Becky Burns

Insurance is purposely opaque. If you've ever tried to read an insurance summary plan description, it's horrid. Quickest way to a nap time. But really understanding what are the pieces you need to know and what are the things to look for. When you know what the fight is, it's easier to have it.

Narrator

Welcome to the PDSA podcast, Bruised but Not Broken, Living with ITP. Welcome to the PDSA podcast bruised but not broken living with ITP. The diagnosis of a bleeding disorder like immune thrombocytopenia may leave you wondering, how can I really live my life with ITP? PDSA's podcast, Bruised but Not Broken, Living With ITP, brings empowering stories, the latest research and treatment updates, lifestyle tips, and answers to the real-life questions the ITP community is asking. Here's your host for this episode, Barbara Pruitt.

Barbara Pruitt

Hello. Today we are diving into a topic that affects so many of us in our community, navigating insurance, financial barriers, and the real-life challenges of accessing treatment for ITP. Whether it's the cost of medication, frustrating delays, or confusing insurance rolls, the path to care isn't always straightforward. Well, joining us today is Becky Burns. She is the Chief Operating Officer of the Bleeding and Clotting Disorders Institute. Becky has over 15 years of non-for-profit accounting and management experience.

In her role, Becky oversees the business and pharmacy operations of the Bleeding and Clotting Disorders Institute. She is a passionate advocate for the bleeding disorders community and specializes in access to care issues. She's also widely regarded as an expert in insurance, payer issues, and 340B pharmacy policy operations. Becky has deep insight into the financial and systemic barriers patients face and what can be done to improve their access. So, thank you so much for joining us today, Becky.

Becky Burns

Thanks for having me.

Barbara Pruitt

And I understand you are located in Illinois, correct?

Becky Burns

We are. We're in central Illinois, smack dab in the middle.

Barbara Pruitt

That's great. All right. With Dr. Tarantino, correct? Who's one of our famous favorite doctors on our medical advisory board. Well, these are issues that all of us in the ITP community have faced.

Becky Burns

Correct.

Barbara Pruitt

And I look forward to having you try to help us overcome some of these obstacles. So, let's start by going through a common scenario that probably we all have faced. Okay, so I'm an ITP patient. and my doctor has just prescribed a new medication for my ITP. He sends it to the pharmacy, and then the pharmacy calls me and tells me that they can't fill the prescription because it needs a pre-authorization. What does that mean, and how do I deal with it?

Becky Burns

So, pre-authorizations or prior authorizations are becoming exceedingly popular as payers look to lower their overall spend on medications. We saw them a little bit when I first started with the ITP drugs, but really we're seeing them almost every time now. And what that means is that for your provider to be able to fill your medication, even though it is a covered medication under your plan, they have to submit this prior authorization request to your insurance company. It's basically the insurance company saying, yes, this drug is appropriate for this patient at this time. I would like to say it's as easy as just filing a piece of paper and you're done. Unfortunately, the process can be very long and drawn out, especially when we look at the high-cost drugs that we're dealing with. When you get into some of the TPO arrays or the other biologics for like your rituximab, things like that.

On the provider side, it's a very complex process that hopefully you as a patient don't have to see all of. We would submit the prior auth on your behalf and they payer will either approve it or deny it. If they approve it, then the pharmacy can go forward with filling your medication. If they deny that prior authorization, we have different pathways to coverage. I will say what I see is there are a lot more denials on the front end that end up getting approved, but it seems to be their like first gut reaction is denied. And the provider at that point needs to reach out. We will do first an appeal. Typically, the provider will do this on your behalf. They may have you sign paperwork that says we're allowed to appeal on your behalf should they you deny any medication. A lot of times you won't even see that paperwork necessarily by itself. It's part of the financial information that you would sign when you first start with that provider.

So, we'll file that appeal. It typically requires a provider to give a letter of medical necessity saying why you need this particular medication. If that's denied, then we can do what's called a peer-to-peer. So, we actually, a provider would speak to a provider at the payer to discuss why this drug is appropriate. We see that a lot where step therapy has been recommended. And I see a lot of step therapy recommendations in ITP.

Barbara

What does step therapy mean?

Becky

So step therapy is where the payer wants to use a lower cost, either drug or treatment before they will approve the higher cost. So you have to fail the lower cost option. So typically we see, okay has the patient used corticosteroids? If not, you need to do that, show that they've failed the steroids and then move on. What's interesting is I've seen you have to get a splenectomy and fail a splenectomy before you can get your next medication. I have a real big problem with them telling you you have to remove an organ before you have access to a medication but

Barbara

Absolutely. That seems quite ridiculous.

Becky

Yeah. And that's where those peer-to-peer conversations typically will come in.

Barbara

Okay. Where we can actually have our physicians speak to another physician and discuss the clinical aspects of the case and why this is not appropriate.

Barbara

Right, because mostly what you're dealing with is people that are not necessarily trained medically.

I know that my doctor numerous times has had to have the peer-to-peer conversation and explained why he's prescribed x medication. And it has been approved that way. It's a lot of hurdles, and I think as a patient, we're not always involved. And that's a blessing if we don't have to be involved and it's all done in the behind, you know, in the back. But as long as the approval does come through and your doctor is there to hopefully advocate for you with that, then hopefully you can have a good outcome. Question, you know, okay, so we finally do get this approved, whatever hoops we had to jump through. But then I go to the pharmacy to pick up the prescription and my copay is like $500 or something exorbitant and I can't pay it. What should I do then?

