IBD Drive Time: Millie Long, MD, on Insurance Barriers to IBD Care

Dr Millie Long and her IBD Drive Time cohost, Dr Raymond Cross, talk about ways health insurers create barriers to timely treatment for inflammatory bowel disease, particularly through requirements for prior authorization.

Raymond Cross, MD, is a professor of medicine and director of the IBD Program at the University of Maryland School of Medicine in Baltimore. Millie Long, MD, is a professor of medicine, vice chief of education, and director of the fellowship program in the Division of Gastroenterology and Hepatology at the University of North Carolina at Chapel Hill.

TRANSCRIPT:

Dr Cross:

Welcome everyone to IBD Drive Time. I'm Raymond Cross from the University of Maryland School of Medicine, and my co-host is Millie Long from UNC, who's actually our guest today also. So Millie, uh, welcome to IBD Drive Time.

Dr Long:

Thanks. It's fun to be on this chair, instead of the other, so looking forward to chatting with you about one of our new studies.

Dr Cross:

So Millie and coinvestigators presented an interesting paper at the Crohn's and Colitis Congress in January entitled, Insurer Mandated Medication Utilization Barriers are Associated With Decreased Insurance Satisfaction and Adverse Clinical Outcomes. And it was an IBD Partners survey. So, before I have Millie describe the rationale for that, Millie, can you describe IBD Partners to the listeners who may not be familiar with this cohort?

Dr Long:

Absolutely. So this cohort has really been an amazing partnership really, with patients to answer important questions in the field of inflammatory bowel disease. So we started this cohort in 2011, if you can believe it. So you know, over a decade ago, and it was actually the idea of Lloyd Mayer, who is a famous gastroenterologist specializing in inflammatory bowel disease, who sadly passed away some time ago. But he had the idea, which at that time was a novel idea, that with the internet we should be able to really harness its power and recruit patients from all over the world and answer important questions. And he tasked our group here from UNC with figuring this out and implementing it. And what we developed was a cohort called IBD Partners, which really partnered with patients. We had a patient steering committee that helped to guide, you know, every aspect of what we did.

We prioritized returning information to patients, we prioritized patients proposing questions, and we followed patients longitudinally through surveys, usually at least twice a year, where we captured information on medications and various patient-reported outcomes. And along the way we received funding from PCORI to turn this into something called a Patient Powered Research Network. And that really enhanced the collaboration with patients in terms of determining really those questions of most importance.

So we've been able to study things outside the box. We've been able to study dietary interventions and inflammatory bowel disease. We've been able to study things like this insurance, and lack thereof, and issues with insurance and how that impacts outcomes. Each of these questions is really incredibly relevant to the patient sitting in front of us. And so we felt that it would be really important to use these longitudinal data to be able to share some of these important questions.

Now, sadly, IBD Partners has ended. It ran for about 13 years. We really had an amazing partnership with patients, we're really able to look at longer term outcomes. And the data still exists, and they're housed both at the Crohn's and Colitis Foundation and here at UNC. And we hope to continue to use some of the historical data and studies in the future. But this really became a model of how to conduct direct to patient research. And over the course of that time period, we learned so much with our patient partners.

Dr Cross:

And then just remind me, there, there were about 15,000 patients in this cohort, is that right?

Dr Long: Yeah, at the height, 16,000. And so we had obviously inflammatory bowel disease—both Crohn's disease and ulcerative colitis is rare, thankfully—but when you harness the power of the internet, you can really recruit patients from all over. And frankly, we did have a worldwide involvement. Now, one of the limitations was we really only used patients who are English-speaking, so that we could have all of our validated survey instruments and things like that in the same language. But while the majority of course came from the US we had representatives from every state in the US and, internationally, many other countries were English is spoken.

Dr Cross:

And remind me, how many, about how many papers did have you guys published using this?

Dr Long:

Oh, at one point it was over 60 papers. Over 400 researchers have accessed the data and many more abstracts in terms of assessing different aspects. A lot of young investigators were able to harness the power of the data often, kind of having such a large sample. It was kind of a hypothesis-generating preliminary idea that you found signals in IBD Partners. And then that led to your next study. So not only do we have large studies such as this answering important questions surrounding barriers with insurance, but we also were able to provide kind of that pilot data for many young investigators to really launch their careers and move forward with other investigations.

Dr Cross:

Yeah, and you know, as a clinician, I'm just thinking of one example. You guys published something on NSAID use and flares and I still cite that, I still cite that to my patients every day in clinical practice. So a lot of meaningful stuff came from that very good investment from the foundation at PCORI. So what was the rationale for this study, Millie?

Dr Long:

Well, the rationale for this study was actually proposed by both patients and providers because I think both patients and we as gastroenterologists truly feel that our patients are having to jump through more and more hoops even to just stay on the medicine that they've been on that has been effective, much less to be able to initiate a new therapy if their last therapy is no longer effective for them. And that there are increasingly delays associated with this. Our question is do those delays cause downstream harm for our patients? And by understanding and quantifying that, are we able to then make changes, obviously in our health care system to help to minimize some of these delays? I think you, Ray, know just as well as I that with step therapy and the requirement for prior authorizations, and no matter how hard our office staff work as advocates for the patients, it's unusual not to have delays where patients have gaps in therapy. And what do those gaps in therapy mean? I mean, I'm sure you struggle with this on a daily basis as well.

