR T is a groundbreaking and life-saving treatment for children and young adults with acute lymphoblastic leukemia, and also for adults with diffuse large B cell lymphoma.  But it comes with serious side effects, an extraordinary price tag and a limited number of places--at least in the United States--where the treatment is currently available. Today Dr. Westin and I will discuss the current state of the science on CAR T-cell therapy, as well as access issues that are facing those patients who are seeking treatment with this new modality. Welcome, Dr. Westin, and thank you for joining me today.   Dr. Jason Westin: Thank you for having me. Before we begin, I'd like to disclose that I have clinical trial funding disclosures that are listed on the ASCO conflict of interest website. Those that I view to be specifically relevant for today's discussion include advisory work as well as clinical trial research funding for CAR T-cell companies including Kite/Gilead, Novartis and Juno. I also do clinical trial work with Celgene, Genentech, AB V, Amgen, MorphoSys, Curis, and 47 Inc.   Dr. Clifford Hudis: Thank you very much for that. We appreciate that. Let's get into the real focus of our conversation today. And let's start, of course, with CAR T-cell therapy. What is it, for those who might not be familiar? How would you describe it? And further, what makes it so potentially transformative in oncology?   Dr. Jason Westin: CAR T-cell therapy is an incredible breakthrough for our patients fighting cancer. The word car--c a r--stands for chimeric antigen receptor. What a CAR T-cell is taking a T-cell that's functional and in the body to fight infections, infusing a new receptor on the outside, often a receptor that has an antibody fragment fused to parts of a T-cell receptor that now allow this car T-cell to recognize the wolf in sheep's clothing that's the cancer.  CAR T-cells are usually modified genetically using a virus to introduce new DNA into the patient's T-cell. And these are prepared in the lab, modified in a way that these can now recognize a surface marker, and then these cells are re-infused into the patient, where they can now grow. They can now find the cancer, and they can destroy it  This has been potentially transformative because it is something that has completely different resistance mechanisms than standard chemotherapy. CAR T-cells have shown incredible promise in clinical trials and now in early days standard of care. And the sky is the limit for how this could be used in the future, targeting other markers on other types of cancer and really opening up a whole new field of how we treat cancer, much in the way that immunotherapy with checkpoint antibodies has done over the past decade or so.   Dr. Clifford Hudis: Well, that's exciting. But you just hinted at what I think is the obvious next question. Breakthrough though this may be, clearly this has, at least for some patients, fairly significant side effects. And some of them, I understand, are somewhat different from what an earlier generation of oncologists might have been trained to recognize and to treat. Can you talk a little bit about what some of those side effects are, typically at least? And how we hope to limit that in the future?  Dr. Jason Westin: CAR T-cell side effects are certainly unique and not overlapping in the way that we think of oncology therapies side effects. The CAR T-cell therapy side effects in the short term are broken down into two main camps. The first is something called cytokine release syndrome, sometimes abbreviated CRS. Cytokine release syndrome is effectively almost like sepsis, in that it's an overwhelming immune response where the T-cells that have been manufactured and infused into the patient release an avalanche of cytokines to effectively recruit other immune cells to come help fight the cancer.   And in doing so, induces sepsis-like phenomenon of organ dysfunction, fever, and sometimes hypertension, which can be severe. The other acute short-term side effect that we can see from CAR T-cell therapy is a significant neurologic toxicity. And this is a new diagnosis, a new syndrome that's recently been classified by a consensus group as immune effector cell associated neurologic syndrome, or ICANS, for short.  This can range from mild slowing of speech or mild slowing of cognition all the way to status epilepticus and anything in between. The most common troubles folks have are mild slowing, but aphasias and/or seizures can certainly occur and can be quite distressing to the patient and to the family.   Thankfully it seems that both cytokine release syndrome and ICANS, the neurologic toxicity, appear to be fully reversible in the nearly all patients, in the vast majority of patients. The late side effects of CAR T-cells are also unique and different from what we've seen from prior chemotherapy-type induced side effects. These include, depending upon what target you're going after, an effective lack of the target expression long term.   And for CD 19 focusing therapies, this effectively means a B cell aplasia that can sometimes be for a year or longer after the one infusion of car T-cells are administered. We know from other immune therapies that depleting certain parts of the immune system is not usually overwhelming infections or other obvious toxicities, but can result in chronic infections, inflammation and need for replacement of things like intravenous immunoglobulin to replace immunoglobulin deficiency.  So, CAR T-cell side effects are not what we typically think of in terms of chemotherapy, of cytopenias, nausea and fatigue, or immune therapies of inflammatory responses off target from the projected cancer. These are more specific toxicities related to the extreme expansion and cytokine release of these Car T-cells during the battle against cancer as well as lingering effects from these T-cells remaining active for many months and maybe even years after the infusion.  Dr. Clifford Hudis: There are a number of barriers right now. You've highlighted some of them. First of all, we don't have applicability yet established for a large number of diseases. That's an area for research. There are special toxicities. And it sounds like, realistically, anybody starting to do this needs to be trained and needs support staff and teams, just like you described. So there's a geographic limitation.  But beyond all of that, there's also a more conventional limitation, which is just outright cost. And as I understand it, the cost, or at least the list price for available agents, can range from $373,000 to treat an adult with an advanced lymphoma up to 475 to treat a pediatric indication.  And further, I think these prices do not include the additional costs of hospitalization or managing side effects, and maybe other adverse events. I'm curious, do these prices matter day to day in your practice? Do your patients need assistance navigating this? Or what's the real-world experience, given this price point?  Dr. Jason Westin: This is a major concern for us for the future of CAR T-cell therapy. The accessibility not just based on physically being able to get it but financially being able to get these therapies, as you mentioned. The cost of the actual product itself, the one-time infusion of these T-cells that are manufactured specifically for each given patient, it's a major cost.  But in addition to that, the actual hospitalization, which is usually a significant amount of time. For most patients that receive CA

In the latest ASCO in Action Podcast, American Society of Clinical Oncology (ASCO) CEO Dr. Clifford A. Hudis is joined by ASCO Chief Medical Officer Dr. Richard Schilsky to discuss the recently released 2020 Clinical Cancer Advances report, which named the refinement of surgical treatments for cancer as the Advance of the Year.  "A lot of the advances we're seeing in surgical approaches now are driven by better systemic therapies for cancer. These systemic treatments have improved survival outcomes and quality of life for our patients, and have now begun to transform the role of surgery in cancer management by reducing the amount of surgery in some cases, eliminating the need for it in others, or, conversely, increasing the number of patients who could undergo surgery when it's needed for treatment of their cancer," says Dr. Schilsky.   Subscribe to the ASCO in Action podcast through iTunes and Google Play.     Transcript Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  Dr. Clifford Hudis: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a wide range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of ASCO's podcasts, including this one, at podcast.asco.org. The ASCO in Action podcast is ASCO's podcast series that explores policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for--people with cancer.  My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of this series, and I'm delighted today to have as my guest the Society's Chief Medical Officer and Executive Vice President, Dr. Richard Schilsky. He's also an executive editor for the recently released 2020 Clinical Cancer Advances Report. In this report, ASCO identifies the most important clinical research advances of the past year across the full trajectory of the disease, from prevention and screening, to treatment and survivorship. The report also announces ASCO's Advance of the Year and updates our list of research priorities that have great potential to accelerate progress against cancer. Rich, welcome, and thank you for joining me today.  Dr. Richard Schilsky: Thanks a lot, Cliff.  Dr. Clifford Hudis: Now, starting at the beginning, this year ASCO has recognized refinement of surgical treatment of cancer as the Advance of the Year, and this is an area of clinical cancer research that has demonstrated the most significant progress in a year's time. I have to say, before we get into that, it seems almost poetic to me that this has happened this year because, one, we lost a leading surgical investigator in our field, Bernie Fisher, this year, and two, as I think about it, it came as a little bit of a surprise to me only because the mid 19th century was really the beginning of the century of surgery, and surgery for cancer dates back to Roman and Greek times, actually. So, can you tell us, in light of all of that, what was it that brought this back to the fore this year?  Dr. Richard Schilsky: Over the years, we've seen a great deal of progress in developing the new systemic therapies for cancer, and this really, I think, illustrates the prescient work of Bernie Fisher in his seminal research on adjuvant therapy for breast cancer, because a lot of the advances that we're seeing in surgical approaches now are driven by better systemic therapies for cancer. These treatments have improved survival outcomes and quality of life for our patients, and they've now begun to transform the role of surgery in cancer management by reducing the amounts of surgery in some cases, and even eliminating the need for it in others. Or conversely, increasing the number of patients who can undergo surgery when, in fact, it is needed to help in the treatment of their cancer.  Dr. Clifford Hudis: That's great to hear, because I was wondering at first if it was simply the fact that we just had a president who was a surgeon, and it's clearly about much more than that. What are some are the specific advances that you actually would cite as supporting this call out of surgery this year?  Dr. Richard Schilsky: Yeah, I think there some really interesting reports that are summarized in this year's Clinical Cancer Advances that really speak to this issue. In melanoma, for example, there are two studies that examine the efficacy and safety of neoadjuvant treatments for patients with locally advanced disease. Australian researchers examined the combination of two molecularly targeted drugs, dabrafenib and trametinib, given before surgery in patients with stage 3c melanoma that has BRAF V600 mutation. Not only did 86% of patients on the trial respond by the time of resection, but almost half had a complete response, either obviating the need for or simplifying the surgical treatment.  In another study, patients with stage three melanoma that was still treatable with surgery received ipilimumab and nivolumab for two cycles prior to surgery, resulting in a pathologic response rate of 77%. These studies are already changing practice, helping patients with locally advanced melanoma avoid surgery in many cases, or making surgery possible in patients with locally advanced disease who might not otherwise have been candidates for surgical resection. So this really is the year, I think, where we're seeing highly effective systemic therapies making surgery more possible where surgery can contribute to achieving better cure rates, or obviating the need for surgery where surgery is actually no longer necessary given the effectiveness of systemic treatment.  Dr. Clifford Hudis: From your point of view, as you look at both our Clinical Cancer Advances for this year and also the totality of public health data, what role would you ascribe to federal funding in generating these advances?  Dr. Richard Schilsky: Well, I think it's pretty clear that essentially every cancer advance begins in the basic science laboratory. It begins with new discovery, new understanding of biology, new description of mechanism of cancer progression, and the identification of novel cancer targets, and all of that basic research that's funded by NCI and NIH more broadly is the foundation for all the progress that we've made in development of new therapies, as well as prevention strategies and early detection strategies and so on. So, the federal funding is critical.   This year's Clinical Cancer Advances Report highlights 10 studies that were supported, directly or in part, by funding from the NIH, so that highlights another important role for the federal funding. Not only is there the discovery work, but there is also the work through NCI-funded cooperative group studies and other clinical trials that actually is helping to translate those basic science discoveries into clinical trials, and more importantly, helping to design clinical trials that are not likely to be pursued by commercial interests, but that answer important clinical questions that directly impact the way patients are treated by their physicians.  Dr. Clifford Hudis: This is the second year that ASCO has included with its Clinical Cancer Advances Report a specific set of research priorities. Can you tell us a little bit about the motivation for creating this so-called research agenda for the country, and then the criteria that are used to select these specific priorities?  Dr. Richard Schilsky: Well, as you said, as much progress as we're making, there still is substantial unmet need, and so we need to continue to accelerate progress in many areas and focus our resources, so we launched ASCO's list of research priorities to accelerate progress against cancer by sparking momentum in those areas of research where the opportunity is really ripe to spur new advances. The goal in doing this is to provide the cancer community with direction, or at least insight as to where to focus their investments and resources. The research priorities represent areas that have the potential to significantly improve the knowledge base for clinical decision-making and help us address vital needs in cancer care that remain unfulfilled.  Dr. Clifford Hudis: Now, these priorities are nominated by ASCO volunteers and clinical experts who've worked on the Clinical Cancer Advances Report and have identified not only what the big advances are for the year, but what the unmet needs are, where the opportunities still lie to continue to accelerate our research momentum. So, they were then discussed and distilled and evaluated by various groups of ASCO experts, and what's now in the report represents our best current thinking about where we have opportunities to really have a big impact.  And I think, if I'm not mistaken, one of the hopes for results of this is to recognize that there are areas that get a lot of research. We know there are literally more than 100 I-O drugs theoretically in development right now around the world. Our goal here, I think, is to highlight some of the areas that may not be supported directly by industry necessarily, but in fact, may be dismissed as people think about high-impact targets. There are some places where we need to make progress in order to offer the most patients the greatest benefit.  Dr. Richard Schilsky: I think the research priorities are not necessarily what might be thought of as underrepresented areas of research, but they are areas where ASCO feels that there is opportunity to have a big impact, because there's already sort of a

