The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

A final deal cut between President Joe Biden and House Republicans extends the U.S. debt ceiling deadline to 2025 and reins in some spending. The bill signed into law by the president will preserve many programs at their current funding levels, and Democrats were able to prevent any changes to the Medicare and Medicaid programs.

Still, millions of Americans are likely to lose their Medicaid coverage this year as states are once again allowed to redetermine who is eligible and who is not; Medicaid rolls were frozen for three years due to the pandemic. Data from states that have begun to disenroll people suggests that the vast majority of those losing insurance are not those who are no longer eligible, but instead people who failed to complete required paperwork — if they received it in the first place.

This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, Lauren Weber of The Washington Post, and Jessie Hellmann of CQ Roll Call.

Panelists

Jessie Hellmann
CQ Roll Call

@jessiehellmann

Read Jessie's stories

Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico

@JoanneKenen

Read Joanne's stories

Lauren Weber
The Washington Post

@LaurenWeberHP

Read Lauren's stories

Among the takeaways from this week’s episode:

• Lawmakers and White House officials spared health programs from substantial spending cuts in a last-minute agreement to raise the nation’s debt ceiling. And Biden named Mandy Cohen, a former North Carolina health director who worked in the Obama administration, to be the next director of the Centers for Disease Control and Prevention. Though she lacks academic credentials in infectious diseases, Cohen enters the job with a reputation as someone who can listen and be listened to by both Democrats and Republicans.
• The removal of many Americans from the Medicaid program, post-public health emergency, is going as expected: With hundreds of thousands already stripped from the rolls, most have been deemed ineligible not because they don’t meet the criteria, but because they failed to file the proper paperwork in time. Nearly 95 million people were on Medicaid before the unwinding began.
• Eastern and now southern parts of the United States are experiencing hazardous air quality conditions as wildfire smoke drifts from Canada, raising the urgency surrounding conversations about the health effects of climate change.
• The drugmaker Merck & Co. sued the federal government this week, challenging its ability to press drugmakers into negotiations over what Medicare will pay for some of the most expensive drugs. Experts predict Merck’s coercion argument could fall flat because drugmakers voluntarily choose to participate in Medicare, though it is unlikely this will be the last lawsuit over the issue.
• In abortion news, some doctors are pushing back against the Indiana medical board’s decision to reprimand and fine an OB-GYN who spoke out about providing an abortion to a 10-year-old rape victim from Ohio. The doctors argue the decision could set a bad precedent and suppress doctors’ efforts to communicate with the public about health issues.

Also this week, Rovner interviews KFF Health News senior correspondent Sarah Jane Tribble, who reported the latest KFF Health News-NPR “Bill of the Month” feature, about a patient with Swiss health insurance who experienced the sticker shock of the U.S. health care system after an emergency appendectomy. If you have an outrageous or exorbitant medical bill you want to share with us, you can do that here.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: The New York Times’ “This Nonprofit Health System Cuts Off Patients With Medical Debt,” by Sarah Kliff and Jessica Silver-Greenberg.

Jessie Hellmann: MLive’s “During the Darkest Days of COVID, Some Michigan Hospitals Made 100s of Millions,” by Matthew Miller and Danielle Salisbury.

Joanne Kenen: Politico Magazine’s “Can Hospitals Turn Into Climate Change Fighting Machines?” by Joanne Kenen.

Lauren Weber: The Washington Post’s “Smoke Brings a Warning: There’s No Escaping Climate’s Threat to Health,” by Dan Diamond, Joshua Partlow, Brady Dennis, and Emmanuel Felton.

Also mentioned in this week’s episode:

KFF Health News’ “As Medicaid Purge Begins, ‘Staggering Numbers’ of Americans Lose Coverage,” by Hannah Recht.

Click to open the transcript

Transcript: Debt Deal Leaves Health Programs (Mostly) Intact

KFF Health News’ ‘What the Health?’Episode Title: Debt Deal Leaves Health Programs (Mostly) IntactEpisode Number: 301Published: June 8, 2023

[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]

Julie Rovner: Hello and welcome back to “What the Health?”. I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We are taping this week from the smoky, hazy, “code purple” Washington, D.C., area on Thursday, June 8, at 10 a.m. As always, news happens fast and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico.

Joanne Kenen: Hi, everybody.

Rovner: Lauren Weber, of The Washington Post.

Lauren Weber: Hi.

Rovner: And Jessie Hellmann, of CQ Roll Call.

Hellmann: Hello.

Rovner: Later in this episode we’ll have my interview with KFF Health News’s Sarah Jane Tribble about the latest KFF Health News-NPR “Bill of the Month.” This month is about the sticker shock of the American health care system experienced by residents of other countries. Before we get to this week’s news, I hope you all enjoyed our special panel of big health policy thinkers for our 300th episode. If you didn’t listen, you might want to go back and do that at some point. Also, that means we have two weeks of news to catch up on, so let us get to it. We’re going to start this week, I hope, for the last time with the fight over the debt ceiling. Despite lots of doubts, President Biden managed to strike a budget deal with House Republicans, which fairly promptly passed the House and Senate and was signed into law a whole two days before the Treasury Department had warned that the U.S. might default. The final package extends the debt ceiling until January 1, 2025, so after the next election, which was a big win for the Democrats, who don’t want to do this exercise again anytime soon. In exchange, Republicans got some budget savings, but nothing like the dramatic bill that House Republicans passed earlier this spring. So, Jessie, what would it do to health programs?

Hellmann: The deal cuts spending by 1.5 trillion over 10 years. It has caps on nondefense discretionary funding. That would have a big impact on agencies and programs like the NIH [National Institutes of Health], which has been accustomed to getting pretty large increases over the years. So nondefense discretionary spending will be limited to about 704 billion next fiscal year, which is a cut of about 5%. And then there’s going to be a 1% increase in fiscal 2025, which, when you consider inflation, probably isn’t much of an increase at all. So the next steps are seeing what the appropriators do. They’re going to have to find a balance between what programs get increases, which ones get flat funding — it’s probably going to be a lot of flat funding, and we’re probably at the end of an era for now with these large increases for NIH and other programs, which have traditionally been very bipartisan, but it’s just a different climate right now.

Rovner: And just to be clear, I mean, this agreement doesn’t actually touch the big sources of federal health spending, which are Medicare and Medicaid, not even any work requirements that the Republicans really wanted for Medicaid. In some ways, the Democrats who wanted to protect health spending got off pretty easy, or easier than I imagine they expected they would, right?

Hellmann: Advocates would say it could have been much worse. All things considered, when you look at the current climate and what some of the more conservative members of the House were initially asking for, this is a win for Democrats and for people who wanted to protect health care spending, especially the entitlements, because they — Republicans did want Medicaid work requirements and those just did not end up in the bill; they were a nonstarter. So, kind of health-care-related, depending on how you look at it, there was an increase in work requirements for SNAP [Supplemental Nutrition Assistance Program], which is, like, a food assistance program. So that will be extended to age 55, though they did include more exemptions for people who are veterans —

Rovner: Yeah, overall, that may be a wash, right? There may be the same or fewer people who are subject to work requirements.

Hellmann: Yeah. And all those changes would end in 2030, so —

Weber: Yeah, I just wanted to say, I mean, if we think about this — we’re coming out of a pandemic and we’re not exactly investing in the health system — I think it’s necessary to have that kind of step-back context. And we’ve seen this before. You know, it’s the boom-bust cycle of pandemic preparedness funding, except accelerated to some extent. I mean, from what I understand, the debt deal also clawed back some of the public health spending that they were expecting in the billions of dollars. And I think the long-term ramifications of that remain to be seen. But we could all be writing about that in 10 years again when we’re looking at ways that funding fell short in preparedness.

Rovner: Yeah, Joanne and I will remember that. Yeah, going back to 2001. Yeah. Is that what you were about to say?

Kenen: I mean, this happens all the time.

Weber: All the time, right.

Kenen: And we learn lessons. I mean, the pandemic was the most vivid lesson, but we have learned lessons in the past. After anthrax, they spent more money, and then they cut it back again. I mean, I remember in 2008, 2009, there was a big fiscal battle — I don’t remember which battle it was — you know, Susan Collins being, you know, one of the key moderates to cut the deal. You know, what she wanted was to get rid of the pandemic flu funding. And then a year later, we had H1N1, which turned out not to be as bad as it could have been for a whole variety of reasons. But it’s a cliche: Public health, when it works, you don’t see it and therefore people think you don’t need it. Put that — put the politics of what’s happened to public health over the last three years on top of that, and, you know, public health is always going to have to struggle for funds. Public health and larger preparedness is always going to happen to have to struggle for funds. And it would have, whether it was the normal appropriations process this year, which is still to come, or the debt ceiling. It is a lesson we do not learn the hard way.

Weber: That’s exactly right. I’ll never forget that Tom Harkin said to me that after Obama cut, he sacrificed a bunch of prevention funding for the CDC [Centers for Disease Control and Prevention] in the ACA [Affordable Care Act] deal, and he never spoke to him again, he told me, because he was so upset because he felt like those billions of dollars could have made a difference. And who knows if 10 years from now we’ll all be talking about this pivotal moment once more.

Rovner: Yeah, Tom Harkin, the now-former senator from Iowa, who put a lot of prevention into the ACA; that was the one thing he really worked hard to do. And he got it in. And as you point out, and it was almost immediately taken back out.

Weber: Yeah.

Kenen: Not all of it.

Weber: Not all of it, but a lot of it.

Kenen: It wasn’t zero.

Rovner: It became a piggy bank for other things. I do want to talk about the NIH for a minute, though, because Jessie, as you mentioned, there isn’t going to be a lot of extra money, and NIH is used to — over the last 30 years — being a bipartisan darling for spending. Well, now it seems like Congress, particularly some of the Republicans, are not so happy with the NIH, particularly the way it handled covid. There’s a new NIH director who has been nominated, Dr. Monica Bertagnolli, who is currently the head of the National Cancer Institute. This could be a rocky summer for the NIH on Capitol Hill, couldn’t it?

Hellmann: Yeah, I think there’s been a strong desire for Republicans to do a lot of oversight. They’ve been looking at the CDC. I think they’re probably going to be looking at the NIH next. Francis Collins is no longer at NIH. Anthony Fauci is no longer there. But I think Republicans have indicated they want to bring them back in to talk about some of the things that happened during the pandemic, especially when it comes to some of the projects that were funded.

Kenen: There was a lull in raising NIH spending. It was flat for a number of years. I can’t remember the exact dates, but I remember it was — Arlen Specter was still alive, and it … [unintelligible] … because he is the one who traditionally has gotten a lot of bump ups in spending. And then there was a few years, quite a few years, where it was flat. And then Specter got the spigots opened again and they stayed open for a good 10 or 15 years. So we’re seeing, and partly a fiscal pause, and partly the — again, it’s the politicization of science and public health that we did not have to this extent before this pandemic.

