Podcasts about asco's government relations committee

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  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, 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.  Thank you. Good to be here.  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?  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.  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?  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.  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?  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.  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?  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.  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?  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.  I guess I have two questions. One, what is the benefit of this broader approach to the PCOP model? And the second is, what are some of the challenges that that brought?  I think one thing that's really unique in the update in the model-- it's certainly not something that we had envisioned initially, and it's why evolution, I think, of the model is important-- is the recognition that quality improvement happens slowly if you're in a silo. And so PCOP is really designed to bring together geographic communities of providers, payers, policymakers, and then it yokes them together to the patient's benefit. It allows for efficient sharing of best practices. One of the things that being involved, I think, in both the Washington State Medical Oncology Society here in my state and in ASCO at the same time has taught me that being collaborative helps our patients a whole lot more than being competitors.  I asked this question a little bit before, but now, even thinking about networks and collaboration, I'm going to ask it again and maybe push, even, a little harder. But in practice, how do you implement PCOP? How does a practice go from, it's Tuesday morning and we're running along the way we have since 2003, and it's Wednesday and now I'm in PCOP? What actually do you do to engage?  Yeah, I do think that there is a bit of a hurdle there. But there are also, I believe, some natural places that this could happen and get a foothold, and that once people see how this model worked and how effective it was, that it would certainly gain in popularity. I think Medicare Advantage plans, Medicaid HMOs, some accountable care organizations in particular have really struggled with, how do we manage oncology? And one way to do it is to partner with the providers and be able to manage together, and PCOP would be a godsend for some of those payors.  Well, I think-- not to get too inside the beltway about this-- we know for sure that the bandwidth and resources within CMS right now-- in CMMI, rather-- are limited enough that it is unlikely that they will wholesale adopt our model. And that leaves two possibilities. One is, they may take pieces of it as they upgrade the existing model. The other is that we might go it alone-- that is, outside of the Medicare system. But I think, in either case, we're really hitting on something which I wanted to get out there. It feels to me like it isn't ultimately-- narrowly-- up to the practice to adopt this. It's up to the payers to press practices in this or another direction. This is a response to pressure from payors. Do I have that right, or am I off base on that?  I think different communities feel pressures differently. In Washington state, I think we've been a little bit slow for our payers to step in and begin pressing us for alternative payment models. It's been more common in other places. But I do think that practices should consider this their counterproposal to some of the draconian efforts that we're seeing payers develop in other parts of the country. It's going to be a whole lot easier, I think, long-term if we're working together than if we are at odds.  And as-- this really raises two questions, a narrow one about the ideal practice setting for this, and the other is about the resources necessary to make this step. So, I guess my question is, do you think that this is targeted specifically at small community practices, or is it applicable to other types of practices? And related to that, can you talk about how ASCO itself is able to provide additional support for people that might want to do this?  I know that the concepts in PCOP can improve patient care and they can lower costs. I think it would ultimately invigorate our specialty and our practices if we were to move in this kind of direction. We know our current system is unsustainable, and ultimately won't be good for us or our patients. This represents a real opportunity that, as they say, you're either at the table or on the table.  Well, ultimately, for this to succeed, it has to fill a need, or it has to help with something. We know that the majority of practices are dealing with a variety of meaningful, serious pain points. Our most recent ASCO Practice Census found that almost 60% of practices found payer pressures-- or cited payer pressures as their top concern. How would the PCOP reduce that pain for those practices?  Well, somebody's going to listen to this and they're going to think I'm a complete Pollyanna. But I really think the biggest reason for the enmity between the providers and payers is that we're playing with two different sets of rules. And PCOP allows for setting the rules for both of us. So if our focus is on the patient-- and I really do think that most payers want a patient focus of care-- I think we can find common ground around PCOP once we get together and start talking to each other instead of talking at each other.  Do you think that this is-- or how big of a part do you think this is in the ongoing transformation from fee-to-service to fee-for-value-- in other words, the conversion to value-based care? Is this ultimately how we get there, or do you think there'll be other routes that practices can follow?  