Becky

That's an important point because just because the drug is approved doesn't mean that patients can afford the drug. Right. There's actually a study that was done that showed in the Journal Managed Care Pharmacy that When the cost share is over $100, 75% of prescriptions are abandoned at the pharmacy counter, which means the patient is never filling that medication.

Barbara

Oh my gosh. And that that's detrimental to your health.

Becky

It absolutely is. And so luckily there are options out there. If you are not on Medicare or Medicaid, if you were on a commercial insurance plan or employer-sponsored insurance plan or something off of the marketplace, you would qualify for copay assistance. A lot of the manufacturers do recognize that barrier, you know that abandonment rate. And so, they've created these copay assistance programs to assist you in paying that copay up to your maximum out-of-pocket. Now, most of the time, that's the right solution. There are a couple things that have been put in place by payers that are challenging that. And this is where I spend a lot of my time is in the accumulator adjuster programs, copay maximizers, or most lately the alternative funding programs. So, copay accumulator adjusters, we say we have that copay assistance or they call it a coupon. It's not really a coupon. It's just you submit the claim to a third party to pay it; the copay. But they have said in these accumulator adjuster programs, anything that you do not personally pay out of your pocket does not count towards your copay or out-of-pocket maximum. So, what that means for you, it doesn't mean that you can't use that copay card. In fact, they want you to use the copay card. So, what they will do is they will use that copay card until it runs out. Once you've exhausted that copay card, then you have to pay your maximum out-of-pocket If you think of it as a patient going in and you have, say, a $5,000 deductible on your plan that you have to pay before it kicks in, which is not uncommon in a high deductible health plan, it can be up to $8,000. So you have a medication, you've got a $5,000 deductible, but you have $10,000 worth the co-pay assistance available. In theory, you're going to go in to fill your first prescription, say it's $10,000 prescription. You pay your $5,000 out-of-pocket with that copay assistance. In theory, you have $5,000 left of the copay assistance because you've only used half of it, but you've now met your deductible and max out-of-pocket. So, the next time you come in, you shouldn't know anything, which was what we would see. The patient would go in in February. Now they fill their January prescription, February. Well, February, they still don't have any out-of-pocket, but what they don't see in the background is when they fill that prescription in January, the insurance company reset their accumulator. So, your accumulator is that amount that you paid towards your deductible or maximum out-of-pocket. So, they reset that because you didn't personally pay that $5,000. Now in February, remember, we've still got $5,000 sitting over here on this copay assistance. So, they're going to use that as well. So, February, you're going to fill your prescription. You still don't necessarily know as a patient that anything's different. You assume that you've met your maximum out-of-pocket and you should be good.

The problem comes in March when you go to fill that prescription because you're going to go to that pharmacy counter and they're going to say, okay, we've got your prescription here. It'll be $5,000. Now, when the average American cannot afford a $4,500 emergency bill, the idea of someone being able to pay $5,000 out of pocket is a non-starter. So, we've actually worked with a number of states. There are over 20 states in the U.S. that have actually banned these programs when there's no generic equivalent.

So, let's step back to why these programs were created. They were created where there is a very high-cost drug, brand name drug with a lower cost generic alternative. The manufacturers in those cases realized that the cost share for a patient to get the brand name drug was prohibiting them from wanting that brand name drug. It was driving them to the generic, which is why the plans designed it that way was to just steer the patient to the lower cost drug. The manufacturer said, okay, we're going to offer you a copay coupon. These truly were coupons that will take your copay on the brand name drug down to the same as the generic. It doesn't take what the payer spends down to the same as the generic, just what you as a patient would spend. So- when you look at why payers implemented these programs, I do understand it. And it does make sense. They were, because of these manufacturers and their coupons, they were paying more for something that they didn't need to pay more for. The generic equivalent was therapeutically the same, and there was no real reason to go to the brand.

But when you're dealing with specialty drugs that do not have a generic equivalent, this is where we have the problem, where now you're creating an access to care issue. So, we did work with over 20 states in the U.S. have passed legislation that bans these when there's no generic alternative. And so, we don't see as many of these as we used to. What we have seen is a move to what they call a copay maximizer program. So, a copay maximizer program cannot be used in an ACA compliant plan, plans that have to follow the Affordable Care Act. However, an employer sponsor, a self-insured employer plan which typically happen in employees over 50, 68% of patients in the country who are insured under an employer plan are actually insured under a self-insured plan. Those plans do not have to follow the ACA guidelines. They are not governed by the State Department of Insurance. They are actually governed by a federal law. It's the ERISA law that was originally intended for retirement plans. It wasn't intended for health plans. However, because of the way these are structured, they are legislated by ERISA. So, they don't have to cover essential health benefits. That's important because that is how they're using these maximizers. What they've said is, okay, we understand the access to care barriers that these accumulator adjusters were causing. However, we want to get the maximum amount that that manufacturer is going to allow towards the copay assistance. We want to take advantage of that. So, what we're going to do is we're going to carve out your drug. And we're going to call it a covered non-essential health benefit. Still covered, but it's not considered an essential health benefit. Therefore, it's not subject to the normal plan deductible or max out of pocket. What they will do for these drugs is they actually create a deductible and max out of pocket that is the exact same amount of the available copay assistance. So, you don't have an out-of-pocket, which is great. If I have to pick between accumulator adjusters or maximizers, I will pick maximizers all day, every day, because it doesn't create an access issue for the patient until you change insurance plans. Because if you say you leave your employer and you go to a different employer, your first employer had a copay maximizer in place. The way these are structured is because they've changed your deductible. So, say there's $20,000 worth of available assistance for your drug, they've set your deductible at $20,000. If you've hit that before you change plans, you've exhausted the totality of that available copay assistance. Well, now your next employer, you get on the plan, now you have to meet their deductible.

