How Patients Lose Access to Medication — The Hidden Impact of Alternative Funding Programs

Alternative funding programs are rapidly spreading across employer health plans—but many patients don’t understand how these programs can affect their access to medication.

In this episode, William Sarraille, professor of practice and patient advocate, explains how AFPs work, why they’re expanding, and what they mean for patients who depend on high-cost therapies.

Together we explore:

• What alternative funding programs are
• How some plans remove specialty drugs from coverage
• Why patients are redirected to third-party assistance programs
• Research showing average therapy delays of up to 68 days
• How ERISA and ACA regulations create legal openings for AFPs
• Privacy and discrimination risks tied to health data sharing
• The ethical impact on limited manufacturer and charity programs
• An active legal challenge involving foreign-sourced medications

We also discuss how patients and advocates are pushing back—and what individuals can do to protect themselves.

If you’re navigating a self-funded health plan or supporting someone who is, this episode provides important context and practical steps for protecting access to care.

Subscribe for more conversations about patient advocacy, healthcare policy, and access to treatment.

Learn more about William Sarraille:

https://www.linkedin.com/in/william-sarraille-634a8827/

Related Research:

HOPE Charities also conducted a peer-reviewed survey examining patient experiences with alternative funding programs (AFPs), including delays in medication access, financial burden, and treatment disruptions. The study highlights how these programs may impact patients relying on specialty medications.

Read the study here:

https://pubmed.ncbi.nlm.nih.gov/39471273/

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

Welcome, Sponsor, Guest Intro

SPEAKER_02 0:05

Welcome to the Hope Podcast. My name is Jonathan James, and I am so glad to be with you today. Thank you so much for taking some time out to tune in to this episode. I'm really, really excited about this conversation today because I've invited a very special guest to join us to talk more about alternative funding programs and how they are really a problem for patients, employers, and the greater system that we all depend on. So looking forward to having that conversation. If you haven't already, make sure you like and subscribe to get more episodes like this. We really love being content to you to be able to help you understand more about healthcare challenges, especially as it pertains to bleeding disorders. Before we get into our episode, I want to say a huge thank you to our episode sponsor, Janentec, for sponsoring this episode to provide more educational content just like this. I want to tell you a little bit about my guest who's coming, and I am so excited about uh him joining us today. This is going to be a great conversation. I want to read you a little bit of his brief bio because he is just an incredibly uh well-tenured uh patient advocate. Bill Sorrell is actually a professor of practice at the University of Maryland, Francis King Carey School of Law and a retired senior partner from Sidley Austin LLP, where he spent two decades leading their healthcare practice. He has been repeatedly named one of the best lawyers in America and leading healthcare lawyer by Chambers USA. His expertise covers the full range of healthcare matters from Medicare, Medicaid coverage, pharmaceutical pricing and reimbursements, privacy and security rules, and compliance laws like Stark Law and anti-kickback statutes. We make Bill, what really makes Bill the ideal voice for this conversation is his lifelong commitment to patients. He served as a general counsel, special counsel, and policy advisor to multiple patient advocacy organizations, sits on the board of Rare Disease Society, and works with groups focused on HIV, hepatitis, cystic fibrosis, and rare disease access. Bill has dedicated his career to fighting for patient access for treatments, especially for those with complex conditions who depend on specialty drugs. So without further ado, boy, that is a long resume, but uh you could tell that he is incredibly uh filled his life with advocating for patience. And so without further ado, Bill, it is great to see you today. Thank you so much for joining us for the Hope podcast.

SPEAKER_01 2:37

Well, I'm delighted to be here.

SPEAKER_02 2:38

Thanks for inviting me. I uh was looking at your resume, and I I think that could be literally if it was read, the whole thing was read. It was like an hour and a half long. So I just touched like the very tip of the iceberg. So you're a busy man.

SPEAKER_01 2:53

Well, not as busy as you, but I'm delighted to be here today.

SPEAKER_02 2:57

Well, it's a real treasure to have you on the show, and I'm really excited to dive into an important uh topic that really is near and dear to our hearts. So many people in um rare and chronic disease, people who are dependent upon high-cost medications, have really been faced with uh all kinds of nuanced challenges. We've gone through years and years of fighting against copay accumulators and maximizers and all types of things. And the antics never seem to cease. They just keep coming from every direction. And another avenue that insurance companies and employer plans now have sort of created this other model to prevent people from getting their medications in a timely manner and uh, or in some cases not getting them at all. And that's what we call AFPs or alternative funding programs. And I know you've done some work on this and and continue to be an advocate for patients being able to access their medications. Um, but I think it'd be really good for you to just maybe give us a definition of what are what are AFPs? What are you seeing out there? And and how would you, if somebody's maybe encountering trouble with their employer plan, how would they know if they have an AFP or don't have an AFP?