I'm certainly not going to say there's only one way to do anything. But I think-- I could certainly get in trouble in some circles for saying this out loud, but I think that the demise of fee-for-service medicine and buy-and-bill chemotherapy is coming. I think ASCO should take the lead in implementing the change. I think oncology as a community should take that lead and then improve on it. So, I don't think this is the end-all. I think there could be other ways to do it. But right now, I think this is the clearest way to get there.  If you talk to policymakers and you listen to candidates on the campaign trail, health care costs in general-- drug prices specifically-- are clearly at the top of the agenda and get a whole lot of rhetoric these days. So, if PCOP were to be implemented, how do you see it actually changing the cost of care? Where would the cost savings come from? And I think, alluding back to the comment you made before regarding fee-for-service, how confident are you in the ability of the health care system to distribute high-quality providers and access to care the way we need it, to be sustained? Because that obviously is sustained in part by the fact that people can make a living doing this.  Yeah. Data and experience tells us that the savings available through triage pathways, proactive patient-reported outcomes, efficient use of hospital facilities to limit ER visits and hospitalizations can produce real savings. The savings that occurred in the United Healthcare demo all came out of those kinds of savings, not from changing drug prescribing habits, or at least drug costs. I think there's also sufficient evidence to believe that value-based clinical pathways do bring savings. And I think there's a lot of improvement yet to be done in that arena.   ASCO has estimated that PCOP could bend the total cost curve for cancer care by 8%. That's huge. It doesn't try to measure the impact that widespread use of value-based pathways may have on drug prices. In my opinion, if everybody was on a value-based pathway, the only way to move up on the pathway if you're a drug company may be to lower your price, and we may see competition on list prices. That's something that's never happened in brand-name drugs today. I think that there's an opportunity, if this caught on and large numbers of practice were doing it, to actually bend the cost curve on drugs beyond just the 8% that ASCO has estimated so far.  And-- I'm just curious. You alluded already to the fact that the Center for Medicare and Medicaid Services model-- the pilot program, which was the first oncology alternative payment model, called the OCM-- that it's actually about to sunset. And you talked already about that pressure of time-- and I'm thinking about cost control, which is really their issue-- how does PCOP build on what we've learned from OCM? There must be some lessons that we can then implement in round two here, no?  Yeah, I think there is. And we've answered some of this in our discussion already. The amount of data that the practices have access to has really allowed them to fine-tune their practices and lead the practice transformation. Unfortunately, we've had to hire actuaries to figure it out, but that may be the price of success. We've tried to take the good-- we have OCM incorporated into our new proffered PCOP-- and leave the bad.   As we've mentioned, I really believe the Achilles heel of our OCM is that it puts drug list prices front and center and makes providers responsible for them. I know that CMMI has doubled down on this, and they believe that they can win their way into limited risk. But it still makes winners and losers based on luck of the draw-- based on who walks in your door. So, I really hope that CMMI will take a hard look at PCOP-- test as it is, or tear it apart piecemeal and use its best parts to improve OCM. It would be a shame if OCM was thrown out as a failed experiment just because it hasn't reached a point where people are ready or capable of taking two-sided risk.  We've covered a lot, and yet we've, I think, just begun to scratch the surface. So, if a practice listening to this-- a payer, if an employer or any other stakeholder has their interest piqued by our discussion and wants to implement PCOP, or just wants to learn more, what should they do? Who should they contact?  Well, I think that first they can head to the ASCO website at asco.org. They can also reach out to Clinical Affairs Department at clinicalaffairs@asco.org.  I think that-- for those of you that didn't get a chance to write it down, I would just urge you, clinical affairs as written as one word. So clinicalaffairs@asco.org. That's an attended email box. And frankly, by coincidence, I happened to be looking for the PCOP article this morning. And if you just Google PCOP and ASCO, one of your first few hits will be the 64-page PDF with a nice introduction from our current president, Skip Burris.  I do encourage people to follow Jeff's lead and dig into this, and start to familiarize yourself both with the specifics, but also with the concepts. I think this is likely to be a long-standing conversation and a gradual evolution for our community. So, with that, Jeff, is there anything else you want to add? Do you think we've missed any important topics as we are closing out this conversation today?  I'm sure we have. I can't think of them.  Well, I do want to thank you for joining me for this particular ASCO in Action podcast. It's always nice to have you back. And we look forward to hearing about the progress of PCOP and hearing even from CMMI what their review of it is in the months ahead.  It's exciting times. Thanks.  And for those of you listening today, if you've enjoyed what you heard, 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 upcoming 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. For now, and until next time, thank you for listening to this ASCO in Action podcast.  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. 