Barbara

Okay. Can you do that with the maximizer plan again, or can you not?

Becky

No, you've already exhausted that copay assistance for the year. So you no longer have access to any it.

Barbara

You can't start over again.

Becky

Correct. Again, I understand why. They're looking at this, you know, drug costs are astronomical. There's no other word for it. They're expensive. There are reasons why specialty drugs are more expensive. You know, I'm not going stand here and say that they can't come down in price at all. But I will say that there is a reason that specialty drugs are more expensive. And it's because if you look at, especially like ITP, for example, you have a finite population. It's a rare condition. You don't have, you know, this isn't the cold or the flu where you have a lot of people that are going to use the medications. So, all of the time and effort you spend in research and development for that drug, all the money that you spend in that, you can recoup it over a lot of people in a short period of time. You have a smaller population that you're really recouping that R&D. And if you look at how many drugs go through that process and don't make it to market, when you're paying the R&D on that drug, you're paying for every trial that failed. as they tried to get to that place.

Barbara

Right, all the ones before that.

Becky

So really, when you're looking at why these drugs are so expensive, also, if you're looking at some of these specialty drugs, like the TIPO-RAs, you know, rituximab, IVIG, those drugs have special handling requirements. They have to be given in specialized settings. It's not just a pill that you'd grab off the shelf and hand to someone. So, there are other pieces to why they're more expensive, but it also creates a bigger access burden to patients as we're looking at these.

Barbara

Absolutely. And the stress of all this, when you're going through it, and it actually sounds like a language that you did not grow up with. It's like almost speaking a second language because of all the words that are used that are unfamiliar. But the stress is really there for the patient. I mean, it's not only the financial stress, but the emotional stress that the patient feels. And I've been there. And that stress can affect our physical health, which is already compromised because we're dealing with an autoimmune disease. What or do you have any suggestions regarding that?

Becky

I wish I had a magic wand to fix it. Unfortunately, I mean, I've been on the phone with a mom at nine o'clock at night whose son is bleeding and she can't get access to his bleeding disorders medication. There's nothing I can do that's going to fix that emotional stress. I can tell you one of the things that we do is, I spend a lot of time talking to our legislators about these exact stories of what the toll on patients truly is. And you brought up a really good point. When you have an autoimmune disease and now, you're increasing your stress levels, this is like a vicious cycle. You are just asking for more trouble because of something that's being brought on by you trying to address the problem in the first place.

Barbara

Exactly. And stress is kind of our enemy. It's like adding fuel to the fire.

Becky

And that's where organizations like PDSA, I can't say enough for the work that they do to really get out there and advocate on behalf of the patients. And you know they are telling these stories to legislators. You're getting their attention on things. There is, an effort right now to try to bring comprehensive care to ITP patients to really give them the totality of not just a physician's visit, but you know all of those ancillary services. We have a medical social worker who works with all of our patients to really address some of those issues and try to help with coping mechanisms and stress reduction. and we have a whole team that works on the insurance stuff. So hopefully our patients don't have to. I can't fix all of it, but we're able to do that stuff. And I will say it's because of organizations like PDSA and the work that they're doing; that Caroline and the team are doing to really be out there and advocate on behalf of the patients that we are starting to see some resolution to this. I mean, that's how we got the accumulator adjusters band was through direct advocacy.

Barbara

That's great. And I'm so proud of the PDSA for the advocacy that they do for the ITP patients. And as you know, they've been to the Hill speaking to legislators. They also have virtual Hill Days where our members can join and participate and get their message through to their representatives so that they know that this is real, that this is really a problem that needs to be addressed. And unfortunately, it doesn't happen overnight. It takes a lot of perseverance with the advocacy. And hopefully they'll hear us and hopefully things can change in the future. Like you said, you were able to make a change with that one program. What was it called?

Becky

The Accumulator Adjusters.

Barbara

Accumulator Adjusters. See, there's that other language I was talking about. I know, it's a shame. I know that the doctors and their office do spend a lot of time when it comes to approving these drugs. And like you said, the prior authorization and the peer-to-peer thing, it seems like it takes a lot of time away from the doctor and what he needs to be doing, seeing patients. And I know for myself, when I see that explanation of benefits come across, you know, my mail or my email, I really feel bad because the amount of money my insurance pays the doctor for the time he spends with me is not that great. I don't know. does it end up working out in the office? I mean, you have secondary people that handle a lot of this stuff, and which does help.

