Denied While Insured? Kim Czubaruk Explains Alternative Funding Programs

You pay for insurance—so why are patients still being denied medication?

In this important episode, Jonathan James sits down with healthcare policy advocate Kim Czubaruk to unpack Alternative Funding Programs (AFPs), how they work, and why more patients are facing treatment delays, denials, and confusion while still paying for coverage.

They discuss how some employer-sponsored health plans exclude specialty medications or trigger behind-the-scenes denials while steering patients into outside vendor programs. Kim explains why this can create dangerous gaps in care, emotional distress, and added burdens for families already managing chronic illness.

Topics include:

• What Alternative Funding Programs are
• Why patients can be denied while insured
• Treatment delays and access barriers
• Impact on bleeding disorders, cancer, and chronic illness
• Employer plan risks and responsibilities
• What advocates are doing to fight back

If you’ve ever battled insurance for medication access, this episode is for you.

🎧 Hit play, share this episode with someone navigating insurance challenges, and don’t forget to follow. Every listen helps us bring patient-first conversations on healthcare access to more people who need them.

Hope Charities is a national nonprofit focused on helping people living with rare and chronic illnesses thrive. Our programs specialize in helping people with genetic bleeding disorders and #hemophilia navigate the challenges of invisible disease by providing emotional, educational, and tangible support. To learn more about our programs, visit our website www.hope-charities.org. 

Transcript

Why Patient Advocacy Matters

SPEAKER_00 0:07

Welcome to the Hope Podcast. My name is Jonathan James, and I'll be your host today. It is wonderful to be a part of this moment in time to talk to you a little bit more about patient advocacy and policy issues related to healthcare, especially for those people living with bleeding disorders like myself. You know, policy and advocacy work is something that's very intricate, very difficult to understand at times, but most of the time it's birthed out of pain points that we all have as patients living with bleeding disorders. It's important for us to share notes and compare ideas to be able to understand and collaborate together on what we're experiencing that are causing problems for us as it pertains to access challenges. Maybe you've had trouble with your insurance giving you heartache for declining your access to your medication, or maybe you've had even a failure in your coverage where it you thought it was one thing and it really proved not to be true. These things are a plague to those of us who depend on life-saving medications that sometimes can be even worse than the disease itself. And one of the things that we're focused on as an organization is making certain that we highlight the current issues that are facing our communities and also bring together more people who have experience and understanding on how to navigate these challenges so that we can advocate for positive change to defend the rights of those of us living with bleeding disorders day in and day out. Before we get into our episode, I want to say a huge thank you to our episode sponsor, Genentech, for sponsoring this episode to provide more educational content just

Sponsor Thanks And The Main Topic

SPEAKER_00 1:40

like this. Today we're going to talk about an important subject that I think is necessary for us to dive deep into called alternative funding programs. And this issue has been one that we've been wrapping a lot of concern around and trying to educate legislators as well as each other to be able to understand more about how we can navigate these challenges. I've invited a very special guest to join me today to talk more about this as well as her longstanding experience within rare disease, chronic illness, understanding these policy challenges, Kim Zabark. It's great to see you and thank you so much for joining me today on the Hope Podcast.

SPEAKER_01 2:17

Oh, I'm I'm thrilled to be here, Jonathan, and looking forward to talking to everybody who watches your podcast. I know I am a frequent watcher of them, and I continue to learn from them. So thank you.

SPEAKER_00 2:29

Well, I'm so uh you're like a hero to me. I'm kind of a fanboy of Kim Zabark. So you have been uh gracious enough to teach me the ways of uh how to navigate some of these things. And I've just learned so much from you. And and I just really uh have tremendous respect for the progress that you have been on the cusp of influencing in policy change through many years of advocating for people living with cancer and and really rare disease as well as chronic illness in general. There's been so many access issues that you've been on the front lines of. And so I'm excited to dive into your personal journey a little bit and talk about really where you came from, what got you interested in this type of work, and and really a little bit of your background of how you've uh been involved in some significant pathways for change with accumulators and maximizers and all kinds of stuff. So let's start off with introductions and maybe share a little bit about what got you involved in patient

Kim Zabark’s Path Into Advocacy

SPEAKER_00 3:25

advocacy.

SPEAKER_01 3:26

Sure. I it goes back a while, to be honest. I started my career as a civil litigator uh with law firms. Um interesting, loved the you know, challenge of the legal issues, but quite frankly, I found a calling when I had my first child uh who had a medical condition. I first started off as a volunteer uh with an organization that focused on that area and then eventually moved over into that space. And I've been happily using my legal skills and education on that front to help uh patients with different diseases or conditions ever since then.

SPEAKER_00 4:06

Yeah, and you've been a force to be reckoned with. I know that you were on the front lines of being able to sort of identify what copay accumulators were, and that was an area that you forged a you saw themes and trends very, very early on in the process when many other people didn't even know what it was. We didn't really have a name for it per se. And you joined forces with some of the folks in the bleeding disorder very quickly to try to set up a coalition effort to work towards these issues as it pertains to co uh Copay accumulators, which now is has a vast amount of work going on in that space, but you were on the tip of the spear of discovering some of that, right?

SPEAKER_01 4:45

Yeah, I was part of the steering committee that you know really was bringing it to the attention uh when it was first really taking hold. And and to be honest, uh my my colleagues, Calek Kulianos, amongst others, uh within the within the bleeding disorder community. Unfortunately, it it seemed that the hemophilia community specifically was a bit of the canary in the coal mine with these entities and and other um uh pairs trying to see, okay, what can we get away with? Um it's a small community relative to cancer, anyway, right? And it's it's a high-cost disease for treatment. So I unfortunately think uh, we're of the opinion anyway, that they chose bleeding disorders as a pathway to see, hmm, can copay accumulators work, not for patients, but rather for payers.