Dr Cross:

Oh my gosh, yeah. I think it's probably, if you asked, if you surveyed us, we'd say it's probably the most frustrating thing and the thing most likely to result in burnout. And it's interesting, — this morning I was reading in Clinical Gastroenterology and Hepatology, the February issue, Brad Constant also has published a survey of providers about this same topic and showing what a burden it is to providers and how many hours they're spending. So this is a huge, huge problem for providers and patients. So obviously this was survey research, so anything else about the methodology that the listeners need to know?

Dr Long:

IBD partners is a self-report cohort, patient self-report that they have inflammatory bowel disease and their medications and other survey instruments. That said, early on we did do a validation study where we actually, with permission from patients, contacted providers confirmed diagnoses and medical records, and 97%, of the patients whom we validated, had inflammatory bowel disease. So I do think, while it is a self-report based cohort, we do have data that, it is validated and that really these patients, do have inflammatory bowel disease. And so, you know, certainly there are some limitations. There are some limitations also in any survey-based research in that you're not capturing 100% of the population out there, right? So that means that there may be a selection bias in terms of who actually completed the surveys.

It's possible there could be a recall bias because we're asking patients, think about your most recent time period, how when you had your medication authorization, please. And we ask various factors surrounding that. And so certainly those biases are there. But I think what is very objective is we're asking, we're looking at really hard outcomes like, did the patient need a surgery, these things that aren't necessarily subjective, that I think can be really helpful in terms of trying to objectively quantify some of the downstream complications associated with these insurer-based mandates for prior authorization and everything else that can cause delays. So what we aim to do in this study, what the first was to quantify the frequency of the these barriers by insurers among patients with IBD and look by various plan types.

We also wanted to determine how these influence the patient's satisfaction with their insurance. And then finally, what we think is probably most important, is that we looked for associations between these barriers and clinical outcomes, hard clinical outcomes, so surgery, steroid requirement, measuring their disease activity in the year following the survey. And so what we did is we queried patients from the IBD Partners Patient Powered Research Network. We invited about 4,000 patients to participate. And they filled out a survey with information surrounding their health plan, whether it was public or commercial, and also kind of frequency of insurance barriers as well as their satisfaction through a validated survey. So we actually had over 2300 participants who completed the survey. So that was a 57% response rate.

People were in their mid-40s, which is characteristic of the cohort. Majority female, about two-thirds had Crohn's, the remainder with ulcerative colitis, and that is representative of our cohort as well. It tends to be a little bit more individuals with Crohn's disease. And part of that is just that we recruited a lot from the foundation and many of the member patients who are associated with the foundation, that also tends to be a little bit more Crohn's disease than ulcerative colitis. And it was a very biologic-exposed population— over 70% were biologic-exposed and almost 90% were steroid-exposed. And the majority had private health insurance rather than public— public being, Medicare, Medicaid, VA— and actually a very high percentage—and I see this in my practice too—were on these high-deductible insurance plans.

And this is an astounding number. Ray, I'm sure you'll feel that this is accurate, but 72% of patients experienced an insurance barrier. So that's the vast majority of our patients. About half, prior authorization with a median delay of 2 weeks. Two weeks is a lot for a patient who's stable on a therapy. A denial, 15%; a step therapy requirement, meaning you couldn't go on the drug that your provider had recommended and you were forced to use a different therapy, 11%. Insurer forced medication switch—now, I really hate this as a provider, meaning I have a patient doing well on a therapy and the insurer says you have to switch— 7%; and a gap in therapy related to insurance 22%, and the median duration was 4 weeks for that gap. So, I mean, that's pretty astounding, isn't it?

Dr Cross:

Yeah I think that that's completely consistent with what I see in practice. And Frank Faraye and a fellow from Mayo Jacksonville, it was maybe 2 DWS ago, looked at the prior authorization process. And the whole point of that is to prevent inappropriate use of therapy. And I can't remember how many hundred charts they looked at, but basically in none of those situations, did the PA overturn the drug the prescriber was using? So it's just a completely…

Dr Long:

So it was appropriate. They're just having to jump through hoops, right?

Dr Cross:

Yeah. And it was just a delay stall tactic. So maybe they'll go to a different insurance or maybe they'll get frustrated and go to a different drug. So it's completely ineffective. So I completely agree with those numbers.

Dr Long:

And we asked the patients if they were satisfied generally with their insurance company, and, you know, most were but there are a reasonable number that are not; 81% would recommend their insurance company and 62% were at least somewhat satisfied with their current insurer, but certainly those numbers are not at 100%. When we look at—this is kind of the take-home of the study, which I think is really important, and I'd like our listeners to remember— is that when we looked at adverse clinical outcomes within a year among those that were denied a new medication, there was a 9-fold increased risk of surgery in the next year. So that's a huge corticosteroid requirement among those with a prior authorization delay, 2.25 increased risk of needing corticosteroids. That's horrible. Our patients know what corticosteroids are, like, you and I know what corticosteroids are like we, we want, don't want to use those.