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis is joined by Dr. Jeffrey Ward, a leading contributor to the society's updated Patient-Centered Oncology Payment (PCOP) model, to discuss how PCOP can improve patient care and lower costs.    "If we don't find a way to bend the cost curve, we're not going to be able to fulfil the mission to take care of our patients," said Jeffrey Ward, MD, FASCO.  Currently the clearest way to move from fee-for-service to value-based care, notes Dr. Ward, PCOP "will invigorate our specialty and our practices" and "improve the way we give care."  Take the ASCO Podcast Survey and help improve our podcast program: https://www.surveymonkey.com/r/ascopodcasts    Transcript Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a wide range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of ASCO's podcasts, including this one, at podcast.asco.org. The ASCO in Action podcast series explores policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, those individuals we care for-- people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series. For today's podcast, I'm delighted to have as a returning guest Dr. Jeffery Ward, past chair of ASCO's Government Relations Committee. He's here today to talk with us about ASCO's newly updated Patient-Centered Oncology Payment model, or PCOP. This is an alternative payment model which he had a major role in authoring and developing. Dr. Ward, who in many respects could be considered a Founding Father of ASCO's payment reform initiative, is going to tell us more about the significant updates in this model, its goals, and how it could work to improve care for patients with cancer. Welcome, Dr. Ward. Dr. Jeffery Ward: Thank you. Good to be here. Dr. Clifford Hudis: Jeff, I'm going to dive right in. I've called you a Founding Father because you played such a critical role in shaping ASCO's more than five yearlong effort to develop a viable alternative to the current pay-for-service reimbursement system. Before we get into the updated model, can you tell our listeners a little bit about how we got here today? Why are you a Founding Father? Dr. Jeffery Ward: Well, my recollection is that it actually began about eight years ago, but it took three years to get a work product. Through an intermediary, the Brookings Institute, they asked ASCO if we had any ideas or offerings that the Congressional Budget Office could score as savings without driving oncology out of business. At the time, I was a brand-new CPC chair, and waiting with Rocky Morton from Iowa. We pulled together-- the CPC steering committee-- about 15 doctors, mostly from community practices, and had some fairly heated meetings focused on what has proven, over time, to be a very tall peak to climb-- alternatives to buy-and-bill chemotherapy. At the end of the day, we told the supercommittee that we had nothing for them but promised to stay engaged. That wasn't a good feeling. It wasn't a good day. And we decided that that wouldn't happen again. So, we put together a payment reform workgroup consisting of community, hospital, and academic-based oncologists, pulled in a lot of ASCO support staff, and hired a consultant-- or mediator-- to try and keep us focused. The only prerequisite to be on this group was that you had to be reform-minded, and our task was to forget everything that existed and propose a novel reimbursement model. Dr. Clifford Hudis: Well, that brings us right to the current day and we recently put out the update of this. The official name is the ASCO Patient-Centered Oncology Payment, which is a community-based medical home model-- or PCOP for short. But at a very high level, can you tell us, what does this updated PCOP do? What makes it unique as an alternative payment model? Dr. Jeffrey Ward: I think at a high level, it makes the oncologists responsible for being a good steward of our cancer care delivery system-- I think, arguably, the best cancer care delivery system in the world-- without making us responsible at the same time for what the market will bear-- drug prices that are both ridiculous and entirely out of our control. So, I think it aligns what we aspire to and how we get aid into one cohesive model. Dr. Clifford Hudis: What are the specific approaches that our PCOP uses to make sure that patients have access to high-quality care, and practices have the resources they need to provide that care? And you alluded to the tension already, but I'll clarify, maybe, even more. There are those critics who will say that doctors should be focused solely on quality of care and outcomes for individual patients. And there are many others in our community who make very clear arguments for our responsibility to society to balance benefits against costs. So how do we thread that needle? Dr. Jeffrey Ward: Well, I don't think that that's a dichotomy. I think what you have to do is, you have to say, those two goals can and should be married into a cohesive model of both delivery of care and reimbursement. PCOP actually has two reimbursement models. It has a starter track. It'll be familiar to followers of Medicare's oncology care model demo. It takes a performance-based reimbursement system and puts it on the backbone of traditional fee-for-service. But there's one big difference, in that it doesn't hold practices responsible for drug list prices. Then there's an advanced track that's really closer to the original payment model we first published in 2014. It transitions fee-for-service oncology to monthly bundled payments and replaces the margin on drugs with a suitable pharmaceutical management fee. Critically, both tracks then marry the reimbursement model with an oncology medical home model of care and value-based clinical pathways in an effort to hold us responsible for care management and appropriate utilization of oncologics that, I believe, broadly applied, would put downward pressure on pharmaceutical drug prices without putting practices in the middle anymore. Dr. Clifford Hudis: I want to drill down a little bit on this oncology medical home framework. What would it actually take for a practice to engage in this, and how would a patient perceive benefit? Dr. Jeffrey Ward: For a practice to be able to say, "we're going to do this", they would start, probably, with the simpler track and work their way up. In the advanced track, the PCOP payment methodology actually involves three components. There are monthly payments, there is residual fee-for-service reimbursement, and then there's performance incentive payments. Practices are held accountable for providing high value, evidence-based care under three different performance categories. These three scores of equal weight then contribute to a score that, done well, improves your reimbursement. Done poorly, it lowers your reimbursement. And though it's contrary to business as usual, I think it's hard to argue that it shouldn't, particularly when you as a practice had a role in creating the parameters themselves. Dr. Clifford Hudis: What happens-- just for people who might either be interested in this, but haven't participated, or for people that are approaching this slightly more academically, you're going about your business and you're in a practice. What triggers you to start doing this? Another is, why don't you just put your head down and keep doing things the way you have? Dr. Jeffrey Ward: I think for several reasons. One reason is that we have a system that isn't going to be able to continue the way it is. There's no doubt that prices are accelerating in such a way that, if we don't find a way to bend the cost curve, we're not going to be able to fulfill the mission we have to take care of patients. The second reason is that this is a pathway that actually is going to improve the way we give care. The struggle we have with fee-for-service medicine in general is that it rewards the provider for doing more. This effect is amplified dramatically when you apply it to the cost of drugs. On the other hand, value-based pathways-- what we've built into this-- that look at efficacy first, toxicity second, and cost as a tiebreaker, can reward me for using the right drug in the right patient at the right time. And a well-constructed pathway will avoid both over and under-utilization of therapies. And that helps make PCOP, I think, uniquely different from payer-mandated pathways because it's a prospective pathway agreed upon by the providers and the payers in a transparent and collaborative way. So, there's several things, I think, that we've done to try and combine both reimbursement and care into one cohesive model, instead of two separate tracks that incentivize different things. One other aspect of this-- beyond the internal control that you have with pathways-- is, of course, that nobody practices in a vacuum. And I understand a major element of the PCOP design is its emphasis on implementation in communities that include multidisciplinary providers and practices. It also includes, at least theoretically, multiple kinds of payers-- federal and state on the one hand, and then private on the other, the latter including employers. And finally, it can include patients with some mobility and span regional health networks. Dr. C

In the latest ASCO in Action Podcast, ASCO CEO Dr. Clifford A. Hudis, discusses updates that will affect oncologists in the 2020 Medicare Physician Fee Schedule final rule, which outlines changes to Part B reimbursement policies and the Quality Payment Program.   ASCO's goal will always be "to ensure that oncologists can provide the right treatment, at the right time," says Dr. Hudis, "and we aim to help CMS implement policies that advance that goal."  Take the ASCO Podcast Survey and help ASCO improve its podcast program: https://www.surveymonkey.com/r/ascopodcasts   Transcript  Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Dr. Clifford Hudis: Welcome to the ASCO in Action Podcast, brought to you by the ASCO Podcast Network, a collection of 9 programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. The ASCO in Action Podcast is ASCO's podcast series that explores the policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for—people with cancer. I'm Dr. Clifford Hudis, CEO of ASCO and the host of the ASCO in Action podcast series. For this podcast, I wanted to provide a quick update on an important announcement from the Centers for Medicare & Medicaid Services, which of course we refer to as CMS on this podcast. In early November, the agency released its final rule for the 2020 Medicare Physician Fee Schedule—commonly referred as the "physician fee schedule"—and other changes to Medicare Part B reimbursement policies, including proposed updates to the Quality Payment Program.   Just to review, the physician fee schedule is a complete listing of fees that Medicare uses to pay doctors or other providers and suppliers. It is also a comprehensive listing of maximum fees that is updated each year and used to reimburse providers on a fee-for-service basis. At ASCO, we always review this rule closely and assess its likely impact our members and, most importantly, our patients. The top takeaway from the rule is that CMS estimates a zero percent overall impact for the hematology/oncology and radiation oncology specialties in 2020. Though it's important to note that the actual impact on individual physician practices will depend on the mix of services the practice provides, and practices in certain states may see a change due to the elimination of the 1.0 threshold previously applied to the geographic practice cost indices. CMS also finalized provisions to align Evaluation & Management (or E&M) coding with changes laid out by the CPT Editorial Panel for office/outpatient E&M visits. This is a welcomed update that comes after ASCO and other stakeholders expressed concerns that earlier CMS proposals to consolidate E&M codes would have diminished the resources available to care for Medicare beneficiaries with cancer. We appreciate the fact that CMS listened to our perspective and revised its plans to better serve people with cancer. The physician fee schedule rule also finalizes updates to the Quality Payment Program for 2020 and beyond. A key update to the Merit-Based Incentive Payment System (or MIPS)—one of the Quality Payment Program's two tracks—is that all four MIPS performance categories will remain at their 2019 weights in 2020, but the performance threshold, which is the minimum total MIPS score needed to avoid a negative payment adjustment will increase to 45 points in 2020 (up from 30 points in 2019). CMS also finalized its plan to establish "MIPS Value Pathways" (or MVPs) beginning in 2021. CMS has described MVPs as a way to reduce the burden of participating in MIPS and for CMS to collect more meaningful performance data. The MVP framework would connect activities and measures from the four MIPS performance categories that are relevant to a patient population, a medical specialty, or a specific medical condition such as cancer. For years, ASCO has encouraged the use of high-quality oncology clinical pathways to help ensure patient access to high-quality, high-value cancer care. We are hopeful that this provision in the CMS final rule is a move in the right direction. We have also appreciated CMS' recent efforts to reduce administrative burden for providers. MVPs, if implemented appropriately, may help improve the quality and accessibility of cancer care. We will continue to work closely with CMS as it implements this new provision. I hope this summary of the updates to the physician fee schedule for 2020 was helpful to our listeners. Our ultimate goal is always to ensure that oncologists can provide the right treatment, at the right time, and we aim to help CMS implement policies that advance that goal. To that end we will submit detailed comments on the final rule during the open comment period, to ensure CMS understands the needs of the oncology community, and the full impact this rule is likely to have. If you'd like more information on Medicare physician reimbursement in 2020, please visit the ASCO in Action website at asco.org/ascoaction. Until next time, thank you for listening to this ASCO in Action podcast and if you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts or wherever you listen and while you are there, be sure to subscribe so you never miss an episode. The ASCO in Action Podcast is just one of ASCO's many podcasts; you can find all of the shows at podcast.asco.org. Survey Promotion: If you like what you hear from the ASCO podcast, please let us know. Take our listener survey and help shape the future of the ASCO Podcast Network. Visit podcast.asco.org click on the Survey link. Once again, that's podcast.asco.org. The survey will just take a few minutes to complete and will help us get to know you better. Thank you so much for listening. 