Rovner: Yeah, I think it’s been a while since NIH has been under serious scrutiny on Capitol Hill. Well, speaking of the CDC, which has been under serious scrutiny since the beginning of the pandemic, apparently is getting a new director in Dr. Mandy Cohen, assuming that she is appointed as expected. She won’t have to be confirmed by the Senate because the CDC director won’t be subject to Senate approval until 2025. Now, Mandy Cohen has done a lot of things. She worked in the Obama administration on the implementation of the Affordable Care Act. She ran North Carolina’s Department of Health [and Human Services], but she’s not really a noted public health expert or even an infectious disease doctor. Why her for this very embattled agency at this very difficult time?

Kenen: I think there are a number of reasons. A lot of her career was on Obamacare kind of things and on CMS kind of quality-over-quantity kind of things, payment reform, all that. She is a physician, but she did a good job in North Carolina as the top state official during the pandemic. I reported a couple of magazine pieces. I spent a lot of time in North Carolina before the pandemic when she was the state health secretary, and she was an innovator. And not only was she an innovator on things like, you know, integrating social determinants into the Medicaid system; she got bipartisan support. She developed not perfect, but pretty good relations with the state Republicans, and they are not moderates. So I think I remember writing a line that said something, you know, in one of those articles, saying something like, “She would talk to the Republicans about the return on investment and then say, ‘And it’s also the right thing to do.’ And then she would go to the Democrats and say, ‘This is the right thing to do. And there’s also an ROI.’”. So, so I think in a sort of low-key way, she has developed a reputation for someone who can listen and be listened to. I still think it’s a really hard job and it’s going to batter anyone who takes it.

Rovner: I suspect right now at CDC that those are probably more important qualities than somebody who’s actually a public health expert but does not know how to, you know, basically rescue this agency from the current being beaten about the head and shoulders by just about everyone.

Kenen: Yeah, but she also was the face of pandemic response in her state. And she did vaccination and she did disparities and she did messaging and she did a lot of the things that — she does not have an infectious disease degree, but she basically did practice it for the last couple of years.

Rovner: She’s far from a total novice.

Kenen: Yeah.

Rovner: All right. Well, it’s been a while since we talked about the Medicaid “unwinding” that began in some states in early April. And the early results that we’re seeing are pretty much as expected. Many people are being purged from the Medicaid rolls, not because they’re earning too much or have found other insurance, but because of paperwork issues; either they have not returned their paperwork or, in some cases, have not gotten the needed paperwork. Lauren, what are we seeing about how this is starting to work out, particularly in the early states?

Weber: So as you said, I mean, much like we expected to see: So 600,000 Americans have been disenrolled so far, since April 1. And some great reporting that my former colleague Hannah Recht did this past week: She reached out to a bunch of states and got ahold of data from 19 of them, I believe. And in Florida, it was like 250,000 people were disenrolled and somewhere north of 80% of them, it was for paperwork reasons. And when we think about paperwork reasons, I just want us all to take a step back. I don’t know about anyone listening to this, but it’s not like I fill out my bills on the most prompt of terms all of the time. And in some of these cases, people had two weeks to return paperwork where they may not have lived at the same address. Some of these forms are really onerous to fill out. They require payroll tax forms, you know, that you may not have easily accessible — all things that have been predicted, but the hard numbers just show is the vast majority of people getting disenrolled right now are being [dis]enrolled for paperwork, not because of eligibility reasons. And too, it’s worth noting, the reason this great Medicaid unwinding is happening is because this was all frozen for three years, so people are not in the habit of having to fill out a renewal form. So it’s important to keep that in mind, that as we’re seeing the hard data show, that a lot of this is, is straight-up paperwork issues. The people that are missing that paperwork may not be receiving it or just may not know they’re supposed to be doing it.

Rovner: As a reminder, I think by the time the three-year freeze was over, there were 90 million people on Medicaid.

Kenen: Ninety-five.

Rovner: Yeah. So it’s a lot; it’s like a quarter of the population of the country. So, I mean, this is really impacting a lot of people. You know, I know particularly red states want to do this because they feel like they’re wasting money keeping ineligible people on the rolls. But if eligible people become uninsured, you can see how they’re going to eventually get sicker, seek care; those providers are going to check and see if they’re eligible for Medicaid, and if they are, they’re going to put them back on Medicaid. So they’re going to end up costing even more. Joanne, you wanted to say something?

Kenen: Yeah. Almost everybody is eligible for something. The exceptions are the people who fall into the Medicaid gap, which is now down to 10 states.

Rovner: You mean, almost everybody currently on Medicaid is eligible.

Kenen: Anyone getting this disenrollment notification or supposed to receive the disenrollment notification that never reaches them — almost everybody is eligible for, they’re still eligible for Medicaid, which is true for the bulk of them. If they’re not, they’re going to be eligible for the ACA. These are low-income people. They’re going to get a lot heavily subsidized. Whether they understand that or not, someone needs to explain it to them. They’re working now, and the job market is strong. You know, it’s not 2020 anymore. They may be able to get coverage at work. Some of them are getting coverage at work. One of the things that I wrote about recently was the role of providers. States are really uneven. Some states are doing a much better job. You know, we’ve seen the numbers out of Florida. They’re really huge disenrollment numbers. Some states are doing a better job. Georgetown Center on Health Insurance — what’s the right acronym? — Children’s and Family. They’re tracking, they have a state tracker, but providers can step up, and there’s a lot of variability. I interviewed a health system, a safety net in Indiana, which is a red state, and they have this really extensive outreach system set up through mail, phone, texts, through the electronic health records, and when you walk in. And they have everybody in the whole system, from the front desk to the insurance specialists, able to help people sort this through. So some of the providers are quite proactive in helping people connect, because there’s three things: There’s understanding you’re no longer eligible, there’s understanding what you are eligible for, and then actually signing up. They’re all hard. You know, if your government’s not going to do a good job, are your providers or your community health clinics or your safety net hospitals — what are they doing in your state? That’s an important question to ask.

Rovner: Providers have an incentive because they would like to be paid.

Kenen: Paid.

Weber: Well, the thing about Indiana too, Joanne, I mean — so that was one of the states that Hannah got the data from. They had I think it was 53,000 residents that have lost coverage in the first amount of unwinding. 89% of them were for paperwork. I mean, these are not small fractions. I mean, it is the vast majority that is being lost for this reason. So that’s really interesting to hear that the providers there are stepping up to face that.

Kenen: It’s not all of them, but you can capture these people. I mean, there’s a lot that can go wrong. There’s a lot that — in the best system, you’re dealing with [a] population that moves around, they don’t have stable lives, they’ve got lots of other things to deal with day to day, and dealing with a health insurance notice in a language you may not speak delivered to an address that you no longer live at — that’s a lot of strikes.

Rovner: It is not easy. All right. Well, because we’re in Washington, D.C., we have to talk about climate change this week. My mother, the journalist, used to say whenever she would go give a speech, that news is what happens to or in the presence of an editor. I have amended that to say now news is what happens in Washington, D.C., or New York City. And since Washington, D.C., and New York City are both having terrible air quality — legendary, historically high air quality — weeks, people are noticing climate change. And yes, I know you guys on the West Coast are saying, “Uh, hello. We’ve been dealing with this for a couple of years.” But Joanne and Lauren, both of your extra credits this week have to do with it. So I’m going to let you do them early. Lauren, why don’t you go first?

Weber: Yeah, I’ve highlighted a piece by my colleague Dan Diamond and a bunch of other of my colleagues, who wrote all about how this is just a sign of what’s to come. I mean, this is not something that is going away. The piece is titled “Smoke Brings a Warning: There’s No Escaping Climate’s Threat to Health.” I think, Julie, you hit the nail on the head. You know, we all live here in Washington, D.C. A lot of other journalist friends live in New York. There’s been a lot of grousing on Twitter that everyone is now covering this because they can see it. But the reality is, when people can see it, they pay attention. And so the point of the story is, you know, look, I mean, this is climate change in action. We’re watching it. You know, it’s interesting; this story includes a quote from Mitch McConnell saying [to] follow the public health authorities, which I found to be quite fascinating considering the current Republican stance on some public health authorities during the pandemic. And I’m just very curious to see, as we continue to see this climate change in reality, how that messaging changes from both parties.

[Editor’s note: The quote Weber referenced did not come from McConnell but from Senate Majority Leader Chuck Schumer, a Democrat, and would not have warranted as much fascination in this context.]

Kenen: But I think that you’ve seen, with the fires on the West Coast, nobody is denying that there’s smoke and pollutants in the air — of either party. You know, we can look out our windows and see it right now, right? But they’re not necessarily accepting that it’s because of climate change, and that — I’m not sure that this episode changes that. Because many of the conservatives say it’s not climate change; it’s poor management of forests. That’s the one you hear a lot. But there are other explain — or it’s just, you know, natural variation and it’ll settle down. So it remains to be seen whether this creates any kind of public acknowledgment. I mean, you have conservative lawmakers who live in parts of the country that are already very — on coasts, on hurricane areas, and, you know, forest fire areas there. You have people who are already experiencing it in their own communities, and it does not make them embrace the awareness of poor air quality because of a forest fire. Yes. Does it do what Julie was alluding to, which is change policy or acknowledging what, you know, the four of us know, and many millions of other people, you know, that this is related to climate change, not just — you know, I’m not an expert in forestry, but this is not just — how many fires in Canada, 230?

Rovner: Yeah. Nova Scotia and Quebec don’t tend to have serious forest fire issues.

Kenen: Right. This is across — this is across huge parts of the United States now. It’s going into the South now. I was on the sixth floor of a building in Baltimore yesterday, and you could see it rolling in.

Rovner: Yeah. You have a story about people trying to do something about it. So why don’t you tell us about that.

Kenen: Well it was a coincidence that that story posted this week, because I had been working on it for a couple of months, but I wrote a story. The headline was — it’s in Politico Magazine — it’s “Can Hospitals Turn Into Climate Change Fighting Machines?” Although one version of it had a headline that I personally liked more, which was “Turn Off the Laughing Gas.” And it’s about how hospitals are trying to reduce their own carbon footprint. And when I wrote this story, I was just stunned to learn how big that carbon footprint is. The health sector is 8.5% of greenhouse gas emissions in the United States, and that’s twice as high as the health sector in comparable industrial countries, and —

Rovner: We’re No. 1!

Kenen: Yes, once again, and most of it’s from hospitals. And there’s a lot that the early adopters, which is now, I would say about 15% of U.S. hospitals are really out there trying to do things, ranging from changing their laughing gas pipes to composting to all sorts of, you know, energy, food, waste, huge amount of waste. But one of the — you know, everything in hospitals is use once and throw it out or unwrap it and don’t even use it and still have to throw it out. But one of the themes of the people I spoke to is that hospitals and doctors and nurses and everybody else are making the connection between climate change and the health of their own communities. And that’s what we’re seeing today. That’s where the phenomenon Laura was talking about is connected. Because if you look out the window and you can see the harmful air, and some of these people are going to be showing up in the emergency rooms today and tomorrow, and in respiratory clinics, and people whose conditions are aggravated, people who are already vulnerable, that the medical establishment is making the connection between the health of their own community, the health of their own patients, and climate. And that’s where you see more buy-in into this, you know, greening of American hospitals.

