Helping Medicaid Patients Access Their HIV Medications

John Fangman: [00:00:12] Hello! We're excited to welcome you to the HIV Medicine Association's podcast series, Let's Talk HIV, why Medicaid matters. This podcast series covers the ins and outs of Medicaid, the federal health program that provides care for millions of low-income Americans. I'm your host, Dr. John Fangman, an infectious disease doctor at Mass General Brigham in Boston and an HIVMA member. This podcast episode will dive into some of the challenges people may experience in accessing medications that they need through Medicaid, and how HIV clinicians can help advocate for their patients. We're happy to welcome two exceptional guests today who are true experts on this topic. Dr. Kate McManus is a professor of infectious disease at the University of Virginia. Hello, Kate.

Kate McManus: [00:00:57] Hello. Thanks so much for having me today.

John Fangman: [00:00:59] And Dr. Ryan Westergaard is a professor of infectious disease at the University of Wisconsin, as well as the chief medical officer and state epidemiologist for communicable diseases for the Wisconsin Department of Health. Hello, Ryan.

Ryan Westergaard: [00:01:11] Hello, John.

John Fangman: [00:01:12] We are really glad to have both of you with us today. Let's start by unpacking some of the ways medications can cause headaches when it comes to medication access for people living with HIV. Kate, can you kick us off with some of the ways that Medicaid limits access to drugs and how that might affect people living with HIV?

Kate McManus: [00:01:30] So Medicaid has to cover most of the drugs that people with HIV need to stay healthy, but they can and they do limit the coverage of the drugs in different ways. So some of the different examples of utilization management include having co-pays on a medication, requiring prior authorizations, which can include requiring step therapy, putting the drug in a specialty tier, which means the medication has to be filled by a mail order pharmacy. And all of these sorts of utilization management can make it harder for a patient to access medications, and also can make it harder for a clinician to know what to prescribe for a patient. So Medicaid does have something called a preferred drug list. This is a list of medications that they have decided can be prescribed without prior authorization, and without many of these utilization management techniques being used. Often, the things that go into deciding whether medication will be on that list is the clinical efficacy, as well as the cost. For HIV medications, cost often can factor into that decision. In 2019, the spending on antiretroviral medications for people with HIV on Medicaid was $5 billion. That was about 7% of all the expenses that Medicaid had for outpatient drug spending, while less than 1% of people with Medicaid have HIV. So we know the antiretrovirals are a high cost medication for Medicaid, and we know that the cost is impacting the access for our patients.

John Fangman: [00:02:55] Thanks, Kate. That was a terrific overview of utilization management and preferred drug list. Ryan, can you add anything to this Medicaid picture?

Ryan Westergaard: [00:03:03] As most of your clinician listeners know, the concept of prior authorization is a part of modern practice. And, well, in many cases, it provides some reasonable guidance in situations where there are multiple options for a treatment. The idea of what are equivalent choices might take more of a patient centered view to know whether patients are really being served. For example, a prior authorization structure might be set up to say that a multi pill regimen is clinically equivalent to a single tablet regimen, but a patient centered approach might recognize that there are patients for whom that's a very big deal. So it can interfere with the doctor patient relationship by having a perception of taking some choices away. Another thing that those of us who work in HIV realize is that a lot of social and structural determinants of health that we as a health care team help our patients with. Prior authorization can take time, sometimes it involves forms that are actually paper forms that need to get faxed. And that's taking members of our care team away from helping the patients with things that they need. So I think most people recognize that some of these utilization management issues are serving the public good and trying to make sure that we use our healthcare resources efficiently. It's a level of bureaucracy that can can sometimes make taking efficient care of people a little more challenging. So something that we have a need to, to be involved with and try to be part of the conversation and doing this in a way that meets everyone's needs.

John Fangman: [00:04:25] I love that reminder, Ryan, of patient centeredness and some of this, and how it is something that the interface is at the level of the clinic and your staff and you as you're sitting there taking care of patients. Now that we understand some of the ways that Medicaid might limit access to HIV and HIV related drugs, let's talk about what HIV clinicians can do to help their patients who face some of these access challenges. Kate, let's start with you. In Virginia, I understand some changes have been made to the Medicaid program around coverage policies for HIV drugs. Can you tell us how this happened and how it's impacted your patients living with HIV?