SPEAKER_00 5:43

Yeah. The issue is ultimately they're trying to save money to prevent from these high-cost medications cost them tremendous amounts of resources. And so um, instead of really honoring the contract that binds or is bonded to the person that is paying their premium and that is meant to be a risk

Copay Accumulators And Early Warning Signs

SPEAKER_00 6:05

pool that's diverged to a larger population of people and mitigating that risk so that someone doesn't go and have to face bankruptcy and financial ruin as a result, they instead of respecting the contract that was established to begin with, they create these sort of uh formulary challenges and complications, basically to save themselves money. And and in some cases, they really exploit a loophole in federal policy, right?

SPEAKER_01 6:35

Yeah, you know, and and there's a group of us who and we often refer to, or it's it is often referred to as being a loophole, but you know, the way we read different provisions is there's not a loophole. They're just they're coming out and they're saying, well, this is permissible. And then they just take off and they they you know, they implement copay accumulators, they implement copay maximizers, and then it's been the patient group responsibilities and patients themselves having to join together to say, wait a minute, that is not permissible. But initially it's almost like patron groups are on their on their on their back feet in a way because these these uh other entities who implement these programs have no shame and they just go full force forward. Um, and then we're playing catch up. So when it comes to, I know we'll talk a little bit about alternative funding programs you know soon. Uh, we're trying to get ahead a little bit. Uh they they beat us to it because I would say that uh alternative funding programs are a first cousin or second cousin to accumulators and maximizers. And right now, as we're speaking, I'm sure there's another strategy being created that will really land on patients as far as you know the harm and the cost going to the patient in order to avoid any cost to plans um and other other entities.

SPEAKER_00 8:02

Yeah. I um it's amazing to me. We've even noticed this in the work that we've done with PBM reform, how there has been sort of like this that the plan B and C are already in place. So as there's pressure from Congress to really focus on transparency and some of these other issues, they've already sort of mapped the future as planning for if that fails, then they know what they're gonna do next. And unfortunately, um, you know, we have far, as patients, we have far less resources and and and don't have the depth of of you know financial uh support to necessarily be able to fight these things on our own. And it's really an incumbent uh upon us to be able to link arms with other disease states. And one of the things that you've pointed out to me, which I I find just tremendously fascinating, is that you say oftentimes you see you you've tried to keep a pulse on what's happening in the hematology space, even though you're primarily working in oncology, because there seems to be a almost like a testing ground, like you said, the coal uh care canary in the coal mine. It's almost a testing ground of antics that are tried in hematology. And if they if they gain confidence and and you see it leap forward into oncology, that that could be an indicator that they feel really confident about their their strategy. Is that is that am I picking up on that right?

SPEAKER_01 9:21

No, that's that's definitely been the trend that we've been seeing. It's they focus first on smaller populations of a certain condition, whether it be cystic fibrosis, hemophilia, and that. And then eventually, if they feel confident um in what they have achieved so far and everything's in place, and any pushback or challenge hasn't to date been very successful, or they've defeated because they have all the extra resources, then they move on to diseases such as oncology, which encompasses a lot more people, and also more people are familiar with it. So when somebody learns, you know, uh something's impacting somebody's access to cancer, uh right or wrong, I'm not saying it's right, as society as a whole is like, oh, that's bad because they're just not as familiar with a lot of the other conditions that are very serious, high cost, and that really impact people's lives. But when cancer is involved in it, it gets the attention. So I always think of it as we have a responsibility. Those of us who work in oncology have a responsibility because we we do get that attention as a disease state, and we need to make sure, whether it's a rare disease, whether it's another condition, that the attention that we get is used for good to bring up and raise all of our you know, fellow populations of people with medical challenges.

SPEAKER_00 10:52

Right. One of the things that fascinates me in general is that there is a sense of um where it's it's almost like there is um, you know, it if we have this amazing RD that we've been able to find new medications that have continued to uh at least sustain life longer than anticipated. Um, in in many cases, there's been tremendous advancements that have been made in cancer. We've seen the same in hemophilia where there is in bleeding disorders where people were just having, you know, the mortality rates were just through the roof, and people were experiencing um tremendous suffering. And because of the advancement of medication, it's continued to taper down and there's been a trend in the right direction where there has been uh improvements of quality of life, but also just life itself, right? I mean, it just mortality rates continue to decline, which is incredible. But I think the the um the frustrating part is that uh what good does it do if we have all this great research and this great technology, but you can't get access to it? And it it then puts us almost, I feel like that's this giant seesaw that happens in our country where it's like, look, we have great advancements in healthcare. And then almost flip-flopped in in another sense, if you get denied for access for a medication that is working for you, or one that does have maybe some advanced qualities, um, then then you literally can be in no better than a situation as someone living in a third world country or developing country, right? I mean this is huge problem. And and I I think that what's unfortunate is that we don't have, you know, we're always gonna have less money to fight it or whatever. But I think getting organized about the issues and finding that laser-focused area that we can advocate for change in is what's so important. That's why I appreciate your perspective so much because you come from that legal background, but you also have you have the eye to be able to look for these things and and find out where these policy issues really intersect so that we can focus on sort of plugging the holes in the boat, right?

SPEAKER_01 13:01

I mean, I'll share a little bit too uh on a personal front, is my mother had leukemia and on her as she started, you know, the the diagnosis and the treatment options. We uh it wasn't it wasn't looking very good. Her prognosis was about uh two to three years. And we were lucky enough to find a clinical trial um in which she was accepted, and she was really some of the first targeted drugs for this type of leukemia. Uh and she lived close to 16 years. Um, and you know, and it was not the leukemia, um, was not the reason that she passed away. It was not what caused her eventual death. And, you know, she saw the you know the birth of uh another grandchild, uh, children, you know, graduations, just fun vacations, simple time spent, you know, every day with family and friends. It it's amazing. We saw that, but I will say, you know, it's it we also found it telling because we we

Innovation Without Access Makes No Sense

SPEAKER_01 14:10

had me, right? As a family, we had my knowledge to at least uh look into clinical trials, how they worked, where to look, what options were. So we had that. A lot of people don't have that background or don't feel comfortable, which is something I know both of our organizations work very hard to help people um find those opportunities. And, you know, also a little bit, there was a little bit of help where, you know, somebody wasn't taking new patients, but somebody knew somebody, so we got in, and that's where all those other factors play in, um, where it's a little bit of luck and a lot of determination. But where we want to get to the point where everybody has access to the most appropriate treatments for their condition, regardless of financial or where they live or any of those other factors, cost, etc. So that's really our hope and what we strive to do, you know, every day, uh, at least, you know, in my position, I know in yours as well.