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.   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 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.   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.   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.   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.   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.   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.   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.   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.   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.   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.   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.   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.   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. 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 year-- have a much lower participation rate in clinical trials, and we are therefore missing a lot of patients who could be benefiting from those clinical trials and who could be contributing to the science. And these patients don't have the financial resources to pay for their routine cost of care. They cannot afford to pay the E&M visit, or for a chest x-ray, or a CAT scan on their own. So that would pose a huge barrier for them to even consider participating in a clinical trial. And one of the things that frequently is stated is, of course, this means that if you can't participate in a clinical trial, that they might be missing out on life-extending or life-saving therapy. And we have to admit that that, of course, is uncommon, but not impossible. But there are also more subtle ways that clinical trial participation can benefit the individual. Clifford Hudis: They may enjoy a higher quality of life with some experimental therapies sometimes. And the other thing, of course, is that we all, as a society, benefit it clinical research studies are concluded more quickly. We get an answer faster and we can move on to the next big thing or build upon what we've learned. So it isn't as if the cost of this is limited solely to people with Medicaid. It's something, I guess, we all pay, right? Melissa Dillmon: As a society, I think we suffer when patients are not able to participate in these studies.

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 advocacy issue where we really felt heard. We were able to share patients' stories and also deliver data that ASCO had collected to help support our view. So it was really an exciting experience for me. And then I got to replicate that experience on Capitol Hill, meeting with congressional representatives from New York in their offices, but then also, as you said, going to government agencies, which was a different experience as well. So I really got to see a broad perspective of how you can advocate for policy issues for ASCO. CH: Dr. Yang, how would you describe your initial advocacy meetings for someone who hasn't participated before? What does it feel like to walk into that first meeting and begin that first discussion? JY: Sure. I've done that for my friends before. I've described these meetings. And they always say, it's really not at all what they expected. And I think that Dr. Daly's description is exactly right. So you go with your group-- usually it's by state-- to the member's office. And then depending on how much room there is and how many meetings are being held that day, your meeting is either going to be in a conference room in the member's office or even, more frequently, in the hall or any room that's available. And the member is not always there, but one of their staffers is, or sometimes multiple staffers, who are always really young but super, super, super knowledgeable about the issue. Basically, you go around, and you introduce yourselves and then describe the issues that you're here to discuss. And it's interesting because ASCO always does a great job of making you exceedingly well-prepared with the facts. But the truth is that most members and most staffers are most interested in hearing the patients' stories, which is why it's so important that oncologists come to the Hill to have these meetings. I think that no matter how well you try to prepare, ultimately, it really just comes down to engaging with the staffer and finding some area of common ground. And cancer is so common that most of the time in these meetings, I find that staffers or members will say, I have a family member or friend or some other loved one who has cancer. And it's really great that you guys are here. CH: My own experience-- I mean, I'm here to talk to you. And the listeners want to hear from you. But I just can't help but share. When I got involved in this before you all were, the key issue that we were confronting was the decade-long flat-- in dollars-- flat funding of the NIH and the NCI. And my first trips to Capitol Hill consisted of virtually beating on doors and explaining why this was a mistake for the country and for our people, and getting what felt like the cold shoulder. Over and over again, the same arguments seemed to fall on deaf ears. But-- and this is an important "but"-- what I have learned is that repeatedly making rational, evidence-based, and appealing anecdotal arguments, just as you describe, can ultimately move the needle. And it does. And so my personal cynicism with regard to politics and making a difference has gone down, not up, with aging. And I think listeners should think about this. You will never go to a congressional office and change a mind in one quick phone call. But when dozens and hundreds of people do it repeatedly over months and years, we actually do have the chance to positively influence policy and legislative actions and regulations in the United States. And you should forgive me for waxing so poetic. You should be proud that you've committed to doing this early. And I hope you start to see the rewards. So I'm sorry to carry on about my own experience here. But it really is part of what has helped motivate all the staff to get behind this program and launch it and support it. Looking back, I'll turn back to you Dr. Daly. You're a couple of years removed now from the program. Can you identify one or several key learnings from your time as an ASCO Policy Fellow that have stuck with you, that you find yourself coming back to in your daily life? RD: Yeah, I mean, I think what you've just said, Dr. Hudis, about how you can really have an impact is something that I learned during this fellowship. It wasn't something that I had been aware of in the past, because I had never done advocacy work before in the past. So I think what this fellowship really trained me to do is to be an effective advocate. And that is something that I can use in a multitude of different areas as an oncologist. So combining the patient stories that we talked about that are so visceral and so needed when you're trying to get through to those legislators or policymakers that you're trying to reach-- but