Delays, Denials, And Patient Harm

SPEAKER_01 4:14

Well, uh, as you've noted in your work, they may not know. Uh and so great that we're doing this uh this podcast. Um AFPs, alternative funding programs, are a fairly amorphous thing. So I'm not sure there's a one-size-fits-all definition that uh that really encapsulates all of the different things that uh different uh vendors out there who advertise and market these programs to employer sponsors, um, you know, we we in a single definition, I don't think could catch all of the different versions of this concept. But at its core, the notion is that instead of the employer sponsor being responsible for the uh specialty drug, that instead the uh the vendor on behalf of the sponsor goes out and looks for third parties to effectively pay the cost of the drug therapy. And that third party can be lots of different folks. Uh it can be a manufacturer uh patient assistance program, it can be an independent 501c3 charity that provides uh co-payment uh and other support uh to patients. It can be an alternative mechanism of securing the drug therapy. It can involve uh foreign sourcing of drugs, where the vendor establishes often a very complicated set of relationships with different non-US parties whereby the drug is shipped from outside of the United States into the United States and uh thereby creates uh a set of very significant legal issues about uh whether or not that process is even lawful under the Food and Drug Act. Um uh quite quite a different range of ways that uh some third party or third-party involvement can end up delivering a drug. And as you mentioned, one of the real issues is that because uh these systems work outside the regular way that patients access their drugs, at the very least, even if they end up getting a US approved drug, which is not always the case, it is almost invariably the case that the patient has a significant delay between the therapy uh start that they hoped to achieve, or even the continuation of the therapy that they were on and the continuation of the therapy under this alternative mechanism.

ERISA, ACA, And Plan Design Loopholes

SPEAKER_02 7:04

Yeah. Yeah, that's so true. You know, we we did um some research on this uh topic and trying to wrap our arms around what specifically people were facing with these things because they seemed to be so different than the accumulator maximizer, but there were some similarities. We just didn't know exactly what was going on. And so we actually did um a project on this, which I think you kind of uh talked about briefly, is it in this project we discovered that people were even in their delay? This was a peer-reviewed research project that we did, it showed that they were on average getting 60, their medications 68 days delayed. And in some cases, with people who are dependent upon these high-cost medications for their livelihood, these things cannot be delayed sometimes more than three days. I mean, that that's a long time. Uh, and so when you're talking about two months, and and then there was some portion of the people that we talked to uh that did not ever receive medication, period. And I think one of the first indicators that we heard from folks in in our research was that one of the first indicators was that they were either getting a denial to say that they were told by their employer, hey, first of all, I think it's level set and important to just make sure everybody knows that these are for employer plans. This is not usually on Medicaid Medicaid, we're not seeing that there. But we're seeing these on employer plans, and they're specifically self-funded employer plans. Now, that may be really hard for some folks to know whether or not they're on a self-funded plan or not, but there's a legal reason why they have this loophole to basically exclude specialty medications from their benefit plan, even though they have major medical coverage. And in that process, one of the challenges that we started to see was that people were told up front when they were going through the enrollment period, yeah, you're gonna get everything's gonna be the same. You're not gonna get anything else. But we want you to enroll in this program, like, and they would name some third-party company, like you mentioned. And in that process, they'd go, Yeah, you're gonna get your medications. We're gonna even give you a dedicated person who's gonna help make certain that you get your medications on time. And then a lot of times the next thing they would get in the mail a few weeks down the road after they had enrolled in these things was a denial letter saying, Oh, your medications aren't covered. And that sent people into an emotional tailspin. And then they would get this call from this third-party person that would say, Yeah, I'm gonna help you get it. And then essentially what they would do is go to these free drug programs or go to these other, maybe out of country. And man, it just creates all kinds of chaos and and frustration and anxiety. We saw people reporting high anxiety rates with all of this. And so, in that process of these things happening, there are some legal reasons uh that that these things are occurring. And so I guess maybe one of the questions I'd like to ask you is what is what is the maybe the the reason why these things are currently allowed to be even created in a loophole to begin with within ERISA law, for instance?

