 Our next speaker will be Dr. David Rubin. David is the Joseph B. Kirstner Professor of Medicine and the Chief of the Section of Gastroenterology, Hepatology and Nutrition, also the Co-Director of the Digestive Diseases Center at the University of Chicago. David also currently serves as a faculty member at the McLean Center for Clinical Medical Ethics, where he and I and Andrew Aronson run the first-year medical student course on ethics and the doctor-patient relationship. David's research interests are wide. They include the genetics of inflammatory bowel disease, novel therapies for inflammatory bowel disease, and colon cancer prevention, along with clinical medical ethics. David is the editor of a best-selling book on inflammatory bowel disease. Now in its second edition, and an author or co-author of many, many peer-reviewed articles on IBD genetic testing and cancer and inflammatory bowel disease. Today, David Rubin will speak to us on the topic, are there ethical standards for health insurance companies? David Rubin. Thank you, Mark, and it's an honor to be here again. And as many in this room know about how things like this happen, this was a page I received. Mark said, we'd like you to speak at our conference. What's your topic? And I had just gotten off the phone doing a peer-to-peer discussion with an insurance company on behalf of one of my patients. So this is a perfect continuance of the two wonderful lectures we've heard. First from Andrew, where we heard about cures for hepatitis C and thought about how we as a healthcare organization and as society might support such a scientific advance. And now, of course, Stacey's discussion on how do we deliver care across the population, even at some minimal level, and hopefully improve it. This is more about the story of individual patients and an individual provider, that person being me. And the questions I keep asking, which is how can insurance companies get away with what they're getting away with so often? And in preparing this talk, I came to a couple conclusions. The first was in answer to the question, are there ethical standards for health insurance companies? I still can't tell, despite reviewing what I could and reading as much as possible on this topic. And secondly, in terms of should there be, I say emphatically yes. I'll give you an outline of what I think should be occurring with the health insurance industry and with payers in general. I do have disclosures, and I am going to be speaking about a specific therapy for Crohn's disease, and I do consult for the company that has brought that therapy to market. And the University of Chicago treats patients with that therapy, as you'll soon see. But I do not receive any equity or other financial remuneration for prescribing these therapies, of course. I'm also involved in a couple other entities that I don't think are relevant to this presentation. A disclosure I didn't remember to include, but will mention is that I'm currently serving a three-year term as the Chair of Government and Industry Affairs for the Crohn's and Clydes Foundation. And they often send me problems that other members of the organization have encountered with patients receiving therapy or payers providing the support that we believe they might need. I'll start with this, which actually I just received last week from a patient. She brought in her bill. This is her bill for receiving a therapy called Eustachinumab for her Crohn's disease, which is the first line on this slide. You can see what the price was through the University of Chicago for one dose of this therapy, which is administered four times a year, and the other costs on here, including an MRI of the abdomen and pelvis. These are charges, of course. This isn't what anyone can pay, but you can also see here that her total bill for outpatient services was $102,000. Medicare had a payment of $13,000. There was a discount for Medicare of $75,000. How nice of them. And then some adjustment that I have no idea what it is, followed by a Blue Cross payment because she has secondary insurance. She is not over 59 or 65 yet. And she was given this bill, which was for $12,000 that she was responsible for. And she could not afford it, despite being fully employed, but as being a single mother of two, she said to me, my Crohn's disease is better, but I can't pay this bill. Can you help me? So this is not uncommon. And everyone in the room who takes care of patients, I'm sure, encounters some version of this at some point. But when you see the numbers on a piece of paper, it's quite dramatic. So that's my first-case scenario. The second one is what leads to the discussion about health insurance ethical standards. And this is another patient, different from the one I just presented, a 25-year-old woman with newly diagnosed Crohn's. I'll remind you Crohn's is an immune condition of the intestinal tract. Often or most often affects young people, is a chronic condition and is treated for the most part in immune-based and immune-modifying therapies. She presents with the common symptoms of Crohn's disease, which is weight loss, diarrhea, abdominal pain, and anemia. And in discussion with her doctor, who is me, we decide to treat her with a new therapy called Vettolizumab. Vettol is a monoclonal antibody. This particular therapy is unique because it is the first therapy we've had that actually targets the immune system of the intestinal tract only. So unlike all the other therapies in the historical treatment of Crohn's disease in which we suppress the entire body's immune system, we now have