SPEAKER_00 15:09

Yeah, that's so true. So good. What a great success story with your mom. And I know that that that's probably one of the things that drives you uh is to try to do that for the communities that we serve, right?

SPEAKER_01 15:22

Oh, absolutely. And uh, you know, I understand well uh when you're fighting a condition, you know, people say, well, do this, do this, this is on your checklist, and it's all good and well. And you do have to be your own advocate. It's important to understand you need others, but you also have to be your own advocate. But it's exhausting and people are ill and they're not feeling well. Um, and so it's a lot to take on. So whenever there's an opportunity for a support group, whether it be family or friends or organizations like yours or cancer care, it's so important to reach out and have that support because it's a lot, it's a lot to handle, and time is of the essence for so many of these conditions.

SPEAKER_00 16:02

That's so true. It's so true. I'd like to talk a little bit about sort of your your journey with putting together um uh you know the the the um all copay's account coalition and the work that you put into trying to understand in the early development days. What made you start really reaching out when you saw that this was sort of uh going to be a trend of things that we might have to sort of get tooled up to defend with Copay accumulators, what were some of the first early stages of where you started reaching out and trying to collaborate with other organizations? Because I mean, there's there's been there's been a lot of coalition efforts, but far as uh, you know, there there haven't been, I would say that there's many that go on for long, long periods of time, but you've done such an effective way of being able to collaborate with a lot, a broad swath of a lot of different disease states. What was some of the challenges that you faced with trying to bring people together and and getting people educated on this issue so that you could defend it?

SPEAKER_01 17:05

Yeah, I think it's important. It doesn't necessarily matter which other diseases join the effort, but it is very important to have other diseases join the effort, right? Um I know with uh you know the accumulator issue, I don't want to leave anybody out, but some that immediately come to mind that that helped uh start it and lead it were the arthritis um foundation, um, HIV uh organization. Um can't uh I was with another cancer organization at the time, the hemophilia community. And even amongst ourselves, it was very important because there were there was uh misunderstanding, or better, I guess it's more accurate to say that terms that were put out there in public that were being used generally weren't correct terms. And we needed to really walk that back a little bit for making sure we were all on the same page of the what we were calling it. Um, not to say coupons, because they really weren't coupons because people are paying, right? The cost of the drug does not decrease, it's just a matter of getting assistance to help people pay for part of that drug. So we need to, we needed to walk back the use of the term coupon, which has, you know, people think, oh, it's it's cheaper. I'm getting, you know, I'm getting a discount off of the cost of something. And that's that was not the case. So we worked together, uh, you know, within each of our organizations, uh, outside of our organizations, but then reach out to the broader community so that we could all be on the same page. And we when we consistently were using the same terms and everybody was aware. Now, you know, it it took a lot of education, even amongst ourselves. These were not issues that we were born with knowing, right? Off the top. So we need we did a lot of research and reaching out to others. Um, but we needed to make sure the patient community as a whole was speaking with one voice, even though we were representing many people with different conditions.

SPEAKER_00 19:13

Yeah, and that synergy is really, really important because, like you said, the terminology is especially in the early stages, we don't really we're kind of flying blindly in a sense. And and this is something that you know we've seen recently in this AFP issue specifically, where uh, you know, uh, for not to jump ahead too far, but I mean, I think in many ways, even the organizations that are alternative funding programs don't even call themselves that. And so there's been this sense of like, how do we identify terms? How do we come to agreement on terms? How do we get all of these different, you know, uh these interested parties to understand like what terminology to use? And and uh I could see how that could be really difficult. We've, you know, I I do think that after a period of time, we kind of put these things into buckets, you know, like accumulator and maximizer and AFP or whatever. And in some ways, that's a shorthand for us. But I do think as advocates, one of the things I've learned the hard way in some regards is that we are educators, right? We're we're we're trying to educate in kind of a every direction. We're trying to educate ourselves, we're trying to educate the legislators. If there's a need for a policy change, we're trying to educate maybe even stakeholders within the framework of maybe uh like you know, some of the existing framework that could provide some sort of enforcement uh on these things, like different departments of the government. Um, and so advocacy groups play an important role to be able to make certain that we coordinate so we have the same tech terminology, right? So that we can then be able to educate our you know the people around us on what these specific policy issues are, right?

SPEAKER_01 20:54

Absolutely. And you know, part of the challenge is to keep it simple, right? We we know when you know, if anybody's had the opportunity to talk to their representative or their senator at the federal or the state level, um, or you know, other organizations or speak to other people just with conditions, sometimes we unintentionally use terms and terminology because we may be steeped in that, but somebody else is not. And if we want to really bring about change, then we need to make sure that the people we're speaking with understand what it is we're speaking about. Um we need to, you know, don't get too deep in the weeds. If they, if people want to do follow up questions or if they ask you something, that's great. But I think we need to get to the heart of the matter. And, you know, something like alternative funding programs. The heart of the matter is people are paying very good money, and a lot of people struggle to pay the premiums uh for that. Insurance. They have a serious condition or they're diagnosed with a condition, they need the medication, and they're not able to get that medication,

Coalitions Need Shared Language

SPEAKER_01 22:10

but they're still required to keep paying, you know, that that cost for their premiums and their cost sharing or anything else for other medications that they need. So we need to bring it home on what the problem is. Or else I think, you know, it's easy to, there's so many issues to coming to policymakers every single day. So many different issues. And, you know, it's easy for them to say, okay, very good. And they might at the time, but then it'll get lost in translation. So bring it home. What's the main point we're trying to get across? What is the risk and the harm to people? And how can we work, whether it be legislators, whether it be employers, any other stakeholder providers, how can we all work to try to align? Because it's not, it's simply not right. People need to get access to the treatment. That's like you said earlier, we are blessed to really have great treatments, innovation, we all pride ourselves on that. But if people aren't able to get access to that medication, then it's not helping anybody.