also backing that up with data, and I think ASCO really equipped us well as advocates to have the data, as well as the personal stories, to influence change. So using tools like CancerLinQ to be able to look at broader data sets and say, we know this is impacting our patients. We can see that. And now we need to think of a solution for change. And I think being involved in helping to create some of those solutions was also really valuable for me. So with the pathways, creating the policy paper, but also serving on committees during that fellowship year on MACRA and other issues, like opioid legislation, that were really affecting our patients, and seeing how ASCO is effecting change in those areas, was something that will stay with me throughout my career. CH: And how about you, Dr. Yang? Do you see any practical day-to-day impact, for example, in your work with patients from your time in the fellowship? JY: Yeah, absolutely. I think because I spent most of the past year thinking about high drug costs, both for chemotherapies, immunotherapies, and supportive drugs, I'm much more thoughtful about the costs that are passed on to our patients. And that can actually be really significant. And one of the things that I do much more often is I ask about cost to my patients when I prescribe medications. And that I really attribute directly to work that I was doing with ASCO. The other thing is that working with patients actually often gives me ideas. So I'll see patterns emerging. And I'll think, we really need to work on a policy that addresses this. And the great thing about the Health Policy Fellowship is that you remain involved with ASCO. So when I see these issues, I'm able to take them back to ASCO and to the committees. CH: Well, speaking of the committees, after you and all of our Fellows complete the one-year program, you were automatically added to one of ASCO's relevant committees. And I think you're both members of the Clinical Practice Committee. I'm curious-- I'll start with you, Dr. Daly-- has your time as a Health Policy Fellow helped you in your work on the CPC, and how? RD: I think, absolutely. It's made me more fluent in the issues that the CPC is confronting, the sort of things like the Oncology Care Model, rural cancer care. I now have a foundation where I'm able to contribute in a way on that committee that I never could have before or without the Health Policy Fellowship. CH: Yeah, I think it's often the case that sometimes-- or I shouldn't say often-- I think sometimes it's the case that people get onto committees and really do have a steep learning curve. It seems like maybe this could have accelerated your start on the committee. Is that your experience, Dr. Yang? JY: Yeah, I think so. I think that the Health Policy Fellowship, that first year is a really steep learning curve. But it does, as Dr. Daly said, provide a great foundation to just be aware of all of the issues that affect cancer doctors and cancer patients. CH: So I'm going to go to a little bit of a speed round, if you will, and ask you both to think about the other members of our community who have not had the opportunity to do this and might not ever have thought about it. Dr. Yang, finishing the program last summer of course-- so it's fresher, I think, for you-- why do you think it would be important for oncologists to be aware of and engaged in policy discussions, rather than nose to the grindstone, thinking about their clinical and research responsibilities on a daily basis? JY: Mainly, I really think that the reason for oncologists to be involved in this is that regardless if you are thinking about it or not, health policy affects you. And it affects oncologists. It affects how they practice. It affects how they are able to care for their patients and the type of care that they're able to provide. And if oncologists aren't involved, their voice is going to be lost. And oftentimes, they're the most important voice for their patients. CH: And Bobby, what would you say to the old version of me, the cynic, who says, this is a waste of time-- I'm not getting involved? RD: Well, I do think it really makes your career more exciting to be involved in health policy issues. It really broadens your view of how you think about patients and how you think about cancer care, and makes coming to work every day, I think, more exciting because you have this other lens that you're looking at issues with. CH: And looking back more specifically, and not intending to turn this into a sales job for the Policy Fellowship-- we only have two slots a year-- but I wonder what each of you would say to young colleagues thinking about this. What's the best reason to get involved in the Health Policy Fellowship at ASCO? I'll start with you, Dr. Yang. JY: I think that if you're interested in quality of care, the costs of care, access to care, then this fellowship is the right fellowship for you. And I think that being interested in those things doesn't necessarily provide you with the skill set you need to actually do meaningful work in that realm. And I think that the fellowship program really does provide you with tangible skills that you can then use to write policy briefs, to hold meetings, to be an advocate, all of which are really, really, really important. CH: Dr. Daly, is there anything you can add to that? Or does that pretty much sum it up? RD: I think that's absolutely right. I would just add the mentorship of the fellowship is really incredible, so getting to interact with the ASCO leaders, like Robin Zon, or Ray Page, or Blase Polite, but also the ASCO staff as well, who are incredible in the policy area, like Deb Kamin. I think I learned so much from being in their presence for a year and just absorbing all of their knowledge that they had, an experience they had. And when I was at the annual meeting just a couple of weeks ago, it was just such a fun pleasure to be there and see all of them and know that those relationships are something that will be with me throughout my career. And they really influenced me. CH: Wow. I think that's great. And I am so proud of both of you and all the participants in these and the other development programs that we offer. I will share with you that from the perspective of the board of directors, these programs really represent the crown jewel, something that the board members take the light in. And you should be proud to have contributed the way you have. So Dr. Daly, Dr. Yang, I want to thank you again for joining me today for this ASCO in Action podcast. RD: Thank you so much for having us. JY: Thank you. And for all of our listeners, if you want to learn more about ASCO's Health Policy Leadership Development Program, please visit us at asco.org and search for "policy leadership." The application period for the 2020-2021 year is now open, and it will be open through the end of September. So there is time to get those applications in. And with that, until next time, I want to thank everyone for listening to this ASCO in Action podcast.  

