Addressing the Impact of Prior Authorization on Access to Cancer Treatment

Drs. Nathan Pennell and Nancy Lin discuss emerging data on the growing problem of prior authorization and insurance denials in cancer care, their potentially harmful impact on patient outcomes, and what can be done to fix the problem. TRANSCRIPT Dr. Nathan Pennell: Hello, I'm Dr. Nathan Pennell, your guest host for the ASCO Daily News Podcast today. I'm the co-director of the Cleveland Clinic Lung Cancer Program and vice chair of clinical research for the Taussig Cancer Institute. More importantly, today, for this podcast, I'm also the editor-in-chief for the ASCO Educational Book. On today's episode, we'll be discussing the growing problem of prior authorization and insurance denials, and how that impacts both providers and patients in their ability to access cancer care.  Joining me is Dr. Nancy Lin, a breast cancer medical oncologist at the Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School. She's addressed this problem in a recently published article in the 2023 ASCO Educational Book, and she's joining me today to highlight some emerging data on the possible harms from prior authorization and insurance denials, and what we can do to fix this problem.  Nancy, thanks so much for coming on the podcast today. Dr. Nancy Lin: Thank you for inviting me. Dr. Nathan Pennell: Some of our listeners may have noticed that we also did a podcast a number of years ago on a similar topic when we were with the Journal of Oncology Practice, and I was kind of hoping that prior authorizations would not be as big a problem, now, probably 8 or 9 years later, and unfortunately, it seems like it has gotten even worse.  Before we begin, I should mention that our disclosures are available in the transcript of this episode, and disclosures relating to all episodes of the podcast are available on our transcripts at asco.org\DNpod. So prior authorizations were, of course, originally intended as a cost control on the overuse of expensive medical care. However, in recent years, it seems like prior authorization has been extended to, more or less, all medical care, including supportive care medications and essential cancer care interventions that we need to use in almost every patient. We're also hearing more and more reports on patients who are denied coverage, and I think the doctors can sympathize with this, with their increasing peer-to-peer requests. And this is leading to patients being forced to wait to receive second-best options, impacting their out-of-pocket costs. And potentially, we all fear this is impacting patient outcomes, although we really would like to learn more about how this is really impacting their care. So, Nancy, can you talk to us a little bit about how prior auth is impacting patient access to cancer care today? Dr. Nancy Lin: Of course, we all have to acknowledge that part of the impetus for prior authorization is just the increasing cost of cancer care. There are some recent statistics that the U.S. spends over $200 billion annually on cancer care and that oncology drugs are a huge part of the overall drug cost in the nation and a large part of the oncology drug budget. So, I think we can't deny that the increasing costs of cancer care are in part driving this drive for more prior authorization. But this has costs, and there are costs in terms of direct patient costs as far as their quality of care, and also costs in terms of the health care providers and health care system.   And so we, as part of our article, actually solicited patients to provide their stories. And in fact, in our article, we have selected, with their permission, 3 patients who share their experiences. And these are experiences that, as a practicing oncologist, you'll be very familiar with. A patient wrote that she had been on capecitabine for a year, her disease is responding, and all of a sudden, on a Friday late in the day, she's told, “No, you need a prior authorization now, and you can't get your drug refilled.” And that led obviously to stress and delay and whatnot. And then another example is of a patient whose oncologist requested what sounds like next-generation sequencing, some sort of tumor panel and was denied. And the peer-to-peer here had apparently indicated that they are not aware of the data for the use of genomic testing and cancer treatment, which clearly there is a role for the use of genomic testing in cancer treatment. And in fact, we now have many articles that show that there's unequal access and, if we look at underrepresented minorities or other marginalized groups, that there is a dramatic difference in the utilization of advanced molecular testing. And then just the overall experience on patients and their families feeling like, at a time when they're sick, need to take charge of all of this paperwork and back and forth with insurers that is very stressful.   And then, from a provider or health care system standpoint, many, many hours are expended on prior authorizations for things like very new drug approvals that are maybe not on a pathway yet, or very commonly, simple things like a CAT scan for restaging of somebody who has advanced breast cancer where every scan requires prior authorization or antiemetics, or somebody receiving highly immunogenic chemotherapy and these kinds of death by a thousand cuts I think is how people in the health care experience the aspect of prior authorization.  Dr. Nathan Pennell: It's one of these things where we used to get a peer-to-peer for say, atypical reason for a PET scan, which made perfect sense, and you'd have to talk to an experienced expert to explain what you were doing and try to get a good rationale for that. And now, it's come to the point where a routine 2-month, 3-month CT scan is getting denied and having to be talking to someone who's not as experienced in this. Again, it feels still like a collection of anecdotes though in many ways. Is there any sort of published data on denials of care and prior auths and how this is impacting approvals and patient access? Dr. Nancy Lin: There are survey data, which one has to admit is not necessarily gold-standard data, but there are data from the American Medical Association, as well as a 2022 ASCO member survey. And in that ASCO member survey, over 90% of oncologists reported that they had personally experienced, in their patients, a delay in treatment related to prior authorization. Over 90% had issues getting needed diagnostic evaluations. Over 90% reported that they were, "forced to go to a second choice of therapy." And about a third of oncologists reported that they believed that the prior authorization, either delays or denial of care, led to changes or worsening of patient survival, which I think is the most concerning statistic of all.  