Savings Claims, Fees, And Hidden Costs

SPEAKER_01 10:16

Well, uh ERISA law generally uh creates an environment in which employers can do whatever they want to do in terms of benefit design. The uh underarching, overarching policy of ERISA was the federal government's thought that uh employers, if they were subject to a lot of mandates, would just stop providing health care insurance. And so ERISA mostly gives employers uh pretty substantive carte blanche about uh what benefits they actually commit to providing. Does impose on them a series of procedural uh requirements that are meant to protect employees to some meaningful extent. But you know, the basic underlying premise of ERISA is to give employers wide latitude. The Affordable Care Act changed that a little bit, actually created some uh requirements, some expectations for employer uh sponsored insurance in various circumstances. And so uh one issue that some employers have is that if they choose to provide pharmaceutical benefits, they are subject to this thing in the Affordable Care Act uh called the essential health benefit uh restrictions. So uh, you know, to the extent that you commit as an employer to providing pharmaceutical benefits, you may be subject to this mandate. And so uh the first step for uh vendors working with those employers is often to rewrite the benefit so that the drug is not at least officially covered anymore by the employer, so that there is a mechanism now to go to a third party and to relieve the employer of the commitment that the employer had previously made to cover this drug. Another reason why uh the there may be a denial in particular issue to a patient is that when going to third-party sources for coverage and reimbursement, whether that's a manufacturer patient assistance program or an independent charity, uh that organization may have, often does have a requirement that the patient be shown as not having coverage and reimbursement for the drug. Obviously, it doesn't make sense for these third parties that are focused on patient assistance to give assistance to people whose drugs should already be covered. So there has to be this at least uh sham of a denial before an application is submitted. And in some cases, it does in fact appear to be a sham. In some cases, the patient is being told you're gonna get a denial letter, but you're not really being denied. We will cover it if the third party does not, in fact, provide coverage and reimbursement. And that, of course, uh introduces uh a distinct possibility that uh that uh a criticism that can be made of at least some of these programs is that they are in fact fraud. They involve the use of misrepresentations or deception with respect to these third parties. They are being told that uh the patient does not have coverage when in fact the patient does have coverage.

Ethical Strain On Charities And Access

SPEAKER_02 14:05

Wow. I, you know, you bring up a great point about the sort of the shell game that's going on where there's this misdirection happening essentially, where one party is saying that they, you know, that they're not covered, and then another party is saying they are covered, and then the patient, I think at the end of the day, the employer and the employee still are under this perception that everything's gonna be just status quo. It's gonna go as it always did. Maybe there's a couple extra steps, but it it's really a financial savings benefit to the employer if they can offload this high-cost medication to some other charitable thing, which those systems were never made or created to basically get free drug infinitely. Many of them, I know it's specifically in bleeding disorders, there's a number of units that are limited to be distributed on a free drug basis. Sometimes there's a number of months, it depends on the program, but there's a limit. It's it's not indefinitely 12 months of free drug forever. And the employer essentially is kind of by this third party and benefits organization. They're basically sold this concept of, hey, we can at least give you six months of relief and reprieve from not having to pay for this drug. And then if they get denied or whatever down the road and then they can't get any more free drug, then we'll report it back to you and you can pay it. But at least you're getting some benefit. And I think the bigger sort of maybe fraudulent or uh maybe criminal side of these activities is that in many cases they're charging a commission by percentage. And we've seen some really high commission rates that have been charged to the employer based upon what the employer didn't have to pay, but somebody was paying for it. The the the the drug manufacturer was paying for it, the charitable somebody was paying for it. They just weren't having to, and so they were charging them a commission on something that was intended to be for a gap uh fill for somebody who was really in a crisis, right?

Privacy, HIPAA Risks, And Discrimination

SPEAKER_01 16:00

Yeah. Well, you mentioned uh 18 great things there. So I'll try to respond to a couple of them. Um one is yes, these programs are marketed to the employers as creating savings. There's a real question as to whether or not they actually create savings. Part of the concern there is what you mentioned. The vendors charge a typically percentage fee that is quite high, and that eats up uh a significant portion of the quote unquote savings. But beyond that, uh money is fungible. And so uh there is a significant degree of concern out there that the employer uh saves with one hand and loses with another. That uh particularly where the vendors are connected to PBM or other third-party administrators, as is not infrequently the case, other fees, other charges take back uh through different transactions even more slices of the savings and arguably all of the savings at the end of the day. So that when you compare the performance of some of these employer plans before and after the uh the implementation of these programs, it's unclear that there's been any savings at all when you look at the big picture. Uh so we don't have a lot in the way of research uh with respect to that question, in part because uh obviously these programs are not transparent in the way that would permit that sort of analysis. But we do know from uh uh analysis of accumulator and maximizer programs, which offer a different uh mechanism by which employer sponsors are promised savings, that they don't appear to result in the reduction, for instance, of premium costs, as is often the promise that is made, the representation that is made in marketing those programs. So that uh that the question of whether there even is uh in the final analysis savings is uh is an important one. And then I think another important point that you made there is that obviously these manufacturer patient assistance programs, these independent 501c3s, have ultimately a finite amount of resources and the need out there is significant. So if employers are uh are uh taking uh spaces in the line, well, they're taking spaces in the line, and then people who do not have coverage in any sense, in any fashion, are then not going to be served and are not going to have access. So unfortunately, uh there is no cost-free solution. Uh, and unfortunately, the reality may be that the people who ultimately are paying here, not insignificantly, are patients who would be assisted but can't be assisted because of the prevalence of these AFPs.