Rovner: Speaking of issues that that seem insoluble but people are starting to work on, drug prices. In drug price news, drug giant Merck this week filed suit against the federal government, charging that the new requirements for Medicare price negotiation are unconstitutional for a variety of reasons. Now, a lot of health lawyers seem pretty dubious about most of those claims. What’s Merck trying to argue here, and why aren’t people buying what they’re selling?

Hellmann: So there’s two main arguments they’re trying to make. The primary one is they say this drug price negotiation program violates the Fifth Amendment, which prohibits the government from taking private property for public use without just compensation. So they argue that under this negotiation process they would basically be coerced or forced into selling these drugs for a price that they think is below its worth. And then the other argument they make is it violates their First Amendment rights because they would be forced to sign an agreement they didn’t agree with, because if they walk away from the negotiations, they have to pay a tax. And so it’s this coercive argument that they are making. But there’s been some skepticism. You know, Nick Bagley noted on Twitter that it’s voluntary to participate in Medicare. Merck doesn’t have a constitutional right to sell its drugs to the government at a price that they have set. And he also noted — I thought this was interesting — I didn’t know that there was kind of a similar case 50 years ago, when Medicare was created. Doctors had sued over a law Congress passed requiring that a panel review treatment decisions that doctors were making. The doctors sued also under the Fifth Amendment in the courts, and the Supreme Court sided with the government. So he seems to think there’s a precedent in favor of the government’s approach here. And there just seems to be a lot of skepticism around these arguments.

Rovner: And Nick Bagley, for those of you who don’t know, is a noted law professor at the University of Michigan who specializes in health law. So he knows whereof he speaks on this stuff. I mean, Joanne, you were, you were mentioning, I mean, this was pretty expected somebody was going to sue over this.

Kenen: It’s probably not the last suit either. It’s probably the first of, but, I mean, the government sets other prices in health care. And, you know, it sets Medicare Advantage rates. It sets rates for all sorts of Medicare procedures. The VA [U.S. Department of Veterans Affairs] sets prices for every drug that’s in its formulary or, you know, buys it at a negotiated —

Rovner: Private insurers set prices.

Kenen: Right. But that’s not government. That’s different.

Rovner: That’s true.

Kenen: They’re not suing private insurers. So, you know, I’m not Nick Bagley, but I usually respect what Nick Bagley has to say. On the other hand, we’ve also seen the courts do all sorts of things we have not expected them to do. There’s another Obamacare case right now. So, precedent, schmecedent, you know, like — although on this one we did expect the lawsuits. Somebody also pointed out, I can’t remember where I read it, so I’m sorry not to credit it, maybe it was even Nick — that even if they lose, if they buy a extra year or two, they get another year or two of profits, and that might be all they care about.

Rovner: It may well be. All right. Well, let us turn to abortion. It’s actually been relatively quiet on the abortion front these last couple of weeks as we approach the one-year anniversary of the Supreme Court striking down Roe v Wade. I did want to mention something that’s still going on in Indiana, however. You may remember the case last year of the 10-year-old who was raped in Ohio and had to go to Indiana to have the pregnancy terminated. That was the case that anti-abortion activists insisted was made up until the rapist was arraigned in court and basically admitted that he had done it. Well, the Indiana doctor who provided that care is still feeling the repercussions of that case. Caitlin Bernard, who’s a prominent OB-GYN at the Indiana University Health system, was first challenged by the state’s attorney general, who accused her of not reporting the child abuse to the proper state authorities. That was not the case; she actually had. But the attorney general, who’s actually a former congressman, Todd Rokita, then asked the state’s medical licensing board to discipline her for talking about the case, without naming the patient, to the media. Last month, the majority of the board voted to formally reprimand her and fine her $3,000. Now, however, lots of other doctors, including those who don’t have anything to do with reproductive health care, are arguing that the precedent of punishing doctors for speaking out about important and sometimes controversial issues is something that is dangerous. How serious a precedent could this turn out to be? She didn’t really violate anybody’s private — she didn’t name the patient. Lauren, you wanted to respond.

Weber: Yeah, I just think it’s really interesting. If you look at the context, the number of doctors that actually get dinged by the medical board, it’s only a couple thousand a year. So this is pretty rare. And usually what you get dinged for by the medical board are really severe things like sexual assault, drug abuse, alcohol abuse. So this would seem to indicate quite some politicization, and the fact that the AG was involved. And I do think that, especially in the backdrop of all these OB-GYN residents that are looking to apply to different states, I think this is one of the things that adds a chilling effect for some reproductive care in some of these red states, where you see a medical board take action like this. And I just think in general — it cannot be stated enough — this is a rare action, and a lot of medical board actions will be, even if there is an action, will be a letter in your file. I mean, to even have a fine is quite something and not it be like a continuing education credit. So it’s quite noteworthy.

Rovner: Well, meanwhile, back in Texas, the judge who declared the abortion pill to have been wrongly approved by the FDA, Trump appointee Matthew Kacsmaryk, is now considering a case that could effectively bankrupt Planned Parenthood for continuing to provide family planning and other health services to Medicaid patients while Texas and Louisiana were trying to kick them out of the program because the clinics also provided abortions in some cases. Now, during the time in question, a federal court had ordered the clinics to continue to operate as usual, banning funding for abortions, which always has been the case, but allowing other services to be provided and reimbursed by Medicaid. This is another of those cases that feels very far-fetched, except that it’s before a judge who has found in favor of just about every conservative plaintiff that has sought him out. This could also be a big deal nationally, right? I mean, Planned Parenthood has been a participant in the Medicaid program in most states for years — again, not paying for abortion, but for paying for lots of other services that they provide.

Kenen: The way this case was structured, there’s all these enormous number of penalties, like 11,000 per case or something, and it basically comes out to be $1.8 billion. It would bankrupt Planned Parenthood nationally, which is clearly the goal of this group, which has a long history that — we don’t have time to go into their long history. They’re an anti-abortion group that’s — you know, they were filming people, and there’s a lot of history there. It’s the same people. But, you know, this judge may in fact come out with a ruling that attempts to shut down Planned Parenthood completely. It doesn’t mean that this particular decision would be upheld by the 5th Circuit or anybody else.

Rovner: Or not. The same way the mifepristone ruling finally woke up other drugmakers who don’t have anything to do with the abortion fight because, oh my goodness, if a judge can overturn the approval of a drug, what does the FDA approval mean? This could be any government contractor — that you can end up being sued for having accepted money that was legal at the time you accepted it, which feels like not really a very good business partner issue. So another one that we will definitely keep an eye on.

Kenen: I mean, that’s the way it may get framed later, is that this isn’t really about Planned Parenthood; this is about a business or entity obeying the law, or court order. I mean, that’s how the pushback might come. I mean, I think people think Planned Parenthood, abortion, they equate those. And most Planned Parenthood clinics do not provide abortion, while those that do are not using federal funds, as a rule; there are exceptions. And Planned Parenthood is also a women’s health provider. They do prenatal care in some cases; they do STD [sexually transmitted disease] treatment and testing. They do contraception. They, you know, they do other things. Shutting down Planned Parenthood would mean cutting off many women’s access to a lot of basic health care.

Rovner: And men too, I am always reminded, because, particularly for sexually transmitted diseases, they’re an important provider.

Kenen: Yeah. HIV and other things.

Rovner: All right. Well, that is this week’s news. Now we will play my “Bill of the Month” interview with Sarah Jane Tribble, and then we will be back with our extra credits. We are pleased to welcome back to the podcast Sarah Jane Tribble, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” story. Sarah, thanks for coming in.

Sarah Jane Tribble: Thanks for having me.

Rovner: So this month’s patient is a former American who now lives in Switzerland, a country with a very comprehensive health insurance system. But apparently it’s not comprehensive enough to cover the astronomical cost of U.S. health care. So tell us who the patient is and how he ended up with a big bill.

Tribble: Yeah. Jay Comfort is an American expatriate, and he has lived overseas for years. He’s a former educator. He’s 66 years old. And he decided to retire in Switzerland. He has that country’s basic health insurance plan. He pays his monthly fee and gets a deductible, like we do here in the U.S. He traveled last year for his daughter’s wedding and ended up with an emergency appendectomy in the ER [emergency room] at the University of Pittsburgh in Williamsport.

Rovner: And how big was the ultimate bill?

Tribble: Well, he was in the hospital just about 14 hours, and he ended up with a bill of just over $42,000.

Rovner: So not even overnight.

Tribble: No.

Rovner: That feels like a lot for what was presumably a simple appendectomy. Is it a lot?

Tribble: We talked to some experts, and it was above what they had predicted it would be. It did include the emergency appendectomy, some scans, some laboratory testing, three hours in the recovery room. There was also some additional diagnostic testing. They had sent off some cells for a diagnostics and did find cancer at the time. Still, it didn’t really explain all the extra cost. Healthcare Bluebook, which you can look up online, has this at about $14,000 for an appendectomy. One expert told me, if you look at Medicare prices and average out in that region, it would be between $6,500 and $18,000-ish. So, yeah, this was expensive compared to what the experts told us.

Rovner: So he goes home and he files a claim with his Swiss insurance. What did they say?

Tribble: Well, first let me just say, cost in the U.S. can be two to three times that in other countries. Switzerland isn’t known as a cheap country, actually. Its health care is —

Rovner: It’s the second most expensive after the U.S.

Tribble: Considered the most expensive in Europe, right. So this is pretty well known. So he was still surprised, though, when he got the response from his Swiss insurance. They said they were willing to pay double because it was an emergency abroad. Total, with the appendectomy and some extra additional scans and so forth: About $8,000 is what they were willing to pay.

Rovner: So, double what they would have paid if he’d had it done in Switzerland.

Tribble: Yeah.

Rovner: So 42 minus 8 leaves a large balance left. Yeah. I mean, he’s stuck with — what is that — $34,000. He’s on the hook for that. I mean, it’s better than having nothing, obviously, but it’s a lot of money and it’s really striking, the difference, because, you know, in Switzerland, they’re very much like, we would pay this amount, then we’ll double it to pay you back. And he still has this enormous bill he’s left paying. He’s on a fixed income. He’s retired. So it’s quite the shock to his system.

Rovner: So what happened? Has this been resolved?

Tribble: Let me first tell you what happened at the ER, because Jay was very diligent about providing documents and explaining everything. We had multiple Zoom calls. Jay’s wife was with him, and she provided the Swiss insurance card to UPMC. Now, UPMC had confirmed that there was some confusion, and it took months for Jay to get his bill. He had to call and reach out to UPMC to get his bill. He wants to pay his bill. He wants to pay his fair share, but he doesn’t consider $42,000 a fair share. So he wants to now negotiate the bill. We’ve left it at that, actually. UPMC says they are charging standard charges and that he has not requested financial assistance. And Jay says he would like to negotiate his bill.