SPEAKER_00 23:14

Yeah, so true. So true. And I I just I want to talk more about this AFP issue because um this is something that I think is is real time. It's it's it's currently unfolding and we're still trying to wrap our arms around it. One of the things that I do think that is unique to um the AFP issue is that it's really segmented only to employer health insurance plans. And then even within that segment, it's it's even relegated to even a subgroup of those plans. But um, can you maybe help our audience bring everybody up to speed in terms of just defining what is an AFP and then uh talk a little bit about what are we what are we doing in terms of coalition efforts as it relates to to trying to you know wrap our heads around this and get on the same page with some terminology of it, this issue itself.

SPEAKER_01 24:06

Sure. And I'll try to uh practice what I just preached as far as keeping it simple. Um so alternative uh funding programs generally work, and I say generally, because again, they're morphing

How Alternative Funding Programs Operate

SPEAKER_01 24:20

as we are speaking right now, but they generally work in one of two ways. Um, these external vendors or external for-profit companies approach an employer and they say, Listen, we're going to help you save a lot of money on what you would otherwise spend for people who are employees or their their family members who need an expensive uh medication. So we're gonna do that in one of two ways, and they they select which way. Uh, the first way was how they originally started, is they exclude most or all specialty medications from the formulary. They're just not covered. And when that happens, they say, but it's not covered. And then we will help you, employer, we'll help you try to get that not covered drug from patient assistance programs, uh, which are uh really run by they're run by manufacturers of the drugs, but there's also other entities, um, charities, and other groups that also can assist. For the most part, the target is to get that drug from the manufacturer through their patient assistance program. But that patient assistance program was created to help people who really truly don't have coverage for the drug. Right. You know, people who are uninsured or or indeed very much underinsured, not people who are working for an employer paying, as I mentioned before, very good money, a lot of money for their insurance, for their plan, and then to have that carved out in this scheme to go around, you know, around the plan having to pay the cost for the drug. Now, before I get to the second way they can work, um, you know, these external vendors, these for-profit companies are not doing this out of the goodness of their heart. The employer is paying, but just in a different way. Sometimes there's an arrangement there where there's a um a set fee with that vendor, that outside company help helping them with this. Other times it's a percentage of the cost savings that the employee, the percentage of the cost that the employer would have otherwise paid had had they gone and covered the medication. So there's there's a cost here, um, and that's in addition to a lot of administrative um difficulties for the employer. But before we get into that, the second way an AFP can work is that the drug is covered, it's on the formulary, but when a person goes to submit their script for that drug, it's already prearranged behind the scenes, behind the curtain, that there will be an automatic denial of that prior authorization that's put on that drug. And then the same process happens. Um, this external entity reaches out to the employee and says, you know, your employer has hired us to help you try to get your drug from another source. And in both instances, it's very burdensome. The employees have to provide tax returns, they have to answer sensitive questions about their medical condition, which is a concern in and of itself. Even before that, it's you know, we hear that how did you know about my medical condition? I don't know you, X, Y, or Z company. Who are you? And why do you have access to that personal information of mine on my medical condition? And almost always a limited power of attorney is required. So these organiz these companies can use uh their own resources, people they hire, to help complete that application process, quote, on your behalf. So that is a challenge in itself.

SPEAKER_00 28:08

There's so much to unpack there. And I think that I think that one of the things that that you mentioned was that these programs and oftentimes are free drug programs from the drug manufacturer themselves, and and they're called different things, but they are they are set apart in a foundation, a charitable foundation uh mechanism, and then oftentimes um were created uh during a time uh where many people may remember when we had pre-existing condition clauses, we had uh also uh lifetime caps. And so when you had these issues coming about um, you know, uh, and people could not get their medication for one reason or another, or maybe they changed jobs and they went through a gap where they had two or three months where they they didn't have insurance, this was these programs were really created and instituted as a way for um these drug manufacturers to say, hey, we're willing to give for maybe a short period of time to make certain that these people don't digress and get into a a backwards motion with their disease progression. And we'd like to keep them on the medication through this short period of time. What's unfortunate is these types of programs that we're calling alternative funding programs are essentially um, they're basically trying to, they're convincing the employer in a way that they can still get this treatment or this medication on an ongoing basis. I mean, in some cases, especially for those of us living with bleeding disorders, this is an annualized thing. We're not going to not need it uh six months from now. We're going to need it ongoing. And so um, unfortunately, these programs were never designed for that. And so, in a sense, there's a false premise that they're convincing this employer they can just get this medication in some form or fashion through this free drug program, but basically say that they're not insured, even though they are insured, right?