Subscribe to the podcast through iTunes or Google Play. Welcome to this ASCO in Action podcast. This is ASCO's podcast series where we explore policy and practice issues that have impact on 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 the ASCO in Action podcast series. For today's podcast, I am delighted to have as my guest Dr. Jeffrey Ward. He's the chair of ASCO's Government Relations Committee, and a longtime active member in that area. In addition to his important contributions to ASCO over the years, Dr. Ward is a medical oncologist and a hematologist at the Swedish Cancer Institute in Edmonds, Washington. Our conversation today will focus on utilization management in cancer care, or the policies that public and private insurers use to control the use of anticancer drug therapies, such as prior authorization requirements, restrictive formularies, step therapy, or fail first requirements, and specialty specific tiers. These are all new and complex topics for some listeners. For others, there's great familiarity. And we're going to explore all of them in the coming discussion. In September of 2017, ASCO published in the Journal of Oncology Practice a policy statement on the impact of utilization management practices specifically directed at cancer drug therapies. In that statement, ASCO outlined its opposition to payer imposed utilization management policies that restrict patient access to high quality, high value cancer care. The statement also points to high quality clinical pathways as the best first option for ensuring the appropriate utilization of anticancer drugs and the delivery of the highest quality cancer care. So with that as introduction, Dr. Ward, I'm delighted to welcome you to the podcast, and really looking forward to hearing your thoughts on utilization management. Thank you for being here. It's a pleasure. Thanks for inviting me. So to get the conversation started, can you just define first exactly what we mean by the phrase utilization management? Utilization management is classically when insurers or payers put controls over what care a patient may receive. And in our case, that usually means control of the drug therapies that they're going to get. I think that utilization management more strictly could also include when providers themselves use practices that try to strive for the highest quality care at the best price. So that already raises the possibility that there are a number of utilization management policies that payers could employ focusing, for example, on the use of specific prescription medications or other interventions. What are some of the more common utilization management practices that are being used specifically in cancer care? Well, I think the one that we run into every day is specialty care pricing. I was talking to the MedPack folks at Congress just a couple of months ago and began telling them the contortions we go through in a practice, where in my practice, we have seven docs. We have two full-time people who their whole job is to get authorization for drugs, and then to figure out how the people are going to pay for their co-pays that can sometimes be several thousand dollars a month. It's a restriction that I suspect the drug companies actually utilize to try and market their drug by providing co-pay support. At the same time, I think payers build it into the pricing of their insurance. So it's become a big part of what happens. And it's almost a dance between practices and payers. But it takes a tremendous amount of time and effort. And I'm not sure that it accomplishes a whole lot. Wow. I mean, I think there's a lot that we could unpack there. And I think for some of our listeners, it would help to frame this in even more realistic terms. We shouldn't use specific drugs or drug names. But I'm curious if you could provide a more concrete example of what exactly would happen to Mr. Smith in your office when you make a recommendation for a treatment, and what then ensues in terms of this specialty tier pricing. Sure. So Mr. Smith has prostate cancer. And he is appropriately treated with a very expensive oral medication along with his castrate therapy. And in doing so, I write a prescription. I send that prescription to a specialty pharmacy. They then begin doing a preauthorization process, or that preauthorization process may be done from the doctor's own office. They get preauthorization for the drug, but they find out that the patient has a 20% co-pay. This drug may cost $12,000 a year, and so the patient is now responsible for the other 20% of that cost. If it is a commercial payer, then the patient will-- then the specialty pharmacy will go to the drug company, and the drug company will provide co-pay support. That requires often the patient to give them a copy of their last tax return, and there will be some other requirements to show that they don't have the ability to easily pay for that co-pay. If that kind of process wasn't in place, the patient would probably in many circumstances deny the treatment and not get the best care that they deserve. If it's a Medicare patient, then the drug company directly providing co-pay support is called fraud. And so in that circumstance, the pharmacy will then-- or the practice will turn to foundations that help provide co-pay support, and try and get the patient foundation support. You're better apt to do that in January or this