Rovner: So that’s where we are. What is the takeaway here? Obviously, “don’t have an emergency in a country where you don’t have insurance” doesn’t feel very practical.

Tribble: Well, yeah, I mean, this was really interesting for me. I’ve been a health care reporter a long time. I’ve heard about travel insurance. The takeaway here for Jay is he would have been wise to get some travel insurance. Now, Jay did tell me previously he had tried to get Medicare. He is a U.S. citizen residing in Switzerland. He does qualify. He had worked in the U.S. long enough to qualify for it. He had gone through some phone calls and so forth and didn’t have it before coming here. He told me in the last couple of weeks that he now has gotten Medicare. However, that may not have helped him too much because it was an outpatient procedure. And it’s important to note that if you have Medicare and you’re 65 in the U.S., when you go overseas, it’s not likely to cover much. So the takeaway: Costs in the U.S. are more expensive than most places in the world, and you should be prepared if you’re traveling overseas and you find yourself in a situation, you might consider travel insurance anyway.

Rovner: So both ways.

Tribble: Yeah.

Rovner: Americans going somewhere else and people from somewhere else coming here.

Tribble: Well, if you’re a contract worker or a student on visa or somebody visiting the U.S., you’re definitely [going to] want to get some insurance because, wherever you’re coming from, most likely that insurance isn’t going to pay the full freight of what the costs are in the U.S.

Rovner: OK. Sarah Jane Tribble, thank you very much.

Tribble: Thanks so much.

Rovner: OK, we’re back, and it’s time for our extra credit segment. That’s where we each recommend a story we read this week that we think you should read, too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Lauren and Joanne, you’ve already given us yours, so Jessie, you’re next.

Hellmann: Yeah. My extra credit is from MLive.com, an outlet in Michigan. It’s titled “During the Darkest Days of COVID, Some Michigan Hospitals Made 100s of Millions.” They looked at tax records, audited financial statements in federal data, and found that some hospitals and health systems in Michigan actually did really well during the pandemic, with increases in operating profits and overall net assets. A big part of this was because of the covid relief funding that was coming in, but the article noted that, despite this, hospitals were still saying that they were stretched really thin, where they were having to lay off people. They didn’t have money for PPE [personal protective equipment], and they were having to institute, like, other cost-saving measures. So I thought this was a really interesting, like, a local look at how hospitals are kind of facing a backlash now. We’ve seen it in Congress a little bit, just more of an interest in looking at their finances and how they were impacted by the pandemic, because while some hospitals really did see losses, like small, rural, or independent hospitals, some of the bigger health systems came out on top. But you’re still hearing those arguments that they need more help, they need more funding.

Rovner: Well, my story is also about a hospital system. It’s yet another piece of reporting about nonprofit hospitals failing to live up to their requirement to provide, quote, “community benefits,” by our podcast panelist at The New York Times Sarah Kliff and Jessica Silver-Greenberg. It’s called “This Nonprofit Health System Cuts Off Patients With Medical Debt.” And it’s about a highly respected and highly profitable health system based in Minnesota called Allina and its policy of cutting off patients from all nonemergency services until they pay back their debts in full. Now, nonemergency services because federal law requires them to treat patients in emergencies. It’s not all patients. It’s just those who have run up debt of at least $1,500 on three separate occasions. But that is very easy to do in today’s health system. And the policy isn’t optional. Allina’s computerized appointment system will actually block the accounts of those who have debts that they need to pay off. It is quite a story, and yet another in this long list of stories about hospitals behaving badly. OK, that is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks, as always, to our ever-patient producer, Francis Ying. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me, at least for now. I’m still there. I’m @jrovner. Joanne?

Kenen: @JoanneKenen

Rovner: Jessie.

Hellmann: @jessiehellmann

Rovner: Lauren.

Weber: @LaurenWeberHP

Rovner: We will be back in your feed next week. Until then, be healthy.

Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News’ ‘What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

How should journalists cover political candidates who make false claims about the safety and effectiveness of vaccines? That question will need to be answered now that noted anti-vaccine activist Robert F. Kennedy Jr. has officially entered the 2024 presidential race.

Meanwhile, South Carolina has become one of the last states in the South to pass an abortion ban, making the procedure all but impossible to obtain for women across a broad swath of the country.

This week’s panelists are Julie Rovner of KFF Health News, Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat, and Sarah Karlin-Smith of the Pink Sheet.

Panelists

Rachel Cohrs
Stat News

@rachelcohrs

Read Rachel's stories

Sarah Karlin-Smith
Pink Sheet

@SarahKarlin

Read Sarah's stories

Alice Miranda Ollstein
Politico

@AliceOllstein

Read Alice's stories

Among the takeaways from this week’s episode:

• Republican lawmakers and President Joe Biden continue to bargain over a deal to avert a debt ceiling collapse. Unspent pandemic funding is on the negotiating table, as the White House pushes to protect money for vaccine development — though the administration has drawn criticism for a lack of transparency over what would be included in a clawback of unspent dollars.
• In abortion news, South Carolina is the latest state to vote to restrict access to abortion, passing legislation this week that would ban abortion after six weeks of pregnancy — shortly after pregnant people miss their first period. And Texas is seeing more legal challenges to the state law’s exceptions to protect a mother’s life, as cases increasingly show that many doctors are erring on the side of not providing care to avoid criminal and professional liability.
• Congress is scrutinizing the role of group purchasing organizations in drug pricing as more is revealed about how pharmacy benefit managers negotiate discounts. So-called GPOs offer health care organizations, like hospitals, the ability to work together to leverage market power and negotiate better deals from suppliers.
• Lawmakers are also exploring changes to the way Medicare pays for the same care performed in a doctor’s office versus a hospital setting. Currently, providers can charge more in a hospital setting, but some members of Congress want to end that discrepancy — and potentially save the government billions.
• And our panel of health journalists discusses an important question after a prominent anti-vaccine activist entered the presidential race last month: How do you responsibly cover a candidate who promotes conspiracy theories? The answer may be found in a “truth sandwich.”

Also this week, Rovner interviews KFF Health News senior correspondent Aneri Pattani about her project to track the money from the national opioid settlement.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: KFF Health News’ “Remote Work: An Underestimated Benefit for Family Caregivers,” by Joanne Kenen

Alice Miranda Ollstein: Reuters’ “How Doctors Buy Their Way out of Trouble,” by Michael Berens

Rachel Cohrs: ProPublica’s “In the ‘Wild West’ of Outpatient Vascular Care, Doctors Can Reap Huge Payments as Patients Risk Life and Limb,” by Annie Waldman

Sarah Karlin-Smith: The New York Times’ “Heat Wave and Blackout Would Send Half of Phoenix to E.R., Study Says,” by Michael Levenson

Also mentioned in this week’s episode:

• KFF Health News’ “Abortion Bans Are Driving Off Doctors and Closing Clinics, Putting Basic Health Care at Risk,” by Julie Rovner.
• Stat’s “House Panel Takes First Steps Toward Reining In Hospitals With ‘Site-Neutral’ Changes,” by Rachel Cohrs.
• Vice’s “ABC News and CNN Manage to Demonstrate Exactly What Not to Do With Robert F. Kennedy Jr.,” by Anna Merlan.

click to open the transcript

Transcript: When an Anti-Vaccine Activist Runs for President

KFF Health News’ ‘What the Health?’

Episode Title: When an Anti-Vaccine Activist Runs for President

Episode Number: 299

Published: May 25, 2023

[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]

Julie Rovner: Hello and welcome back to “What the Health?”. I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, May 25, at 10 a.m. As always, news happens fast and things might have changed by the time you hear this. So here we go. Today we are joined via video conference by Rachel Cohrs of Stat News.

Rachel Cohrs: Hi, everybody.

Rovner: Sarah Karlin-Smith of the Pink Sheet.

Sarah Karlin-Smith: Hi, Julie.

Rovner: And Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Hello.

Rovner: Later in this episode we’ll have my interview with KFF Health News’ Aneri Pattani about her project tracking where all of that opioid settlement money is going. But first, this week’s news. I suppose we have to start with the debt ceiling again, because how this all eventually plays out will likely impact everything else that happens in Washington for the rest of the year. First of all, as of this taping, at 10 o’clock on Thursday morning, there’s still no settlement here, right?

Ollstein: There is not. And depending who you listen to, we are either close or not close at all, on the brink of disaster or on the brink of being all saved from disaster. There’s a lot of competing narratives going around. But yes, as of this taping, no solution.

Rovner: I want to do a spreadsheet of how often the principals come out and say, “It was productive,” “It’s falling apart,” “It was productive,” “It’s falling apart.” I mean, it seems like literally every other time, particularly when Speaker [Kevin] McCarthy comes out, it was either “very productive” or “we’re nowhere near.” That seems to have been the gist for the past two weeks or so. Meanwhile, it seems like one thing Republicans and Democrats have at least tentatively agreed to do is claw back something like $30 billion in unspent covid funds. But, not so fast. The New York Times reports that the Biden administration wants to preserve $5 billion of that to fund the next generation of covid vaccines and treatment and another $1 billion to continue giving free covid vaccines to people without insurance. I feel like this is the perfect microcosm of why these talks are almost impossible to finish. They’re trying to negotiate a budget resolution, an omnibus spending bill, and a reconciliation bill all at the same time, with the sword of Damocles hanging over their head and a long holiday weekend in between. Somebody please tell me that I’m wrong about this.

Ollstein: Well, Congress never does anything unless there’s a sword of Damocles hanging over them and a vacation coming up that they really want to go on. I mean, do they ever make it happen otherwise? Not — not in our experience. But I do want to note that it is interesting that the Biden administration is trying to fight for some of that covid funding. Meanwhile, what they’re not reportedly fighting for is some of the other public health funding that’s at risk in that clawback, and I reported last week that some of Biden’s own health officials are warning that losing those tens of billions of dollars could undermine other public health efforts, including the fight against HIV and STDs [sexually transmitted diseases]. We have syphilis at record rates right now, and public health departments all around the country are counting on that money to preserve their workforces and do contact tracing, etc. And so that is another piece of this that isn’t getting as much attention.

Cohrs: There has been this ongoing fight between the White House and Republicans over covid money and how it’s being spent, for years at this point. And the White House has never really been fully transparent about exactly what was going to get clawed back. The Appropriations Committee was the one who actually put out some real information about this. And I think that trust has just been broken that the money is used where it’s supposed to be. I mean, even for the next-generation research project [Project NextGen] — I mean, they launched that like a couple of months ago, after Republicans had already threatened to take the money back. So I think there are some questions about the timing of the funding. [White House COVID-19 Response Coordinator] Ashish Jha said they didn’t know they had leftovers until recently, but I think this has just really turned into a mess for the White House, and I think the fact that they’re willing to offer some of this money up is just kind of a symbol and just a “ending with a whimper” of this whole fight that’s been going on for two years where they’ve been unsuccessful in extracting any more money.