a therapy that targets the lymphocytes that are on their way to the gut and only those lymphocytes, which accounts for about 5% of your circulating cellular immune system. By doing so, it offers benefit in controlling an intestinal immune disease, but does not have the risk of therapies that we've used before. In fact, the safety profile this drug is the best one we've ever had. So we now have a therapy that we learned from extensive clinical trials and FDA approval is effective for the disease but offers the best safety profile that we've previously offered. Like other biological therapies and the standard of care previously, anti-TNF biological therapies, it costs about $42,000 per year. And that's if you're getting it as an outpatient infusion center. If you get it in a hospital like ours, if you want to get it here because she felt more comfortable doing so, add another 50% to that charge because they upcharge it. The insurance company who requires pre-authorization in any smart clinician and patient knows that they should get pre-authorization denies therapy for Vettelizumab. They say that they require the patient to fail these older therapies first before they can get to Vettel. That's a common strategy or maybe not strategy, but they say that they need to start another therapy in the anti-TNF. They say that if the anti-TNF therapies get tacked on at the end, they review the label, they think about where it should be positioned. I should note that the label for Vettelizumab does not require patients to fail the anti-TNF therapies or really to fail anything else before getting it, so that's important to know. But they tell us we have to use the anti-TNF therapy first for a number of years. Now, if it worked, we might have a different thought about all this, but unfortunately it didn't work and about 60% of our patients do not respond to these therapies, so this is not uncommon. We give her her loading doses, we give her a couple of maintenance doses of this therapy and she has had no improvement in her disease symptoms. Now a standard way, and this is across the entire field to assess non-response to therapy is you measure a drug level. Well, the first thing that happens is the insurance company says that the drug level assessment was experimental and they deny coverage for that. Then, we ask them well can we give her Vettelizumab now? We did what you asked and they said oh sorry, we have a two-step failure process. You need to give her another drug in the same class that works by the exact same mechanism as the one that just didn't work, before we'll let you consider Vettelizumab. It's a policy that many insurance companies had adopted and I will tell you without getting into how we learn all this that the reason for this has nothing to do with the science of taking care of Crohn's disease. It has everything to do with the contracts they have with the companies that sell these drugs and provide them. So the insurance company has agreements with the companies that make Adalimumab and Infliximab and the other drugs that are in the same class which have been around for a while but a discount by using those therapies and therefore despite the fact that on paper they look like they all cost the same, the insurance companies have their conflict which is related to their fiduciary responsibilities and their attempt to keep money flowing properly in recommending or mandating use of these other therapies before you can go to this newer one which hadn't been around long enough and they hadn't been smart enough perhaps to price themselves or to develop with a patient who we think would benefit from a therapy which is safer than the others who's already failed one and now I'm told I have to give her another expensive therapy that is the exact same mechanism that failed in this patient already. So there are many questions we can ask and I'm not answering them all here, I can't but first of all am I providing standard of care therapy? Well everyone in the room who knows standard of care might say well this is a new drug just came to market it might not be standard of care yet. So perhaps there is an argument to support insurance saying this isn't quite where we need to be yet. I'm willing to actually say that that's possible. Does the insurance company have the right to refuse coverage? Well of course they do that's in their contract, in their agreement with the patient. What are my ethical responsibilities to the patient however? I still have a patient who I think would benefit from this mechanism I'm convinced more now that she needs it and I also want her to have a therapy that's safe and so does she. And do I have an ethical responsibility to pay her? I think I do I have to be responsible enough not to recommend therapies that I think aren't going to work or to use resources unwisely. Does the physician have an ethical obligation to recommend therapy that's only covered by the payer so she doesn't get the bill for that blood test I ordered of her drug level? Well we might say sure but then I would actually turn to all of my physician colleagues and say how often can you actually know that when you're ordering a blood test especially now we're learning with our electronic medical records what therapies are covered and we can sometimes make decisions maybe we do I certainly have a discussion with patients about how are you going to pay for this when you get a bill. And lastly and what I'll spend the rest of my time on does the payer have an ethical obligation to the patient which they call members how nice of their ethical