MedPod Today: Big Medical Bill; GLP-1 Agonist Plateau; Grateful Patient Fundraising

Derick Alison
Derick Alison
19 Min Read

The following is a transcript of the podcast episode:

Rachael Robertson: Hey everybody. Welcome to MedPod Today, the podcast series where MedPage Today reporters share deeper insight into the week’s biggest healthcare stories. I’m your host, Rachael Robertson.

Today we’re talking with Cheryl Clark about how a change in Medicare left a patient with a massive surprise bill. Plus, Sophie Putka shares her reporting on the GLP-1 agonist plateau that nobody’s talking about. After that, Michael DePeau-Wilson tells us about a new position statement on “grateful patient fundraising.”

Let’s get into our first story about a man named George Beitzel.

Every 2 months for 5 years, George Beitzel went to a Sacramento clinic so a nurse could inject him with the drug Stelara [ustekinumab], which his doctors prescribed to him for Crohn’s disease. With Medicare and a supplemental plan, he never paid a dime. It was important to him that a trained professional give him the injections because Mr. Beitzel also has Parkinson’s disease tremors. But in October 2021 without telling him, the Medicare agency CMS changed its policy, and now Beitzel is fighting a $176,000 bill for four injections he got afterwards. Cheryl Clark is here with us to tell us more and this was one of our most read stories last week.

So Cheryl, that is a ton of money. Why is Beitzel facing these bills?

Cheryl Clark: Thanks, Rachael. This is one of the strangest examples of Medicare policy gone wacko. CMS decided 2 years ago based on claims data that more than 50% of the people who use Stelara inject the drug themselves. Therefore, everybody who uses it should be able to inject the drug themselves. The drug would then be called a “SAD” drug. This is literally a sad, SAD drug story, because SAD stands for self-administered drug.

That decision in effect meant that CMS would not pay for the drug any longer when people who need it get it administered in a clinical setting. But they apparently didn’t tell the clinic about the change in policy. And they certainly didn’t tell Mr. Beitzel, who continued getting four more injections until the bills started piling up. And so Mr. Beitzel, understandably, got very upset. As he told me in a phone call, he’s 84 and his Parkinson’s causes him to shake like a bug. And if he tried to give himself the shot, he could not only waste the drug, but he could hurt himself. And Stelara is very expensive. It costs anywhere from $43,000 to $58,000 per dose. It’s so expensive that Medicare has listed it as number nine among the 10 medicines that will be subject to negotiation under the Biden administration’s Inflation Reduction Act.

Robertson: Oh my gosh. So what did Mr. Beitzel do?

Clark: Well, he’s a smart man. He tried to appeal Medicare’s denial of payment through its multilayer appeals process. And the clinic where he was getting the injections also tried to appeal, but nothing worked. He kept getting denied. He went over to Sacramento’s McGeorge School of Law, and got help from an attorney with the school’s Elder Law Clinic. And with the help of another attorney from the Center for Medicare Advocacy, they filed a lawsuit against the Secretary of Health and Human Services, which runs Medicare – Xavier Becerra.

That’s the last step in a Medicare appeals process, you have to sue the government. The lawsuit was filed in federal court as a class action on behalf of Mr. Beitzel and another patient who needs the drug for her psoriasis. But she has severe arthritis, which prevents her from injecting the drug herself, and other users of Stelara and many other high-cost drugs that have been reclassified as SAD drugs – they’d be in the class too. There’s a long list. You can imagine the many conditions an older person might have that would prevent them from being able to safely inject, you know, arthritis, tremors, heck, I broke my wrist last year and I would have fallen into this category if I had had to use an injectable drug that was a SAD drug!

Robertson: So what is the lawsuit asking for?

Clark: One of the strangest things about this story is that according to the complaint, Medicare rules do not require the agency to inform patients when it changes a drug status to SAD. So the lawsuit wants the court to issue a permanent injunction. That would require the agency to give notice so patients can make arrangements if they can and not continue getting the drug from the clinic. It’s also asking that the patient’s liability for the cost of the drugs – that $176,000 that Mr. Beitzel would have to pay – would be waived since they weren’t told about the policy change. And they want an exception for people like Mr. Beitzel who can’t inject the drug himself because he has Parkinson’s. They think he should still have Medicare coverage of the drug if he gets it from a clinic. And by the way, we asked CMS to comment on all of this, but the agency refused, saying it doesn’t comment on pending litigation.