CancerLinQ Medical Director Dr. Robert Miller discusses how ASCO's new initative, mCODE (Minimal Common Oncology Data Elements), will help take the oncology community one step further to achieving interoperability in electronic health record systems. In the latest AiA podcast with host ASCO CEO Dr. Clifford Hudis, Dr. Miller says that doctors are expected by their patients to have all their relevant medical information to ensure they receive the highest quality cancer care. mCODE is working to encourage vendors to adopt a consistent set of data elements in their EHR platforms to achieve that goal.   Transcript   Survey Promotion: If you like what you hear from the ASCO podcast, please let us know. Take our listener survey and help shape the future of the ASCO Podcast Network. Visit podcast.asco.org and click on the survey link. Once again, that's podcast.asco.org. The survey will just take a few minutes to complete and will help us get to know you better. Thank you so much for listening.  Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  Dr. Clifford Hudis: Welcome to this ASCO in Action Podcast, brought to you by the ASCO Podcast Network. This is a collection of nine programs covering a wide range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of ASCO podcasts, including this one, at podcast.asco.org. The ASCO in Action Podcast is ASCO's podcast series that explores policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer.  My name is Clifford Hudis, and I am the CEO of ASCO, as well as the host of the ASCO in Action Podcast series. For today's podcast, I am delighted to have as my guest Dr. Robert Miller. Dr. Miller is the medical director of ASCO's CancerLinQ initiative. And as many of our listeners know, CancerLinQ is a big data technology initiative that collects and analyzes real world cancer care data from multiple health care IT systems seeking to deliver insights to physicians, improve quality of patient care, and support new research.  What our listeners may be less familiar with is that, earlier this year, ASCO and CancerLinQ announced a very exciting collaboration that has the potential of bringing the oncology community one step closer to our goal of achieving interoperability amongst electronic health record systems. The project is called mCODE. That's a lowercase m and then capital C-O-D-E. It stands for Minimal Common Oncology Data Elements, or mCODE.  Dr. Miller is going to tell us a whole lot more about this important initiative. And I welcome you. Thanks for joining us, Dr. Miller.  Dr. Robert Miller: Thanks for having me.  Dr. Clifford Hudis: So, we've all heard about the inability of electronic health record systems to share information with each other. And I always, at the beginning of this, used to talk about my favorite proverbial story. A patient is discharged from a big-city emergency room after a month in the hospital. That hospital uses a single electronic record system, all the details are there. The person is on their way home and developed chest pain, ends up in a neighboring emergency room a mile away. And in most cases, how much of their record from the hospital where they spent a month, to the hospital where they're finding themselves in the emergency room, is transmittable at that moment?  Dr. Robert Miller: Yeah, I think that's an important question. And that's an example that I think we all have had experience with ourselves personally in health care, or their families. And it's easy to say, well, that's because the systems don't talk to each other. To answer your question specifically, it's probably a small percentage, a minority. There are certain laboratory values and other things that may make it across, but a lot of the important information is missing. And it's just not easy to get.  Dr. Clifford Hudis: Well, if they're in different health care systems, and even sometimes if they have the same health record system installed, sometimes there's essentially no real transmission possible. And I mention that only because I think outside of medicine, people who are less familiar with this expect this to work like banking or airline reservations. They expect transmittal of the entire package of relevant information at that moment's notice. And unfortunately, sadly, in modern medicine, and indeed in oncology, we don't yet have this. And I'll just close this little editorial soliloquy by pointing out that Congress thought they were supporting the development of this when they passed HARP legislation more than a decade ago. But in fact, the reality isn't that. And that is the setup for what we're really going to talk about now, isn't it? Which is how mCODE can help fix this problem.  Dr. Robert Miller: Exactly.  Dr. Clifford Hudis: So, tell us a little more now that we've set up the problem. How is mCODE able to begin to address this issue?  Dr. Robert Miller: So, I think it's important to realize that while all medical care is complex, there's a certain level of complexity in oncology given the explosive growth in knowledge and a lot of the new therapies even in the last five to 10 years. But I think what is really underlying the source of the problem is the fact that so many of the important parts of the cancer patient journey are just not entered into electronic records in a way that they can be easily retrieved.  So what I mean by that is things like measuring the cancer stage, or the basic biomarkers, or in the pathology report, or in the blood, and certainly more abstract concepts like, is the cancer growing or not, is the patient getting worse, or are they getting better, and so forth. The outcomes, the adverse events, are put in the electronic record in a variety of incompatible ways.  And that's not really through, necessarily, anyone's fault or the way things were designed. It's because the electronic record today looks very much like the paper record of yore. And largely, this type of information is captured in what we call an unstructured note, or a document, so that the clinician either dictates, or types, or just puts in text that tells a story. And that's important to tell the story, but it's not easy for a computer to retrieve that information.  Dr. Clifford Hudis: And the real point is, at scale, you can't take 1,000 patients and consolidate some of the basics into a single file that you could then interpret, right?  Dr. Robert Miller: That's right. The problem is that you can try. You can take human beings--we call this abstraction, or curation--and you can pull out the data elements from the notes and from the stories, but that doesn't scale. It's incredibly expensive, and it's also very inaccurate.  Obviously, there's a very big problem here. Tell us a little bit about how this actually came to be.  The mCODE project started last year in 2018, and there was the alignment of a number of individual work streams. So, let me just say that, as background, ASCO had already been active in the area of data standards going back a number of years. They worked with the standards organization called HL7.  If you look at the QOPI program, that's a quality registry that has to capture data, at least in certain fields. And one of the volunteer work groups at ASCO, the Informatics Task Force, was looking at the idea of a minimal data element. And of course, CancerLinQ--which you mentioned earlier--is a big data initiative that has to bring in cancer data in a certain way.  I think this really didn't align until the middle of 2018, and that was--I will give credit to the leadership of Dr. Monica Bertagnolli, who was ASCO President at the time. She also continues to hold the position of Chair of the Alliance for Clinical Trials. And her theme at the ASCO annual meeting, as we all remember, was caring for every patient, learning from every patient.  So that really, in a way, is a data problem. It basically says that if you really want to learn from every patient, from their information, from the data that's in the electronic record, you have to be able to retrieve it. ASCO, under Dr. Bertagnolli's leadership, together with the organization MITRE-- MITRE is a not-for-profit. It's what's called an FFRDC, or a Federally Funded Research and Development Center.  They were already working on something they called the Standard Health Record, or SHR, and they were trying to use modern data standards to improve the quality and the capture of electronic data. They weren't necessarily focusing on cancer, but there was this alignment in 2018. This was all built on a standard called FHIR, which is an acronym for F-H-I-R, which stands for Fast Health Interoperability Resources, or FHIR.  ASCO convened a group of experts in the summer of 2018 to try to create a minimal data standard to provide structured oncology data for electronic health records. So, this was ASCO volunteers and all the clinical oncology specialties, it was other scientists. It involved experts in standards, and quality, and policy, and so forth. The group met over a series of face-to-face meetings, and phone calls, and WebExes. We brought in experts from industry, as well, from electronic health records for their advice.  And the group created a data standard, or a data specification, saying these were the important data elements. They were open to public comments in January of 2019, and ultimately were approved by the mCODE executive committee, and announced publi

On September 25-26, ASCO held its 2019 Advocacy Summit, during which oncology care providers from across the United States came to Capitol Hill to urge Members of Congress to support policies that will improve access to high-quality, high-value care for people living with cancer. Listen to coverage in this new ASCO in Action podcast. Transcript Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Dr. Clifford Hudis: Welcome to this ASCO in Action podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all of ASCO's podcasts, including this one, at podcast.asco.org.   My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series, which explores policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for: people with cancer.   Recently, ASCO held its 2019 Advocacy Summit. More than 130 oncology care providers from across the United States came here to Washington DC to meet with members of Congress and to urge support for policies that improve access to high-quality, high-value care for people living with cancer.   This is one of the highest impact events that ASCO holds every year. There's nothing like seeing ASCO advocates hit the halls of Congress with such passion and dedication, with the collective goal of ensuring that lawmakers focus on policy changes that will improve the lives of people with cancer and the care they receive.   ASCO president Dr. Howard, or "Skip", Burris kicked off the activities at the Advocacy Summit and spoke about why it's so important for us to be on Capitol Hill.   Dr. Howard "Skip" Burris: ASCO's on Capitol Hill today so that our members actually get to meet with their representatives and congressmen and their staff so they understand how important cancer care is to this country, and to make sure that they understand the issues that are facing our patients that we care for who are experiencing cancer.   The decisions that Congress makes, with regard to health care and cancer care in particular, is so important and powerful to cancer patients. Access to therapy, timely access to getting treatments initiated, making sure that there's appropriate coverage of new therapies, all those things are critical for us to implement the great scientific and clinical advances that we've made into the care and outcomes for our patients.   Dr. Clifford Hudis: ASCO advocates asked lawmakers for their support for legislation that will make a big difference in the lives of individuals with cancer. One of those pieces of legislation is HR 913, the CLINICAL TREATMENT Act, which would guarantee coverage of the routine care costs associated with clinical trial participation for Medicaid enrollees with life-threatening conditions, including cancer. Medicaid is the only major payer, including Medicare, that is not required to cover these care costs today, and we hope to address this.   Dr. Karen Winkfield, chair of ASCO's Diversity Inclusion Task Force, says that changing this policy is critical to improving the validity of clinical research data and to improving patient outcomes. Dr. Karen Winkfield joined other ASCO advocates in urging members of Congress to support this bill.   Dr. Karen Winkfield: So the Clinical Treatment Act is really vitally important because it will allow all patients equal opportunity to access clinical trials that would be beneficial to not only them, but also other individuals who may come from the same backgrounds, including racial and ethnically diverse populations, but also those of lower socioeconomic status. We want our clinical trial to be representative of every single individual in this country.   Dr. Clifford Hudis: The Advocacy Summit was packed with meetings with congressional lawmakers and their staff. Dr. Jason Westin, a member of ASCO's Government Relations Committee, participated in the summit and he spoke about why these direct meetings are so important.   Dr. Jason Westin: I think advocacy is very important for cancer doctors and cancer professionals to be an advocate for our patients. I think that there are so many opportunities for us to help our patients in the clinic, in the research arena. But if we're not involved in advocacy, then others are advocating in other directions that may not benefit our patients in the way that we would like.   Many doctors view that as somebody else's job, or they view that as something that's not important for them to be involved in. I think if we don't step up, if we're not sitting at the table, then we may be on the menu.   