Becky

Yeah, so it does. But this is one of the arguments that I've had with our legislators. We actually worked with the state of Illinois to change the requirements for prior authorizations because we were having to prior auth drugs every single month for patients. oh boy And yeah you can look at the resources that that takes. And so I met with one of our local legislators and I explained to him, this is the challenge that we as providers, our providers aren't seeing patients when they're stuck on peer-to-peer calls. I have to hire three additional staff members just to work prior authorizations and chase insurance and what I'd rather use those resources to take our patients. When you look at why healthcare care costs so much, you know, it's, it's a shell game of, okay, let's move it from here to here. And where is it coming here, here, here? If we could cut back some of this red tape, we could lower the cost of healthcare. care and make it easier. We see consolidation of providers. We are one of the few independent offices that still exist.

It's next to impossible to find primary care in an independent office because it's not profitable. Providers are losing money. We have a doctor shortage. It is partially because of the stress that doctors take on. And I have spoken to more than one, like our physicians, physicians that I'm friends with that say, look, I did not go to medical school to fight with insurance companies. I went to medical school to take care of patients. And so we do have the luxury of having a staff that can do this so that really the providers getting involved on creating a letter medical necessity or you doing that peer to peer, but everything up to that point, you know, our back-office staff can handle. But even then they're spending a lot of time doing that constantly. And it does take away from their ability to see patients. And it takes away from their job satisfaction.

Barbara

Yeah, I see that. I'm fortunate with, I know one of my medications that needs a prior authorization, at least I get it, the prior authorization for an amount of time. It's either six months or a year. But I know from experience, before I get that next month filled, when they're going to need the prior authorization, I will alert my doctor and I'll say, you know, I need a new prescription for this. They are going to ask for prior authorization. And then I follow up personally to make sure that that's done and it's sent in. Because I've spent time on the phone in tears because something was not coming through And I needed it. And I you know, as an ITP patient, you can't just stop a medication because that causes you to plummet. You know, your platelet count will just dive bomb. And you have to have that continuity of medication when you're on something. And when you're going through all these hurdles, it certainly does not help. And again, the stress level that it's giving us at that time.

I think about it and I go, what all can we do? I think the advocacy is a huge part of it. What do you suggest that an individual does, you know, when they're running into all these problems?

Becky

So, I think part of... What I try to do is help our patients understand their insurance. Understand what you're up against because when you know what the fight is, it's easier to have it. Insurance is purposely opaque. If you've ever tried to read an insurance summary plan description, it's horrid. Quickest way to a nap time is to try to read a summary plan description. But really understanding what are the pieces you need to know and what are the things to look for. When we talk about the alternative funding position, this is something that we've seen in the last few years. And we first started seeing it really specific to hemophilia or the like super high cost disease days, but now we're seeing it in any specialty drug. And so, for ITP, you have a number of meds that are specialty drugs. This is, again, I told you that the self-insured plans are governed at the federal level by ERISA. The other piece to remember is they don't have to cover anything. Like there is no requirement for coverage for them. So what happens? And I don't typically see this in very, very large plans, like your Boeings, your United, your Caterpillars. This is not where you see this. It's typically in that, you know, 50 to 150 life plan where you don't have a large group of people to spread risk over. And they will get a patient on a specialty drug and these brokers will come to them and they'll say, because I've sat as an employer across the table from this. And they said, in our case, you have 300 lives. You have three patients with HIV on your plan. If you cut HIV from coverage, you will save $3 million dollars this year. You can see if you put yourself in the employer's shoes as the costs of everything across the border rising, where the employer would be like, oh my gosh, like I'm looking at closing my doors and now I can save $3 million dollars. And most employers will ask a second question. Well, how does my, how does my member get their medication? Because obviously these aren't medications; ITP medications aren't medications you're taking just for fun. You're taking them to survive and for quality of life. And so, Employers ask that and they're told by these brokers, so don't worry about it. These manufacturers make so much money on their medications. They can afford to pay for it. They have patient assistance programs that we can utilize and we can leverage that to stop your spend and eliminate your spend on these patients. What they don't say in that same breath is they charge up to a 50% cost avoidance fee to the plan. That's a whole nother argument. But what it means for the patient is you no longer have any coverage for your medication, period. Now, they will send patients to these patient assistance programs. When it started, patients would be approved for the patient assistance programs. Now, these are programs, these are charity care programs that exist from the manufacturers for stopgap issues. Patients are temporarily without insurance while they either qualify for Medicare, Medicaid, or look for another job. They were never intended for long-term solutions. And I would argue that if any business is giving away free product over here, They're raising the cost over here.

Barbara

They have to make their money somehow.

Becky

Yeah. And I will tell you, the people who always have to pay for drug are Medicare and Medicaid. They don't have the option to take it off. So you're paying for it in the long run through your taxes. But separate argument. What it means from the patient perspective is this I had a patient have this happen. If you make no changes to your plan, this is in October, you make no changes to your insurance, you will keep the same plan you had last year. Or you can get on these other new plans. This particular patient said, you know what? I like my insurance. I'm covered with it. I'm not going to make any changes. In December, he gets a letter from this patient advocacy company who wants to help him contain the cost of his high-cost medication. And he was a little confused. He's like, okay, who are these people and how did they get all my information? He got more confused when they asked him to sign a power of attorney. So, his plan had implemented an alternative funding program. They had carved out specialty medications. So was all specialty medications. And he now had to source those through manufacturer free drug program. If a patient is approved for those manufactured free drug programs, the average time to approval is 68.1 days.