Now, I think that one can argue that these are essentially physician self-report and what's the gold standard as far as whether there has been an impact? But I think that the fact that these reports are so prevalent means that, even if the reality is half of what has been reported, it's still a lot. And I think that  the power of these kinds of surveys is just enormous, that a high prevalence of the problems have been reported, I think, points to something even if we don't have gold standard quote data now.  Within our institution, Dana-Farber, we have done an analysis of oral medication prescribing. So, we do have gold standard and very granular data on patients that we've seen. And we've seen denials and requirements of prior authorization not only for expensive cancer medications and growth factors but also for even medicines like generic tamoxifen, which, honestly, how does that need prior authorization in this day and age? Medications like supportive care, antiemetics, and really things that ultimately, we were able to get approved 97% of the time, but [prior authorization now] introduces a delay and introduces stress. And although one may not be able to measure a so-called negative outcome from a patient recurrence standpoint, I think that there are other kinds of negative outcomes that are important, including just the experience of a cancer patient undergoing treatment, the stress of all of the denial letters and the delays that can occur as a result. Dr. Nathan Pennell: And it's not just patients. Obviously, we want to be patient-centered in our care and focus on how this impacts them. But this is also significantly impacting practitioners and cancer centers and physicians and the administrative burden of having to do the prior authorizations, which of course are not standardized in any way and vary from payer to payer and geographic area to geographic area. Is there data on how the changes in prior auth have impacted practices and physicians? Dr. Nancy Lin: Yes. In fact, there have been several surveys as well as in the practice types of studies trying to understand the staffing that is required to manage the prior authorization requests. And some of the estimates are an additional 40 hours per week per oncologist, that’s a full-time position. Some of these tasks can be carried out by non-oncology-trained providers but many of them do require either the oncologist or a nurse practitioner equivalent to be on the phone for the peer-to-peer or a full-time clinical provider and you are given a 4-hour window to do a peer-to-peer in the middle of clinic, that’s very disruptive. And I think that that’s fine if it’s every now and then for drugs that we all agree are perhaps outside of their usual indication. But if this is every CAT scan and every brain MRI and every time we prescribe an oral drug, it really does affect both clinic workflow, and just the psychology; I think it really contributes to burnout.  There was a very interesting survey actually of oncology trainees who, not even to the point where one is an attending physician, but at the trainee level indicating that this was something that was causing them a lot of distress, and in some cases, questioning the whole idea of going into medicine. And then when you think with the attrition that we’re seeing in the health care workforce, we do really have to be careful about these burnout issues because we really can’t afford to lose a lot of oncology staffing as the patient population ages and we’re seeing higher prevalence of cancer. I think it’s imperative that we take care of our oncology workforce. And I think this survey was very interesting because it went beyond the attending physician to other levels of oncology care, all of which are affected.  And there have been, as you know, many growing or nascent attempts at various residency programs to think about unionizing and what are the kinds of concerns or complaints that trainees bring up. And one of [the complaints] that  comes up a lot is, “We have to do these prior authorizations and there’s all this administrative paperwork that doesn't require an entry-level person.” I’m not saying that they should or shouldn’t do it - I’m not going to take a position on that - but the fact is that somebody has to do it in the current system, and whoever does it, it causes burnout. And I think that that is important. And the other piece of it has to do with equity and access to care because we’re coming from academic institutions. We have a staff of people who help with prior authorization. That's not true in every practice in the United States. And I really worry about not so much denial of care but even a step beyond that, which is if you are in an under-resourced office and it’s too hard to get certain things done, you don’t do them because you just don’t have the ability or you don’t have the staffing to be able to find insurance. And I think that is very concerning to me in terms of access to care, access to some of our immune-targeted therapies, and access to the optimal support of care medications. We come from very well-resourced places as far as the administrative staff, relatively speaking, and that’s just not true everywhere.  