Kate McManus: [00:04:59] Yes. So I practice in Virginia at the University of Virginia Ryan White Clinic. We were really excited to have Medicaid expansion implemented in January of 2019. We also knew that sometimes with these changes, there are unintended consequences. So we wanted to study what would happen for our patients. In Virginia, we had a high rate of people with HIV who had ADAP, or Aids Drug Assistance Program subsidized health insurance. So Virginia was a little bit unique in that we had a lot of patients who were going to transition from private health insurance to Medicaid through Medicaid expansion. We studied this quantitatively as well as qualitatively. In the quantitative study, we found actually higher rates of viral suppression for people with Medicaid than historical studies had found in the past. However, we found that when this transition happened in our clinic, people who transitioned to Medicaid actually had a decrease in their viral suppression rate while not having a change in their engagement and care rates. So we decided to do a qualitative study to try to talk to the patients and understand what exactly was going on. We heard about gaps in insurance coverage, which we might have expected, but we also heard about overlaps where when people were transitioning from private insurance or from direct access through Aids Drug Assistance Program to Medicaid, each of those different plans would point to each other and say, no, that one should cover it or that one should cover it. So with this information of decreased viral suppression rates for people who transition to Medicaid, as well as with the information from our patients that they were having gaps and overlaps, we went to Virginia Medicaid and talked with them about these findings.

Kate McManus: [00:06:37] They were really open to hearing about these findings, as well as some different patient stories that we shared with them. And so they actually did some sweeping changes that have had really positive impacts on our patients. So some of the changes that they made, they aligned all of the antiretroviral formularies between Virginia Aids Drug Assistance Program and Medicaid. They also created one formulary, or one preferred drug list, for the Medicaid fee for service. And then all of the managed care organizations have to align to that formulary as well. They removed all the prior authorizations on first line antiretroviral medications as well as co-occurring conditions. They ensured that the first line antiretroviral therapies are available in retail pharmacies. They allow 90 day supplies of medication, removed co-pays, and these changes have really made it dramatically better to prescribe for people with HIV, with Medicaid. Now, when I'm seeing someone in the clinic and I see they have Medicaid, I can ask them what is their preferred retail pharmacy. I don't have to worry about a prior authorization or mail order or specialty. And this has really been remarkably impressive. I think at the clinic level as well as for the patients, it's reduced a lot of barriers.

John Fangman: [00:07:48] Kate, I got to say, that is just such an amazing story. You and your colleagues should be so proud of the impact, starting with observations in clinic about what you were seeing, and then designing an analysis that helped you understand where the where the problem was in the system, and then translating that into policy changes. Just amazing. If you had one piece of advice to give us, those of us out listening to this podcast on how to push back on policies that might limit access to medications for people living with HIV, what would you tell people?

Kate McManus: [00:08:16] You know, we all practice in different states. We are often facing different challenges based on what are the policies, what's the political environment in our state. But I think that we can all look at what's going on to our patients and listen to their stories in the exam room. Often a patient will say to me in the exam room like, oh gosh, you're not the right person to complain to about this. And I'm like, well, actually, in this clinic, we are the right people to complain to because we're going to take these stories, we're going to try to study it, we're going to take it to, you know, different state officials and make sure your voice is heard. Listening to those stories, it can be hard because day after day we do hear a lot of barriers. A lot of logistical or policy barriers. But I think listening to those and listening for themes and then working with colleagues to study those and bringing the stories, whether it's data or stories, bringing that to your state officials. You know, we started this project, we didn't know what the outcome would be, but I think it has inspired us to keep looking for these problems and keep shining light on them. And hopefully in other states, people will start to do the same thing and bring those stories, because it was the data and the stories that helped to make the positive change.

John Fangman: [00:09:27] Thanks, Kate. That is fantastic advice. Ryan, as we all know that antiretroviral therapy and access is foundational to the care of people living with HIV. But more and more, we're dealing with other co-infections or other chronic diseases that our patients are experiencing. You had similar challenges not around HIV medications in Wisconsin, but on coverage for hepatitis C for curative therapy using direct antivirals. Can you tell us a little bit about what happened in Wisconsin and the conversations you had with Medicaid around coverage for these medications?