Rovner: And yeah, I was just going to say, the White House keeps asking for more money and then they keep, quote-unquote, “finding money” to do things that are really important. Sarah, I wanted to ask you, how freaked out is the research establishment and the drug industry at whether, you know, will they or won’t they actually pony up money here?

Karlin-Smith: I think this could be pretty problematic because some of the type of companies that get this funding — some of them might be in a position to do this on their own, but others would essentially — you know, there isn’t necessarily a market for this without the government support, and that’s why they do it. That’s why the U.S. created this BARDA [Biomedical Advanced Research and Development Authority], which kind of funds this type of pandemic and other threats research. And so I think there are companies that definitely wouldn’t be able to continue without this money, because some of it is for things that we think we might need but don’t know if we definitely will. And so you don’t necessarily want to make the investment in the same way you know you need cancer drugs or something like that.

Rovner: We will see how this plays out. Perhaps it will be played out by next week or perhaps they will find some sort of short-term patch, which is another tried-and-true favorite for Congress. All right. Let’s turn to abortion. Last week, the North Carolina Legislature overrode the Democratic governor’s veto to pass a 12-week ban. This week was the South Carolina Legislature’s chance to say, “Hold my beer.” Alice, what happened in South Carolina, and what does it mean for availability of abortion in the whole rest of the South?

Ollstein: The governor is expected to sign this new restriction into law. Like many other GOP-led states. South Carolina was expected to quickly pass restrictions last year as soon as Roe v. Wade was overturned, but they got into fights within the Republican Party over how far to go, whether to have exceptions, what kind of exceptions, etc. It was the classic story we’ve seen play out over and over and over where, while Roe v. Wade was still in place, it was very easy for people to say, “I’m pro-life, I’m against abortion,” and not have to make those difficult, detailed decisions. So, yes, this could have a big impact, you know, especially with Florida moving for a much stricter ban. You know, the whole region is becoming more and more unavailable, and people are going to have to travel further and further.

Rovner: And South Carolina ended up with one of these six-week, quote-unquote, “heartbeat bills,” right?

Ollstein: That’s right.

Rovner: So it’s sort of shutting off yet another state where abortion is or really could be available. There’s more abortion-related court action, too. This week, in Texas, eight more women who experienced dangerous pregnancy complications joined a lawsuit seeking to force just a clarification of that state’s abortion ban that they say threatened their lives. One of them, Kiersten Hogan, had her water break prematurely, putting her at risk of infection and death, but says she was told by the hospital that if she tried to leave to seek care elsewhere, she could be arrested for trying to kill her baby. Four days later, the baby was born stillborn. Yet sponsors of the state’s abortion bill say it was never intended to bar, quote, “medically necessary abortions.” Why is there such a disconnect? And Texas is hardly the only place this is happening, right?

Ollstein: Yeah. Situations like this are why people are arguing that the whole debate over exceptions is sort of a fig leaf. It’s papering over how these work in practice. You can have exceptions on the book that say “life-threatening situations, medical emergencies,” etc. But because doctors are so afraid of being charged with a crime or losing their license or other professional repercussions, that’s just creating a huge chilling effect and making them afraid to provide care in these situations. A lot of times the state law also contradicts with federal law when it comes to medical emergencies, and so doctors feel caught in the middle and unsure what they’re supposed to do. And as we’re seeing, a lot of them are erring on the side of not providing care rather than providing care. So this is playing out in a lot of places. So I’m interested to see if this informs the debate in other states about whether to have these exceptions or not.

Rovner: And I get to promote my own story here, which is that we’re seeing in a lot of states either doctors leaving or doctors deciding not to train in states with abortion bans because they’re afraid of exactly those restrictions that could land them, you know, either in court or, even worse, in jail. We’ve long had abortion care deserts. Now we could see entire women’s health care deserts in a lot of these states, which would, you know, hurt not just the people who want to have abortions, but the people who want to get pregnant and have babies. We will continue to watch that space. Well, meanwhile, in West Virginia, another court case, filed by the maker of the generic version of the abortion pill mifepristone, could turn on a recent Supreme Court decision about pork products in California. Can somebody explain what one has to do with the other?

Karlin-Smith: There is basically a ruling that the Supreme Court issued the other week in a California case where the state was regulating how pigs were treated on farms in California. And the court basically allowed the law to stand, saying, you know, it didn’t interfere with interstate commerce. And the people who are protesting GenBioPro’s suit in West Virginia are basically saying that this, again, is an example where West Virginia’s regulation of the abortion drug, again, doesn’t really impact the distribution of the drug outside of the state or the availability of the drug outside of the state, and so this should be allowable. Of course, GenBioPro and the folks who are protesting how West Virginia is curtailing access to the suit are trying to argue the same ruling helps their cause. To me, what I read — and it seems like the comparison works better against the drug company, but it always is interesting to see this overlapping — you know, the cases you don’t expect. But I also, I think, when this ruling came out, saw somebody else making another argument that this should help GenBioPro. So it’s very hard to know.

Rovner: If it’s not confusing enough, I’m going to add another layer here: While we’re talking about the abortion pill, a group of House Democrats are reaching out to drug distribution company AmerisourceBergen, following reports that it would decline to deliver the pill to pharmacies in as many as 31 states, apparently fearing that they would be drawn into litigation between states and the federal government, the litigation we’ve talked about now a lot. So far, the company has only said that it will distribute the drug in states, quote, “where it is consistent with the law.” In the end, this could end up being more important than who wins these lawsuits, right? If — I think they’re the sole distributor — is not going to distribute it, then it’s not going to be available.

Ollstein: It also depends on the — at the 5th Circuit, and that will go back to the Supreme Court, because if it’s not an FDA-approved drug, then nobody can distribute it. That’s the ultimate controlling factor. But yes, since they are the sole distributor, they will have a lot of power over where this goes. And when I was reporting on Walgreens’ decision, they were pointing to this and saying that their decisions, you know, depend on other factors as well.

Karlin-Smith: And there’s a lot of nuance to this because my understanding is AmerisourceBergen, they’re particularly talking about distributing it to pharmacies where you could — under this new FDA permission to let pharmacies distribute the drug, which in the past they hadn’t.

Rovner: And which hasn’t happened yet.

Karlin-Smith: Right. They haven’t actually gone through the process of certifying the pharmacies. So it’s like a little bit premature, which is why I think Walgreens realized they probably jumped the gun on making any decision because it couldn’t happen yet anyway. But AmerisourceBergen is still saying, “Oh, we’re giving it to providers and other places that can distribute the drug in some of these states.” So it’s not necessarily like the drug is completely unavailable. It’s just about ease of access, I think, at this point.

Rovner: Yeah, we’re not just in “watch that space”; now we’ve progressed to “watch all those spaces,” which we will continue to do. Well, while we were on the discussion of drug middlepeople, there’s a story in Stat about the Federal Trade Commission widening its investigation of pharmacy benefit managers to include group purchasing organizations. Sarah, what are group purchasing organizations and how do they impact the price of prescription drugs?

Karlin-Smith: So group purchasing organizations are basically where you sort of pool your purchasing power to try and get better deals or discounts. So like, in this case, one of the GPOs FTC is looking at negotiates drug rebates on behalf of a number of different PBMs, not just one PBM. And so, again, you know, the idea is the more people you have, the more marketing you have, the better discount you should be able to get, which is — I think some people have been a little shocked by this because they’re like, “Wait, we thought the PBMs were the ones that did the negotiation. Why are they outsourcing this? Isn’t that the whole purpose of why they exist?” Yeah, so FTC has sort of a broader investigation into PBMs, so this is kind of the next step in it to kind of figure out, OK, what is the role of these companies? How are they potentially creating bad incentives, contributing to increased drug pricing, making it harder for people to perhaps, like, get their drug at particular pharmacies or more expensive at particular pharmacies? Again, because there’s been a lot of integration of ownership of these companies. So like the PBMs, the health insurance, some of these pharmacy systems are sort of all connected, and there’s a lot of concern that that’s led to incentives that are harming consumers and the prices we’re paying for our health care.

Rovner: Yeah, there’s all that money sloshing around that doesn’t seem to be getting either to the drug companies or to the consumers. Rachel, you wanted to add something?

Cohrs: Sure. I think GPOs are more used with hospitals when they buy drugs, because I think PBMs — you think of, like, going to pick up your drug at the pharmacy counter. But obviously hospitals are buying so many drugs, too. And their, you know, market power is pretty dispersed across the country. And so they also are a big customer of GPOs. So I think they’re also trying to get at this, like, different part of the drug market where, you know, a lot of these really expensive medications are administered in hospitals. So it will be interesting. They’re certainly not very transparent either. So, yeah, interesting development as to how they relate to PBMs, but also the rest of — you know, encompassing a larger part of the health care system.

Karlin-Smith: Yeah, I have seen complaints from hospital systems that the GPOs require them to enter into contracts that make it very difficult for the hospital to pivot if, say, the GPO can’t supply them with a particular product or maybe it’s … [unintelligible] … and then they end up stuck in a situation where they should, in theory, be able to get a product from another supplier and they can’t. So there’s lots of different levels of, again, concern about potential bad behavior.

Rovner: Well, while we are on the topic of nerdy practice-of-medicine stuff, Rachel, you had a story on the latest on the, quote, “site-neutral” Medicare payment policy. Remind us what that is and who’s on which side, and wasn’t that one of the bills — or I guess that wasn’t one of the bills that was approved by the House Energy and Commerce Committee yesterday, right?

Cohrs: No, so “site neutral” is basically hospitals’ worst nightmare. It essentially makes sure that Medicare is paying the same amount for a service that a doctor provides, whether it’s on a hospital campus or provided in a doctor’s office. And I think hospitals argue that they need to charge more because they have to be open 24/7. You know, they don’t have predictable hours. They have to serve anyone, you know, regardless of willingness to pay. It costs more overhead. That kind of thing. But I think lawmakers are kind of losing patience with that argument to some degree, that the government should be paying more for the same service at one location versus another. And it’s true that House Republicans had really wanted an aggressive form of this policy, and it could save like tens of billions of dollars. I mean, this is a really big offset we’re talking about here, if they go really aggressively toward this path, but instead they weren’t able to get Democrats on board with that plan yet. I think the chair, Cathy McMorris Rodgers, and the ranking member, Frank Pallone, have said they want to keep working on this. But what they did do this week is took a tiny little part out of that and advanced it through the committee. And it would equalize payment for, like, drug administration in physician’s offices versus a physician doing it in the hospital, and the savings to the federal government on that policy was roughly $3 billion. So, again, not a huge hit to industry, but it’s, you know, significant savings, certainly, and a first step in this direction as they think about how they want to do this, if they want to go bigger.