Dr. Nathan Pennell: This whole idea kind of falls under the idea of creating friction in the system to try to slow things down. I've seen data suggesting that things like peer-to-peer requests for appeals actually lead to a majority of physicians not having time or taking the time to actually do that. And that may be sometimes because they know it's indefensible and don't want to go through the process. But probably a lot of the time it's just because they don't have time to do it in their busy day and those patients then don't get their care covered. So, it's really a problem.  Now, the other thing that is really remarkable to me is, this is 2023 and everything is so technologically advanced. You can make major financial transactions electronically on your phone in just a few seconds, really complicated things. And yet this kind of [prior authorization] process really is still often done over the phone and by fax and with 100 different systems that don't talk to one another. And at the same time, oncology is becoming more and more guideline-driven where what we do actually have is really good evidence behind it. And there are even published guidelines for almost every disease and line of care about everything that we do from scan intervals to what kinds of treatment and how often and what supportive care is necessary. So, this would seem like an optimal situation for a technology solution where we tie in guidelines to what should and shouldn't be covered. What's going on out there in terms of trying to fix this? Dr. Nancy Lin: Some important questions are: Who makes the guidelines? What are the regulations as far as which guidelines insurance might adopt - their own internal guidelines or NCCN or comparable organizations? And what do you do when somebody wants to deviate from the guideline or pathway? And then finally a practical question, which is you don't really want to have a different platform and a different guideline for every insurance plan for every patient. And I think that is a little bit of even if we move to a purely electronic system, that will still be a problem.  The state of Florida had done this pilot study that tried to use or incorporate the NCCN guidelines as part of their approval or review process for prior authorization requests and at least based on the report that's published, saved $15 million in costs. And we would hope if the care was more NCCN guideline-concordant, which has been shown to improve outcomes, that would have been done without a detriment to patient outcomes. I don't think we have enough granular information to be 100% sure of that, but I would assume that that's most likely the case. I do think that some amount of guideline use could be useful.   And one of the things that we proposed in our article was the idea that one could create a sort of gold card system such that if a provider or a practice, for example, adheres to certain pre-agreed-upon guidelines or pathways more than 80% of the time, which is sort of considered good adherence and taking into account patient preference and comorbidities and whatnot, that that practice or provider could be sort of gold carded, so to speak, and actually have many of the prior authorization requirements go away so long as that is adhered to. And so that's one idea.  One of the concepts that Dario Trapani, who was the first author of our paper, put forward is that you don't necessarily need every person to be compliant with every guideline. Generally, you need for there to be compliance and that there could be different categories of treatment so that supportive care medications, pain medications for cancer-related pain, could potentially be exempt from prior authorization requirements completely. And then at the same time for other kinds of prior authorization requests, it's not enough to just change a fax form to an electronic form. That's an improvement from having faxes going back and forth by paper, but really isn't a fundamental change in the prior authorization process or vision. And so, this idea of the pathways and then only when something is deviated in some sort of major way in various categories to be determined that sort of triggers a peer-to-peer review that would both hopefully serve the purpose of reducing overuse of unnecessary or non- indicated treatments and save money. But also, in a way, I think that is less burdensome to the health care system. And I fully acknowledge that I am not a policy expert, I mostly research metastatic breast cancer, but this issue really affects us all very personally every day.   Dr. Nathan Pennell: I know you just said you're not a policy expert, but can you talk to us a little bit about what Congress and ASCO are doing to help from a legislation standpoint or a regulatory standpoint to help make this a little bit less painful? Dr. Nancy Lin: Yeah. So ASCO has endorsed the so-called “Improving Seniors Timely Access to Care Act.” And for those out there listening, particularly patients, you might say, “Well, I'm not a senior.” But it's important because how Medicare deals with issues often is then adopted by private insurers. And so starting with “Improving Seniors Timely Access to Care Act,” the intent is that it will also affect people with cancer at all age groups. But some of the provisions or the proposals are to convert to an electronic prior authorization system, to put systems in place for timely and efficient communication between providers and insurers, to ensure a process for real-time decisions that have some timeframe or timeline or deadline associated with it, to facilitate guidelines and pathway-informed decisions, and to also, importantly, be fully transparent about approvals and denials, portions that are denied, these sorts of reasons for denials, to really have transparency in that process which at the moment does not really exist. I think these are all very, very important steps with the overarching goal to promote timely and appropriate access to medications, procedures, and evaluations for oncology patients. Dr. Nathan Pennell: I'm just curious, in your opinion, do you think that there is actual inertia to try to change some of these things from a policy perspective? It can be kind of frustrating sometimes. It seems like the insurance industry has really kind of taken command of this by implementing these and we see the problems and we talk about them. But from a regulatory standpoint, it really seems like things are kind of maybe being a little bit neglected. Dr. Nancy Lin: I think that this is really something where I do think there will be some movement; maybe it's that I'm an optimist and that's what you need to be to be an oncologist.  