IBD Drive Time: Streamlining the Prior Authorization Process

Dr David Rubin discusses the hurdles of prior authorization and ways to manage the process to ensure patients can receive their IBD therapies with guests David Choi, PharmD, and Mona Shah, MPH.

David T. Rubin, MD, is the Joseph B Kirsner Professor In Medicine and chief of Gastroenterology, Hepatology, and Nutrition, at the University of Chicago School of Medicine. David Choi, PharmD, is a clinical pharmacist and the associate director of the Inflammatory Bowel Disease Center at the University of Chicago. Mona Shah, MPH, is senior director of policy and strategy at Community Catalyst, a nonprofit health policy organization headquartered in Boston, Massachusetts. 

RESOURCES for providers and patients:

https://rubinlab.uchicago.edu/patient-resources/

https://www.crohnscolitisfoundation.org/science-and-professionals/program-materials/appeal-letters

https://communitycatalyst.org/resource/patient-complaints/

https://www.cms.gov/CCIIO/Resources/Consumer-Assistance-Grants#statelisting

https://www.healthcare.gov/appeal-insurance-company-decision/

https://www.healthcare.gov/marketplace-appeals/

https://content.naic.org/sites/default/files/consumer-health-insurance-appeal-denied-claims.pdf

https://content.naic.org/state-insurance-departments

TRANSCRIPT:

David Rubin: 

Welcome to IBD Drive Time. Today, the title of this podcast is Prior Authorizations and Re-authorizations. What can we do to Streamline the Process? I'm the guest host, Dr. David Rubin from the University of Chicago. And joining me today are two renowned experts, David Choi and Mona Shah.

Let me tell you a little bit about them and then we'll get right into it. David Choi completed his doctor of pharmacy degree at the University of Colorado School of Pharmacy, and then he completed an internship in pharmacy and residency in pharmacy at the Johns Hopkins Hospital. He's currently serving as the associate director of the Inflammatory Bowel Disease Center at the University of Chicago and works to help our patients get their therapies as well as to advocate for patients to have better support in doing so.

Mona Shah is the senior director of policy and strategy and a member of the senior management team at Community Catalyst, an organization that partners with local and state groups to ground healthcare policy and practice change goals within the community. She received her Juris Doctorate with a certificate of concentration in health law from the University of Maryland School of Law, as well as a master of public health and health policy and management from Emory University. Welcome David and welcome Mona. So we're going to jump right into it. We have a few questions and I'll start by asking David to comment. David, what are the current challenges patients with inflammatory bowel disease face in getting their medications?

David Choi:

Hi, Dr. Rubin. Thank you for having me on the podcast today. Really excited to kind of talk about this topic, which is very near and dear to my heart. I'll say there are quite a few challenges that patients face in terms of getting their medication. First and foremost, prior authorizations tends to be one of the big ones that we talk about. When we think about a clinic visit where a patient may see a provider and the plan is to initiate some kind of therapy, the shared decision making was done, a lot of things to choose the best therapy for the patient. So now the battle becomes trying to get access to that therapy. That tends to be a little bit challenging. Insurance companies have come up with a lot of barriers, a lot of challenges that don't allow patients to start it. So they need to say, yes, we agree with the plan for the patient to start this therapy.

More often than not, though, there's very strict criteria, very yes-no type answers that lead to denials and that can interrupt, delay, make it challenging for patients to start their therapy. Something that I will say more so that we've been encountering more especially over this past year are the increased uses of copay accumulators, copay maximizers, and the use of these third-party alternative funding programs that have actually really been challenging for our patients. So even though we get the therapy approved by the insurance, we're starting to see these new challenges pop up where it's more about affordability and they make it where patients can't afford these therapies or they're trying to force patients to use patient assistance programs and things like that. So in my mind, those are the current challenges that we've been encountering and it's definitely something that we're working very hard on in terms of trying to address at University of Chicago.

Dr. Rubin:

Well, for those of us who take care of these patients and who advocate on their behalf, we certainly appreciate these challenges. Can you just elaborate—what's a copay accumulator?