But just because of a prior authorization delay, over a 2-fold increase, individuals with a prior authorization delay who were previously in remission, 1.9, increased risk of developing active disease if they had a prior authorization delay. And then also importantly, when there is an insurer-forced medication switch, you can see that individuals have continued disease activity over 3-fold increased risk. So these are real and tangible outcomes for our patients. And I think, obviously, this is step 1—describing the volume of the issue. And then we need to work with our advocacy organizations. We need to work with, frankly, Congress. We need to find ways to advocate, to remove some of these barriers because it's clearly impacting patient care.

Dr Cross:

And if people don't believe this, , Frank Scott has done work in this field, I believe, using claims type data, and he's shown very similar findings about the increased need for steroids, hospitalization, and even surgery with delays. And so this completely— you're validating each other's study. So, we know what the limitations are of survey type research. How do you think this population is representative of the population in the US with IBD? And if not, how might the results look different if it was applied more generally to patients?

Dr Long:

I think this population is a little bit different. This is a very highly insured population. Many have insurance and many have private insurance. Interestingly, when we looked, the patients with that were represented in our cohort with public insurance or those high deductible plans were actually the patients at highest risk. And so since we had such an oversampling of well-insured patients, I actually would argue that it may be an even bigger problem than what we're seeing here as you account for more public insurances and high deductible plans. And so I, I think that this is the tip of the iceberg, so to speak.

Dr Cross:

Yeah, I completely agree. And that was highlighted last year at DDW when they looked at some of these issues and patients that were in Vermont, Boston, and Mississippi, and showing that patients in Mississippi had really difficult time with access and delays in getting therapy. So I think you're right. So before I ask Millie what the implications are going to be for this, I just want to remind our listeners that the first regional advances in IBD of 2024 will be in Boston, April 5th to 6th. And as always IBD Drive Time is sponsored by the AIBD Network and we are available on Spotify and Apple Podcasts. So Millie, what are the implications for our listeners, administrators, maybe any payers that are listening to this?

Dr Long:

Absolutely. And let me start, before I launch into this last moment, of just kind of really recognizing the coauthors on this project. So Amber Elder is a patient advocate in inflammatory bowel disease. He was integral in developing this project. Frank Scott, whom you mentioned, at University of Colorado; Brad Constant, who's a pediatric gastroenterologist; and then, Peter Higgins, who's at University of Michigan, who initially developed the insurance survey within IBD Partners. And so it was a great team to work with, and I hope that this just in increases visibility of this issue.

So what are the implications? I think the implications are huge. I mean, in reality, by putting these step requirements, these prior authorization requirements, these delays in place, what insurers are doing, they're actually increasing their costs because you're seeing this extremely high rate of needing surgery, continued active disease, all of these aspects that are associated with complications.

And so, you know, while I wish I could snap my fingers and make it go away. I think that advocacy is the next step, a patient voice, a provider voice, and that we need to make changes, and we need to push back against these processes at the insurance companies. And the more data we have like this, the better. I will say, if there are any patients listening, being incredibly proactive, meaning that oftentimes these prior authorizations are every year, know this, be prepared, don't be late for your medicine already when one of these comes up, because then there's not much we can do to help to prevent these delays. So really, kind of scheduling this, being proactive about reaching out to your provider and your insurance company and making sure these are in place. We have to work within the system until we can fix the system.

Dr Cross:

Yeah, I agree, and I think for patients, this is where you absolutely, absolutely need to be a squeaky wheel. You need to let your provider's office know that you don't have drug, that there's delay, because sometimes they're not aware and they can intervene and help. You can call your insurance company and remember a lot of these payers, I'm not saying all payers are bad, but many payers realize that if you just simply reject the claim that a significant number of people aren't going to argue, they're not going to appeal. So this is a time where you really need to advocate for yourself and for providers out there that are struggling with this. The Crohn's and Colitis Foundation does have excellent letters on their website for providers that you can use as a template to appeal these decisions. And I know Millie and I, and all of us in the IBD world, like to help one another. And so certainly if you don't like those letters, you can email Millie or I or other providers and I always share letters that are successful. So I think there's a lot we can learn from this and hopefully a few payers are going to listen and maybe this will— pie in the sky—maybe they'll change some of their policies. It’d be nice.

Dr Long:

I agree. I agree.

Dr Cross:

So Millie, any final comments before we end?

Dr Long.

No, I don't think so. I hope that folks will join us in the future upcoming AIBD regional events that we have throughout the year. One note for those regional events that we're always announcing on these podcasts is this year for the first time these events are complimentary for all registrants. So it's a great way to come, get excellent, cutting-edge IBD knowledge, and obviously do so without any out-of-pocket expenses. So we hope to see people at those AIBD regional events.

Dr Cross:

Awesome. Well, Millie, thanks for doing this and congratulations on the study and we'll have you back soon because you're the cohost.

Dr Long:

I'll be back. Thanks Ray.