Robertson: Well, thank you so much, Cheryl.

Clark: And thank you, Rachael.

Robertson: So we’ve been hearing a lot about GLP-1 agonists like Ozempic [semaglutide], Wegovy [semaglutide 2.4 mg], and Mounjaro [tirzepatide] recently, but there’s one thing a lot of these discussions tend to leave out. Medicines like semaglutide and tirzepatide may seem like miracle drugs for type 2 diabetes and weight loss, but they don’t work forever. In fact, experts know that on average, everyone taking this class of drugs will hit a plateau. Here with us is Sophie Putka to tell you more.

Sophie, let’s start with why this plateau happens?

Sophie Putka: Yeah, so something a few of the experts I spoke to mentioned was a great point, which is that for the most part, medicines for chronic illnesses do not continue to lower blood pressure, cholesterol, and so on indefinitely. GLP-1s are no exception. So Gitanjali Srivastava, an obesity specialist from Vanderbilt told me, “there will be a new homeostatic equilibrium, a new weight settling point that is achieved. But what happens is that’s often misconstrued as, oh, the medication is no longer working or this medication stopped taking effect. That’s not the case.” She said, at that point, the condition is being controlled. Go off the medications, and the effect will be reversed.

Jody Dushay, an endocrinologist at Beth Israel in Boston told me, “people, they want the number on the scale to never stop going down, which is kind of a burden that you don’t put on any other medication to treat other chronic conditions.” She also told me, “no one on my watch has disappeared.” The way our society is set up, we tend to hold weight-related conditions apart and separate from other medical issues. And so we expect treatment for them to also be different, but it isn’t for the most part.

Robertson: When should most patients expect the effects to taper off?

Putka: So according to some of the clinical trials for semaglutide and tirzepatide, on average, patients can expect somewhere between 10% to 15% weight loss until around week 60, when it tapers off and patients tend to maintain that weight. At this point. Some of the other changes patients see — like decreases in blood glucose, blood pressure, cholesterol — have also leveled off.

But what these trials don’t capture — individual responses. So each patient’s experience can vary wildly depending on whether they’re taking this medication for diabetes or obesity, what comorbidities they have, other medications they’re taking, or other medical history, like bariatric surgery. Some patients respond quickly and they also tend to respond for longer, but some barely respond at all. The clinicians I talked to expressed some frustration and not being able to effectively predict which patients might be predisposed to one response or another. But that’s something that might come with more research.

Robertson: What do specialists do when this plateau effect happens?

Putka: So this really depends on a conversation between the patient and clinician. If a patient’s clinical goal is to get blood pressure, cholesterol, blood glucose down to a certain level, and these metabolic markers have not yet been reached, some specialists told me they tried titrating up to a higher dose of a GLP-1 if possible, or safely adding another type of medicine that could target appetite, for example. It can get complicated though when a patient who has reached their clinical goals and gone off some medications feels they haven’t yet met their aesthetic goals. And this is really where the stigma we place on weight and larger bodies comes into play.

Fatima Cody Stanford, an obesity specialist from Mass General Hospital in Boston, told me she had one patient who had responded very well to bariatric surgery. Great labs, metabolically healthy – and was maintaining these targets. But she wanted to lose more weight by starting on a GLP-1. So Stanford said she told her, “I don’t see any dysfunction or abnormalities. What you’re striving for is an aesthetic goal, and that’s not the business I’m in. It just isn’t. And so if that’s what you’re looking for, I’m not the right doctor.” Her patient actually ended up finding another doctor.

But another endocrinologist told me that this might be a point to explore with someone – what the meaning behind this desire for additional weight loss is. Is it about reducing joint pain? OK, she might proceed. But is it about societal expectations? Wanting to turn back time? There’s just not always a good answer for that.