David Choi:

Copay accumulators are something that we think about where in instances where patients with commercial insurance, so this is specifically for commercial patients, not Medicare, not Medicaid, anything along those lines. Patients may have a certain copay they're expected to pay that goes towards the deductible of their plan that allows their insurance to then fully kick in. In the past, what patients were able to do were use the copay cards to go towards that deductible. So let's say if someone has a $1000 deductible, they can use a copay card to kind of hit that deductible and at that point the copay drops to $10, $5, something along those lines. The problem now where the copay accumulators prevent copay cards from being applied towards deductible. So let's say a patient tries to fill a medication, it's $1000, so they use that. Next time they go to fill, it's a $1000 again. So somehow the insurance companies have come up with a way of identifying to prevent copay cards from going towards the deductible.

Dr. Rubin:

It sounds pretty intentional. Mona, is this what insurance companies are trying to do and why are they doing this?

Mona Shah:

So I think insurance companies are always trying to do what they can to not have to pay for certain types of care and at Community Catalysts, we strongly believe in providers having full autonomy to make the best treatment decisions for their patients, and then individuals not having to worry, are insurers going to approve the prior auth or are often in other instances there will be a claim filed when that claim will be denied. And so at the moment, there are some federal authorities in place to get more data on these practices, but there isn't as much enforcement as we would like there to be. And the other thing is I think a lot of insurance companies are aware that individuals, especially ones who are very ill, don't have capacity, resources, and time to really advocate for themselves.

And so just one example, just in Medicare Advantage, the Kaiser Family Foundation did a study pretty recently that said that only about 11% of all of the prior authorization denials were actually appealed. And then of those that were appealed, 82% actually resulted in fully or partially overturning the additional denials. So when it comes to prior authorizations— and this was specific just to Medicare Advantage— that was a pretty good success rate. And so I think just making individuals more aware of what their rights are and the channels that they have and streamlining the process, making it easy, not making it so daunting and overwhelming would go a long way.

Dr. Rubin:

Yeah, I'm sure that the insurance companies, the payers know these data—that if they deny once there's a high likelihood that the individual physician or patient will not appeal and therefore they'll end up saving money on a more expensive treatment strategy. But I think that patients, and I would suggest providers like me, are not aware of these data. David, I know you've also looked at the amount of time it takes to get a patient on therapy, whether they need to have an appeal or not. Do you want to comment on those data that I think you're publishing?

David Choi:

Yeah, absolutely. So that's something that we specifically looked at our own internal data of how we're doing with prior authorizations related to self-administer medications, so self-injections, oral, so not including the infusions. What we found was the significant delays kind of associated with this process. So prior authorization, I think on median turnaround time was about 10 to 14 days. So about 2 weeks, 1 to 2 weeks for us to kind of hear back from the insurance companies regarding, yes, it's approved or it's denied. What we found out though was within an appeal that had to then be submitted, that was an additional 2 weeks, 2 to 4 weeks that needed to be done to get a determination from that standpoint. So I know the importance of cost containment strategies and things like that, but I think something that's been a little bit challenging for us is those delays are quite significant.

And sometimes those reasons for denial is literally just a very simple yes or no. Instead of looking at the request holistically or as a whole, it's just really this one question, you got caught with this one question and that was an automatic denial. So I think some of these automatic denial processes has definitely delayed the process. And furthermore, I think kind of bouncing off what Mona was saying, I think in addition the second-level appeal and then the very last external review, those were also months that were added. So that's like additional month per step of the process. So some of this can literally lead to about 3- to 4-month delays in therapy.

Dr. Rubin:

So it's sort of adding insult to injury. So not only is there a delay that requires appeal, but in the ultimate decision that's a denial, the patient's been waiting even longer before they can go to a different treatment strategy. Mona, some insurance companies would argue we're just trying to provide the greatest good for the greatest number and health care is too expensive. What do we say back to that argument?