Ryan Westergaard: [00:09:58] A version of this story is has taken place or is taking place in many, if not most, state Medicaid programs, going back about more than a decade in 2013 was when the treatment revolution and hepatitis C infection occurred, whereas in the days before that treatment was very poorly tolerated and not terribly effective. But direct acting antivirals, which started to become available in 2013 and have improved in the decades since then, changed hepatitis C to be highly likely to be cured with oral treatment only, so it's a big change. The catch was that the medications were extraordinarily expensive back in the days. At some point you heard $1,000 a pill for a treatment regimen that took 12 weeks. So it's a very expensive and all state Medicaid programs initially recognize that they needed to do something to cut costs in. What most states did were was to restrict what types of providers could prescribe these medications, and exclude certain patients from being eligible to receive the medications based on issues such as did they have severe liver disease, did they have a substance use disorder, and so forth. People who had a lot of history working with patients in HIV were part of a advocacy movement to acknowledge that just because patients have some of these mental and behavioral health comorbidities, such as substance use disorder, isn't really a valid reason to restrict care.

Ryan Westergaard: [00:11:28] And over the course of the decade, state after state, in some cases through legal challenges, have tried to get their state Medicaid programs to remove those restrictions so that a larger number of people can have access to hepatitis C treatment. In Wisconsin, it was some of our colleagues who had been involved with either research or policy making in the in the area of HIV and in the ADAP program in Wisconsin. And we had productive conversations with state Medicaid leaders around the time, around the same types of discussions with related to prior authorization for a drug list. But we also made a philosophical argument, which is that these are medications that patients need to prevent liver cancer and severe liver disease down the road. And just like in HIV, where we as a matter of policy, don't want anyone to go without treatment, we shouldn't restrict who can receive based on comorbidities such as such as substance use disorder. And there is no evidence that people who have early liver disease are not going to benefit in the long term compared to people who already have advanced liver disease.

Ryan Westergaard: [00:12:29] So there were, of course, economic arguments to be made over time, the drug prices have come down. But Wisconsin was one of the earlier states that did away with the restrictions of what types of patients can receive these treatments and what types of providers, meaning that now any licensed provider can prescribe antiviral treatment for Medicaid. And this has opened the door for hep C treatment to be treated in a wider number of places and in substance use disorder clinics and also in primary care.

Ryan Westergaard: [00:12:58] And we're making a bit of progress. Our data shows that back in 2016, 2017, when these restrictions in place, only between 5 and 10% of people enrolled in Medicaid were getting treated for their hep C within six months of diagnosis. It's now up better than 30%, which, if you ask me, is still far too low. Our goal as a country is for it to be 80 or higher, but it's allowed us to make some progress in this area, and working together as advocates, as clinicians and policy makers was a way to move the needle at least a little bit in the area of hep-c.

John Fangman: [00:13:30] Kate and Ryan, I just am inspired as a clinician sitting here talking to you guys about how you find the time to do work that most of us throw our hands up on very early on. I'm assuming you didn't get training on this when you were a fellow, so I'm wondering if, first Kate, then Ryan, you could describe how you found the time to develop the expertise and how you avoided burning out on the complexity of what you've described, because I think it's a really powerful, I mean, amazing impact in Virginia and in Wisconsin on the care of of a broad swath of our populations. How did you how did you come to that point? Can you just give us a little bit of background on how you found the time in the midst of a busy clinical and academic life, and family life too, to do this work?

Kate McManus: [00:14:14] I've been fortunate that in my fellowship I had a substantial amount of time for research. I pursued this work as my academic research, as a physician scientist. So at the University of Virginia, I had a lot of great mentors who were doing basic science research or kind of HIV research related to engagement and care. I was interested in looking for ways to study health policy and how health policy impacted our patients. I have been in medical school and we've been learning about all this amazing antiretroviral therapy. And then I got into the clinic and I couldn't get it into people's hands. And so to me, that was that was where I needed to focus and what I needed to study. So I had funding from the agency for Healthcare Research and Quality and then from the National Institute of Health as well, to study this line of research. In terms of not getting burnt out, I've had to keep my eye on the long game. You know, these studies take a long time. One of my mentors here, Dick Grant, would say, dream the dream and then do the doable. So, you know, originally we want to study the impact of Medicaid expansion in all of Virginia. And when it became clear that we weren't going to be able to get data across Virginia, we said, okay, well, what can we do? We can study it within our clinic. That's also something that was a good lesson for me to see what a single clinic study could do, that it could still have a big impact and change Medicaid for people with HIV in Virginia.