obligation to the member and to me. So I would like to make the argument that insurance companies in particular have special obligations and unique power and therefore should be held to a standard that we should enforce and consider I wouldn't necessarily go so far as saying regulating but certainly broadly discussing I think that that's because first of all this isn't a simple contract agreement with individuals like any other business I think when we start talking about healthcare and taking care of people and in the extremes of course life and death there are special obligations that are distinct. The obligations are for the insurance company to understand what the standard of care is we often encounter insurance companies who don't know anything about inflammatory bowel disease they instead take what is known about a different disease state that uses similar therapies to increase that entire policy into their section of their manual they have an obligation to be apprised of updates in care that may change the efficacy and safety ratios or affect outcomes into monstrous ways so in the extreme Andrew taught us that we can cure hepatitis C everyone learned about that and was very interested in it right away but insurance companies weren't paying attention about this drug it sort of snuck up on them that it had a completely different mechanism and the reason is there are many fewer people with inflammatory bowel disease than there are with rheumatoid arthritis and other diseases which don't get treated by this new drug they also have in my opinion an obligation to provide transparency related to their denial decisions I would like to know what their contract agreement is with ABV or with Janssen Pharmaceuticals that leads them to require two-step failures when a patient has a primary non-response to the first drug. I also think insurance companies have to be able to do that and that can be cost effective when used properly to mandate prevention to enforce certain health behaviors like smoking cessation and to engage in disease management in fact there's an entire industry of disease management companies that work with insurance companies to help make sure their patients are getting what would be considered to be appropriate care and I've been involved in some of that I'll remind you that health insurance exists because at the bottom line is really not affordable for anybody regardless of their resources but certainly there are those who are at higher risk and the general idea of providing good health care is to provide people with the range of opportunities that they are somehow entitled to for good health and what they can get out of life and health insurance is supposed to provide you with financial security everyone here has heard and understands a little bit about the challenge of distributive justice and understanding how do you somehow figure out how people can all support one another in a health insurance company and actuaries can teach us a lot about this but we run into some challenges when care becomes too expensive and we already heard that from Andrew so the general idea then becomes how do you balance equity with the efficiency and effectiveness and so we can break this down into a number of different potential problems the first one is providing care to the greatest number but with lesser benefits versus providing the most care to a smaller number like we heard from Andrew the second is the obligation to provide care at all versus the obligation to shareholders to be profitable so what insurance companies do when their quarterly earnings don't look as good as they thought is they just tweak up everyone's premium amounts and we all have seen that and that's how they can continue to be profitable but I think that if they're able to do that they have an obligation to reinvest in providing better care and they certainly have an obligation to know what the science of medicine is providing there's a necessity to embrace cost effective care compared to embracing over therapies that might change things but are expensive and then there's the established standard of care practice versus the emerging evidence based practices and the patient provider expectations and assumptions for coverage which are often confusing as we all know versus the reality of the limitations that are there where they're always saying things like oh well if you had read our letter you had 14 days to appeal and now it's day 17 sorry that's real that happens so my position is that payers have an ethical obligation to use the resources to provide the best care to the most patients and that I'm not seeing and therefore I'm proposing that they should 1. Invest in appropriate expertise in education about advances in disease management there's not been any appropriate way that that's been done at least in the field that I work in in GI 2. Actively seek information regarding new therapies as opposed to waiting for us to either sneak it past them because it's under the radar or fighting about it like I've been doing every day since these drugs got approved 3. Recognize conflicts of interest related to their fiduciary responsibilities and be transparent about them and provide transparency for reasons that they're favoring one therapy over another it's so bad that sometimes they tell me on the phone that I should treat my patient with a drug even approved for Crohn's disease and colitis and then I ask the person I'm speaking to why is that and the person says I'm not sure I'm an orthopedic surgeon who works for an insurance company I wish I was making