Mona Shah:

Well, I think, I know David mentioned they see it as a cost containment strategy, but I think if you're on the provider side, you're working with individuals who receive this care, this is essential care. And so we firmly believe that it shouldn't be up to the insurers to make that decision. There are other ways to manage costs, but certainly denying someone their prior authorization or denying a claim, and again, who defines medically necessary as well. There are some standards in the Medicare program around that, but that's not a consistent standard for people who receive their insurance through other ways, whether it's through their employer, through healthcare.gov, one of the marketplaces, et cetera. So I think having a little bit more understanding or commonalities around who decides what's medically necessary, I think is also important.

Dr. Rubin:

Yeah. And I've made the arguments before that it's certainly appreciated that health care is too expensive and the cost of prescription therapies, especially advanced drugs, is too expensive. So we recognize the need for cost containment or cost savings, but that doesn't excuse making decisions that are not evidence-based or consistent with standards of practice. And one of the challenges that I personally have encountered and have railed against has been decisions that are not keeping with the times or worse, tell patients that the doctor recommending something that's quote, unquote, experimental when in fact it's clearly not. So why don't we move to some practical points from both of you. How can doctors and other prescribers improve the authorizations and acceptance rates? How do we miss the easy things or what can we do to make sure that we don't make errors that would otherwise get things passed right away? David, why don't you start us off?

David Choi:

I think there are a few things that prescribers can do to really kind of help make this a more efficient process as well to improve the likelihood of approval. So there's a few things that I think would be helpful. The first one is just always make sure that the right insurance is uploaded for the patient, that we do have the most up-to-date insurance information. Second, your notes mean everything when we submit this. So a lot of the prior authorizations that we submit, we need to submit chart notes with it. So more recently, over the past couple years, I think the insurance companies are really digging through and reading through the chart notes as well. So if they see any indication where there's a questionable diagnosis or they don't even think this medication's going to work, but they want to try it, I think those kind of increase the likelihood of denial. So really those chart notes, just making sure that they show all the previously failed therapies, the rationale, just making a very good case, I think is very helpful.

Dr. Rubin:

Yeah, I think that we modified our notes to satisfy billing requirements for clinic visits and clinical services and procedures, we could easily be more proactive in modifying our notes to anticipate the need for prescription authorizations and reauthorizations. Mona, what suggestions might you have for people who are prescribing therapies or maybe on the patient's side to help with these things?

Mona Shah:

I think it's a nice segue to what David has mentioned is having all of that documentation is really key when you are filing an appeal. And so the next step is partnering, whether it's state or local organizations, there's quite a few that have navigator programs. The federal government also funds consumer assistance programs and being able to link patients up with those organizations who can provide the support and resources. So if they have everything well documented and then they have the support to file the appeal, I think that's really important. And just an awareness of what the process looks like, what the avenues are. I certainly hear the frustration of when you do file an appeal, it further delays the care and it takes even longer. And then the other thing I should mention is obviously claims denials, prior authorization denials, they don't exist in a vacuum alone.

And so something we're doing at Community Catalyst is looking more broadly about health care costs and out-of-pocket costs for individuals. So we've been really looking at the issue of medical debt, for example, because what happens when you're denied a prior auth or denied a claim and it's still care that you very much need, patients will still receive it but then go into medical debt as a result because it wasn't covered. And so there are certain things also in terms of knowing their rights, like when you do go to a hospital setting, asking about a financial assistance policy and seeing whether you qualify for that. A lot of hospitals are not very overt in letting individuals know that they could qualify in filling out the form. So I think a lot of this for us is making sure that both patients and providers have resources to direct them in ways to advocate for themselves.

David Choi:

The one thing I was hoping to actually add, and I think that's a very good point, is thinking about some of the creative ways of getting access to medications as well. Insurance is definitely one route, but like Mona mentioned, the financial assistance programs, patient assistance programs that may exist, foundation support, kind of things along those lines. That's something that I think at University of Chicago we always keep in our back pocket. It's the ace in the back pocket that we always kind of use to ensure our patients are able to get the medications they need. So just really being creative, I think, in terms of the different programs available and things along those lines. And I do think that's such an important point.