Ryan Westergaard: [00:15:40] Thanks, Kate, for me, very similarly, the work that I've been involved with in the policy realm has grown out of a research interest. I started my clinical practice and clinical research training focused on the intersection of HIV and substance use disorder. Patients affected by the combination of those things can really have a challenging time, and their care and their lives and their ability to be engaged in their care is dependent on a lot of community and also state level policies. As I looked for ways in pragmatic clinic and community-based interventions to improve care for people that were coming up against these social and structural determinants of health, that it led to some collaborations with partners in state government, both in the Department of Corrections and the Department of Health Services here in Wisconsin, who became great friends after working toward a common goal, became collaborators on research. As we share data and we brainstorm ideas for how to do the work that we do better and support each other. And when opportunities come to participate in conversations that someone who works on the clinical side or the academic side can contribute a potentially a new or a different type of voice or provide information. The door was open. So my advice is make friends with people that you come into contact with who have a role in policy, understand how and why they do what they do, and work as a team to try to make things better.

John Fangman: [00:17:16] Those are fantastic comments from both of you. I love the Dr. Quote. I tend to be way up in the stars too often [laughs] so that one really resonates with me. And then Ryan, about relationships that that that is what it's about. There are people inside of government, inside of these organizations that really want to help. And, you know, providing them the tools and the evidence is something that both of you can do that they can't necessarily do as clinicians. And so I think those are wonderful, wonderful comments. I'm going to finish us off with a philosophical question. And I'm going to start with you, Ryan. Do you think Medicaid sees itself as a public health program, and if not, should it?

Ryan Westergaard: [00:17:50] Well, at the state level, it certainly can. And it should, in my opinion. As a government program with implementation in 50 different states by different state governments, there's obviously going to be wide variation in the perspective among Medicaid leaders on what is the appropriate role of government in health care and medicine. But in that environment, there are, like you said, people working in all areas of Medicaid who care about public health want people to be healthy, care about justice, and we can work with those people and try to learn how they do their jobs and figure out how we can influence their work. We've been really fortunate in Wisconsin since I've been here to have some great partners who I believe do see Medicaid as a tool in improving population and community health, and we're honored to be able to support them in that endeavor.

John Fangman: [00:18:44] Thanks, Ryan. As you know, Kate, Ryan is somebody who's working both inside and outside of government. What about you? From your perspective, what is the role of Medicaid as a driver of public health change going forward?

Kate McManus: [00:18:55] State Medicaid programs probably have different answers to that question depending on the environment that they're in, whether they view themselves as a public health program. But I think that with them being the most common insurance coverage for people with HIV, they do have an important role in public health and in HIV care, and them taking a more active role in public health. And the health for people with HIV will benefit the individuals in terms of higher rates of viral suppression, longer lifespans, improved quality of life, and then also can benefit public health in terms of less HIV transmissions, when more people with HIV have viral suppression, and then in terms of HIV clinicians, what we can do is we can try to make connections with our state Medicaid office, offer ourselves as a resource, and see if there are priorities around which we can partner. There are great partners at many state health departments and in within many great state Medicaid programs, and we just need to look out for them and reach across and communicate about what we're seeing in the clinics.

John Fangman: [00:19:54] Perfect. Well, you guys, this has been an extraordinary conversation. I've learned a lot talking to you. I just, on a personal perspective, you guys are kind of heroes to me, for your ability to take your clinical, academic insights and to translate them into things that make the lives of our patients better. And we have all learned a lot about the mechanics of accessing medication and some of the challenges. But I also think the thing I'm going to take away from this is the example you guys provide that change is possible and in diverse environments around this country, and it's really, really important work that you're doing. So thank you both.