Enforcement Gaps And Legal Pathways

SPEAKER_02 19:22

Yeah, that's so it's it's so hard all the way around. I think one of the things that you mentioned earlier was that ERISA law was really created to sort of protect employers so that there was this idea that employers may stop offering benefits if they if they don't uh, you know, like health insurance, um if if they're not protected from the extreme costs at some level. There seems to be a bit of hypocrisy, though, in this concept that in in these plans, you can only be a self-funded, you know, you can only qualify to choose as an employer. If I'm an employer, I can only get approved to be self-funded if I am willing to take on the full financial responsibility as an employer to pay those claims myself directly. And it has to be done on an audit basis prior years to see what we were paying. And then what can, and you have to answer the question can I be a fiduciary and take that responsibility on? But then these third parties interrupt the process by basically saying, hey, we're gonna we're gonna qualify you to deny specialty coverage in your employer plan by saying that you can pay for it. And then simultaneously, we're gonna come back and say, we're gonna save you money so that you don't have to pay for it. And it sounds on the surface to an employer like, I can save money and still achieve the same thing. Sure, why not? I mean, employers make those kind of decisions, business people make those kind of decisions every day. The problem is that a person's life, a person's child's life is on the line when it comes to some of these medications. And and and what what I don't think what has started out in some ways as an I think for many employers, it started as an unintended consequence. They didn't really know that it was going to necessarily in some cases. I I actually talked to several employers that were like, we had no idea that this was gonna create all this hardship for these people. And actually the following pre benefit year, they actually changed and got rid of the AFP as a result of that. But these AFPs are really just pumping this out and saying, you could we could save you all this money, but we're gonna prove that you can pay for it. And so it's one thing if you don't have the money and you can afford it. It's a totally different thing if you have proven to the government that you can afford it, and then you're still basically essentially being led down this path of choosing not to spend that money. And yet someone's life is really in the balance of that. I think the most vulnerable people in our population are being made more vulnerable by these types of harmful policies and programs, don't you think?

Foreign Importation And The Court Fight

SPEAKER_01 22:11

Yeah, absolutely. Without, without doubt. Uh self, yeah, there are two kinds of ERISA plans in in big picture terms, two buckets. There are fully insured plans, which uh generally are smaller or mid-sized employers who don't have the financial resources to take on the insurance risk themselves of covering their employees. So what they do is they buy a commercial insurance policy from a large insurer like Aetna, and that's the mechanism through which it provides its services. Well, their uh their premium is their premium. It's a function of their contract with the Aetna or whatever insurance company they interact with. But for larger employers, uh, they don't need to purchase somebody else's policy. They have enough resources to be able to fund the uh the insurance coverage that they themselves directly provide. They're called self-uh uh funded insurers, self-uh-funded uh ERISA uh plans. And uh yeah, so we are talking about that segment of employers that have more in the way of resources. I think you're absolutely right that uh that employers are given a bunch of uh marketing speak at the front end about how great this program will be, how seamless it'll be, how it'll be not just to their benefit, but the patient's benefit will reduce the co-payment to zero, uh, on and on. And uh you're right that a fair number of employers uh after a year's experience see the terrible impact uh for their patients and sometimes the absence of any real savings for themselves and say, you know, this was a mistake. We're gonna, we're gonna sunset this program, but unfortunately someone has paid the price in the in the interim. And that's a sad fact, but it's true.

SPEAKER_02 24:15

Yeah. You know, the thing that we're always advocating for, and I know you have spent your entire career doing the same, is that it seems to me that the people, again, the most vulnerable, the people who are living with these chronic illnesses, the people who are living by being devastated when they can't get their medications, permanent crippling results, all these things. We have this great technology. We we tout all the time in this country about how great we have all this act, you know, we've got great RD going on, research and development happening, new medications being discovered, new diseases getting treatment. But if people can't get to it, it's a whole nother problem. And and we we've seen that that occur in so many ways. I think uh, you know, we we've seen it occur in in pretty much every type of insurance benefit, but but this is targeting a very specific segment. But you've got 65% of the American population is insured by an employer. So this is this is a large, you know, potential, you know, uh a group that could be affected by some of these things. And and it's important to talk about. I want to kind of pivot to another part of this because this does require some what I believe is inappropriate disclosure of PHI, protected health information, to your employer, which we have spent decades and decades on on ensuring that, you know, like for instance, HIPAA law, where there's portability and protection of private information. And now some of this is being almost forced. The patients are the individuals, the employees are feeling like they're being forced to disclose now to their employer what their health condition is in order to even receive their benefits. Tell me a little bit about what the responsibility is in terms of what is occurring, number one, and is that inappropriate? And then I guess number two to that is what can maybe is there something we can do to sort of does a person, even if they're feeling persuaded to provide this information, do they have to?