Barbara

Wow. And you'd be without your medication.

Becky

Yeah. And again, it's a double-edged sword because now you're without your medication. You're having other complications from not having that continuity. This particular patient made too much money for the patient assistance program. In that case, there are two ways that they approach these alternative fundings. One of them is they're able to write it back into the plan. Under medical necessity. So that's what we call kind of a false exclusion. It's excluded until ah they don't qualify and then it's written back in.

The patient's then able to use their plan. But again, we've had a delay. In this particular patient's case, it was three months, but he had a delay. Luckily, he was at a hemophilia treatment center. We were able to take care of him and get him product in the interim, but not everybody can do that. And with ITP, we only have a handful of centers that treat ITP and are even able to do that here, hemophilia treatment centers. Your regular doctor's office isn't equipped to take on the cost of those drugs for that period of time. So, if the patient wouldn't have had this medical exception override, the other option is you just don't have coverage. You have nothing. So now this patient's left with absolutely no coverage for his medication. He can go get on steroids, but he's already failed steroids. Sorry, you don't have an option. It is terrifying to think of the unintended consequences of these plans. And again, this is where they're hard to find. It's not clear in the plan document. When I look at plan documents all day, every day, this is what I do. I have trouble finding them sometimes when I know it exists in the plan and I'm trying to find the language that's identifying it. They're difficult and they're purposely difficult to find. It's that purposeful opacity that allows them to get away with this. So, from a patient perspective, know as much as you can about your plan. If you don't know it or don't understand it, because not everybody does, honestly, find a trusted resource that does. go to PDSA. If you don't have any other resources, reach out to PDSA. They can connect with other resources throughout the country that do what I do and help with that and try to find solutions. Tell your story; you know, this is where, again, that advocacy is key. When I've gotten in front of legislators, I've had a legislator ask me, what can I do? Tell me what to do. This can't happen. I wish it were as easy as that and we could just make it go away. mean, we're actively working with a number of legislators on potential ways to solve this, but it's not easy and it's not quick. Those stories are the key though. Those stories are what get that engagement. Me just saying it doesn't help. But when I can say, here's a patient story, here's how it's actually affecting people.

Barbara

It's the personal influence. I mean, when you tell your story directly to your legislator, that's real. That's not something written in a report. That's a real human being sitting in front of them telling their story. And that that has a lot of weight. That's why the advocacy is so, so important.

Becky

And the other thing I think you said, Barbara, that was really good is you know when your prior authorizations are expiring and you reach out to your doctor proactively. Unfortunately, a lot of patients aren't on top of that as much. And so they're calling when they're out of medication. Well, when you're out of medication, I have a very tiny window to get stuff done. If I have a little heads up, if you call me, always tell our patients, call me when you have a week of drug left. Because that gives me a week to work through any hurdles that we're going to run up against. Not guaranteeing I can get it done in a week, but it at least gives me a little leeway to try to get that done. And remember, most provider offices, they're taking on a lot of burden of a lot of different things at once. They don't have someone just doing this.

Barbara

That's very true. Well, one thing that I mentioned in your introduction was this 340B drug pricing program. Can you explain what that is? Because it's unfamiliar to me.

Becky

The 340B drug pricing program is quite possibly one of the smartest things our federal government has ever done because it costs the government very little money, but it has a huge return on investment. However, it's a wee bit controversial because it was expanded and there's been some nefarious dealings in some of the expansion population. So, the 340B program was originally intended for patients with high cost, high touch, rare disease states that either put them in a financial position where they couldn't afford their medication or required such specialized care that they weren't able to get it throughout the country. So, we're talking VA black lung clinics, white HIV clinics, hemophilia treatment centers. These original grantees under the program received grants from various federal agencies that then allow them access to this 340B drug program. The way the program works is for a manufacturer to qualify to sell to the federal government through the Medicaid program and Medicare, they have to agree to be part of the 340B program. That program for covered entities requires them to sell drug at a lower price than what they would to anyone else. The covered entity is then able to use that margin that spread on the drug from what they charge the insurance company versus what they bought it for to run their programs. So, reach more patients, serve underserved areas, expand services into those vulnerable patients, and provide care to patients who are uninsured and underinsured. Within that, we have reporting we have to do. So, there's a lot of reporting. It's very transparent how we spend our funds. We have to report every year to our granting agencies how we're spending the funds and how we're furthering the goals of our grant. With the ACA, the amount of covered entities was expanded. So, it now includes disproportionate share hospitals, children's hospitals; a lot of larger systems. And within larger systems, and this isn't picking on anyone, the more layers of bureaucracy you get, the harder it is to follow you know a dollar from day one to the end. And so within these larger health systems, what we were seeing what we've seen, and there had been a lot of reporting on this, it's nothing new, systems that were meant to use this money to serve underserved populations were building in very affluent areas, were serving very affluent populations. And so, the question comes up, are they truly using these 340B funds for what they're intended? I will tell you in some of those cases, absolutely not. However, what that's done is created a group of people in DC who want to get rid of the program, which I think is challenging; you know, when we talk about that patient who was in the delay of care for three months and how we were able to provide him his medication in the meantime, in the interim through our compassionate use program that exists because of our access to 340B. You know, the other piece of the 340B program is and not everyone has the same philosophy, I can speak for myself and the other hemophilia treatment centers that are part of the group that I'm part of. We do feel that it is our job to use what we need of that revenue to run our programs and serve more patients, but also use it to break down access barriers.