Dr. Clifford Hudis: Many ASCO members are concerned with payer-imposed strategies that are designed to contain costs, but often unnecessarily, and sometimes dangerously, delay care for patients with cancer. Dr. Melissa Dillmon, chair of ASCO's Government Relations Committee, explained why these utilization management practices can be particularly harmful in cancer care, and also spoke about legislation that will help address these concerns.   Dr. Melissa Dillmon: So, utilization management strategies, like step therapy and prior authorization, hurt our patients because they cause delays in care and cause patients to take drugs that are less effective. So, we are asking for support on two critical bills.   One is Improving Seniors' Timely Access to Care Act, which really looks at prior authorization and simplifying the process, making sure that it's a timely approval of medications that are critical to getting them on treatment and getting them healthy again.   The other act that we're asking for support on is the Safe Step Act, which really looks at step therapy and making sure that if step therapy is in place in an insurance program, that it does not prevent patients, especially oncology patients, from getting the best drug at the right time.   So, as oncologists we're really fortunate in that drugs are being developed in a rapid manner, and we have many new drugs to help us fight their cancers. And so, we don't have the ability to use the cheapest drug always, because the best drug is sometimes the newest drug. And it may not be the one that's first approved on that step therapy utilization management strategy.   Dr. Clifford Hudis: One of the highlights of the Advocacy Summit is presenting ASCO's Congressional Champion of the Year award to lawmakers whose leadership on behalf of patients with cancer deserves special recognition. This year, we recognize Congressman Ben Luján from New Mexico and Congressman Gus Bilirakis from Florida for their work. Congressman Luján addressed the attendees at the reception.   Rep. Ben Luján: Your work and the difference you make every day saves people's lives. And it's certainly why I'm hopeful that more of my colleagues that have not had the chance to learn from you take a moment to meet with you, to spend time with you, to understand the magnitude of a difference that you're delivering for the constituencies that we all represent.   Dr. Clifford Hudis: We also recognized ASCO volunteers whose advocacy efforts made a significant impact in 2018. Dr. Alexandra Thomas, a participant in ASCO's Leadership Development Program, was named ASCO's Advocate of the Year.   Dr. Alexandra Thomas: Receiving this honor only makes me embrace the exciting work ahead even more. And I hope that will include extending our network so even more voices can join in this chorus, so Dr. Burris's picture of the ASCO Advocacy Summit will get bigger each year.   But perhaps even more importantly, the virtual picture will get bigger as more and more of us join in and advocate and tell our patients' stories and realize robust and continuous government support to improve the lives of our patients with cancer.   Dr. Clifford Hudis: The ASCO Advocacy Summit is a unique opportunity to educate members of Congress and their staff about the current realities of the cancer care delivery system and how their decisions impact real people who have cancer. The support of lawmakers is critical to ensuring that our patients have access to high-quality, affordable cancer care.   This is why we feel it is so important that our collective voice be heard on Capitol Hill. A big thank you to all of ASCO members who participated in the summit, as well as those who participated virtually, by sending messages to their members of Congress through social media or ASCO's ACT Network.   I encourage all of our listeners to participate in ASCO's advocacy efforts. Visit asco.org/actnetwork to learn more about how you can get involved. To stay up to date on all of ASCO's advocacy work, visit asco.org/ascoaction.   Until next time, thank you for listening to this ASCO in Action podcast. If you enjoyed what you heard today, don't forget to give us a rating or review on Apple Podcasts or wherever you listen. And while you're there, be sure to subscribe so you never miss an episode.   Until next time, thank you for listening to this ASCO in Action podcast. 

Subscribe through iTunes and Google Play. In this interview, ASCO President Dr. Howard A. "Skip" Burris discusses why he became an oncologist, the importance of mentors in his career, the most significant changes he's witnessed in cancer care during the past three decades, and his vision for the coming year as he serves in this top volunteer position. Dr. Burris stresses that we can't "divide and conquer, to conquer cancer," a message underscored by his ASCO presidential theme, "Unite and Conquer: Accelerating Progress Together." Find all of ASCO's podcasts at podcast.asco.org   Shannon McKernin: Hi. My name is Shannon McKernin, and I'm the host of the ASCO Guidelines Podcast series. When a new ASCO guideline publishes, we release a podcast episode featuring an interview with one or more expert panel members. Each episode highlights the key recommendations and the implications for patients and providers. You can find the ASCO Guidelines Podcast series on Apple Podcasts or wherever you're listening to this show, and you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content and offer enriching insight into the world of cancer care at podcast.asco.org. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Clifford Hudis: Welcome to this ASCO in Action podcast brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content offering enriching insights into the world of cancer care. You can find all of ASCO's podcasts including this one at podcast.asco.org. This ASCO in Action podcast is part of our series exploring policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals who care for people with cancer. My name is Clifford Hudis, and I am the CEO of ASCO as well as a host of the ASCO in Action podcast series. For today's podcast, I am delighted to be joined by Dr. Howard, or "Skip", Burris. He's ASCO's president for the 2020 term, and if we're lucky today, we'll find out why he's called Skip. In the meantime, Dr. Burris is joining me to share his vision for his presidential year. That is what he hopes to accomplish by this top ASCO volunteer leadership position is an opportunity to leave a lasting mark on our organization and indeed the larger oncology community. Skip, welcome and thank you for joining me today. Howard "Skip" Burris: Thank you for having me. Looking forward to the conversation. Clifford Hudis: So, Skip, every one of us comes to oncology for individual reasons and personal motivations, and I know that's true for you as well. So before we get into the details of your current role at ASCO, I think our listeners will be interested in learning why you became a medical oncologist when there are so many places to go in medicine, so many exciting specialties, what was it that drove you to choose taking care of patients with cancer for your career? Howard "Skip" Burris: Interesting question and story. I was driven to medicine really thinking that I wanted to do something that was meaningful, something that helped others. And I was influenced by actually a number of friends whose fathers were physicians when I was in high school. And as I initially went into the medical field, I thought surgery was so exciting, and I actually spent many of my electives doing surgical sub-specialties and in particular thoracic surgery. And it was an exciting time in the '80s with heart transplantation and bypass surgeries. And yet I also was dissatisfied with the fact that it seemed transactional. While important, and certainly lifesaving for those patients, these were surgeries and then, quote unquote, were done taking care of that patient. And then I had a seminal moment after rounds one day when we were in the intensive care unit. And I was talking to a patient, and the team moved on. And my attending yelled at me, "hey, Burris, what are you doing?" I looked at him and he said, "Come on. He's fixed. Let's go." And I half smiled and I thought, well, this guy's got such an interesting story and he was terribly appreciative of the care he'd receive, but he looked at that attending as somebody had truly had saved his life. And so fast forward to fumbling through internship and trying to figure out really what type of specialty I might want to go into. And two groups of folks that I ran into contact with shaped my career. One were the oncology patients. Rounding on the oncology patients, doing that elective early in my internship, they were grateful. They were so appreciative. It was a great program in San Antonio. It was folks participating in clinical trials. And these were patients who not only wanted to help themselves but understood that what they were doing might help others. But really every person was so unique and had such a powerful story. And then secondly, the attendings that were taking care of those patients, the oncologists truly seemed to love what they were doing. And it was really those two groups, I thought these are the kind of patients I'd like to take care of, and these are the types of physicians that I'd like to practice with. And I began shifting as many rotations as I could as a resident into oncology, and I've enjoyed being an oncologist now for almost 30 years. Clifford Hudis: And so it was the patients, and it was the physicians really that in the end drove you into this specialty it sounds like, right? Howard "Skip" Burris: Yes. I had been taught early on, and I tell some of our younger folks today, working with people that you like and working with people that you respect is such an important part of the job. And then the service that you're providing knowing that folks are appreciative and there's a teamwork in that both the doctors and the patients in the field of oncology are so special. Clifford Hudis: So you just touched on a big part of what I think motivates or at least supports so many of our members throughout their careers and that is collaboration, working with others. And I can't help but imagine that your experience in terms of your education at West Point and your service with distinction in the Army has a relationship to that camaraderie, that connection, and that collaboration. How do you see that experience as preparing you for medicine, or maybe you think it didn't? Howard "Skip" Burris: Actually it did, and I appreciate the question, the opportunity to comment on that. Going to the US Military Academy, going to West Point for undergrad was a decision made because I wanted to go to a great school. It was a great scholarship package, the way they handled it. And I knew I'd get a great education and was attracted, one of these kids in high school who gravitated toward leadership positions, and going to an institution that would teach leadership was attractive. And then you realize as soon as you get to West Point, you're part of this big team. Everything you do during your years there is all about your group of individuals, your team, your squad, your company, surviving together, thriving together, and being successful. And, in fact, the motto that they teach is strength is one. And it was clear that you were at school with a talented group of folks who all wanted to be leaders, and everybody had to learn how to fit in, pick their place to lead, pick their place to be humble, pick their place to take charge. And those sorts of teachings and the mentors and the colonels and generals that were my teachers on that led the program, they were simple things but they were things that stuck with me forever, and I think they've served me well as a physician. One was around the simple concept of you know if no one's following, you might not actually be leading. And you got to stop and take a look behind you and see if while you're heading in whatever direction you might be going, if no one's following, you got to check yourself. I think a second thing that has stuck with me is better to be decisive than to be sure you're right. Very rarely are you sure you're right, and I think that teams even in medicine and maybe particularly in medicine really like a decisive leader. And I think that's something that is a great characteristic for physicians, gathering the appropriate data and making the decision and moving forward. But looking around and trying to emulate some of those folks who became leaders of the country was inspirational and then also gave you the opportunity to take away some of those teachings and try to embed them in terms how you carry yourself. One thing about the army it's very hierarchical, but the generals, you know, know that those privates are what's going to make them successful. So the chain of command and that respect for each other, respect for the position, and respect for their role on the team is very similar to the role of doctor to nurse to the support staff and the like. So it actually ended up being a great foundation for my career. Clifford Hudis: So it's interesting throughout medicine and especially in the last few decades, we have increased our emphasis on the role of mentoring. And I have I guess two questions which would be, one: how did you find mentors in your post military career given the strength of the leadership that you saw displayed there? And the other question is how did you translate that into your own service as a mentor? Howard "Skip" Burris: Yeah, so I think important-- I think picking the right mentor-- maybe picking the mentor where you resonate with that person and think that somebody who you'd like to model and picking that me