Why Patient Stories Matter

SPEAKER_01 26:11

Yeah. Well, it's a bit complicated. Um certainly there is risk. One of the risks that employers face from this is that at least through the vendor and sometimes through their own actions, they are obviously using and considering the health status information, the disease and condition information of patients, which could very well be a significant step towards an employee eventually concluding that they were discriminated against based on a disability or other protected class under the uh the discrimination law. So the uh the uh discrimination laws uh that apply in an employment context talk not just about the acts of hiring and firing, promoting uh employees, but also the terms and privileges of their employment, which include the welfare benefit program, the health insurance. And so uh the employers are creating an environment when they act on this information that increases the risk of discrimination claims. So that's one component. You're sort of focused on uh, I think, uh, the HIPAA privacy uh issues and the corresponding state privacy acts. And there could be uh issues uh from that perspective as well. Is that uh third-party vendor uh appropriately being provided access to information uh from the employer as a business associate or under some other legal framework which allows that access. In many cases, the vendor is actually introduced to the patient by the employer. There is a use of private information in just creating that introduction that creates a potential issue. Then the vendor seeks typically an authorization from the patient to permit its continued use and disclosure of the information to third parties. I have looked at some of those authorizations, and I think that they are highly problematic because they involve either miss or disinformation about the reason that the data is being requested and how it will be used. And an authorization, of course, is only as good as the circumstances that are framed from the person who is giving the authorization. So if uh there is deception or misrepresentation in uh the act of securing that authorization, well, the authorization is null and void. Uh so yes, there are a series of issues there. There are you know other issues that arise. A lot of these conditions obviously have a genetic component. And so those uh federal and state statutes that talk about uh an employer having limited uh access and only for specific reasons to genetic information could also be implicated by these arrangements.

Practical Protections: Read Before You Sign

SPEAKER_02 29:49

Yeah, it's it's very um not only it's very disheartening. We hear from people every year who have been discriminated against, even though it's illegal. I mean, there's plenty of precedent for this where we should not be hiring, firing, uh targeting someone. Uh any employer should not be able to do that because of uh a personal health condition that they have, or maybe their child has that could be potentially costing the employer money. Those decisions uh have been been made in in courts for many years. I think the problem is that we do see that still occurring every day. I mean, that the target, there is no doubt targeting goes on at employers who are, especially in self-funded, essentially they're seeing a lot of this back-end information anyway. I think that that's been the argument from some of the benefit groups we've talked to. I got a chance to go and speak uh on this topic at the Employer Health Benefits Conference last year and talked to many benefit plan design companies. And that was one of the things we're like, well, they see it anyway, because they're paying, they have to write the check for it. So they see it anyway. I think the problem is that, you know, there's um something called, you know, that you're very familiar with a covered entity, which is usually a prescribing agency or hospital pharmacy, so on. And they're held by very strict standards when it comes to what the information sharing can be about certain diagnosis and personal health information. And these third-party vendors that are benefit plan companies and these case managers that are assigned to your situation, these folks are not really operating under a covered entity status. Therefore, they're not, they're not being held accountable to that. But here they are sharing information back and forth with each other and with the employer all about someone's diagnosis and their disease state and the cost of their medications. And decisions innately have to be are being made uh by all parties based upon this information. It just feels like it feels like it's unethical, uh, for sure, but it feels like that there should be some legal reason that that should be being enforced differently than it is.