Rovner: So while we’re talking about the Energy and Commerce Committee, those members, in a fairly bipartisan fashion, are moving a bunch of other bills aimed at price transparency, value-based care, and a lot of other popular health buzzwords. Sarah, I know you watched, if not all, then most of yesterday’s markup. Anything in particular that we should be watching as it perhaps moves through the House and maybe the Senate?

Karlin-Smith: Yeah. So there was — probably the most contentious health bill that cleared yesterday was a provision that basically would codify a Trump-era rule in Medicaid that the Biden administration has sort of tweaked a bit but generally supported that basically tweaks Medicaid’s “best price” rule. So Medicaid is kind of guaranteed the best price that the private sector gets for drugs. But drugmakers have argued this prevents them from doing these unique value-based arrangements where we say, “OK, if the patient doesn’t perform well or the drug doesn’t work well for the patient, we’ll kind of give you maybe even all your money back.” Well, they don’t want the Medicaid best price to be zero. So they came up with a kind of a very confusing way to tweak that and also as part of that to, you know, hopefully allow Medicaid to maybe even take advantage of these programs. And Rep. [Brett] Guthrie [(R-Ky.)], Rep. [Anna] Eshoo [(D-Calif.)] on the Democratic side, want to codify that. But a number of the Democrats pushed back and over worries this might actually raise prices Medicaid pays for drugs and be a bit more problematic. And the argument from the Democrats, the majority of Democrats on the committee who oppose it, were not completely against this idea but let it play out in rulemaking, because if it stays in rulemaking, it’s a lot easier to —er, sorry — as a rule, it’s already made.

Rovner: To fix it if they need to.

Karlin-Smith: Right. It’s a lot easier to fix it, which, as anybody who follows health policy knows, it’s not actually as easy as you would think to fix a rule, but it’s definitely a lot easier to fix a rule than it is to fix something codified in law. So that’s sort of a very wonky but meaningful thing, I think, to how much drugs cost in Medicaid.

Rovner: Last nerdy thing, I promise, for this week: The Biden administration says it plans to conduct an annual audit of the cost of the most expensive drugs covered by Medicaid and make those prices public in what one of your colleagues, Alice, described as a “name and shame” operation? I mean, could this actually work, or could it end up like other HHS [Department of Health and Human Services] transparency rules, either not very followed or tied up in court?

Karlin-Smith: Experts that my colleague Cathy Kelly talked to to write about this basically were not particularly optimistic it would lead to big changes in savings to Medicaid, basically. One of the reasons is because Medicaid actually gets pretty good deals on drugs to begin with. But that said, even, again, like I said, they’re guaranteed these really large rebates are the best price. But in exchange for that, they have to cover all drugs. So that’s where you start to lose some of your leverage. So the hope with some of this extra transparency is they’ll get more information to have, like, a little bit of additional leverage to say, “Oh, well your manufacturing costs are only this, so you should be able to give us an additional rebate,” which they can negotiate that. Again, I think people think there’ll be sort of maybe some moderate, if any, benefits to that. But some states have actually tried similar things in kind of similar “name, shame” affordability boards. And the drugmakers have basically just said, “No, we’re not going to give you any more discounts.” And they’re kind of stuck.

Rovner: “And we’re not ashamed of the price that we’re charging.”

Karlin-Smith: Right.

Rovner: “Or we wouldn’t be charging it.”

Karlin-Smith: So it’s a tough one, but there’s, like, an argument to be made that drugmakers just don’t want to be on this list. So maybe some of them will more proactively figure out like how to get their price point and everything discounts to a point where they at least won’t get on the list. So maybe, again, it might tweak things around the edges, but it’s not a big price savings move.

Rovner: And we shall see. All right. Well, this is — finally this week, it’s something I’ve wanted to talk about for a couple of weeks. I’m calling it the “How do you solve a problem like RFK Jr.?” For those of you who don’t already know, the son of the former senator and liberal icon Robert Kennedy has declared his candidacy for president. He’s an environmental lawyer, but at the same time, he’s one of the most noted anti-vaxxers, not just in the country but in the world. Vice has a provocative story — this actually goes back a couple of weeks — about how the media should cover this candidacy or, more specifically, how it shouldn’t. According to the story, ABC did an interview with RFK Jr. and then simply cut out what they deemed the false vaccine claims that he made. CNN, on the other hand, did an interview and simply didn’t mention his anti-vaccine activism. I am honestly torn here about how should you cover someone running for president who traffics in conspiracy theories that you know are not true? I realize here I am now speaking of a wider — wider universe than just RFK Jr. But as a journalist, I mean, how do you handle things that — when they get repeated and you know them to be untrue, at least in the health care realm?

Karlin-Smith: I mean, I really like the thing that Vice mentioned, and I think maybe Jay Rosen, who’s a journalism professor at NYU [New York University], he might be the person that sort of coined this, I’m not sure — this, like, “truth sandwich” idea, where you make sure you sort of start with what is true, in the middle you put the sort of — this is what the false claim of X person — and then you go back to the truth. Because I think that really helps people grasp onto what’s true, versus a lot of times you see the coverage starts with the lie or the falsehood. And I think sometimes people might even just see that headline or just see the little bit of what’s correct and never make it to the truth. And I understand some of the decisions by the news outlets that decided not to air these segments and just didn’t want to deal with the topic. But then I guess I thought they did make a good point that then you let somebody like Kennedy say, “Oh, they’re suppressing me, they’re deliberately hiding this information.” So the Vice argument was that this truth sandwich idea kind of gets you in a better … [unintelligible]. And again, as journalists, our job is not to suppress what politicians are saying. People should know what these people claim, because that is what the positions they stand for. But it’s figuring out how to add the context and be able to, you know, in real time if you need to, fact-check it.

Rovner: I confess, over the years I have been guilty of the CNN thing of just not bringing it up and hoping it doesn’t come up. But then, I mean, it’s true, the worst-case scenario — probably not going to happen with somebody running for president — but I think we’ve discovered all these people running for lower offices, that they get elected, you don’t talk about the controversial things and then you discover that you have a legislator in office who literally believes that the Earth is flat. There are — can Google that. So if these things aren’t aired, then there’s no way for voters to know. Anybody else have a personal or organizational rule for how to handle this sort of stuff?

Ollstein: I think there can be smart decisions about when to let someone say in their own voice what they believe versus saying as the news organization, “In the speech, he spent X minutes advancing the discredited assertion of blah, blah, blah, blah, blah,” and not just handing over the platform for them to share the misinformation.

Rovner: Yeah, I just want the audience to know that we do think seriously about this stuff. We are not just as sort of blithe as some may believe. All right. Well, that is this week’s news. Now, we will play my interview with Aneri Pattani, and then we will come back with our extra credits. I am pleased to welcome back to the podcast my colleague Aneri Pattani, who is here to talk about her investigation into where those billions of dollars states are getting in pharmaceutical industry settlements for the opioid crisis are actually going. Aneri, I am so glad to have you back.

Aneri Pattani: Thanks so much for having me.

Rovner: So let’s start at the beginning. How much money are we talking about? Where’s it coming from, and where is it supposed to be going?

Pattani: So the money comes from companies that made, distributed, or sold opioid painkillers. So these are places like Purdue Pharma, AmerisourceBergen, Walgreens, and a bunch of others. They were all accused of aggressively marketing the pills and falsely claiming that they weren’t addictive. So thousands of states and cities sued those companies. And rather than go through with all the lawsuits, most of the companies settled. And as a result, they’ve agreed to pay out more than $50 billion over the next 15 or so years. And the money is meant to be used on opioid remediation, which is a term that means basically anything that addresses or fixes the current addiction crisis and helps to prevent future ones.

Rovner: So the fact is that many or most states — we don’t actually know where this money is going or will go in the future because that information isn’t being made public. How is that even legal, or, I guess it’s not public funds, but it’s funds that are being obtained by public entities, i.e., the attorneys general.

Pattani: Yeah, a lot of people feel this way. But the thing is, the national settlement agreements have very few requirements for states to publicly report how they use the money. In fact, the only thing that’s in there that they’re required to report is when they use money for non-opioid purposes. And that can be at most 15% of the total funds they’re getting. And that reporting, too, is on an honor system. So if a state doesn’t report anything, then the settlement administrators are supposed to assume that the state used all of its money on things related to the opioid crisis. Now, states and localities can enact stricter requirements. For example, North Carolina and Colorado are two places that have created these public dashboards that are supposed to show where the money goes, how much each county gets, how the county spends it. But honestly, the vast majority of states are not taking steps like that.

Rovner: So for people of a certain age, this all feels kind of familiar. In the late 1990s, a group of state attorneys general banded together and sued the tobacco companies for the harm their products had done to the public. They eventually reached a settlement that sent more than $200 billion to states over 25 years, so that money is only just now running out. But it didn’t all get used for tobacco cessation or even public health, did it?

Pattani: No. In fact, most of it didn’t get used for that. The Campaign for Tobacco-Free Kids, which has been tracking that tobacco settlement money for years, found that about only 3% of the money goes to anti-smoking programs a year. The rest of it has gone towards plugging state budget gaps, infrastructure projects like paving roads, or, in the case of North Carolina and South Carolina, the money even went to subsidizing tobacco farmers.

Rovner: Great. Given the lessons of the tobacco settlement, how do the attorneys general in this case try to make sure that wasn’t going to happen? I mean, was it just by requiring that that non-opioid-related money be made public?

Pattani: So they have added some specific language to the settlements that they point to as trying to avoid, you know, the, quote, “tobacco nightmare.” Essentially, the opioid settlements say that at least 85% of the money must be spent on opioid remediation. Again, that term — that’s like things that stop and prevent addiction. And there’s also a list included at the end of the settlement, called Exhibit E, with potential expenses that fall under opioid remediation. That’s things like paying for addiction treatment for people who don’t have insurance or building recovery housing or funding prevention programs in schools. But the thing is, that list is pretty broad and it’s nonexhaustive, so governments can choose to do things that aren’t on that list, too. So there are guidelines, but there’s not a lot of hard enforcement to make sure that the money is spent on these uses.

Rovner: So, as you’ve pointed out in your reporting, it’s not always simple to determine what is an appropriate or an inappropriate use of these settlement funds, particularly in places that have been so hard-hit by the opioid crisis and that it affects the entire economy of that state or county or city. So tell us what you found in Greene County, Tennessee. That was a good example, right?