Dr. Rubin:

IBD Drive Time is sponsored by the Gastroenterology Learning Network and advances in inflammatory bowel diseases. You can now find our podcasts on Apple and Spotify. Just search for the Gastroenterology Learning Network to find us.

All right. Well, carrying on from what David and Mona both said, can you give us some specific resources that prescribers can use or refer patients to, to help get them the support they need to either get on therapies or stay on the therapies that they're already using? Who wants to start? Mona?

Mona Shah:

I saw David go off mute first so he can go ahead.

Dr. Rubin:

Okay. Sorry. David, go for it.

David Choi:

All right. So I think sometimes the things that we think about in terms of some of the programs and things that are available, one thing that I think has been really helpful, especially with the past couple years, are a lot of the manufacturers have started developing these positions called Field Access Reimbursement Specialists. They are very good kind of resource to have to understand what programs would be available in the manufacturer program and just making sure that we could run kind of complicated patient cases by them to kind of get their thoughts in terms of what the best next steps would be.

So that's something that I do think is helpful just to understand what programs are available with the manufacturers. The patient assistance programs are probably the biggest ones that we would advocate for. There are specific limitations. So generally they have to meet a certain income threshold based on their household size. They may need a certain residency status, kind of things like that. Each manufacturer's a little bit different in terms of what they require, but those are definitely some of the programs to our mind that we really think about in terms of helping access to therapy.

Dr. Rubin:

I think that those are helpful resources. I've said to our colleagues, one patient at a time, you take care of the person sitting in front of you. But I clearly recognize that there's a need for more state, regional, and national or federal engagement in some of these practices and supporting our patients. Mona, can you comment a little bit on what's happening on a national level or ways that we might get more engaged in the advocacy efforts?

Mona Shah:

Yeah, absolutely. So nationally, there's a few pieces of legislation that have been introduced last Congress or this Congress that I think it would definitely be important for individuals to weigh in on. For example, one is called the Medicare Advantage Consumer Protection Transparency Act, which requires insurers, Medicare Advantage, to report on some of this information about denials that agencies and the public would have access to. We have some of this information, but to an earlier point, the more data that states and the federal government have available, the more that can help advocacy efforts and really understand the scope of how often this is happening and on which types of care and why. And then even for example, there's another bill called the Improving Senior Access to Care Act where it actually, would have a new process for implementing electronic prior authorization programs where they establish new federal standards and real-time decision making processes for certain things that may just need some routine approval, but not to the point where it's so automated that things are getting denied, right, instead of being approved.

And some states have been doing some really interesting things too. California, for example, now has 4 nonprofit associations who come together to make coverage decisions. So they don't allow each insurer to come up with their own internal guidelines, which again, sometimes are made publicly available, oftentimes not. And I think the federal government is kind of looking at what some states are doing around data collection, around prior authorization. Personally, I do think that the federal government does have the authority that was given to them under the Affordable Care Act on trying to make some of this information more readily available, more digestible, and they haven't necessarily used that to enforce. So for example, data on the number of claims that are denied, denials due to an out of network provider, denials due to exclusion of a service, all those things they actually have the authority to get, but for various reasons they haven't.

So I think that's one area of advocacy of administrative authority that exists. It's not being fully used. And then I also think there's roles that states can play to make it easier to file complaints. So there are a few states that have set up toll-free hotlines for consumers to report problems that they're having with their health insurance providers. If there are written forms that are used, how simple are they? Are they at that kind of fifth-grade reading level, in multiple languages, easy for individuals to understand? And then do states have some sort of complaints liaison that can walk customers through the whole filing process? So there are legal mechanisms like filing a complaint with the department of insurance or filing a complaint with the AG’s office. But oftentimes, again, the individual person just doesn't have the resources or the time or the knowledge to know how to navigate all of that. So I think pushing states to support more of that would be really helpful as well.