So, we will typically try to lower the cost as much as possible for our patients. Like if I can charge $10 for a pill, but realistically, I only need to make $2, I'm going to charge $2 over my cost because that's what I need to be able to do to run my program. But that $3 difference is going to my patient or $7 difference or whatever that difference is. It's lowering what the patient has to pay because the patient pay, your copay is based on what your insurance company would pay for the drug. In some cases, the insurance company uses list price, which is a whole different argument. But the 340B program in its original intent is truly a fantastic program. Like I said, it costs the government very, very little money. For us to get our grants, the entire network of 140 hemophilia treatment centers throughout the country gets about $8 million. In terms of my budget, $8 million is a whole lot of money, but in terms of the federal budget, that is a drop in the hat.

Barbara

Yeah, exactly. Well, so do a large group of your patient population in your practice, do they avail themselves to the 340B drug pricing program or is it only for a select amount of patients?

Becky

No. So any patients who qualify as patients under our grant have access to our in-house pharmacy. So we have a 340B pharmacy that we run here through our center. And if they are a patient through that, they qualify. Now, they can't always use the pharmacy. So, this is where insurance comes back in. And there are times we have patients where their insurance company says, you know what? Nope, you have to use an in-network pharmacy. It's one of these three. Typically, those three include the pharmacy that's owned by the payer. This is one of the challenges that we've seen in healthcare in general is the vertical integration. So, as we've seen other things tighten up, the way the healthcare industry is adjusted is they've said, okay, well, I'm a payer. I'm also going to buy a pharmacy benefit fit manager. And my pharmacy benefit manager that I own is going to purchase a pharmacy. They're going to purchase a specialty pharmacy. I'm also going to purchase a medical practice. So, in any other world, that's considered monopolistic behavior. Somehow in healthcare, care it's totally acceptable. But I will tell you that when you single source things through an internal supply chain, you have the opportunity to lower cost. But more often than not, you see costs actually rise.

Barbara

Right because the profits are there.

Becky

Well, and we've also created that system, know, with the Affordable Care Act. One of the things that it did, which sounded like a fantastic idea, is they said, all right, you, Mr. Insurance Company, you have to spend 80% of the premiums that you take in you have to spend towards clinical care, towards medical care, paid claims. Because what we were seeing these astronomical profits on the payer side, but increasing premiums. So, the federal government said, look, we're going to solve this. You have to spend 80% of the premiums that bring in on paid claims. Sounds like a really, really good idea. But the devil's in the details. I'll just pay myself if I'm not making my medical loss ratio. Because if you think about it, I just told you that our pharmacy is going to lower the cost as much as possible. So now you're paying claims that you would have normally paid, say, $100 on. You're paying $40 for that claim. Well, this medical loss ratio is getting thrown off because you're being responsible with your funds. So it's disincentivizing lowering the cost of care. Sounded really good, but.

Barbara

Yeah, but there it is. The devil's in the details, like you said. Oh this is somewhat depressing, I have to say, to this conversation. Yeah. but know I'm sorry, but I'm glad there are people like you that understand it so well and can explain it. I mean, because I think there's a lot of our patient population that, like I said, this is another language. And I think your advice is very well taken that you really need to understand what your insurance policy is all about. And there's so many twists and turns. One thing that came to mind as we're talking is, you know, when a new drug comes out, and but has to go through all the hoops is as far as the clinical trials and stuff, and it gets approved by the FDA, you know that it's going to come out and it's going to be expensive because they have to cover all that research and development. But what happens if that new drug is prescribed for a patient? I mean, is their insurance company going to deny it right away? Is there a way to get to that drug?

Becky

Yeah. So typically what we do see is right after approval, it takes the payers a little bit of time to catch up. They usually will know it's coming. I can tell you for us, we know, okay, it's been submitted to FDA realistically within the next six months, we should see a either yay or nay. We know in the background the payers are working through those things, but what the payer doesn't know at that time, we know that it's probably getting approved based on clinical data that we've seen, but we don't know what the cost is going to be. So, payers are working in the background of, okay, at what point should we cover this? Who is it right for? I mean, I look at hemophilia gene therapy. When we had the first gene therapy product hit the market, it is $3.9 million a dose. We got the most expensive drug in the nation. It's great. So, you can imagine as a payer, they're going, whoa, we can't do this for everybody. So, it took them time. We have some of them that still haven't made up their mind on how they're going to cover gene therapy. So, the payers will take a little bit of time to try to figure out, okay, should we cover this? Should we not cover it? What will happen in the meantime is if this is truly the right drug for you, and your doctor determines that, they will file a letter medical necessity request. So, we can do what's called a formulary exception or a non-formulary appeal to say, we know this isn't on your formulary, but we want you to cover it for this patient and this is why. Now, there are a lot of hoops you have to jump through on those, but if you can make a good clinical case for why it's appropriate, a lot of times you can get those covered. What I will say is just because something's approved today doesn't mean that people can even purchase it today. There is a time frame from point A to point B where you know the pharmacy has to contract for the drug that has to go through a distributor and they've got to get the supply in. So, the day a drug's approved, you probably don't have access to it. But you can start the pathway so that when it is available commercially, you have it. And I will say on most drugs, it doesn't take that long for the payers to get those either on formulary, or they will say this is not covered. And again, anytime you have a drug that's not covered, we see this a lot. We've done it with ITP patients where we've used something maybe off-label that happens to work for that. Like we think clinically this is going to work based on this this research. We can still get those exceptions made. it just is a process to get there.