Pattani: Yeah, Greene County is an interesting place. And what I learned is happening there is actually, you know, repeating in a lot of places across the country. So Greene County, it’s an Appalachian county, it’s been hard-hit. It has a higher rate of overdose deaths than the state of Tennessee overall or even the country. But when the county got several million dollars in opioid settlement funds, it first put that money towards paying off the county’s debt. And that included putting some money into their capital projects fund, which was then used to buy a pickup truck for the sheriff’s office. So a lot of folks are looking at that, saying, “That’s not really opioid-related.” But county officials said to me, you know, this use of the money makes sense, because the opioid epidemic has hurt their economy for decades; it’s taken people out of the workforce, it’s led to increased costs for their sheriff’s office and their jail with people committing addiction-related crimes, it’s hurt the tax base when people move out of the county. So now they need that money to pay themselves back. Of course, on the other hand, you have advocates and people affected by the crisis saying, “If we’re using all the money now to pay back old debts, then who’s addressing the current crisis? People are still dying of overdoses, and we need to be putting the opioid settlement money towards the current problem.”

Rovner: So I suppose ideally they could be doing both.

Pattani: I think that’s the hard thing. Although $54 billion sounds like a lot of money, it’s coming over a long period of time. And so at the end of the day, it’s not enough to fund every single thing people want, and there is a need for prioritization.

Rovner: So I know part of your project is helping urge local reporters to look into where money is being used in their communities. How is that going?

Pattani: It’s going well. I think it’s important because the money is not only going to state governments, but to counties and cities too. So local reporters can play a really big role in tracking that money and holding local officials accountable for how they use it. So I’m trying to help by sharing some of the national data sets we’re pulling together that can be used by local reporters. And I’ve also hopped on the phone with local reporters to talk about where they can go to talk to folks about this or finding story ideas. Some of the reporters I’ve spoken with have already published stories. There was one just a week ago in the Worcester Telegram from a student journalist, actually, in that area —

Rovner: Cool.

Pattani: — so there’s a lot of good coverage coming.

Rovner: I’m curious: What got you interested in pursuing this topic? I know you cover addiction, but this is the kind of reporting that can get really frustrating.

Pattani: It definitely can. But I think it’s what you said: As someone who’s been covering addiction and mental health issues for a while, kind of focusing on some of the problems and the systemic gaps, when I learned that this money was coming in, it was exciting to me too, like, maybe this money will be used to address the issues that I’m often reporting on, and so I want to follow that and I want to see if it delivers on that promise.

Rovner: So what else is coming up in this project? I assume it’s going to continue for a while.

Pattani: Yes. So this will be a yearlong project, maybe even more, because, as I said, the funds are coming for a long time. But essentially the next few things I’m looking at, I have a big data project looking at who sits on opioid settlement councils. These are groups that advise or direct the money in different states and, you know, may represent different interests. And then we’re going to be looking at some common themes in the ways different states are using this money. So a lot of them are putting it towards law enforcement agencies, a lot of them are putting them toward in-school prevention programs, and taking a look at what the research tells us about how effective these strategies are or aren’t.

Rovner: Well, Aneri Pattani, thank you so much, and we will post links to some of Aneri’s work on the podcast homepage at kffhealthnews.org and in this week’s show notes. Thanks again.

Pattani: Thank you so much.

Rovner: OK, we’re back and it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Sarah, why don’t you go first this week?

Karlin-Smith: Sure. I looked at a piece in The New York Times called “Heat Wave and Blackout Would Send Half of Phoenix to E.R., Study Says,” by Michael Levenson. And it’s just really sort of a horrifying piece where researchers were sort of able to model the impact of the growing frequency of heat waves due to climate change, and obviously, the U.S. had some electric grid stability issues, and just the disconnect between the amount of hospital beds and people that would be able to care for people in a very hot city due to, you know, heat waves without being able to access air conditioning and other cooling methods. And the amount of people that would be hospitalized or die or just wouldn’t have a hospital bed. The one thing I did think was sort of positive is the piece does have some suggestions, and some of them are fairly simple that could really change the degrees in cities in relevant ways, like planting more trees in particular areas, and often this affects sort of — the poorest areas of cities tend to be the ones with less trees — or, you know, changing colors or the material on roofing. So as much as sometimes I think climate change becomes sort of such an overwhelming topic where you feel like you can’t solve it, I think the one nice thing here is it does sort of show, like, we have power to make the situation better.

Rovner: We can perhaps adapt. Alice.

Ollstein: I picked a upsetting piece but really good investigation from Reuters by Michael Berens. It’s called “How Doctors Buy Their Way out of Trouble.” It’s about doctors who are charged federally with all kinds of wrongdoing, including operating on patients who don’t need to be operated on for profit and having a pattern of doing so. And it’s about how often these cases settle with federal prosecutors and the settlement allows them to keep practicing, and the settlement money goes to the government, not to the victims. And often the victims aren’t even aware that the settlement took place at all. And new patients are not aware that the doctor they may be going to has been charged. And so it’s a really messed up system and I hope this shines a light on it.

Rovner: Rachel.

Cohrs: All right. So mine is from ProPublica, and the headline is, “In the ‘Wild West’ of Outpatient Vascular Care, Doctors Can Reap Huge Payments as Patients Risk Life and Limb,” by Annie Waldman. And I think I found this story timed really well kind of as lawmakers do start to talk a little bit more about incentives for patients to be seen in a hospital versus in more physician offices. And certainly there are cost reasons that that makes sense for some procedures. But I think this story does a really good job of kind of following one doctor, who I think, similar to kind of the story Alice was talking about, you know, was taking advantage of these inflated payments that were supposed to incentivize outpatient treatment to perform way more of these procedures than patients needed. And so I think it’s just important, a cautionary tale about the safeguards that could be necessary, you know, if more of this care is provided elsewhere.

Rovner: Yeah, I think these two stories are very good to be read together. My story this week is from our fellow podcast panelist Joanne Kenen for KFF Health News. It’s called “Remote Work: An Underestimated Benefit for Family Caregivers,” and it’s about how the U.S., still one of the few countries without any formal program for long-term care, that most of us will need at some point, has accidentally fallen into a way to make family caregiving just a little bit easier by letting caregivers do their regular jobs from home, either all the time or sometimes. While many, if not most, employers have policies around childbirth and child care, relatively few have benefits that make it easier for workers to care for other sick family members, even though a fifth of all U.S. workers are family caregivers. More flexible schedules can at least make that a little easier and possibly prevent workers from quitting so that they can provide care that’s needed. It’s no substitute for an actual national policy on long-term care, but it’s a start, even if an accidental one. OK, that is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks, as always, to our ever-patient producer, Francis Ying. And next week is our 300th episode. If all goes as planned, we’ll have something special, so be sure to tune in. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me. I’m still there. I’m @jrovner. Sarah?

Karlin-Smith: I’m @SarahKarlin.

Rovner: Alice.

Ollstein: @AliceOllstein.

Rovner: Rachel.

Cohrs: @rachelcohrs.

Rovner: We will be back in your feed next week. Until then, be healthy.

Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News’ ‘What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

At best, a Colorado panel of medical and pharmacy experts seeking to cut the costs of expensive drugs will be able to help only one of them.

Starting this summer, the state’s Prescription Drug Affordability Board will choose up to 18 high-cost drugs for review over the next three years to determine if the medications are unaffordable and whether to cap what health plans and consumers pay for them.

But with hundreds of expensive drugs to choose from, the board members face tough decisions about who will get help now and who will have to wait.

Do they tackle drugs with extremely high costs taken by only a handful of patients, or drugs with merely very high costs taken by a larger group? Should they consider only out-of-pocket costs paid by consumers, such as for insulin, whose copays Colorado caps at $50 a month, or the total cost of the drug to the health system? Will they weigh only drug prices, or will they try to right social wrongs with their choices?

And what does “affordable” even mean?

“That question alone is a lot harder to answer than it might seem at face value,” said Jennifer Reck, project director for the National Academy for State Health Policy’s Center for State Prescription Drug Pricing. “You immediately get into how utterly complex our drug supply chain is, how opaque it is, how many different prices there are,” she said.

Maryland was the first state to establish a drug affordability board in 2019, but funding challenges and the pandemic have slowed its progress. Colorado passed a bill creating its board in 2021 and has already moved ahead of Maryland in the process. Washington followed in 2022 but is still in its early phases of implementation.

Maine, New Hampshire, Ohio, and Oregon have also established boards, but they lack the power to limit drug payments. And at the federal level, the Inflation Reduction Act of 2022 included a provision requiring the Health and Human Services secretary to negotiate prices with drug companies for a small number of the most costly medications covered by Medicare.

It’s taken years for the Colorado and Maryland board members to create all the rules and regulations to govern their work before getting to the point of looking at specific drugs.

“It’s just a long, tortuous government process to get things up and running,” said Gerard Anderson, a professor of health policy and management at Johns Hopkins University, and a member of Maryland’s board. “You basically have to dot every ‘i’ and cross every ‘t’ in order not to get sued.”

Setting Priorities

On May 12, Colorado released its first list of hundreds of drugs eligible for review, mostly because they each cost more than $30,000 for a course of treatment. Next month, they’ll release a dashboard ranking those drugs according to the board’s priorities. The dashboard can also be used to examine which drugs have the highest price tags, which have had the largest increases in price, and which the state spends the most on. That would allow the board to begin affordability reviews this summer and set payment limits for the first four to eight drugs sometime in 2024. But board members will first have to set their priorities, and those could change from year to year.

“Maybe one year we focus on the impact to the system, and another year we focus on out-of-pocket costs, and one year we focus on a lifesaving drug that has smaller utilization,” said Lila Cummings, director of the Colorado board.

Such approaches could pit one group of patients against others looking for cost relief. But Cummings said not all groups are eager to see payment limits.

“Some of them said, ‘We want the board to focus on our drugs,’ and others said, ‘Please leave us alone,’” she said.

That reluctance likely reflects the close ties that some patient groups have with the manufacturers of their medications, including receiving funding from the drugmakers.

“We have seen cases in public hearings — it seems counterintuitive or surprising — where a patient group, instead of being thrilled that they might have access to the drugs at a lower price, instead are arguing against upper payment limits,” Reck said. “But in most cases, there’s a pretty clear financial connection to drug manufacturers.”

Maryland has also received input from patient groups as it finalizes its regulations.

“So far it has not been, ‘Pick me! Pick me! Pick me!’” Anderson said. But that could change once the Maryland board begins its affordability reviews this fall.

The drug that Garcia, 47, of Denver, takes did not make the board’s list. Diagnosed with four bleeding disorders, including von Willebrand disease, he needs the medication Humate-P, made by CSL Behring, to replace one of the clotting factors missing in his blood. This winter, driving home from his job at the airport, Garcia hit a patch of black ice, spun out, and careened into a concrete barrier at 75 mph. He needed the expensive medication every day for the first five days after the accident, and then every other day for a full month.

“It’s not like I can just sit there and say no to this medication, because my bleeds get so bad,” he said.

According to Perry Jowsey, executive director of the National Hemophilia Foundation’s Colorado chapter, about 300 to 400 individuals are being treated for von Willebrand disease in Colorado. That’s far fewer than the roughly 10,000 Coloradans with MS or the 74,000 who manage their diabetes with insulin.