time of year in March than you are in November, December, because foundations tend to run out of money. So you run around scrounging up foundation support for your patient until you're able to do it. That puts delays that can sometimes last weeks before you can initiate a treatment. And not to put too fine a point on it, but in this example, you recommended a specific therapy, and ultimately the patient getting it, the delay is really in scrounging up or managing the co-pay through these various channels. Is that a fair assessment of what you've described? Or did I miss something? That's exactly right. And so the patient will almost always get the drug, but there can be considerable delays. OK. And so that answers, in a sense, the next question, that the concern about the overall impact of this kind of approach on individual patients is a delay in terms of needed therapies. And sometimes that might be a critically important one, but other times it might be honestly less critical. But it's also a lot of work. And there's a lot of expense on the side of the practice in navigating this. Is that also a fair assessment? Yes. And none of that is, of course, reimbursed. It's become an expected part of practice, but it is a burden on practices. OK. And just out of curiosity, what do you think the alternative would be? Since all of this seems to boil down to the fact that there is co-pay, and there are multiple ways of mitigating the impact of co-pay on the actual individual patient. What would the alternative to this actually be? Well, I think in a perfect world, the alternative would be that the patient would not have the co-pay, and the drug companies would admit that they're actually lowering their price significantly when they provide co-pay support. And patients would pay less. And we wouldn't have to go through the dance now. That seems, at this point in time, unrealistic. But I think that right now, the payers really have this locked into their cost of their insurance. So it is a dance that's expected. If there was a way to get rid of that, that would be great. One suggestion that has been made is that part D drugs that are cancer drugs actually get moved to part B, and that they get paid for that way for Medicare patients. And then the co-pay issue with part D drugs goes away for the Medicare patients. And then maybe some policy might follow on the commercial side. Maybe not, right? Yeah. That may follow. But the commercial side is a little bit easier, because the commercial side, you can get direct support from the pharmaceutical company for their co-pay. And you can't do that for Medicare patients. OK. So let's-- forgive the pun-- take the next step and talk about step therapy. As I understand it right now, the White House and Congress, along with ASCO and other stakeholders, we are all working-- and I think it's true at this point in a fairly collaborative way to try to talk about and start to address the high cost of prescription drugs here in the US. One part of these efforts from CMS has been to propose expanded use of step therapy. Can you describe what step therapy would look like for a patient with cancer? Sure. I think that some of us prefer the word fail first to step therapy, because that's more descriptive of what it is. Step therapy is the idea that before you can get drug B, you have to use and fail drug A. Most step therapy is based on price of the drug. And we don't think that that applies very well to cancer patients. Most of our patients, there is a best drug for them. And to have to use inferior drugs to get to the best drug is problematic, not just in time and delays, but we know that our disease evolves over time. And if you use an inferior drug first, the superior drug may not work nearly so well as a second line therapy. So in an ideal situation, hypothetically, were there two drugs that on average offered the same response rate, progression free survival, overall survival, and similar toxicities where one costs less than the other, this approach might make sense, assuming there weren't mitigating factors at the individual patient level. And it's fair to point out, I think, that in other domains outside of oncology, classically blood pressure management, step therapy has been accepted and is reasonably successful. If I'm hearing you right though, the problem we see in oncology is that kind of ideal equivalence is rare. And most of the time there really are reasons, good reasons, defensible evidence-based reasons, that oncologists select one treatment or another. Is that a fair summary? Yes, I think it is. An example where someone I think might inappropriately use step therapy would be in renal cell cancer, where we have a number of TKIs that are available. Someone may say that they all have similar response rates. Of course, none of them have been compared head to head. And so that makes it very difficult to say whether they're really the same or not. But they do have different toxicities. And so even if you would say on average their toxicities are similar, for a given patient, one drug may be better tolerated or more appropriate than another. To use those drugs in a step therapy fashion would be inappropriate, and I think would harm patients. There are circumstances where I think step therapy is easy to apply in oncology, but they are few and far between. One example where step therapy I think will be