Subscribe through iTunes and Google Play. Dr. Melissa Dillmon, the Chair of ASCO's Government Relations Committee, joins ASCO CEO Clifford A. Hudis to discuss improving access to clinical trials for patients with Medicaid. Medicaid covers 20% of Americans, however unlike Medicare or private insurers, Medicaid is not federally required to cover the routine care costs associated with clinical trials.  Find all of ASCO's podcasts at podcast.asco.org Transcription Shannon McKernin: Hi. My name is Shannon McKernin, and I am the host of the ASCO Guidelines Podcast series. When a new ASCO guideline publishes, we release a podcast episode featuring an interview with one or more expert panel members. Each episode highlights the key recommendations and the implications for patients and providers. You can find the ASCO Guidelines Podcast series on Apple Podcasts or wherever you're listening to this show, and you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content and offer enriching insight into the world of cancer care, at podcast.asco.org. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Clifford Hudis: Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, the individuals who care for-- people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of this ASCO in Action podcast series. For today's podcast, I am really delighted to be joined by Dr. Melissa Dillmon-- Missy-- the chair of ASCO's Government Relations Committee, and a longtime dedicated ASCO volunteer. Now, regular ASCO in Action podcast listeners may remember that just a few months ago, I spoke with one of our colleagues, Dr. Beverly Moy, the issue of financial barriers to clinical trial participation, and we focused on ASCO's work to address those barriers to try to make it easier for patients to enroll in clinical research studies. Today, we're going to follow up on that. Dr. Dillmon is going to join me as we drill down deeper into one of the barriers that we've touched on previously-- in this case, the lack of coverage of routine care costs that are associated with clinical trials, but very specifically, the challenges that are faced by patients who have Medicaid. Dr. Dillmon, welcome, and thank you for joining us today. Melissa Dillmon: Thank you, Cliff, for having me and discussing what I think is a very timely and important issue. Clifford Hudis: Since it's something I know you care deeply about, maybe you could start off at a high level and give us a little bit of background. What is it exactly that we're talking about here, when we talk about clinical research and coverage for patients with Medicaid? Melissa Dillmon: So Cliff, you know that in many cases, clinical trials provide the best or sometimes the only treatment option for our patients with cancer. And we live in a time when there is an incredibly rapid pace of development, with new investigational treatments that are dramatically altering the course of cancer for the better. Patients with Medicaid have a unique barrier to accessing clinical trials because Medicaid is the only payer that is not federally required to cover the routine cost of clinical trial participation. So Medicare and major commercial payers are required to have coverage for routine costs of clinical trial participation. Medicare provided this coverage beginning in the year 2000 after the Medicare National Coverage Determination Act protected their beneficiaries. The Affordable Care Act also requires insurers to cover routine patient care costs for trials participation. But Medicaid was not specifically called out or included in this requirement. So today, commercial payers and Medicare are paying for the routine cost of clinical trial participation, but Medicaid is not required in any of the states by the federal government to cover these costs. And we know that these patients have financial barriers to accessing basic medical care and preventative services anyway. So this lack of mandated coverage makes it even harder for some Medicaid patients to participate in potentially life-saving treatment trials. Clifford Hudis: I remember from, obviously in my days of doing clinical studies, there was often a lot of discussion about what was a routine cost of clinical care and what was a research cost. Can you expand a little bit on which parts of this are covered, or are they all covered, by these requirements? Melissa Dillmon: So routine care costs are the regular doctor's appointment or E&M charge, radiology exams, drugs to manage side effects, supportive care medications, laboratory tests. It is not the cost of the drug or anything specifically related to that, it's just the routine care costs that go along with cancer treatment care, whether that patient was on a trial or on a regular, on-label drug. Clifford Hudis: And in an ideal world, when this is working efficiently, this dovetails neatly with the fact that the non-routine care costs-- those things that are being required only because the participants involved in a very specific research study-- those costs are generally borne by a sponsor, right? Melissa Dillmon: Correct. So perhaps if there is a genomic sequencing that was required, or a special laboratory test to assess a response in a marker that was not a routine care cost, that's usually covered by the sponsor of the clinical trial. Clifford Hudis: And so just to make sure every listener is following, the irony here is without this requirement, in a sense, a person with good commercial insurance historically could find themselves not covered for the exact same costs that normally would have been covered solely because they're getting some treatment that is part of a clinical trial. And that seems like a perverse incentive in the wrong direction for all of us across all of society, right? Melissa Dillmon: Exactly, especially at a time when it's challenging to get enough people on clinical trial, and we're trying to get more people on clinical trials. We're trying to remove those barriers. Clifford Hudis: Right, and I would go even a step further and say it's a little bit of a paradox because it doesn't actually cost the insurer any more money for a person to be on a clinical trial and be covered for routine care. It's not as if they're getting an increased charge back because the patient's on a clinical trial. The research study is typically covering the non-standard research components of care anyway, right? Melissa Dillmon: Correct. And then oftentimes, if there's an investigational drug, they're taking the cost of the drug out of the picture. So in some ways, you're actually saving the insurer that money. Clifford Hudis: So it's funny, as well, a little paradox that Medicaid is the only major payer not federally required to cover their costs. Yet at the state level, I think-- and I just heard about another one today, I'll tell you-- some states have taken half steps or full steps to require Medicaid to cover the costs of clinical trial participation for patients, right? Melissa Dillmon: That's correct. About a dozen states have taken action, through written statutes, or regulations, or policies, to require their Medicaid plan to cover these costs. But that's only a dozen states. That leaves about 42 million Medicaid patients who do not have guaranteed ability to participate in clinical trials. Clifford Hudis: You know, I think some listeners may be surprised that you get that big number-- 42 million. And of course, that raises some basic questions about the reach, and scale, and extent of Medicaid. I think we should talk about that for a moment. So who has Medicaid as their primary insurance? That is, who is covered by Medicaid-- what kinds of patient populations and so forth? Melissa Dillmon: So Medicaid covers about 20% of Americans. Patients on Medicaid are often lower income. It's usually children, older adults, patients with disabilities, and some patients in rural areas are more likely to have Medicaid. So depending on where those dozen states are that have those statutes, those may be states that don't have as large rural populations or lower income patients. So racial and ethnic minorities are also overrepresented in Medicaid. For example, African-Americans represent about 12% to 13% of Americans, but 21% of patients receiving Medicaid are African-American. Hispanics represent 18% of the American census population, but 25% of patients on Medicaid are Hispanic. Clifford Hudis: So this is the same old issue, where certain racial features, as it were, are surrogates for lower socioeconomic status, and that's what you're describing, unfortunately. Right? Melissa Dillmon: Correct. Clifford Hudis: OK. And so we take this group of patients that are, in general, a little bit disadvantaged-- lower socioeconomic status as an average, perhaps more rural, which itself represents a barrier to care-- and then you add on the limitation in terms of clinical trial participation coverage. So how does this translate into an increased burden for this special population, as opposed to everybody else? Melissa Dillmon: Well, we already know that cost is a major barrier to participation in clinical trials. Patients who have larger income are more likely to participate in clinical trials, or be offered a clinical trial, or live in an area where there is a clinical trial available for them. Patients who have a lower income-- less than $20,000 per

Subscribe through iTunes and Google Play. Lisa Lacasse, president of the American Cancer Society Cancer Advocacy Network, speaks passionately about the critical importance of advocacy and ACS CAN's partnership with ASCO in reducing the cancer burden, in latest AiA podcast with host ASCO CEO Dr. Clifford Hudis. Find all of ASCO's podcasts at podcast.asco.org TRANSCRIPT Ad: Hi. My name is Shannon McKernin. And I am the host of the ASCO Guidelines Podcast Series. When a new ASCO guideline publishes, we release a podcast episode featuring an interview with one or more expert panel members. Each episode highlights the key recommendations and the implications for patients and providers. You can find the ASCO Guidelines Podcast Series on Apple Podcasts or wherever you're listening to this show. And you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content, and offer enriching insight into the world of cancer care at podcast.asco.org. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Clifford Hudis: Welcome to this ASCO in Action Podcast, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insights into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. This ASCO in Action Podcast is ASCO's podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for-- people with cancer. My name is Clifford Hudis. And I'm the CEO of ASCO, as well as the host of the ASCO in Action Podcast series. For today's podcast, I am really pleased to have Lisa Lacasse, president of the American Cancer Society Cancer Action Network, or ACS CAN, as my guest. Welcome, Lisa. Lisa Lacasse: Thanks so much, Cliff. It's really great to be with you today. I appreciate the invitation. CH: Well, I'm really delighted that you could join me today for this discussion. And I think there are probably hundreds of topics that you and I could discuss. But I want to start with the big picture first. The American Cancer Society, of course, is a very well-known, nationwide organization with a mission of saving lives and leading the fight for a world without cancer. Can you tell our guests about the American Cancer Society Cancer Action Network, ACS CAN? What's the relationship with ACS itself? And what exactly does ACS CAN do? LL: So thanks. That's a great question, Cliff. So many are very familiar with the American Cancer Society, which is a large, old organization that attacks cancer from every angle. The Society works to advance breakthroughs in research, treatment for patients, providing direction and information to help people manage their cancer care, and also mobilizes volunteers at the community level to really support patients in their fight against cancer. But we know that the fight to end cancer doesn't just happen in a doctor's office or a scientific lab. It really requires the government and all elected officials to join us to impact the disease. And so that effort to engage government requires advocacy. And that's where the American Cancer Society Cancer Action Network, ACS CAN, steps in. And we are the advocacy affiliate of the American Cancer Society. So ACS CAN simply urges lawmakers and rallies all of our community partners to lead in the fight against cancer. And together-- the American Cancer Society and the American Cancer Society Cancer Action Network-- although we're two independent organizations, we're working towards the same mission. However, ACS CAN uses different but complementary set of tools. So we obviously resemble ACS in a lot of important ways. We're both nonprofits. We are both absolutely, obviously evidence-based. And we're both supported by a vast army of volunteers. And we all focus on the ultimate goal of eliminating cancer as a major health problem. But ACS CAN advances this mission using tools that aren't fully available to ACS. One, an electoral program called Cancer Votes, which is really an effort to educate voters on important issues to cancer. And we also do a significant amount of lobbying. And that's not just in Washington DC, but in all 50 state capitals and many, many localities. And because of the breadth of that direct lobbying, that's often beyond what's allowable for a charity. So back in 2001, which is-- we're coming up on our 20th anniversary, which is very exciting-- the American Cancer Society Board really recognized that if we were going to achieve our goal to reduce the cancer mission, we had to do that by improving public policy. And so they decided to create ACS CAN. And my job as president is really to empower this huge network of grassroots advocates across the country. And with their staff partners-- we have about 200 people that work for ACS CAN-- every single day, they're imploring their elected officials, working with administrative officials to impact the cancer burden. CH: Well, I mean, that's a remarkable portfolio. And I would say, obviously that ACS CAN has been a key ally and a natural partner for us here at ASCO in our own mission to conquer cancer through research, education, and the promotion of the highest quality patient care. I know that ASCO shares many advocacy priorities with your organization, including our strong support for robust federal funding for cancer research, improving