I think that a big part is going to be really a focus on the impact on patients because although we certainly feel the impact on ourselves as providers and our staff, I don't know that that in and of itself is going to be enough to move the needle, like doctors complaining that they are having to spend too much time on the phone. I think the real impact is really related to the impact on patients. And as I said, I think that the AMA survey and the ASCO survey, those are very important because they really put the focus on [assessing] the impact on patients living with cancer.  Again, the limitations of a survey-based study are profound. And I do think that the current [White House] administration is very, very engaged in improving care for people with cancer. And in fact, part of this revised Cancer Moonshot [initiative] is not only better science around cancer and better molecular understanding of cancer but at the end of the day, if we can't get the right treatment to the right patient, it doesn't really matter how good the science is. And part of getting the right treatment to the right patient is not just training, guidelines and education. Part of it is just the practical aspect of insurance coverage as one important aspect of that. And so, I do think that there will be some movement on this because I think that it's really gotten to a point where this is not just inconvenient for doctors. I don't think that that's enough to drive anything forward personally, but I think that when you start to see impact on patients, that is really a big deal.  I was struck that one of the studies that we had identified was a study looking at over 13,000 chemotherapy requests and understanding how many were denied and why they were denied. And basically, about 11% of the requests ultimately were denied after peer-to-peer and all sorts of other appeals. And this was essentially the gold standard, so to speak. In this study was the oncologist's opinion as assessed by the so-called board certified oncologist, which is what was described in the publication employed by the insurer. We have these competing narratives and that is ultimately the problem: We have the AMA and the ASCO surveys which are survey-based asking the oncologists, and we have these data which are based on the insurer essentially as the gold standard arbiter. So it's hard to reconcile those two pieces of information because they're not really coming from the same place. And then I think you could also argue that, think about 13,000 chemotherapy requests, that means that essentially 90% were fine.  When we looked at our pathways employed at Dana-Farber where we check to make sure that our physicians are adhering to the pathways, we basically want to aim at about 80% with the idea that some patients decline a standard regimen, and we go to something else. They don't want alopecia with the idea that some patients have comorbidities, that you don't want to micromanage how oncologists are managing their patients. And honestly, in most pathway programs, we consider 80% to be pretty good. In this study, 80% were approved. And you might argue, is it worth reviewing 13,000 requests to this level of scrutiny for 90% to be approved? And again, I think that that really raises this idea of like rather than just switching a fax system to an electronic system to really rethink where's the low-hanging fruit? Where would prior authorization really serve a positive purpose? I think there are places where it could serve a positive purpose and where is it just adding unnecessary friction. Dr. Nathan Pennell: Yeah, it's a complicated picture and there are valid arguments on both sides. One of the things that is very appealing to me about the proposed legislation is requiring the payers to actually report and disclose their levels of denials and prior authorizations and this allow us to maybe take it beyond the anecdotal evidence to actually being able to document what they're doing. Because once you shine a light on things, sometimes it becomes a little bit harder to abuse the system.  Dr. Nancy Lin: Yes, I agree.  Dr. Nathan Pennell: Well, Nancy, thanks so much for coming on the podcast today to discuss this challenging problem. I know we could have talked about this for an hour or more. We really appreciate your work to highlight the impact of this problem both on providers and on patients, as well as outlining some efforts to find solutions. Dr. Nancy Lin: Great, thank you for having me. Dr. Nathan Pennell: I also want to thank our listeners for joining us today. If you value the insights you hear on the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Have a great day. 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. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.   Find out more about today’s speakers: Dr. Nathan Pennell @n8pennell Dr. Nancy Lin @nlinmd   Follow ASCO on social media:     @ASCO on Twitter   ASCO on Facebook   ASCO on LinkedIn     Disclosures:  Dr. Nathan Pennell:   Consulting or Advisory Role: AstraZeneca, Lilly, Cota Healthcare, Merck, Bristol-Myers Squibb, Genentech, Amgen, G1 Therapeutics, Pfizer, Boehringer Ingelheim, Viosera, Xencor, Mirati Therapeutics, Janssen Oncology, Sanofi/Regeneron  Research Funding (Inst): Genentech, AstraZeneca, Merck, Loxo, Altor BioScience, Spectrum Pharmaceuticals, Bristol-Myers Squibb, Jounce Therapeutics, Mirati Therapeutics, Heat Biologics, WindMIL, Sanofi  Dr. Nancy Lin: Stock and Other Ownership Interests: Artera Inc. Consulting or Advisory Role: Seattle Genetics, Puma Biotechnology, Daichi Sankyo, Denali Therapeutics, AstraZeneca, Prelude Therapeutics, Pfizer, Olema Pharmaceuticals, Aleta Biotherapeutics, Artera, Johnson & Johnson/Janssen, Blueprint Medicines, Genentech, Pfizer, Seattle Genetics, Merck, Zion, Olema Pharmaceuticals