SPEAKER_01 30:00

Absolutely. It it it's it puts forth a false premise, right? Um, they they they do have coverage, and I know the manipulations, uh that's why they do those manipulations to make it appear either that they don't have coverage at all in the exclusion example I gave, or that they're underinsured and don't have coverage for this particular drug. Um either way, you know, they're they're really it's it's it's shenanigans. Um and you know, who who ever who would ever think that it used to be that that employer insurance for the most part, and I'm generalizing here a little bit, but employer-sponsored um health insurance or plans, and 65%, keep in mind, 65% of people in our country get their uh insurance through their employer. Not all are self-funded, which are the type of plans that use um these alternative funding programs, but you know, the potential is there. 65% count on their employers for their insurance. So if the needs of the employees are not being met through insurance and employer-sponsored insurance, then it's going to be very disruptive. An entire system is really premised on most people getting insurance from their employer. That's we've decided as a society, that's the path we choose. Understanding there's a need for Medicare, Medicaid, and and and veterans health and other things, but primarily the employer is the source. But if it's not working, people don't generally get the insurance andor pay the high premiums for their coverage for a treatment that is is passing, like you were saying, hemophilia is not. Many cancers are also chronic and other diseases are chronic, right? But people are paying those high premiums and those costs in case a serious condition that they're diagnosed or family member is. Not saying that people don't appreciate having their coverage for you know a strep throat or something else that happens, a broken bone. People appreciate coverage generally for other reasons for sure. But I think if you'd ask anybody in the general public um, you know, the main reason, you know, for their insurance, they want to make sure if that serious condition for themselves or family members there that would cost a lot or you know, be very serious as far as one's life and quality of life. That's really the the reason people make these sacrifices. So if we're having alternative funding programs that go outside of that, and people in the in the best case scenario with an alternative funding program, uh somebody is uh qualifies for, there's income requirements for these patient assistance programs, again, because they're intended for people in need. So the best case scenario, even for somebody who qualifies and meets those eligibility requirements to get their drug, say from a patient assistance program, the time lost in this process of applying, uh applying for that assistance, complying with all the demands of these external vendors, getting a limited power attorney, providing your tax returns, everything else, at the very least, significant and very important time has been lost for the treatment. Um, worst case scenario is people's coverage, it's not there. I mean, it's it's employers uh for the path where a drug is excluded and not covered.

Delays Privacy Risks And Patient Burden

SPEAKER_01 33:40

If somebody does not qualify for uh that drug through the patient assistance program, the employer may, but they don't have to override that exclusion from medical necessity. And we have unfortunately heard really heartbreaking stories where people are told, we're sorry, you just don't have coverage for your chemotherapy. That should not happen to somebody paying good money. And anybody who's even not, I would argue, not paying good money, right? Somebody with cancer in our country when the treatments are there, but certainly not somebody who's paying good money to an employer plan to hear that.

SPEAKER_00 34:17

Yeah. Yeah, it's it's it's really shocking because um, number one, the employer is not excluded from paying, it's not like they're getting it for free. This is the other crazy thing is the lack of ethics in this in this whole exchange that the alternative funding program you mentioned earlier is going and charging the employer a fee for the quote unquote savings was really, you know, um uh a form of theft in a way, because these companies have made it available to have free drug programs for an intended purpose, which is when you don't have insurance, you're in a transition, and here they have insurance, but they've just intentionally excluded it to really um you know take advantage of a of a of really a gap in the law. Maybe it's not a loophole, but there's just no no cle you know uh explicit uh you know uh directive there. But but essentially, you know, they're they're they're highlighting the fact that there's a need that that um you know that that they can fill with getting this free drug and then and then they go and they're charging the employer um some you know some fee for it. And not only is that unethical, but it's it's really uh it really should be criminal. I mean that that you know taking something that is a has a charitable intent and actually charging a fee for it uh is really you know borderline.

SPEAKER_01 35:42

Anybody can apply, anybody can apply to a patient assistance program on their own for free. And it's just a matter of the application and what are the eligibility requirements. So the fact that employers are even paying, you know, these entities, these for-profit companies to do this, um, you know, it it like you're saying, it raises a whole nother uh area of concern, actually, very much so.

SPEAKER_00 36:09

Yeah, we were um one of the first, I believe, to be able to do uh a peer-reviewed research project that helped to be able to sort of outline some of the challenges in this particular segment. And we identified 270 patients that had gone through this with various different types of diseases, um, including cancer as well as hemophilia and other diseases that had experienced this process of AFPs. And one of the things that we found was that the delay, you mentioned specifically that they're not getting uh, you know, this, this um, you know, even their even if they get their products, a lot of times they're not getting it for some quite some time. And one of the challenges that we found was that in this research was that um I'm trying to find it, it's actually towards the bottom here, but we found that they were getting on average uh 68-day delay time. And in many cases, um, these things were literally uh life-threatening if they didn't get their medications within just a few week period, not just a, you know, uh uh, there it is right there. I found it. It's under this section here, 68.2 days of delay. And and this is something that is really, really um uh almost unconscionable when you consider the fact that uh many people are literally their lives depend on access to this medication. And in some ways, I don't totally think that the employer is to blame here. I think that in some cases there they've been sold a bill of goods that isn't true. They've been sold this concept that they're going to be able to just, I mean, in in some of the contracts we've seen, it actually even says you'll continue to get your medications as you always have, and you're not gonna have problems, and we'll everything will stay the same. And then before you know it, uh another thing that we found in our survey results was that people experienced tremendous emotional distress over this because they were getting the first time that they actually heard that they were in an AFP was when they got a denial letter uh that their medication was not going to be delivered to them uh and and and that it and they were denied for access to medication, period. So you're throwing patients into a turmoil. Not to mention, you you talked about the disclosure, the inappropriate disclosure. These are not covered entities like a hospital or a prescriber or a pharmacy where they actually are restrictive to be make certain that the patient information is not being disclosed. Now they're having to fully disclose everything about their disease and their financial status and all of these other things to their essentially to their employer, to a to an entity that's not a covered entity and not abiding by those rules oftentimes. And so, man, the plethora of of the of the sort of the problems that come along with this strategy are not just they're not just inappropriate, they're they're they're actually wrong. And we really need to work to try to find a way to bring it into this kind of behavior because it's it's really harming people more than it's helping people. Wouldn't you agree with that?