patient access to clinical trials, and addressing, among other things, the alarming rise in youth tobacco use-- something listeners will recall, we discussed in detail with Scott Gottlieb last year. So it's really a privilege to be able to talk to you about all of this. One of the efforts I think that many of our listeners would want to hear more about would be the Medicare Part D, six protected classes issue. I think earlier this year, ACS CAN mounted a very public outcry and a very visible advertising campaign against a proposal that would have potentially impeded or limited access to lifesaving drugs within the Medicare Part D program, specifically in the six protected classes. And we were proud to join your campaign. We at ASCO couldn't have been more pleased than we were with the impact. Can you explain why this effort was so necessary and talk to our listeners a little bit about how it turned out? LL: Absolutely. And I do want to say thank you to ASCO's partnership on this issue. It was really important. So this is a regulatory issue. As you mentioned, it's colloquially referenced as the "six protected classes." But that's policy that was established more than a decade ago to make sure that Medicare beneficiaries had access to innovative therapies. So really, the concept's fairly simple. If you're a health insurer and you provide a Medicare Part D plan to a Medicare beneficiary-- so you sell a Part D plan, which is a prescription drug plan-- you are, by definition, required to cover virtually all drug therapies that treat cancer, epilepsy, HIV/AIDS, mental illness, and organ transplant. And unfortunately, late last year, the Department of Health and Human Services proposed to alter that rule. And if the rule that they had put forth had been finalized, we believe it would have dramatically impacted access and affordability to critical medications for cancer patients who are part of the Medicare Part D program. So the proposal, although it was put forth as an effort to save Medicare money-- programmatically to save Medicare money-- we were really concerned that that approach would potentially have the exact opposite effect. We were worried that it would result in raising costs in other parts of the Medicare program and absolutely shifting costs to patients. So that certainly would have happened, because the proposed changes included, for example, excluding drugs from formularies or increasing the use of utilization management tools, such as step therapy. And we know that for a disease like cancer, specific drugs are very important for specific cancers. So if beneficiaries were unable to access their prescription drug that was most medically appropriate for them, they certainly would incur higher costs because it wouldn't be a covered medication. But we also were worried that they wouldn't get physician services, or they would need additional physician services because they weren't getting the right medication, and/or they would end up in the emergency room, which is all things that we know happen if you're not on the right drug regime for your cancer diagnosis. So had these proposed changes gone into effect, it really could have been devastating for cancer patients and survivors. And because of that, once we analyzed the proposed rule, we launched a multi-pronged campaign. It's one of the things that we take a lot of pride in, and we're able to address these issues in many different ways. But one of the most powerful is working in coalition. So ACS CAN and ASCO were joined by nearly 60 other patient and provider organizations. And we ran an advertising campaign-- a very visible advertising campaign. We did a Twitter Day of Action, where all of our volunteer advocates from all of our organizations directed their concern to HHS Secretary Alex Azar. We know that he heard from us. We got confirmation of that. And additionally, ACS CAN and ASCO were among more than 23 patient provider organizations actually went to the Hill for a day, did a lobby day on the hill-- again, making sure that our legislators, congressional members really understood the patient perspective of thi

Subscribe through iTunes and Google Play. Dr. Joanna Yang and Dr. Robert Daly join ASCO CEO Dr. Clifford A. Hudis to discuss the Health Policy Leadership Development Program (HP-LDP). As former fellows, Drs. Yang and Daly provide insight as to how the program has made them better advocates for their patients. TRANSCRIPT Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Clifford Hudis: Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast series, where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer. My name is Clifford Hudis. And I'm the CEO of ASCO as well as the host of the ASCO in Action podcast series. For today's podcast, I am delighted to be joined by not one, but two of ASCO's rising leaders, Dr. Robert Daly and Dr. Joanna Yang. Both Dr. Daly and Dr. Yang are recent participants in ASCO's Health Policy Leadership Development Program, formerly known as the Health Policy Fellowship Program. This is a professional development program designed to build health policy and advocacy leadership expertise among our members. It's a one-year program where fellows get practical experience working with our policy and advocacy staff and council to craft policy positions and statements, along with other educational sessions on communication, leadership, and advocacy. Starting this year, participants will be able to participate as well in ASCO's Leadership Development Program, which offers mid-career oncologists the opportunity to improve their leadership skills and gain valuable training to set them up to be future leaders in oncology. Dr. Daly and Dr. Yang, welcome, and thank you for joining me today. Joanna Yang: Thank you so much for the opportunity. Robert Daly: Yes, thank you so much for having us. CH: So Dr. Yang, I'm going to start with you. You were an ASCO Health Policy Fellow in 2017-2018. And I want to kick off our discussion by talking about what brought you to the program. Why were you interested in developing special expertise in policy work? JY: Sure. So I've always been interested in health policy. And I had the opportunity to study health policy and health economics during undergrad. But of course, studying health policy is very different than creating or influencing health policy. When I started residency, I saw many ways in which health policy on a national level or even state level affected the patients I was caring for. And I felt compelled to do more. But the issue is that there is never any clear way for me to get involved or even to learn how I could learn how to shape health policy. And that's why the ASCO program is so great. I feel like it came at exactly the right time. I was looking for a way to learn more to develop the skills I needed to influence health policy. And ASCO came out with this structured and immersive experience where I could take the things that I had studied in school, and also the things that I'd seen in practice, and use them to actually have an impact on the patients I take care of. CH: So Dr. Daly, you as well were one of our inaugural Fellows. What prompted your interest in applying for the program, especially given I think you were the first year? RD: Yes. CH: Right, so you took a leap off of the ledge there and said, I'll go first. RD: Yeah, I'm similar to Dr. Yang. I had a real interest in cancer care delivery research during my fellowship at the University of Chicago. And I was lucky enough to be mentored by Funmi Olopade and Dr. Blase Polite. And Dr. Polite was really fundamental and helped developing the ASCO Health Policy Fellowship. And so I really saw this as an opportunity to augment that training but really gain skills in leadership, advocacy, and health policy, areas that I hadn't had exposure to in the past. So this seemed like the perfect program for me at that point in my career. CH: I have to say parenthetically that I'm jealous of both of you, because while I was personally drawn, especially in later years in my career to the policy and advocacy aspects of work with ASCO-- and it truly is the reason that I moved from my traditional academic career to this role as CEO at ASCO-- I never, of course, had the opportunity to be trained and to learn how to do this professionally as you two have. So I am in awe of your accomplishments, as well as the opportunities that are going to continue to unfold in front of you because of this. So given that, and given that this is really the beginning, we hope, of a career with impact, we should talk a little bit about what you actually did. The program, as I mentioned earlier, lasts for a year. And during that time, Fellows worked very closely with our policy staff on a mentor project. So I'll start again with Dr. Yang. Can you talk about the project you worked, what it entailed, what you learned, and where this is going? JY: Sure. So I worked on a two-part project with Alex Chen, who was my co-fellow during the past year. And as you hinted at, the work is actually still ongoing. So the first part was we looked at whether a bundled payment model could work in oncology. And this really culminated in a white paper for us. But the second part of the project, which built on the first part, was really the most fascinating. In the second part, it was really asking, if not bundled payments, then what? And we actually built on some of the work that Dr. Daly did that he'll probably describe in a little bit. But we actually worked on designing a pathway-based alternative payment model. And of course, going into this, I had no experience designing alternative payment models at all. But the beauty of the program is that from the very beginning, Deb Kamin, said, we will not be having you do any work that is not necessary. So all the work that you do is important to ASCO, is important to our patients. And that was really true for our project. So we were able to work with the ASCO staff, and our mentors, Ray Page, and Linda Bosserman, and a whole team of experts to create an alternative payment model that we thought would allow oncologists to prescribe the right drug at the right time, without being penalized by the high drug costs. CH: So I guess, based on that, we really should have started with you, Dr. Daly. But your mentor project was centered around clinical pathways. And I understand that ends up being the foundation for the alternative payment model that Dr. Yang just described. So can you talk a little bit about that process, what you did as an inaugural fellow in this and what you learned as you went through the work? RD: Absolutely. So I was lucky enough to be able to serve on the ASCO Task Force on Pathways. So that was an incredible experience for me because I really got to interact with leaders on this issue, including Robin Zon and Ray Page, who are very active in cancer care policy, both at the state level in Indiana and Texas, but also on a national level. So to be able to gain their mentorship that early on in the fellowship was really a great asset for me. And we were looking at, how do we write the criteria for what constitutes a high-quality pathway? So I really got to see, from soup to nuts, how do you write a policy statement? How do you solicit input from those important stakeholders? So the stakeholders in this case were fundamentally the patients, but also providers, ASCO's Government Relations Committee and State Affiliate Counsel, ASCO's board, the vendors-- get all of their input together to create a policy statement that can really influence change. And then lastly, I played the part of representing ASCO and in discussions with the pathway vendors about these criteria for high-quality pathways. So I learned about the important role ASCO can have on influencing the development of products and services that impact patient care, but also the impact ASCO can have on legislation. So in California, Connecticut, and other states, they started to look at policy around pathways, policies around implementing the criteria that ASCO had developed, so that those pathways that were being used in their state were high quality. So it really showed me the reach of ASCO and the impact of ASCO on patients and providers. CH: That is amazing because it really is a reminder-- and I'm going to come back to this idea-- about how much impact one person and one project can ultimately have. And I think that in these sometimes cynical times, people forget that. I alluded to this before about my own engagement with ASCO was accelerated by my experience as an advocate on Capitol Hill-- again, an amateur to your professionalism. So I wonder if you would reflect on your experience during the fellowship program. I understand you were both frequently called on to join in advocacy meetings on Capitol Hill. And this is with federal agencies, as well as, I assume, with representatives, senators, and their staff. Did either of you have any experience doing this before ASCO took it to Capitol Hill? RD: I had never had any experience doing advocacy meetings. So it was really-- the fellowship really helped me learn how to do that and how to do that effectively. CH: What was the first meeting like? RD: My first meeting was here in Manhattan. It was at the office of Senator Gillibrand. And I was accompanied by Heather Hilton, who is an ASCO advocate and someone who's served on the Government Relations Committee. And I was really nervous. I didn't know what to expect. But we met with one of her health policy staffers and really had an engaging discussion about an ASCO a