Closing Thanks And Ways To Reach Out

SPEAKER_01 32:10

Yeah. I mean, do you think there's any Yeah, there definitely there definitely could be legal issues there. Uh again, I think a complication is that there is significant variability in one program versus another. There is the question of uh whether there is an authorization, whether the authorization is effective, uh, whether there's a business associate agreement in place or not in place. Um, so uh, you know, that's unfortunately one of the one of the problems in HIPAA enforcement is that they can be very fact-intensive uh inquiries. And primarily HIPAA enforcement is done through the Office of Civil Rights at the Department of Health and Human Services, which is a notoriously underfunded component of the Department of Health and Human Services. And so uh it's been an office under both Democratic and Republican administrations, uh, which has been slow to act. Uh and uh and so unfortunately that is a significant limitation on what happens in the real world. I think an even bigger limitation from my perspective, because there are different theories that might be advanced under uh state negligence claims, uh, under state unfair and deceptive trade practice act claims, under uh the uh potential that uh the employer is violating its ERISA duty of loyalty uh or is acting in a fashion that's not consistent with its planned document, right? It's supposed to give this uh Bible, if you will, of uh of the rules that it has set and the design of its benefit. It hands that off uh to the planned fiduciary. The planned fiduciary is then supposed to administer the program in strict compliance with that planned document. Oftentimes the plan document isn't changed, it doesn't reflect uh the use of this AFP. Uh it uh may in fact be totally inconsistent with what the plan document says. So there are lots of claims that could be uh brought forward, but uh as we've as we've seen, particularly in the research around HIV and AIDS, uh so many employees are reluctant, even when they know that something is going on that's just not right, uh, to contact uh counsel and to pursue a legal claim because they're afraid of retaliatory action being taken by their employer. Um we are uh very interested. Lots of patient groups are very interested in uh employees who can come forward, who are willing to come forward, and to have their facts and circumstances analyzed and to explore whether their case could be a uh a means to push back on some of these models. A great example uh, which is currently pending, is uh an HIV patient who received uh Turkish product. Uh it was a Turkish version of the drug that this patient was entirely dependent upon for his or her uh his or her health. Uh the product arrived, uh labeled only in Turkish, lacking uh any of the FDA required uh uh disclaimers and uh educational information about, in some cases, black box issues associated with the use of the drug. Uh, the uh patient raised the issue to a physician. The physician communicated to the manufacturer. The manufacturer was able to bring a case uh in its own name against the vendors that were responsible for that program. And there was a very complicated web of vendors that were involved, non-U.S. entities, U.S. entities, uh, a uh PBM affiliate included in that mix of one of the three largest uh PBMs. And uh the manufacturer successfully secured a preliminary injunction against all of those defendants that uh their actions uh constituted a violation of trademark law, that uh effectively by uh importing this product as uh uh uh uh as uh a uh a matter of uh consumer uh confidence, it it uh it uh impinged on the value and the integrity of their U.S. trademark uh by uh creating concerns, consumer concerns, about the safety and appropriateness of this product. That case is now on appeal to the Fourth Circuit Court of Appeals uh and uh a group of patient groups uh filed an amicus brief that I was uh delighted and honored to participate in. We're hoping that these foreign AFPs, these foreign product AFPs, will be significantly challenged if this uh if this district court ruling is upheld by the Fourth Circuit. But you know, we still have these issues with AFPs that work through manufacturer uh patient assistance programs or through 501c3s. Different mechanisms will have to apply there. In some cases, there are other pending cases that challenge those models. But uh, you know, if you if you can do so, if you know that you are in fact being targeted by these programs and you can raise your hand, that could be a very significant contribution that you make to fixing this problem, not just for yourself, but for people across the nation. And, you know, particularly for people who uh now have moved on to another employer. Uh, some of the complications, some of the issues that people struggle with are no longer present. And we really need to hear from people about their experiences and how they've been harmed.

SPEAKER_02 38:42

Yeah, you bring up such a great point. I mean, this is something that we desperately need people to speak up and speak out about. Um, we have talked to many patients that just have gone through this experience and they have privately disclosed their information. And of course, we respect their privacy tremendously. But um many of them have been afraid to step out on a podium or go to an advocacy event or to even be published in a magazine article or a you know newsletter about their story because they don't want to be targeted by their employer in some other way. And uh unfortunately, what we have also seen in our study that we did, uh we saw that people were, when they were affected by these programs, experienced these delays that they were three to five times more likely to move employers. So we have a little bit of a hope that maybe if you moved employers, but you had experience this in a previous employment situation, that should free you up to be able to at least be more confident that you can disclose because it's not tied to your paycheck every day. But I do think, though, that this is important, it's critical that we get more stories, more people to raise their hand and say, I've experienced this. And uh any any type of the documentation or the journey that you've experienced, we would like to see. I think, as you said, uh Bill, that there's so much in each one of these programs are a little bit different. Uh, we've already gotten some calls this year in 2026 from people that have shared some stories that were slightly different than what we heard even last year. So these things seem to pivot a little bit and adjust. They're trying to sort of skirt around, I think, the the legal ramifications of these things. I guess, you know, for you is is this is this one of those things that we've been working together on the AFP task force, which is a great group of people who are, I mean, extraordinarily skilled advocates. We're all trying to put our heads together, trying to figure out how we can, maybe from a legislative point of view, bring something forward to help take action. I know uh Lucy McBath, Congresswoman from uh Georgia, has been really uh outspoken of wanting to address this importation issue. We've worked with her office and her folks, and she's just been a rock star to want to try to squash that part of it. Um also, Congressman Rick Allen has been very, very uh uh interested and wanting to help uh bring some uh some type of legislative action. But while we're still working on the legislative point of view, I think that there is still uh you know a question of is this just one of those things where you have to have a lot of litigation in all the states around the world to try to try to you know persuade this? I mean, I think that's what's really frustrating is people people don't want to go the litigation route, but but is it possible this might be one of those things that we may only be able to bring influence by litigating it? Well, or do you think there's a legislative solution?