Robertson: Sounds super complicated, but thank you for this update, Sophie.

Putka: Thank you.

Robertson: For our next story, the American College of Physicians [ACP] published a new position paper in Annals of Internal Medicine last week that focuses on physicians engaging in fundraising efforts for their institutions. The paper specifically focused on the ethical issues around the practice known as “grateful patient fundraising” and how it can negatively affect the patient-physician relationship. Michael DePeau-Wilson is here to tell us a little more.

Michael, let’s start with what is grateful patient fundraising?

Michael DePeau-Wilson: Hi, Rachael. So grateful patient fundraising refers to the practice of soliciting donations from patients who have already received care from a healthcare institution. The paper says that this is a similar practice to those of colleges and universities trying to get donations from their alumni. And it has become a more common fundraising practice at major healthcare institutions as well now. The ACP’s position on this practice is that it has the potential to disrupt the patient-physician relationship, especially when doctors are getting directly involved in requesting donations from their own patients.

Robertson: We have definitely all received those emails from our alma mater. So what is in this new position statement?

DePeau-Wilson: Well, the authors highlighted three key positions that they want physicians and healthcare administrators to follow when it comes to healthcare fundraising efforts. So first, they said that any physician participation in fundraising should be guided by the best interests and needs of the patient. Second, they emphasize that physicians need to remember that they are responsible for protecting their patient’s privacy, and they should never use that information for fundraising efforts. And third, they said that as far as ACP is concerned, physicians should never be asked directly to solicit donations from their own patients. And they also added that participating in fundraising should never be a condition of employment for a physician.

The overall message is that grateful patient fundraising can introduce ethical issues into the patient-physician relationship and erode the trust between them. They highlighted two specific ways that they see this happening. First, it can put the patient in a position of feeling pressure to give a donation by someone that they’ve entrusted very sensitive personal information to. This can lead the patient to feeling as though they have to give whether they want to or not. And second, they said that it can actually create an expectation on the part of the patient that they’re going to receive priority treatment from the physician because of this donation.

It’s worth pointing out also that the statement does not say that no fundraising efforts should be undertaken by physicians. So they actually outlined a few ways that physicians can engage in fundraising efforts, including speaking at events, attending galas, you know, even using their likeness in campaigns, having their image put on paperwork that sort of promotes fundraising efforts. Mostly, it seems that the ACP doesn’t want physicians to be directly engaging in fundraising with their own patients. But there’s other ways that physicians are allowed to kind of engage in those activities to help with those fundraising efforts that aren’t as ethically concerning.

Robertson: Why did the ACP decide to publish this position statement now?

DePeau-Wilson: Well, Omar Atiq, the president of ACP, told me that they have been watching private equity take a larger role in healthcare for the past couple of decades. And they felt like this was the right time to make a definitive statement about how they think physicians should engage in pressures to help those administrators raise funds for their institutions. He really wanted to focus on preserving that patient-physician relationship and the trust that comes with that. So he said, that can become really strained when physicians are seeking direct contributions from their own patients. And they mainly want to show doctors especially who are in these positions, who might be asked to help with these types of fundraising efforts, that they’re not alone, that the society is there to support them in making that ethical decision when they’re asked to do that. And also to give them guidelines on how they can behave more ethically within the pressures to engage in fundraising, you know, especially related to how, you know, private equity might be sort of looking to use physicians in these ways for these kinds of programs. So they really wanted to take a stand and say, we’re here with you, and this is what we think you should be considering if you’re going to be fundraising for your institution.

Robertson: Awesome. Thank you so much, Michael.

DePeau-Wilson: Thank you.

Robertson: And that’s it for today. If you liked what you heard, leave us a review wherever you listen to podcasts, and hit subscribe if you haven’t already. See you again soon.

This episode was hosted and produced by me, Rachael Robertson. Sound engineering by Greg Laub. Our guests were MedPage Today reporters Cheryl Clark, Sophie Putka, and Michael DePeau-Wilson. Links to their stories are in the show notes. MedPod Today is a production of MedPage Today. For more information about the show, check out medpagetoday.com/podcasts.

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