Barbara

Okay. Now, maybe you know the answer to this or not, but like with Medicare; if there's a new drug approved with the FDA, yeah does it automatically go into the formulary of Medicare?

Becky

No. No, it doesn't. Short answer, no. Medicare is a little bit complex. So, Medicare is one federal program, but it's run through different, they call them MACs. So, Medicare Contractors, Medicare Administrative Contractors is I believe the acronym. Don't hold me to it. But each MAC has to make what they call a local company coverage determination on each drug. So, they determine if it's going to be covered, what edits, like who it's appropriate for, who it's not appropriate for, et cetera. That takes a little bit of time. I will say, I'm going to be in trouble saying this, but Medicare is honestly one of the easier ones to work with on things like that. But it's a double-edged sword because when we talked about the copay assistance, if you're on Medicare or Medicaid, you cannot get copay assistance. A lot of great things that have happened in the Inflation Protection Act lowered the cost, the max cost that you can have for prescription drugs through Medicare to $2,000, which is fantastic. which is fantastic if your medication hits the prescription drug benefit. So, in Medicare, you have two different places that your prescription drug could hit. It could hit Part D, which is the prescription benefit. So those are your typical drugs, your amoxicillins, your insulins, things like that are going to hit that Part D benefit. When you get into specialty drugs, especially the biologics, it's actually hitting Part B, which is a physician office benefit, because these drugs are typically given within the physician office. There is not a limit on Part B drugs.

Barbara

There's not?

Becky

No. Now, if you have an Advantage plan, you could have a max out-of-pocket because those are structured a little bit more like a commercial plan. But if you are using straight Medicare without an Advantage plan, you do not have a limit on cost share. So, if anyone's ever you know been on IVIG and taken a look at how much that costs on your EOB, you could understand how people can get into medical debt extremely quickly on that.

Barbara

Oh, yeah. Because that's very expensive. Absolutely. Wow. Well, how long does a drug have to be on market before someone can create a generic or biosimilar? Is there a specific length of time or does it vary?

Becky

Well, yes and no. So, when the patent is applied for, when the drug company first applies for a patent, they have 20 years from the time that they are approved for the patent to when the patent protection expires. But within that 20 years is their drug development. So, they've patented the idea of this drug, but now they've got to go through all their development, marketing, their final FDA. So, the average effective patent life is 13 to 14 years.

Barbara

Okay. By the time it goes to market and by the time that patent expires.

Becky

However, the Inflation Reduction Act threw chink in this armor. So technically, yes, a generic can't be made for that time. However, with the IRA, they introduced the maximum fair price for Medicare. So, Medicare will negotiate a maximum fair price from these manufacturers on these high cost, no generic equivalent drugs. That is seven years post-approval. So now these drugs went from having up to a 14-year window seven. So, what that's effectively done is decrease the incentive for generic competition on those drugs. So, things are less likely to have generic equivalent. Because that maximum fair price is a significantly lower price, I'll take Xeralto is one of the drugs that I'm just off the top of my head that went through the first round of negotiations. It was sitting somewhere around like $250 pill and went down to like $5 a pill for the brand name So if you're a generic manufacturer and you've got a contract with that, you're up against that $5, you're sealing for the brand. So, you're going to have to come in and negotiate with a manufacturer two or three. Can you make enough margin now at that $2 or $3 margin versus they would have probably gone to $100 a pill before that. So, it's kind of disincentivized that. Now these are small molecule drugs only. This is not your specialty drugs, your biologics. Those do have longer protections. The challenge with those are we don't see a lot of generic competition in those. Because again, if you're looking at the rare diseases, now we have seen like Humira has a biosimilar. That's been a big thing. But when you look at the super rare diseases where you have a smaller population with the biologics, the manufacture of them in and of itself is expensive. You know, generic or not, the process to manufacture them, to store them, to transport them is more expensive. So, they're already not something that you're necessarily even going to look at becoming a generic. But if you're looking at like IVIG, I don't believe there generics currently, but they're looking at Rituxan, those type of drugs, you can get biosimilars for them in theory. But we saw with Humira, there was the big challenge to the biosimilars because when the biosimilars came out, they weren't on formulary for a number of payers. So, everybody was worried, oh I’m going to get switched to the biosimilar, which I'm not a clinician, so I can't tell you clinically, but I can say with a lot of the drugs, a generic is therapeutically equivalent. I mean, that's what they have to show to be a generic. So, it's not something where you're getting up substandard drug necessarily. That said, there've been some challenges with manufacturing out of foreign countries and drug safety. So that's been...

Barbara

Yeah, I've heard I’ve heard of that also. And even some physicians are wary of generics because they don't know where they come from, where they're made.