SPEAKER_01 39:13

Oh, absolutely. And and I and wanted to emphasize and confirm, you know, at least in my opinion, what you're saying is many employers really think, wow, you know, we're we're told that our employees will be fine and nothing will change for them. Maybe a step here or there, right? It's minimized, and but everything will be great and they'll get their medication and we'll save money. So, you know, I mean, to be realistic, employers um do face costs. They try to, you know, the benefits of providing coverage for their employees is a significant cost. And you know, we recognize that we we can't put our head in the sand and say that that's not a factor. How, however, um, it's not a factor to uh, you know, exclude or harm. Employers don't go into planning their benefits with the intent of harming their employees. I I genuinely believe that employers really do want the best. It's a matter of balancing what they can do, but they want to provide the best benefits they can, you know, with within what they're able to afford, which kind of brings up something I'll just touch on for a minute, is it's these self-funded plans that use AFPs for ones that do, it's because they have certain flexibilities under ERISL law that self-funded plans, and those are plans where the employer actually is paying the claims for the of their employees that are submitted. It's coming out of the business. Um, so there's flexibilities that employers have when they're self-funded on formularies and different things that they have to cover or not have to cover. Um, and you know, we we hope and I believe that most employers try to use those flexibilities for good. Um, you know, but when it comes to where those flexibilities are harming and maybe again unintentionally, maybe a certain employer is is should consider not being self-funded, right? Because employers do have a fiduciary duty to their employees. When they're providing uh coverage and health coverage, they have a fiduciary duty to those employees to make sure that they're doing their best to provide that coverage. So if a company is is not in a financial position to be able to uh you know provide the what they're saying to their employees they're doing. And what again, keep in mind, employees are paying significant amounts too. It's it's not just the employer, although the employer may be contributing a great amount, it's also the employees contributing. So perhaps in those cases, an employee, an employer should say, maybe

Self-Funded Plans ERISA And Fiduciary Duty

SPEAKER_01 41:50

I'm not in the best position. I I like the flexibility, but you know what? Maybe financially we're not there in case there's conditions that come up for our employees. Maybe we should be a fully funded plan where we go and repurchase insurance. So, you know, I I would hope that you know, maybe this raises opportunities for employers to take a real serious consideration analysis and look wholeheartedly, not just a way to manipulate for savings, to, you know, and there's competing interests, we understand that, but maybe some would be better off being fully funded and not self-funded so they can really genuinely and meaningfully meet that fiduciary duty to their employees.

SPEAKER_00 42:33

It's so important. You you you touched on so many things there. One of the things that I think is interesting is that if you have to certify that you have the financial wherewithal, many times a self-funded uh uh you know, employer plan has been a plan that they had in place previously. So they're not usually starting out from like a startup or a new company where they just immediately go into full into self-funded. Usually they have a what's called a fully funded, these terms are so closely similar, it's hard to get them straight. But fully funded, self-funded are very distinctly different things. And sometimes you could see this on your insurance card. If you're listening to this right now and you're not sure what you have, you so on some cases, like you could pull out your insurance card and it'll say in the top right-hand corner if it's fully funded or self-funded. But you can uh you know see that a lot of times they were previously under traditional employer insurance plan, and the employer at some point makes the determination that they want to switch to taking on the financial responsibility and not, they still use the the insurance company to be the sort of the front man and provide the card and and and the and the ID and that kind of thing, but they they're they're actually going to pay for all their own bills on the on their own dime. What strikes me is curious when you bring up the fiduciary responsibility issue is that you have to certify that you have the financial wherewithal to be able. To sustain this. So, in a sense, they've already, the employer is having to promise, hey, we have the ability to pay for this coverage. We have the ability to pay for this medication. Not a surprise. They were already paying for it before. And so they have to certify that they were paying for it. And then this third party interjects themselves and says, hey, if you do it this way, we can save you some money. They don't really explain how they're going to save them the money. They don't really go into the details. They're like, and by the way, everybody is going to get their medications just like they always have. They're just going to still get everything. And unfortunately, there's other mechanisms within this that when they choose that path, not only are they saying it, we're not talking about companies. And I hear this argument a lot. This really frustrates me tremendously, is that I hear from the formulary folks and I hear from even the employer plan design companies that it is a solvency issue. If they don't limit their exposure to high cost medications, that they won't be able to, but they've already proven, they've already certified that they they can pay for this. And so the fact that they're they're now at risk, to your point, I believe that they should be maybe reconsidering going back to a fully funded plan where the insurer is carrying that risk and not the employer. It might cost them a little bit more, but it's still something that they need to be able to be thoughtful about because that's the way the system was set up for a reason. By leveraging this sort of sales tactic from this third party that is not a fiduciary and they're also not a they're not a covered entity either, but they're sort of proposing this concept in the in the guise of saving the employer money when in reality they miss out on all kinds of things too. I mean, the the the you mentioned coupons earlier, although this is not a coupon thing. They don't get, they don't anymore, because it's not going through formulary, if the drug is even covered, and they are forced to have to pay part of it, they're not getting the discounted volume rates either, because they're they're they're also going around the system by leveraging this, you know, this self-funded um exclusion. So I I just think that there's so many things that the employer is unaware of a lot of times and making this decision. It sounds good on the surface, but it's kind of like going to a used car salesman. You're going to be told a lot of good things and you pull it off the lot and find out that maybe everything wasn't what you thought it was. And I believe we're starting to see a little bit of attrition from some of the employers that started down this path. We heard of a large employer who I won't say their name, but they actually employed a lot of pharmacists, and none of their pharmacists qualified because they all made more money than what it would allow them to get their medications under. I mean, and and here's what we would call educated healthcare professionals that adopted this plan and then they got into it. We're like, uh-oh, this isn't going to work for our people. And so I do think employers need to be very, very, very, very careful. They're they're put being put in a vulnerable position by even adopting these programs at all.