Dr. Rubin:

Right. And obviously it's good news to hear that there's been some movements, and we have younger patients too, and I want to call the listeners' attention to the Safe Step Act, which is now bipartisan and introduced both in the Senate and the House, which is to try and address some of the challenges we face in having to step through therapies to get patients other treatments which may be more effective or preferred due to the situation for that individual patient. So David and Mona, I'm going to ask each of you for a couple of pearls for prescribers who are listening to our podcasts so that they might take better care of their patients going forward. What should they know and take away from this and how can they get more engaged? So David, why don't you start off and then we'll let Mona wrap.

David Choi:

All right, perfect. So I think there are a few pearls for providers that would really kind of help in terms of improve the authorization and acceptance rates. So number one, once again, those notes being very, very helpful. I know our providers, like Dr. Rubin at University of Chicago, they have a whole section of the assessment plan that's just IBD therapies. So it kind of goes over the history of what therapies they've tried and failed and kind of does that in detail and that's very, very helpful I think, not just for us as the pharmacy team as we're navigating patients through, but insurers really, it's very clear what therapies they've tried and failed. So really I think those notes, just being intentional about making the rationalization for those therapies so that it's really kind of helping patients in that standpoint. So that would be one.

The second one that I think would be very helpful as well, I think kind of Mona alluded to earlier is not giving up and just making sure that we're advocating for patients. So just because the prior authorization is denied doesn't mean it's not worth pursuing the appeal. Obviously, if it's something where it comes down to 2 very similar drugs and they're just asking to use the other, just is it really worth fighting it? But in the patients that do, absolutely. Appealing those decisions and knowing that there's multiple levels of appeal, once again, a first level appeal, second level appeal, and then potentially an external review. So just kind of exhausting all those different pathways I think is important for advocating for our patients. So I think those are some of the clinical pearls that come to mind right now.

Dr. Rubin:

Thanks David. And Mona, what would you add?

Mona Shah:

So following up to David's comments, appeal, appeal, appeal. So again, there are resources that aren't as well-known out there to help individuals and patients go through that process, but I would certainly encourage them to do that. And then the second piece is doing their own part when it comes to being an advocate. So whether it's getting involved with another, whether it's a state-based or a national organization who's really focused on these issues, it's sounds a little facetious, but it's not, that every voice really matters. So even just collecting the patient stories and sharing those. That really does make elected officials hear. And also bringing to light the practices of the insurance industry. Again, a lot of that is kind of done covertly. No one really knows how they make certain decisions.

And so, and I think that's really why there is some federal authority. I think states have more leverage to really require some of this information and data. So I think having more data, understanding how widespread the problem is and then knowing your rights and appealing altogether can go a long way. And then also pulling on existing resources until then, like these financial assistance policies and other consumer support services. I think the 3 together will certainly have a good impact.

Dr. Rubin:

Those are fantastic suggestions. I'll add a couple of my own. One of which is that the Crohn's & Colitis Foundation has a resource page with sample letters for both pre-auths but also appeals for therapies that might be needed specific to the therapies and with citations and references that can sometimes help you in those appeals. So you can go to the Crohn's Colitis Foundation website and see those references. I would also encourage our colleagues to get engaged locally, regionally, and nationally in advocacy efforts. This is something that I think we can all rally behind, whether it's the day on the hill for the Crohn's & Colitis Foundation, or the American College of Gastroenterology or AGA's efforts. There are lots of ways for our professional colleagues to get engaged and to help contribute. And don't forget to look up your state, either attorneys general or you can also look up the insurance representative for the state.

And those contacts are always helpful when you're trying to do this. I want to thank our two experts today for this wonderful podcast. David Choi is a PharmD and the associate director of the IBD Center at the University of Chicago. And Mona Shah is the senior director of policy and strategy and a member of the senior management team at Community Catalyst. You both have been terrific, and I want to thank you on behalf of my colleagues and all the patients for the work you're doing, and I hope that you'll stay engaged in all of this and help us help you get more patients the therapies they need. Thank you both so much for being part of this today.

Mona Shah:

Thank you so much.

David Choi:

Yeah, thank you so much for having us.

Dr. Rubin:

Well, this has been another episode of IBD Drive Time. I hope that you'll check out the other podcasts, which are now available online, and join us for the next great topic.

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