Becky

So yeah, the generic landscape now versus five years ago is maybe a little bit different. But when Humira biosimilar came out, it did not hit formulary. It was significantly cheaper than the brand name drug. The reason it didn't hit formulary was because the rebates that the manufacturer paid the pharmacy benefit managers on the back end made it more profitable for the pharmacy benefit manager to sell the higher price drug.

Barbara

Okay. So that excludes it from a lot of patients then. Yeah. Well, goodness, we have covered a tremendous amount of ground here today, Becky. I really appreciate you spending the time and explaining a lot of this to us, especially you know for our ITP patients where do you turn to get this information? And I want everybody to understand that Becky is going to be speaking at our PDSA annual conference in late July this month. And you'll be there to talk about all these issues. And I'm sure you'll be around to answer some questions too, which will be very beneficial. And I'm sure you'll have a line of people waiting to talk to you. I hope you you're prepared for that. But I want everyone to know that if you can't be at the conference in July, in late July, that a recording will be available of Becky's speech that she's presenting at the conference in September, which is our ITP awareness month. And all of the different conference platforms will be available in September. If you are a PDSA member, and if you're not a PDSA member, it's very easy to become one. All you have to do is go to pdsa.org and join, and it costs you only $25 a year for all the great benefits that they offer us. I want to thank you again, Becky, u for being with us today. You've been a tremendous help to a lot of people, and I look forward to seeing you at the conference.

Becky

Thank you so much for giving me the chance to talk about this, to bring awareness to this. And again, I'll plug PDSA. This is the best resource that patients have to really connect with experts in not only the clinical side, but also the access to care and advocacy side. So thank you.

Barbara

Which is wonderful. Well, thank you again. And I do want everyone to know that if you go to the PDSA website, you can find a booklet that is titled Patient Health Insurance and Assistance Programs for Patients. And in the booklet, there are links to many of the pharma companies that offer some financial assistance and other organizations. There's also on our website, the Patient Bill of Rights and an article on barriers to care and ITP. So, I hope this has been beneficial to our listening audience. I think it certainly has been. And we'll hopefully see you next time. Thanks for joining us.

Narrator

How do you live your life with a bleeding disorder like ITP? From working in the kitchen with knives, to navigating sharp corners in your house, going out to eat in a restaurant, traveling on a plane, attending a sporting event, even dancing at a wedding. ITP patient Barbara Pruitt shares her tips and tricks for moving through life with ITP for more than 60 years. Here's her lifestyle lesson for the day.

Barbara Pruitt

Hopefully you've learned a lot from today's podcast. I have to share that I've learned a lot through the years dealing with health insurance. And there are three things that I think are definitely a must when you are dealing with your health insurance. Obviously, you need to make phone calls. I think the personal touch is important to make a phone call. But number one, when you're making those calls, I feel that perseverance is something that you have to keep in mind. Don't give up. Ask questions. Ask to speak to a supervisor if you're not getting the right responses that you're asking for. If you have to go all the way to the top, you do it, but you have to persevere.

Secondly, I think it's really important to take notes. Personally, I keep a little notebook, and in the notebook when I'm going to make a call, I write down the date, the time of day that I'm calling, the phone number that I'm calling, and then when I'm speaking to someone, I write their name down. And if you can't get their name, you'll say, now, what did you say your name was again? And how do you spell that? And write that down. And I also write notes about whatever is said or promised. I even keep track sometimes of how long I'm on hold and how long the conversation took because oftentimes it can be very lengthy and you need to make sure that you have time when you make that phone call.

The third thing regarding making these phone calls, because I understand this process can be so frustrating. It can be depressing, but you need to be kind, And I say that from personal experience. You know, the old adage that says you attract more bees with honey than with vinegar. It applies to our lives. And it applies when you make these phone calls. The people you're speaking to, they're just trying to do their job. And because their answers may not jive with what you want to hear, you need to understand. And I know I have said many times, I'm sorry if I sound angry I'm just frustrated. I know it's not your fault, but I need to get some clarity on this. I need to understand better why this is happening. So if you're kind and you explain to them that you're just looking for answers and you're not blaming it on them, you will probably get to a place where you will get better answers. And it may be that you need to go to their supervisor or someone else or a different department, but be kind and write down all that information so that in the future, when you have to make a follow-up call, you can say, well, on Tuesday, da-da-da date at such and such a time, I spoke so-and-so and they promised me that I would have an answer to this question in 48 hours. Well, here it is four days later, and I still haven't heard.

So it's important that you persevere, that you take notes, and that you be kind. And hopefully all those will work to your benefit. And my last words to you are, good luck. That's it for today. wishing you lots of happy, healthy platelets.

Narrator

Thanks for listening to the PDSA podcast, Bruised but Not Broken, Living with ITP. Made possible by our presenting sponsor, Amgen. Special thanks to Gus Majorga for composing our theme music. To see what's coming up, visit our website at pdsa.org and subscribe wherever you get your podcasts. Please share this podcast through social media with anyone who you think might benefit from the information and stories we share with the ITP and other platelet disorders community. As always, please speak with a healthcare professional before making any treatment decisions. But know that PDSA.org is a wealth of information and resources to help you navigate life with ITP and other platelet disorders. Remember, you are not alone.