SPEAKER_01 47:04

Yeah, and I think it's important. One thing we haven't touched on is yes, you know, to treat cancer can be expensive, to treat hemophilia can be expensive. You know, those are facts. Um, but what's even more expensive is when people don't get the care or treatment that they need or require. The expenses of hospitalizations, the expenses of a bleed, right, for the hemophilia community, um, when a cancer treatment um that had to be stopped or they couldn't get the medication, um, and then they have challenges, it progresses. My goodness, if we want to talk about costs, that's where the real cost to employers come into play. Not minimizing that you know, our conditions are expensive to treat. Again, we should value the fact that we have innovations now that can make many very serious conditions that really limited life before become now chronic conditions. But it's those hospitalizations, what happens uh when things progress, when people don't get the care that they need, then the employer is on the hook. Often that's may fall under their medical versus their pharmacy benefit, right? Um, so we're I know we're talking a lot about money, and I don't want it to get lost in the discussion, that we're also people and we're fellow community members. An employer, an employee is also a very uh important relationship. Employers can't do their business without their employees. I believe employers do very much appreciate their employees. So, in addition to all the money and the discussion on that, is we have to remember that we're all in this together. And honestly, if somebody doesn't have a condition now or their family member doesn't, at some point they really will. And we want to make sure we're not in the well, that I don't have hemophilia, so that's not really my problem. And nobody in my family has cancer, so it's a good thing, you know. You know, none of us are immune from getting a serious uh diagnosis at any point or a chronic diagnosis that we have to deal with for the remainder of our lives or those love, you know, our loved ones' lives.

SPEAKER_00 49:11

Yeah, that's so true, and such a good point. I think that there's so many people that don't, you know, realize I I I've been able to present some of this information to some of the employer benefit design companies along the way. And one of the things that I've found interesting is that I kind of highlight this point with employers in an effort to try to help them understand is that it's all fun and games until it happens to your favorite employee. And so, you know, you've got some of these plans that are that are ensuring 3,000, 5,000 lives. But if it happens to be the secretary at the front counter that just is your favorite employee in the whole company, the CEO is going to be devastated when they find out that that that person can't get the their child's medication that they need for them or for their mom or whoever it is that's being covered under their plan. You know, and and the same is true with with people like um, you know, it it could be maybe the number two. We've we've actually heard stories of where the CEO said, yeah, let's do this, and then the CEOs on kids weren't able to get the coverage that they needed. You know, so I think that there's a there's a a lot more education that's incumbent upon people and they're being sold a bill of goods that doesn't really substantiate. And like you said, I think most people in in in our country and most people and that are, especially employers, really do want to do what's best for their for their employees. They're offering these benefits for retention purposes. But we found in our data that people were five and a half times more likely to find another job and to move employers because they didn't want to address the issue with their employer directly because they felt like there was a target on their back for being a high cost patient. And then simultaneously they they would then just go and look for another job. So these things are more detrimental, I think, to the employer than they are beneficial. And and and even the cost savings is another thing we didn't really touch on yet, but is is the importation issue, because we have seen some of these people even go to the point where if they couldn't get it through the free drug program channels, through the drug manufacturer programs, they sometimes are also uh referring people to go in and get their medications from other countries. I know um one of the uh groups that are kind of in a part of the AFP task force actually had someone that was uh, you know, receive their medication. It was all in a completely different language, including the insert. And it and they thought, wait a minute, I don't even know how to read this. Like where did they took it to their doctor, and the doctor was appalled because the doctor would never have recommended that either. So there's lots and lots of antics going on in this space that are creating, and it's all in the guise of this of this attempt to say, oh, well, we got a lower cost somehow. But and and yes, you're right, we are dependent on high cost medications. That's that's not untrue. But when you already have uh, you know, when you're taking on the fiduciary responsibility, that should be part of the certification process. You have to do that. And along with that, the need to be able to deliver it in a timely manner. And when you have 68 days of delay, you could literally, we've seen people, we just had a patient not that long ago that passed away because they went two weeks without their medications. And it it literally can happen uh in a blink of an eye because you don't have the correct uh access to the medications that you need. And so these things are are a bad deal, but they're also they're they're really bad for everyone involved. I I think the only people that are benefiting from this are the companies that are trying to sell employers on it. And uh unfortunately, um, and there's been a lot of lawsuits even started up this, but we shouldn't have to sue everybody under the under the sun to be able to get this to be able to be correct. But do you see any path forward in terms of like the work that we're doing in a coalition way with AFP task force and some of the other things? What is there a legislative solution here? What do you what do you think about the path forward? How do we how do we continue to monitor this and and see progress for for these changes?

SPEAKER_01 53:12

Well, it's it's rare that we get to share a little bit of good news, right? We always hope for it and we strive for it, and eventually, and sometimes it comes

Importation Concerns And FDA Response

SPEAKER_01 53:20

in little bits and pieces, and sometimes it comes uh from a you know big piece of legislation. But uh and enforcement's another issue. Um, but recently another member of the AFP task force, the alternative funding program task force, and I'll just say it's about 38 different groups um who represent populations with different conditions that rely on specialty medications. But um AIMED Alliance is a member of the task force. And back in 2024, they filed a citizens petition um to the FDA to inquire about different aspects in AFPs and are they permissible and legal. Um, and just this past March, um FDA provided their complete response. I think they provided an interim response uh about a year and a half ago, but AMD alliance received almost uh from from my discussions with them, they seemed like surprised, they kind of came out of the blue. They weren't extended told, look for you know, an incoming email is coming your way. But the FDA, in response to that 2024 citizens petition, um did write in their letter that AFPs are impermissible under uh the Food, Drug, and Cosmetic Act section 804, which is which addresses importation. So that is good news. We will take that, and you know, it's recent. Now it's a matter of how do we make sure, you know, there's enforcement on that, getting the word out on that. Of course, that happened right uh with maximizers, and there was a court decision, and unfortunately, it hasn't been enforced. So that's another key aspect, but we will take that good news and hold on to it, and then again educate each other. What does that mean in real life? What can we do with that? Um, there was another excellent documentary that we were, I think we were both involved in, and other people as well, and helping guide uh CNBC, if anybody's interested, um, that did an importation aspect on AFPs, and it's an excellent documentary and article. Um, and there too, they interviewed people from uh the FDA who also, if my memory is correct, in that in those interviews said, no, no, they're they're not okay. They they can't do this. And yet, you know, a couple of people later in the same interview, they interviewed these for-profit companies, and they're like, oh no, it's totally legal, right? So it's so it's just a matter, but this um this this citizens petition uh final letter that Aim Delines just received, uh, we will take that as very good news and again work together uh and and speak with each other on how we move forward with that good news.