SPEAKER_01 41:34

Yeah, I think that uh litigation has to be at least part of the answer. Uh you know, that that obviously is in part my background, and so maybe that's uh uh all too natural a thing for me to say. But uh, you know, you can have a law, you can have a regulation, it's got to be enforced. Uh and uh unfortunately the financial incentives out there are awfully strong. Uh there's an entire industry that's developing around these models and these concepts. They, as we see, even in the context of these this foreign importation model that's being litigated in the Fourth Circuit, that these are determined folks with very significant legal resources who uh, from my perspective, are making absurd arguments, but they're making absurd arguments with uh great zealousness and uh and uh litigating uh you know tooth and nail the various uh questions uh uh uh in my from my perspective, sort of bizarrely contending that this model, which seems obviously in violation of uh the Food and Drug Act, is uh somehow in compliance with the Food and Drug Act. So I do think that it's in fact part of the puzzle. Um, and uh the reality is that uh it will only be part of the solution if people start to raise their hand and like this HIV patient who so bravely did so, uh, brings their story forward. There are various things that under different circumstances uh might be possible to uh enable a person to raise their hand without doing so publicly in that particular case. Uh, that individual has not been named uh as part of the court proceeding. So there are in some cases and some circumstances ways to address that sort of concern.

SPEAKER_02 43:37

Yeah, that's so so important. I think the anonymity piece is something that we also have been able to get a couple of these stories out in written form where people have been able to say, well, let's you know, change the name or or eliminate the personal information out of the article so that uh the story, the context, the the journey can be elevated, but maybe not exposing. The person. So I I love that there is a mechanism, uh, even in a legal route, that could maybe help protect someone's um, you know, personal information. And again, I feel like that there has been yes, yeah, yes, in some cases. And I think that there has been still enough people who have moved employers that experience this. One of the things that I know is true about life is that so often, you know, you don't you you have a trauma in your past and you don't want to go relive it. And that is normal. That's normal for everyone. But what we're, I think what what we're asking folks is that for the sake of the betterment of everyone being harmed by these things, so that these things don't grow and become the majority, 65% of of you know, uh plans are employer plans, I think that this is something that's worth us uh taking those courageous steps to try to um, you know, to try to get this story out there. So if if you're listening to this podcast right now, for instance, and you you you're just going, oh my gosh, I wish there was some way I could help, and you think, I think I had this happen to me, call hope, call us, and we'll help you triage to find out is this something that you were and and be able to help to advocate for you. But um, it's so important to get those personal stories.

SPEAKER_01 45:21

Yeah, I would say, you know, one other uh aspect of this is that for some people, they really aren't going to be able to move beyond it unless they address it. Uh so you know, different people have different ways of uh contending with uh a terrible event in their lives like this. And for some people, you know, actually raising their hand is a necessary component of moving forward. And so if you're that person, then you know, there are people that want to help you.

SPEAKER_02 45:53

Yeah, that's so good. So good. I I do want to say um we do have a couple of stories coming out in our Hope Factor magazine that we'll be talking about this soon. We've had a couple of courageous people step up to the plate to talk about it. Um, so I, you know, if this is something that you are interested in learning more about, too, you can go and check out our website and look at the magazine. And uh, but if you have a story like that that you'd like to share, this is this is we we need your story. We need that feedback because um, you know, and and I love what you said, Bill. This is it, it some people need that to get closure on the trauma. And um we'll we'd love to help walk you through that and and talk through that process. Um, I I really believe that this is one of those things that we're gonna be talking about for a while, unfortunately. I wish we weren't. I wish this was something that we could solve. Um, and I think that it's so important that we we continue to keep the pressure on these issues um because with without us people who are advocating for change, no change will actually occur. And um, you know, the Almighty Daughter has a way of making people bow down to all kinds of things that they didn't want to. And I think that this is one of those things that we have to do the right thing because it's the right thing. We have to stand up in the face of these uh challenges or else no army is coming to do it for us. Like we've got to do this together and be engaged. So uh, Bill, thank you so much for for taking the time to to help unpack this. I think we probably talk about this for another hour because there's so much more here that that needs to be um to be explored. But um I certainly hope that that we'll be able to to to navigate these things together and and with more patient stories, who will people will step up. Is there anything that you can think of that for people listening to this today that you would like to encourage them with or share with them, invite them to participate, or anything that they should be looking out for uh even in their journey of maybe signing up for a new employer plan? Any any warnings or any things that you think, any advice that you give anybody listening to this to help protect themselves and to advance the initiatives?