applied-- and I wouldn't have problems with it-- is in the biosimilar products. And my understanding then is that the Medicare Advantage, at least, some of the plans began allowing step therapy just at the beginning of this year, 2019. Have you begun to see or hear about any impact on patients yet as a result of that or is it still too early? I have seen payers doing some step therapy in, for example, the biosimilar realm, or even requiring you to use a filgrastim instead of pegfilgrastim. But I have not yet seen the part D payers using step therapy. I don't know whether ASCO and its state affiliate counsel has begun gathering examples across the country otherwise. The filgrastim-pegfilgrastim issue that you just mentioned, I think, is a good one for highlighting some of the subtle challenges here. It's probably fair to say that the impact on hard measures, like infection or admission to the hospital, will be indistinguishable. But in one case there are multiple either office visits or health care professional interactions or a burden on the part of the family members or patient for regular administration, whereas with the other choice, of course, there's one dose per cycle. So the price, if you will, of that convenience, I think, is another issue that will eventually bubble to the surface. Right? Yes. And the ironic thing about that step therapy is that if a patient decides that they want to self-administer the drug at home, they have to pay co-pays for the privilege of giving themselves a shot. Right. Well, we could probably fill the whole podcast with perverse incentives and bizarre quirks of the system, I'm sure, in terms of drug administration, right? I think that that's one of our problems. So look, we've identified these challenges. Of course, our job here is both to highlight them so that our members and listeners are aware, but even more importantly is to do something about that. So can you start to describe how ASCO is working with Congress and the administration to address some of these issues to encourage policies that would be better for people with cancer? Well, I think one of the first things that we've done is we've collaborated with our state affiliate societies in individual states where there has been legislation regarding some of these utilization management activities that don't make a lot of sense. There are a number of bills last year in just step therapy itself. In a number of states, I think there were a total of about 90-some odd bills that addressed some kind of utilization management in different states across the country last year. We have a similar bill that's in the legislature here in Washington state right now that is looking at step therapies, and to put some curbs on it, and more particularly, to make the processes transparent so that when you do have a step therapy in place, you know it. You understand it. And you know what literature has been used so that you have an ability to appeal it if it's appropriate for your patient. So those kind of processes ASCO is facilitating. The big picture, I think, is that we need to somehow develop a reimbursement system that actually incentivizes oncologists and payers to work together instead of being at odds over this. And that would involve developing pathways that are value based, but in our mind, very distinct from step therapy. Well, I mean, that's a natural segue to the next topic, which is, in fact, ASCO's 2017 policy statement, which addressed utilization management, and pointed to high quality clinical pathways as payers best first option for ensuring appropriate utilization of anticancer drugs. Can you talk a little bit about why we at ASCO have turned to focus on that as the tool to drive the delivery of high quality care? Well, I think there are several reasons. One, we've staked out a position that we believe that as oncologists we should be responsible for the way we use drugs, and the management of our patients' care, and that part of that responsibility should be to be cognizant of the cost and the value of the drugs we give. But we don't believe that we should be responsible for the prices that those drugs carry. A system that we have right now in buy and bill makes us responsible for that. And many of the reimbursement reforms that have been done, the oncology care model being one of them, for example, actually makes oncologists responsible for the cost of the drugs in the reimbursement scheme. We think that that is a mistake, and that there are better ways to try and leverage the cost of drugs than making us responsible for them. Right. I mean, one of the things we say is that we don't set the launch price, and we're not responsible for it. But in these models, it can be the case that expensive new drugs that drive up the cost of care even when they do deliver better outcomes and are the right therapy can become a financial liability for the prescriber, right? And that's a real challenge, I think, for us. Correct. I mean, I was a lead author on a paper that we published a year or so ago in the Journal of Oncology Practice that used a model to demonstrate what the risks of taking on responsibility for the cost of drugs in a model like OCM would be. And in doing so determined that if you were a small practice of less than 10 doctors, there was a 10% risk that you could have a 30% deficit in your drug costs just on the basis of who happened to walk in