that up 5. I think they should fund clinical research with all the changes in our ability to secure funding for good comparative effectiveness studies when they say to me well there's never been a head-to-head trial of Adelimumab compared to Adelizumab so we can't agree with you that it's better or safer I'd like them to then say but we're willing to fund a study to look at it and then I'd be willing to have their skin in the game and talk about it and lastly of course they should provide cost-effective care which should focus on all the things that we know work but they don't necessarily spend as much time in part previously because we knew that if they spent the money on prevention it was not necessarily going to reap benefits to them because people often switch jobs switch insurance companies and we're downstream the return on the investment might be realized so that's a challenge that we certainly face so what else can we do and this is the last part of my presentation this is not the same patient I just presented so I've given you three different real-world scenarios this is something that I ended up doing and I'm not necessarily saying that you should all do it but I hope you do I got off the phone with United Healthcare recently who was refusing reauthorization for a therapy that was actually working for maintenance so my patient was in remission and they require that we prove that it's still working which we did and then they said sorry we're not going to prove it that's not standard of care so I was after one hour on the phone with five different people during which time I was also told that my window for a peer-to-peer discussion had expired and the patient told me that the letter she received was dated a month earlier and that's why it had expired so I tweeted it and I happen to have a fairly large following in Twitter which is all related to inflammatory bowel disease and this was my tweet United Healthcare denies patients who are in stable remission on effective therapy they're meds even with peer-to-peer discussion so there were lots of comments I'm not going to read them all to you but I'll pick a few specific ones including some from around the world where we were reminded by my friend in Chile that there were worse there and there were lots of views of this particular comment then I actually had found out about the 14-day peer-to-peer window so then I said United Healthcare gives 14 days for a peer-to-peer discussion after denial my patient received her denial letter after the 14 days had already expired clever and now I started tagging United Healthcare on my tweets so for those who don't know on Twitter that means that they're getting these messages now and people commented there were lots of views on this one then I got I was obviously had some time on my hands and was very aggravated this day insurance companies don't know and worse appear not to care about downstream savings deny it now pay more later because that's what would happen if you deny maintenance therapy and a patient who's already doing well maybe someone else pays then lots of comments about this my colleague Fernando is in Spain he's commenting on it all sorts of comments then I decided to tweet their quarterly earnings so this is United Healthcare doing better than expected under Obamacare people got a kick out of that one and then after 48 hours of my campaign they did approve the care it's the power of social media or a funny coincidence I'm not sure so then I concluded with what I would conclude with today which is I would like to hold insurance companies to a higher standard I do believe they have an ethical obligation to payers to providers and to patients I would like to see them investing in more science and more cost effective care I don't necessarily hold them responsible for saying a brand new therapy can be positioned ahead of standard of care that was something I thought about a lot and I'm not saying that that's necessary but I certainly think there are many areas that are room for improvement it was one of the comments of one of my patients who follows me on twitter so I appreciate the opportunity to think about something new which has been troubling me and we struggle with every day and it's a little bit more individualized than some of the more global discussions we've had so far this morning but I intend to pursue this actively through my role in the Crohn's and Clydes Foundation and I hope that I've given all of you some things to think about so that you can help us in this discussion Thank you David's paper is open for a question or two or a comment let me ask very quickly many industries have codes of ethics does the health insurance industry or individual insurance maintain such a code I couldn't find it I've been asked some contacts I had at Blue Cross Blue Shield there doesn't appear to be an industry-wide code like that there are certainly business ethics that they adhere to but not related to patient care Peter I have Peter asked if I had tweeted about the cost of drugs because that's certainly something else that we could be talking about today is how do we bring down the cost which is driving this because it's not sustainable if we had everyone on the therapies and if we actually it's another talk entirely if we actually treated everyone with Crohn's disease to the endpoints that we're now talking about we won't be able to do it absolutely agree and next year I may be talking about the emergence of biosimilars in the U.S. market which will drive the price down by at least 35 percent David thank you so much