SPEAKER_01 48:08

Yeah, well, I think that uh a lot of times uh people uh uh are given a piece of paper and feel compelled to sign it without uh asking uh someone, a lawyer, a health advocate, someone else, uh to take a look at it. And I appreciate that. A lot of people are scared of lawyers. Uh we don't have the best reputation the world has ever known. Uh and uh, you know, there can be in some cases an expense associated with that, although there are lots of services out there that are that are free of charge as well. You know, this is this is really important. Uh if this is a product that is uh you know very significantly the difference between your being healthy and unhealthy, it makes sense to take a pause and to get some advice with respect to exactly what's being proposed to you and what it means to you and what your options are at that point. So that would be that would be my observation. There is uh pressure applied in many cases to these folks to act quickly.

unknown 49:22

Uh-huh.

SPEAKER_01 49:22

But as you're mentioning, uh even when these systems work as the vendors intend them to, they often involve 60, 70, 80, 90 days of delay. Uh take a beat. Take a look at what you're signing and what this involves.

SPEAKER_02 49:43

So important, such good advice. I uh I couldn't agree more. And and I'm so uh so appreciative of you um sharing that and and sharing your expertise. Uh I know that people need if they don't already, they can find you and a lot of your advice and your feedback on LinkedIn. Uh, you can learn so much about uh I have to say, you do basically a masterclass on LinkedIn through your publications, your posts that you post on here. So uh I encourage any of the listeners to check you out on LinkedIn under William Sorrell. This is uh this is kind of uh your page there. But if you have these types of issues or or anything else, uh, you know, I I I encourage you, please reach out, just like Bill said. And and uh I really think it's important. We're all here trying to to help people, but uh it's hard to do unless we have the right information and the right stories. And uh and you know, I I you know your your analogy of people just signing stuff without reading it, uh it it is so true. I think about three times a day I click on yeah, accept terms and conditions on some website that I have to look at that I don't even I haven't even like you know pulled it up and read it. And so um behavior.

SPEAKER_01 50:59

Yeah, I can't I can't tell you. I uh even people in my family, uh you know, they sign things, they're they're healthcare related, they have a healthcare lawyer in the family, but it doesn't occur to them.

SPEAKER_00 51:11

Hey, maybe I should call Uncle Bill and ask him, you know, is this a good thing to sign or not to sign? What's why are they asking me to do this?

SPEAKER_01 51:20

So uh yeah, it's it's often good just to take a beat.

SPEAKER_02 51:24

Yeah, that's so good. Such great advice. Well, Bill, we hope to see you again at uh another uh episode. But thank you so much for joining us today on the podcast. I'm just so appreciative of your time. I know it's precious. And uh I know that you're officially retired from your regular practice, but from what I see on online, you you are busier than a one-armed paper hanger. So uh I know that you are uh your your retirement, I think you posted one time and said that your retirement's not going very well because you're doing all of these volunteer work. So thank you so much from the bottom of my heart for what you do for families and for people in our space and the and the people who depend upon these medications. It's just such a such a joy to to be able to um you know rely on you for direction and advice when things get difficult. So thank you so much for your involvement and thank you for being here today.

SPEAKER_01 52:14

Well, great. Thank you for what you do. So I'm I'm grateful for what you do. This is a nice reflection of the many commitments you have to patients and the work that you're doing for patients. So thank you.

SPEAKER_02 52:26

Yeah, I appreciate it. Awesome. Well, we'll see you next time.

SPEAKER_01 52:30

All right.

SPEAKER_02 52:32

Well, another big thank you to Bill for joining me for this podcast. It has been such a privilege to be able to spend time with him. I can't tell you, uh, it it's it's just wonderful to be able to know people who are truly experts in the field of defending the rights of patients. And there isn't anyone who understands the law better than Bill. And uh, I just want to say a big thank you again to him for joining us. Please check out his LinkedIn page that we talked about earlier. He's got a lot of great information that he posts on there regularly, and uh, and there's also uh lots of information on a lot of other topics. But if you have any questions or you are experiencing some of the things that we've talked about today, we want to hear from you. So make sure you go to our website, check that out. You can also email us at info at hope-charities.org about your specific situation, or you can post them in the comments below. We would love to be able to hear more about what you're experiencing, what you're going through, so that we can do everything we can to help you. If you haven't already, if this has been meaningful to you, we would appreciate it if you would like and even subscribe to the channel, only because it helps us to be able to get this information out to more people. It's a free way to be able to support the work that we're doing, but it's also a great opportunity to be able to share this with your friends and family who might be experiencing some of these very things we've discussed today and uh be able to get the information out to more people. So, once again, thank you so much for taking the time to listen to this. If you're listening on our audio channels and also to be able to watch this on YouTube, and uh we really appreciate your time investing in this conversation to educate yourself more on these important issues so that we can all learn and grow together. Again, thank you so much for joining us today, and we look forward to seeing you the next time around. Take care.