your door. The end result would be that if you were in that kind of arrangement and taking on risk for the cost of your drugs, whether you were successful or not would depend less on the skill and the choices you made, but on who walked in your front door. Yeah. And that's a real problem, because we certainly don't want a system where there's an incentive and disincentive to select or select against certain sick patients, obviously. So I guess the one question that some people may ask as they think about this is whether there are any situations where the utilization management policies we're seeing now do provide a benefit. That is, are there patients or outcomes that are improved because of the current utilization management tools? Are there places where costs are controlled or there's more effective management of resources in general? Meaning, are there any silver linings in this right now? I think that for individual payers, particularly large payers, there may be a silver lining that we don't see. So I'm guessing as to whether this exists or not. Many of them, I believe, get rebates, often volume rebates, based on step therapy. Whether that actually computes into lower premiums for patients or not or simply higher profits for the insurer, that would be well out of my realm of knowledge. But I think that there is some leverage. I think there'd be a better way to develop leverage. And that would be if we were using routinely value-based pathways and partnering with insurers to be able to put downward price on drug-- downward pressure on drug prices. Right. So alignment of incentives is what you're describing at the end there. And I think that's ultimately the best solution for many of the problems that plague us in the health care system. With that, I want to thank you, Dr. Ward, once again for joining me on this ASCO in Action podcast. It was a real delight to hear your thoughts, and to gain a little bit of deeper knowledge. Thanks for doing that. You're great. It was fun to be here. For listeners who want more information on utilization management policies and the latest cancer policy news and updates, visit ASCO in Action, which is literally ascoaction.asco.org on the web. And otherwise, until next time, thank you for listening to this ASCO in Action podcast.

Host: Matt Birnholz, MD Guest: Robin Zon, MD, FACP Value-based, patient-centered care has become the destination for all branches of medicine, and is the philosophy driving modern payment reform initiatives like MACRA. But the unique care delivery needs in each specialty challenge the notion that one payment model can serve everyone. And nowhere has this become more relevant than in the field of oncology. Dr. Matt Birnholz joins Dr. Robin Zon, practicing oncologist and vice president and senior partner at Michiana Hematology-Oncology in South Bend, Indiana. Dr. Zon serves as Chair-Elect of ASCO's Government Relations Committee was Past Chair of the Clinical Practice Committee, which alongside other stakeholders at ASCO developed a Patient-Centered Oncology Payment (PCOP) model. Recently, Dr. Zon presented this information at the recent AMA House of Delegates meeting in June. She speaks to the phases of this model, how it can function as a defined APM under MACRA, and its demonstrated positive impacts on oncology care pathways.

Host: Matt Birnholz, MD Guest: Robin Zon, MD, FACP Value-based, patient-centered care has become the destination for all branches of medicine, and is the philosophy driving modern payment reform initiatives like MACRA. But the unique care delivery needs in each specialty challenge the notion that one payment model can serve everyone. And nowhere has this become more relevant than in the field of oncology. Dr. Matt Birnholz joins Dr. Robin Zon, practicing oncologist and vice president and senior partner at Michiana Hematology-Oncology in South Bend, Indiana. Dr. Zon serves as Chair-Elect of ASCO's Government Relations Committee was Past Chair of the Clinical Practice Committee, which alongside other stakeholders at ASCO developed a Patient-Centered Oncology Payment (PCOP) model. Recently, Dr. Zon presented this information at the recent AMA House of Delegates meeting in June. She speaks to the phases of this model, how it can function as a defined APM under MACRA, and its demonstrated positive impacts on oncology care pathways.

Host: Matt Birnholz, MD Guest: Robin Zon, MD, FACP Value-based, patient-centered care has become the destination for all branches of medicine, and is the philosophy driving modern payment reform initiatives like MACRA. But the unique care delivery needs in each specialty challenge the notion that one payment model can serve everyone. And nowhere has this become more relevant than in the field of oncology. Dr. Matt Birnholz joins Dr. Robin Zon, practicing oncologist and vice president and senior partner at Michiana Hematology-Oncology in South Bend, Indiana. Dr. Zon serves as Chair-Elect of ASCO's Government Relations Committee was Past Chair of the Clinical Practice Committee, which alongside other stakeholders at ASCO developed a Patient-Centered Oncology Payment (PCOP) model. Recently, Dr. Zon presented this information at the recent AMA House of Delegates meeting in June. She speaks to the phases of this model, how it can function as a defined APM under MACRA, and its demonstrated positive impacts on oncology care pathways.