SPEAKER_00 56:13

Yeah, that's so incredible. You've done a great job at also educating Congress and helping representatives understand through some congressional briefings. I know we've done some. You hosted one not that long ago with um Congressman Rick Allen and Lucy McBath's office. And that was such a powerful moment, I think, when we had an opportunity to be um you you invited me to be a part of a panel discussion there, which was really just fascinating to hear from so many different perspectives about how these things are are creating harms in different ways and hurdles for patients, and they're not, they're not actually doing what they're billed to do, which is to say that they're helping. And and I just think that um it's it's things like that. Again, I go back to advocates or educators. There's a place here where we really have to be able to educate in all sides of it. And I'll take any progress is still progress. So I I love that uh that news and and that's exciting. And I do think that um, you know, there there is more to to to continue to work towards, um, you know, for sure. But I just appreciate so much your tenacity to keep us focused on these issues and to really hone in on where the where the you know the potholes are in the road and how we can fill them because um everything doesn't have to be a bill. Uh I think there so many people are like, oh, we need a bill, you know, but it really does. Here's pro here's exact, you know, citizens' uh petition is sometimes enough to be able to get uh an established uh you know uh consensus on an issue that's very, very important to the heart of it that doesn't necessarily have to mean that it has to be legislation, but it can be, you know, again, guidance or enforcement. And um, I'm just so grateful for your your help in leading us through that.

SPEAKER_01 58:03

Yeah, no, no, thank you. It's it's uh it is uh a passion of something that you know I take on and and I feel and as as do you, as do others, you know, on the task force, and even those that may not know about the task force, you know, another avenue that we're looking to is we believe there's there's existing regulations that could help rein in alternative funding programs without new legislation, not to say in the future we may, you know, go that route and think, okay, we do need legislation, but there's um regulations that that say claims procedures have to be reasonable. Um the uh employers must not either implement claims uh or procedures for those claims that are unreasonable would hinder or or hamper people's ability to file claims, um, to file an appeal. So there are claims procedures that already address this. We think they're applicable to rein in and stop these practices of AFPs. Another example is if a claim procedure uh could seriously harm or impact the life of somebody trying to initiate that claim. We believe AFPs indeed do that. So we're looking at different mechanisms to use existing

Enforcement Paths Resources And Wrap-Up

SPEAKER_01 59:20

provisions, uh, which is less of a hurdle to jump over than new legislation. And you know, hopefully we're looking towards representatives Allen and McBath. We've had great conversations with them, maybe trying to get the support of other congressional members along this front to work in and show that AFPs indeed violate some of these provisions, um, or at least use AFPs as an example of something that is is does not comply, is not a reasonable claims procedure. So we're working on that, you know, no promises, but we we think um we're optimistic that there's a pathway forward with that. We also look forward and are working with employers, right? We need to we need to work with employers um in order to really make effort. If if if there people are diametrically opposed, advocates on one side, employers on the other, then we're not going to make any progress. Um so it's trying to identify areas of alignment, not that we're going to, we're not going to agree on everything, but areas where we do align, how can we move forward for that so that employers benefit and employees benefit? And again, I'll just go back. I think I mentioned it early on in our discussion, is that our system is designed with a basis of employer-sponsored healthcare. So if we're going to maintain that and people believe that's the right path, then we need to make sure it's working for employers, for them to manage the expenses, but also for the employees. Because this, if it's not, then really our system is up-ended and we need to look at a totally different pathway because it just is not workable. You can have insurance and name, but if it doesn't provide the coverage that people need, then it's not serving any purpose.

SPEAKER_00 1:01:09

It's no insurance at all. It's so true. And and I'm so, you know, that that uh expertise is what's needed to bring clarity uh to a very complex system where simplicity is the only thing that's going to help make change, which is all the things you said when we opened up this discussion. And um I'm just I I just know that there's so much work to be done. We're gonna put the link in the uh description below so that people can actually see that that documentary you mentioned from CNBC, but also some other resources. But um, Kim, I'm just so grateful for you. I I I I know that everyone listening is as well, and I'm so thankful that uh you are here for such a time as this to be able to bring clarity to some of these complex issues. And um I'm just I'm just happy to know you. I want to be uh associated with you. So I'm I'm I'm hanging on to your coattails and wherever this leads, I'm I'm excited to be a part of it. But thank you so much for taking the time out to have this important discussion. I'm sure people got a lot out of it. If you're listening to this for the first time today, leave a comment below and tell us what it is that you have encountered with some of these issues. But Kim, thanks so much again for being here today on the Hope Podcast, and we look forward to seeing you again in the next time.

SPEAKER_01 1:02:28

Thank you so much. And encourage anybody listening, if they have a story, please share it because it's through those stories that we can really make progress. So thank you, John.

SPEAKER_00 1:02:37

Absolutely. Absolutely. Thank you so much, Kim. Well, one other big thank you again to Kim for joining me for this episode. This has been hopefully informative in a way that helps you to be able to understand what alternative funding programs are and what you need to be on the lookout for. If this is something that you've encountered or that you have you think you might be uh in in sort of stuck in a circular pattern with your employer of, we would love to hear from you, just like Kim said, please reach out. Um, you can comment below, but it's even better if you shoot us an email at info at hope-encharities.org, or you can go to our website and uh look up resources there as well. But um a big thank you to Kim for being here today, and we look forward to seeing you again in the next time around. If you haven't already, please like and subscribe. Feel free to share this with your friends and family uh to help get this word and this message out to more people. It really helps with the algorithm, but it also helps to make certain that the people that need to hear it can hear it. So thank you so much for joining us for this podcast episode today. We hope you enjoyed it. We look forward to seeing you the next time around. Thanks so much. Take care.