Subscribe to the podcast through iTunes and Google Play. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Dr. Clifford A. Hudis (CH): Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast, series where we explore policy and practice issues that can impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer.  My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series. For today's podcast, I am delighted to have as my guest, Dr. Richard Pazdur, the Director of the Food and Drug Administration's Oncology Center of Excellence. The OCE was established to expedite the review of novel cancer therapies and products by bringing together expertise from across the FDA. And we'll touch on this a little bit during our conversation. Dr. Pazdur, welcome and thank you for joining me today. Dr. Richard Pazdur (RP): It's a pleasure Dr. Hudis. CH: Thanks. So I want to kick off our discussion by diving right into a hot button issue, expanded access. Can you provide our listeners with some background on this, and explain what the FDA's expanded access program is, and why an oncologist might want to pursue expanded access for an individual patient? RP: Of course. The FDA's expanded access program provides a way that patients with serious or life-threatening diseases or conditions such as cancer can try investigational medical products for treatment when no satisfactory therapies are available, and when there is no opportunity for the patient to enroll in a clinical trial. The process-- to make a request, the patient's physicians will approach the pharmaceutical company to ask for its agreement that the company will provide the medical product. The company has the right to approve or disapprove the physician's request. Then the physician needs to send the request to the FDA. This process can be complex to navigate, particularly for oncologists or physicians who don't have experience working with the clinical trials or these types of requests. FDA allows the vast majority of these requests to proceed. And the FDA has been working to improve the expanded access programs for a number of years, including the development of a more streamlined application process, a more streamlined form. But for many key health care professionals, especially those not familiar with the expanded access program, this process may appear confusing or somewhat burdensome. CH: And so is this a segue to Project Facilitate, which you announced at our annual meeting a few weeks ago? Can you talk a little bit about that and, its practical implications? RP: Yes. The Project Facilitate call center is a pilot program only for oncology that will serve a single point of contact. We have FDA oncology staff there, oncology nurses, oncology pharmacists who will assist the physician and their health care team throughout the process to submit and expanded access request for an individual cancer patient. This is a concierge service to support the patient's medical team throughout the process. It ranges from the initiation of the FDA form 3926. The process will also provide information about IRBs, particularly central IRBs, and really will also follow up on the status of a given patient to determine if that patient has received any benefit from the therapy and if there were any adverse events that need to be reported to the FDA. CH: So imagine that Project Facilitate works as hoped for. What's the thumbnail before and after experience? That is, how will things appear to be different to the physicians and to the patients? RP: It should make the process easier for physicians to get information that they need to submit an expanded access request. As I said before, it's often somewhat complicated, especially for physicians don't have experience with either the drug or with the process. And it's obviously easier to talk to somebody over the phone to ask specific questions rather than just being directed to a website. We're also working in conjunction with Reagan-Udall Foundation for the FDA, which started the expanded access navigator website to educate patients and health care professionals about the expanded access process. This navigator approach offers information provided by companies about their expanded access policy, and now includes the expanded access programs listed in ClinicalTrials.gov. Patients and physicians can look for treatment options. They could discuss clinical trials, and company information could be provided at the navigator at Navigator.Reagan-Udall.org. So this is really to give patients and their physicians information about what is out there. Once the patient obviously has this information and their doctor, then the doctor can utilize the Project Facilitate, which allows easier access to actually submitting these forms and going through the actual process. I'd like to emphasize that companies are now required by the 21st Century Cures Act to publicly list their expanded access policy. And the Reagan-Udall Navigator website helps them comply with that requirement. Again, so once the physician and the patient have identified the investigational therapy they want to try, the physician or other members of the health care team then can contact Project Facillitate for assistance in locating IRB resources and help with the FDA form 3926. CH: So I think you mentioned this when you launched this or announced it at the annual meeting just now, that physicians do already-- or at least before project facilitate often would successfully go straight to pharmaceutical companies and ask for treatments. And I guess in some cases they'd be denied, and in some cases they would be approved. And that would be through the company's expanded access programs. Obviously, that means that regulators wouldn't necessarily know the full extent of expanded access use. So assuming that Project Facilitate will allow the FDA to collect much more data on expanded use, how will the data be useful? And obviously, I'm hinting at the fact that some fear that it will be actually a negative. RP: Well, prior to launching Project Facilitate, the expanded access requests for cancer patients arrived at multiple places within the FDA and were forwarded separately to FDA oncology or hematology   divisions. Sometimes these requests could be delayed, being sent from one place to another in the agency. So this gives a focus point for physicians to contact. In addition, we're seeing that most of the expanded access requests were coming from patients and physicians at larger academic centers. The patients who don't live near these cancer centers and may not be able to get on clinical trials can also hopefully have access to investigational agents by having a more facile and easier process to use here. We're also seeing that many companies have turned down requests from patients, and we have no idea what really the number of requests a company may get if they're turning down these requests. Because generally, they don't come to the FDA. So really, by having the initial contact at the FDA we'll be able to determine number one, the number of patients that are requesting a single patient access. We'll also be able to determine and discuss with the companies their reasons for denying these requests. And there could be multiple reasons. And we also have a process in place that can follow up with what are the benefits that an individual patient may have from this therapy or, as I stated before, were there any adverse events. We have also heard this kind of urban myth-- and I label that in quotations, "urban myth," that companies fear that perhaps adverse events may be held against them when their drug is coming for drug approval. We have not done that. We take into context where the adverse event reporting is coming from. And there really are no instances that I am aware of in oncology where a report of an adverse event has delayed or curtailed an approval of a drug. CH: So really, this is a bright ray of sunshine on a dark corner of drug access. And if it works right, you'll just have much more understanding of the overall use of expanded access. Right? RP: Yeah. I think that gives some clarity to the process here. Here again, we don't know the numbers at this time of actually the number of patients. We only know the numbers of patients that receive a affirmative position from the drug company regarding that the process can continue. But we don't know the numbers of patients that may be requesting single patient access and are denied by an individual drug company. And also, the reasons. And, as I stated before, there can be very legitimate reasons, including inadequate supply of the drug, lack of support staff to follow up on these drug requests, potential interference with clinical trials that the patient may be eligible for. CH: You just used a phrase about patients requesting. And I thought as you described this process you were referring to physicians requesting on behalf of patients. And so I do want to ask, are there resources that are aimed directly at patients or is it really solely aimed at the oncologists in this case? RP: Well, here again, this is a two-prong process. Project Facilitate, the FDA portion of this, is for physicians to call up for assistance in filling out the form and also navigating the process once the decision is made. The other prong of this is, as I stated before, by Reagan-Udall foundation, which patients can call to look at what our options available to them that are potentially listed on ClinicalTrials.gov

Subscribe through iTunes and Google Play.   In the latest ASCO in Action Podcast, ASCO's President, Dr. Monica Bertagnolli, FACS, FASCO sat down with ASCO CEO Dr. Clifford A. Hudis to discuss cancer care in rural America. Improving cancer care access in rural America has been a signature issue in Dr. Bertagnolli's presidential year, during which she has held town halls in communities across the country to discuss the real-world challenges facing patients in rural America and their cancer care teams. The podcast reveals some of Dr. Bertagnolli's learnings from her town halls, and she explains what rural cancer care in America looks like today and offers steps to improve rural cancer outcomes in the future. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.  Welcome to this ASCO in Action podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we care for, people with cancer. My name is Clifford Hudis, and I'm the CEO of ASCO, as well as the host of the ASCO in Action podcast series.   For today's podcast, I am delighted to have with me today ASCO's current president, Dr. Monica Bertagnolli. And we're going to be talking about cancer care in rural America. Dr. Bertagnolli has long been a champion for improving access to cancer care in rural America, and it has been a signature issue for her throughout her presidency at ASCO. Indeed, she has held town halls in communities across the US to discuss the real-world challenges that face patients and the entire care team in these locations.  She shared some of those learnings recently at ASCO's State of Cancer Care in America event, which we entitled Closing the Rural Cancer Care Gap. Today, we're going to talk about what rural cancer care looks like in America and how we can take steps to improve outcomes in these many communities. Dr. Bertagnolli, welcome and thank you for joining me today to discuss this important topic.  It's great to be here, Cliff.  So, to kick off our discussion, I'm going to ask you to describe briefly some of the disparities that currently exist between patients with cancer in rural areas compared to those who live in urban or suburban areas.  Well, just imagine that you live in a town where most things are certainly like they are anywhere else, except the hospital is a very small one. The medical care is a primary care physician and maybe a general surgeon. They can do X-rays. They can diagnose most things. But if you have a need for anything beyond the basics of care, you have to drive three, four, six hours in order to reach it.  I think, throughout our country, we really do have a health care system that gets to most people. But particularly when it's an issue of specialty care, such as a cancer diagnosis, that's not always available.  Finally, there's a lot of our country that fits in this category. By the one government agency that looks at these things, the Federal Office for Rural Health Policy, 84% of the country, of the geographic area of the United States, is a rural location. And in that 84%, 18% of the population lives. So, we think, in oncology, it's very important that we understand more about the people who live in these locations so that we can figure out how to get them what they need.  So, starting in a quantitative way is an interesting mathematical representation, that about a fifth of the country in population is distributed over more than 4/5 of the landmass. And I think that's a way of visualizing the lack of density. But there are common challenges that patients in rural areas face that go beyond just distance and geography. What are some of those that you have uncovered and thought about this year?  You know, it's important not to overgeneralize, because certainly, there are people from every single socioeconomic status and walk of life that live in rural locations, no question. But when you go into big generalities, people who live in rural locations tend to have less education level. They tend to be less affluent. They tend to have more risky behaviors, more smoking and alcohol use. And some of the things that we know are associated with cancer development in general seem to be more predominant in rural locations. And finally, citizens who live in rural locations are, again, generally less likely than those who live in urban locations to have health insurance.  Yeah, so that's a long list of challenges that are only compounded by the geographic challenges that we spoke about before. We go and look at the most recent data that I think you shared at ASCO's State of Cancer Care in America. As we noted a moment ago, just under a fifth of the US population lives in these rural areas. But going one step further, not focusing on landmass but now focusing on the oncology workforce, fewer than 10%-- in fact, we think it's about 7%-- of oncologists practice in those areas. So, on the one hand, there's a lower distribution of American citizens into that space, but there's even proportionately a lower distribution of oncologists. How does this impact patients with cancer?  Well, it's a little bit of what I was referring to before. Going to see a specialist when you've got a disease such as cancer, where knowledge outside of the usual primary care physician's scope is really important, and by the fact that such a small percentage of oncologists live in rural areas and the fact that, in rural areas, distance is so great between various locations means that patients who have cancer just don't have access to the experts that they need.  To get that access, they have to travel. And there's not really public transportation that works between cities that might be 100 miles apart in some rural locations. So, the single greatest issue I hear from many patients in rural locations is the challenge of distance.  Yeah, it's really amazing. So of course, as I'm sure we're going to talk about, at ASCO, we don't enumerate these problems just to make a list. We do this to try to take action, to do something about it. And I guess the first question, and I know one that you've started to think about with ASCO volunteers and staff, is the fundamental one. How can we support the existing infrastructure, the existing oncology workforce in those areas? And taking it a step further, what can we do to possibly expand this workforce, at least bring it to parity with the population distribution?  We were really fortunate to have a very talented team of physicians within ASCO take this task to heart over the last year. And they formed a task force to look at issues of rural access to cancer care. It was led by Dr. Bhatia, who's from the University of Alabama-- Birmingham. And they produced a really great roadmap for us. The one area you're alluding to now is workforce. How do we get care providers? Or how do we get our patients in rural locations access to the care providers that they need?  There's a couple of different approaches the task force identified. The first is to think about education opportunities for rural health care providers. For example, one of the gaps that the task force identified is people with knowledge for the particular needs of cancer patients who live in rural locations.  Well, knowledge is something that ASCO is-- that's our core mission to provide. And so, the task force brought together a whole list of things like expanding ASCO meetings to locations throughout the United States, making it easier for rural care providers to attend, designing and implementing virtual tumor boards. Telephones are everywhere, either web-based or telephone-based communication networks that will allow those taking care of patients in rural locations to get information that they need specifically and support them there.  And then finally, every community is different. Every rural location is different. And one of the things we realized we needed to do as an organization is reach out more to everyone and just find out, what are the individual needs of our care providers?  So, in a way, you're raising the issue of complexity in terms of the built and available infrastructure. But that's paralleled, as was pointed out in the State of Cancer Care in America event, by complexity in terms of our understanding of cancer and how we treat it. So, what challenges does this increased complexity bring to those oncologists and other clinicians who care for patients in rural areas. That is, is it different for them or just more of the same?  So, I can give you some snapshots, because I visited seven different rural communities during my year as ASCO president. And some of the common things all have to do with distance and have to do with access to specialists. But there are other specific issues to each location. Let me just give you some quick examples.  In South Dakota, near the Pine Ridge Indian Reservation, there was a great need for programs that could help address cancer control, screening for cancer, smoking cessation, education for diet and overall wellness, and providers who could engage with the Native American population in order to educate the population and provide those services.  At the complete other end of the spectrum for that community, there was no access whatsoever to palliative care services. So the oncologists, who were about 100 miles away in Rapid City, were struggling with, what do we do when we have an elderly resident of Pine Ridge who has a terminal illness, and we don't have the ability to support them to get palliative care?  And

Subscribe through iTunes and Google Play. Welcome to this ASCO in Action podcast. This is ASCO's podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and most importantly, the patients we care for, people with cancer. My name is Cliff Hudis. And I'm the CEO of ASCO, as well as the host of this ASCO in Action podcast series. For today's podcast, we're going to do something a little different. We don't have a guest today. Instead, we're going to spend some time going over a quick update on an important clarification issued recently by the CDC, the Center for Disease Control and Prevention, and specifically, their guidelines for prescribing opioids for chronic pain, a very topical issue. The clarification they issued was the form of a letter from the agency to ASCO, as well as to ASH and the NCCN. And in this letter, the clarification affirmed that the CDC guideline was never intended to deny access to clinically appropriate opioid therapy for patients suffering with acute or chronic pain from conditions like cancer and sickle cell disease. But I want to explain first why it was important that they issue this clarification and then talk about what we have to do next. Opioid abuse in the United States is clearly a very serious issue. And the tremendous toll that it's been extracting on individuals and families across the nation is well-reported. Indeed, it was one of the reasons originally given for the passage of the 21st Century Cures Act. In fact, one of the motivations had to do with addressing some parts of the opioid crisis. And so this just makes the point that finding a solution to the problem is among the very highest priorities that government and really the general public, as well as professional societies and advocacy groups and all stakeholders, have to be working towards. However, we do have to, at the same time, be careful that we don't overreach and cause additional harm, especially to vulnerable populations, as we take steps to reduce opioid abuse. What happened before was that there was a misinterpretation of the opioid prescribing recommendations that had been issued by the CDC. And this resulted in part in new laws and regulations, as well as third-party payment policies that severely limited essential pain medications from patients with cancer and sickle cell disease. The consequence for them was suffering and even more prolonged hospitalizations and health care expenses. So the challenge here was to fix this mistake. As we talk about how this happened, I want to take a moment and provide a little bit of background on this. Last spring, about a year ago I think, there were papers published, at least one in particular, that highlighted seeming discrepancies-- and I emphasize the word seeming-- between opioid use guidelines that had been issued by the CDC, the NCCN, ASCO, and others. To their credit, the NCCN, led by Bob Carlson, responded to this by reaching out to us at ASCO and asking if we would be willing to collaborate on a meeting of the minds to identify what was true and not true in terms of those supposedly conflicting guidelines and then issue some sort of a unified statement to help address the situation. In November of 2018, hosted here at ASCO headquarters, representatives from ASCO, the National Comprehensive Cancer Network or NCCN, the American Society of Hematology, ASH, and the CDC met to discuss the similarities, as well as the differences, among our various published respective guidelines in the area of managing chronic pain. We also discussed how to more clearly communicate to all of our respective memberships how and when practice guidelines should be applied in patient care. While discussing the CDC guideline, it became very clear to all of us that it was necessary to issue at some point a clarification on the question of where the CDC guideline applied to patients with cancer and sickle cell. And indeed, the first action item we took after this November meeting was that ASCO, ASH, and the NCCN sent a letter to the CDC asking for clarification. We're really happy, again, to report that this collaboration worked. Very soon after they received this letter from us, the CDC responded favorably. And in their response letter, they noted that their guideline, that is, the CDC's guideline, was initially developed to provide recommendations for primary care clinicians who prescribe opioids for patients with chronic pain outside of active cancer treatment, outside of palliative care, and outside of end of life care. So I want to pause for just a second and make very clear the aim of their original publication was primary care docs, not oncologists or hematologists, and the patients they were talking about were by and large not the patients who are seen and cared for in oncologists' offices. So the letter really did clarify that the CDC's guideline was never intended to deny clinically appropriate opioid therapy to any patients with acute or chronic pain from conditions like cancer and sickle cell disease. But instead, it was intended to ensure that physicians and patients consider all safe and effective treatment options for all patients with pain. And underneath all this remained the shared goal of reducing inappropriate use. Beyond this, the CDC also noted that the treatment guidelines from disease-specific experts-- and that means ASCO, NCCN, and ASH-- should be the guide to treatment and reimbursement decisions in the specific circumstances they cover. So let's just spend another 30 seconds on this idea. They did issue a guideline. It does apply to the general population. They never intended for it to apply to cancer patients or sickle cell patients. And they further called out in a sense the primacy of the disease special list in terms of the guideline priority. So it's great that we got this clarification. It's wonderful news. But I would submit to you that it's really just the first step towards ensuring that our patients don't suffer needlessly. So with this clarification in hand, we can and I would say we must act swiftly to correct existing policies that have already resulted in some areas in blanket restrictions on opioid prescribing, again, based on a misinterpretation over application of the CDC guideline. Every single day that goes by, there are Americans who are experiencing debilitating pain that could be avoided with appropriate treatment. We have some evidence for this. In 2018, as you may know, the American Cancer Society Cancer Action Network, that's ACS CAN, reported that 30% of cancer patients and survivors said that they were unable to obtain their prescribed opioid medication because of insurance denials. And that was a significant increase almost threefold from the 11% reported in 2016. So if you remember what we were talking about a moment ago, here's a set of guidelines that come out. They're not meant to be applied to cancer patients. And yet, we saw that as they were being misinterpreted and misapplied, there was a tripling in the number of patients reporting trouble getting indicated medications, and I mean cancer patients. Furthermore, 48% of individuals with cancer reported that their options for pain management were being limited by laws, guidelines, or insurance coverage denials. So this was, again, an external hand influencing their care coming from outside of their doctor's office. And even in states that exempt patients undergoing cancer treatment, there are significant administrative hurdles that are delaying access to much needed pain relief, not to mention that such exemptions often excluded cancer survivors. And survivors can have chronic pain for years sometimes from the disease or treatment. And without that exemption, they would, in fact, be suffering in a way that should be avoided. So it goes without saying, but I'll say it, that we really appreciate the CDC's leadership on this complex crisis. The agency has rightly noted that the opioid epidemic will continue to need ongoing collaboration and leadership. And we all need this as we work towards resolving the crisis. But they also acknowledge the importance of making sure that cancer patients and patients with sickle cell disease get the care and caring that they need and they deserve. I'll also point out that the US Food and Drug Administration plays an important role in advancing the use of evidence-based prescribing guidelines so that they are able to more accurately and appropriately direct the prescription of opioids. Former FDA commissioner Dr. Scott Gottlieb recognized this. And we look forward to continuing this important partnership with acting FDA commissioner Dr. Ned Sharpless. I think it's fair to say that the opioid crisis requires a response that protects the public, limits abuse, and ensures access for individuals who live with severe chronic pain. That's a vulnerable group. Clinicians, legislators, regulators, insurers, guideline developers, and patients have to join forces to make sure that we establish sensible, evidence-based approaches that confront opioid abuse but do not add a new group that suffers unnecessarily. We don't want to have one national crisis become two. So I want to close by extending my deepest appreciation to NCCN and ASH for collaborating with us to address this critically important issue and to ensure that our respective members are able to provide the highest quality care that their patients expect and deserve. If you want more information on our efforts to ensure access to appropriate pain control for patients with cancer and our other policy priorities, please visit ASCO in Action on our website at asco.org/ascoaction all one word. And until next time, I thank you for listening to this ASCO in Action podcast.