“In my shoes, I would target what would help the most people,” Garcia said. “You have to find a balance, especially starting out. You’re not going to be able to help everyone.”

The Colorado and Maryland boards will rely on data from state databases that show how much various public and private health plans pay for drugs. That data, however, doesn’t capture what uninsured patients pay, and it doesn’t give any insight into how much manufacturers pay for research and development.

“The goal is not to stifle innovation,” Anderson said. “But we can’t get any public data, so we have to ask the pharmaceutical industry, and they’re not required to give us the data.”

The boards want to ensure that patients like Reitzel still have access to new and better therapies. Reitzel, 38, of Highlands Ranch, was diagnosed with multiple sclerosis in 2008 and has switched medications several times seeking one whose side effects she could tolerate. “They’re all terrible in their own special way,” she said.

In 2021, she began taking a relatively new drug from Biogen and Alkermes called Vumerity, which was included on Colorado’s list of eligible drugs. But the cost of a three-month supply was nearly $24,000, including a copay of more than $7,000. Biogen provides up to $20,000 in annual copay assistance through a debit card she can use at the pharmacy. But now her health plan no longer credits those payments toward her deductible. It makes it almost impossible for her to meet the $25,000 out-of-pocket maximum under her plan.

“Primarily for this reason, I am no longer taking any medication,” Reitzel said, “and have to only hope my disease does not progress.”

Colorado legislators passed a bill to require health plans to count copay assistance programs toward patients’ deductibles for drugs with no generic equivalents, but that provision does not take effect until 2025.

Insulin as an Outlier?

Just a couple of years ago, insulin may have been a higher priority for drug affordability boards, but now it’s not so clear. Both Colorado and Maryland have established insulin copay caps that provide pocketbook relief, at least for patients with coverage. And manufacturers are making their own moves to lower insulin prices. That could prompt the boards to bypass insulin and concentrate their limited resources on other high-cost drugs.

Copay caps do not lower the actual cost of insulin but instead spread it among members of the health plan through higher premiums. The Colorado copay caps don’t help new state residents and initially did not help those without insurance, either. Both of those hurdles would have applied to Marquez-Farmer when she moved from California to Colorado Springs a couple of years ago.

“I got married to my husband during covid because I didn’t have insurance,” she said. “I loved him, and it all worked out, but a big reason for me to marry him was because I would not be able to afford insulin.”

Marquez-Farmer, 34, said that while insulin may not be the most expensive drug on the market, many Coloradans, particularly those from marginalized communities who have higher rates of diabetes, struggle to afford it.

“I’m not saying the other medicines are not important, because obviously they are,” she said. “The reality is there’s more people who are being affected by not being able to afford their insulin and a lot of people who are dying because of them rationing insulin.”

Andrew York, executive director of the Maryland board, said the payment limits should be viewed as a last resort, a tool that can be used when other cost-control measures haven’t worked.

“The goal is for folks to never be able to say that they can’t afford their insulin. And I think we may get there soon enough just because of how much is happening in that space,” he said. “So if that’s the case, then maybe boards don’t need to use the upper payment limit tool.”

At least one form of insulin was included on Colorado’s list of drugs eligible for review, but not the most commonly taken brand-name insulins. That precludes the Colorado board from addressing insulin costs more broadly.

The pharmaceutical industry has pushed back against the concept of payment limits, warning that drugmakers could pull out of states that set payment limits.

“The boards are acutely aware of this discussion point. The interest and the purpose of these boards is to increase access to the drugs, not decrease it,” York said. “But there’s kind of this game theory element of: How will manufacturers react?”

Reck discounted the notion that a payment limit would prompt a manufacturer to abandon a profitable market.

“Unfortunately, it’s kind of a scary message and it can be impactful on patients,” she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

On May 16, the FTC sued to block the merger of drugmakers Amgen and Horizon Therapeutics, saying the tangled web of drug industry deal-making would enable Amgen to leverage the monopoly power of two top Horizon drugs that have no rivals.

In its lawsuit, the FTC said that if it allowed Amgen’s $27.8 billion purchase to go through, Amgen could pressure the companies that manage access to prescription drugs — pharmacy benefit managers, or PBMs — to boost the two extremely expensive Horizon products in a way that would inhibit any competition.

The suit, the first time since 2009 that the FTC has tried to block a drug company merger, reflects Chair Lina Khan’s strong interest in antitrust action. In announcing the suit, the agency said that by fighting monopoly powers it aimed to tame prices and improve patients’ access to cheaper products.

The FTC’s action is a “shot across the bow for the pharmaceutical industry,” said Robin Feldman, a professor and drug industry expert at the University of California College of the Law-San Francisco. David Balto, a former FTC official and attorney who fought the 2019 Bristol-Myers Squibb-Celgene and 2020 AbbVie-Allergan mergers, said FTC’s action was long overdue.

The Horizon-Amgen merger would “cost consumers in higher prices, less choice, and innovation,” he said. “The merger would have given Amgen even more tools to exploit consumers and harm competition.”

The FTC also announced an expansion of a yearlong investigation of the PBMs, saying it was looking at two giant drug-purchasing companies, Ascent Health Services and Zinc Health Services. Critics claim the PBMs set up these companies to conceal profits.

When Amgen announced its purchase of Horizon in December — the biggest biopharma transaction in 2022 — it showed particular interest in Horizon’s drugs for thyroid eye disease (Tepezza) and severe gout (Krystexxa), for which the company was charging up to $350,000 and $650,000, respectively, for a year of treatment. The complaint said the merger would disadvantage biotech rivals that have similar products in advanced clinical testing.

Amgen could promote the Horizon drugs through “cross-market bundling,” the FTC said. That means requiring PBMs to promote some of Amgen’s less popular drugs — the Horizon products, in this case — in exchange for Amgen offering the PBMs large rebates for its blockbusters. Amgen has nine drugs that each earned more than $1 billion last year, according to the complaint, the most popular being Enbrel, which treats rheumatoid arthritis and other diseases.

The three biggest PBMs negotiate prices and access to 80% of prescription drugs in the U.S., giving them enormous bargaining power. Their ability to influence which drugs Americans can get, and at what price, enables the PBMs to obtain billions in rebates from drug manufacturers.

“The prospect that Amgen could leverage its portfolio of blockbuster drugs to gain advantages over potential rivals is not hypothetical,” the FTC complaint states. “Amgen has deployed this very strategy to extract favorable terms from payers to protect sales of Amgen’s struggling drugs.”

The complaint noted that biotech Regeneron last year sued Amgen, alleging that the latter’s rebating strategy harmed Regeneron’s ability to sell its competing cholesterol drug, Praluent. Amgen’s Repatha generated $1.3 billion in global revenue in 2022.

It “may be effectively impossible” for smaller rivals to “match the value of bundled rebates that Amgen would be able to offer” as it leverages placement of the Horizon drugs on health plan formularies, the complaint states.

Business analysts were skeptical that the FTC action would succeed. Until now the commission and the Department of Justice have shied away from challenging pharmaceutical mergers, a precedent that will be hard to overcome.

Research on the impact of mergers has shown that they often benefit shareholders by increasing stock prices, but hurt innovation in drug development by trimming research projects and staffing.

Waves of consolidation shrank the field of leading pharma companies from 60 to 10 from 1995 to 2015. Most of the mergers in recent years have involved “big fish buying up lots of little fish,” such as biotech companies with promising drugs, Feldman said.

The giant Amgen-Horizon merger is an obvious exception, and therefore a good opportunity for the FTC to demonstrate a “theory of harm” around drug industry bundling maneuvers with PBMs, said Aaron Glick, a mergers analyst with Cowen & Co.

But that doesn’t mean the FTC will win.

Amgen may or may not engage in anti-competitive practices, but “a separate question is, how does this lawsuit fit under current antitrust laws and precedent?” Glick said. “The way the law is set up today, it seems unlikely it will hold up in court.”

The FTC’s argument about Amgen’s behavior with Horizon products is hypothetical. The pending Regeneron suit against Amgen, as well as other, successful lawsuits, suggests that rules are in place to suppress this kind of anti-competitive behavior when it occurs, Glick said.

The judge presiding over the case in U.S. District Court in Illinois is John Kness, who was appointed by then-President Donald Trump and is a former member of the Federalist Society, whose membership tends to be skeptical of antitrust efforts. The case is likely to be settled by Dec. 12, the deadline for the merger to go through under current terms.

Amgen sought to undercut the government’s case by agreeing not to bundle Horizon products in future negotiations with pharmacy benefit managers. That promise, while hard to enforce, might get a sympathetic hearing in court, Glick said.

Still, even a loss would enable the FTC to shed light on a problem in the industry and what it sees as a deficiency in antitrust laws that it wants Congress to correct, he said.

The day after suing to stop the merger, the FTC announced it was pushing further into an investigation of pharmacy benefit managers that it began last June. The agency demanded information from Ascent and Zinc, the two so-called rebate aggregators — drug purchasing organizations set up by PBMs Express Scripts and CVS Caremark.

At a May 10 hearing, Eli Lilly & Co. CEO Dave Ricks said that most of the $8 billion in rebate checks his company paid last year went to rebate aggregators, rather than to the PBMs directly. A “big chunk” of the $8 billion went overseas, he said. Ascent is based in Switzerland, while Emisar Pharma Services, an aggregator established by PBM OptumRx, is headquartered in Ireland. Zinc Health Services is registered in the U.S.

Critics say the aggregators enable PBMs to obscure the size and destination of rebates and other fees they charge as intermediaries in the drug business.

The PBMs say their efforts reduce prices at the pharmaceutical counter. Testimony in Congress and in FTC hearings over the past year indicate that, at least in some instances, they actually increase them.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

El 16 de mayo, la FTC interpuso una demanda para bloquear la fusión de las farmacéuticas Amgen y Horizon Therapeutics, alegando que la enmarañada red de acuerdos de la industria  permitiría a Amgen aprovechar el poder monopolístico de dos de los principales medicamentos de Horizon que no tienen rivales.

En su demanda, la FTC alegó que si se permitía la compra que pretende Amgen por $27,800 millones, Amgen podría presionar a las empresas que gestionan el acceso a los medicamentos con receta —los gestores de beneficios de farmacia, o PBM— para que impongan los dos productos extremadamente caros de Horizon de una manera que eliminaría cualquier competencia.

Es la primera vez desde 2009 que la FTC intenta bloquear una fusión de empresas farmacéuticas, y esta demanda refleja el gran interés de la presidenta Lina Khan por las medidas antimonopolio. Al anunciar la demanda, la agencia declaró que al luchar contra los poderes monopolísticos pretendía controlar los precios y mejorar el acceso de los pacientes a productos más baratos.

Para Robin Feldman, profesor y experto en la industria farmacéutica de la Facultad de Derecho de la Universidad de California en San Francisco, la actuación de la FTC es “un golpe frontal a la industria farmacéutica”. David Balto, ex funcionario de la FTC y abogado que luchó contra las fusiones Bristol-Myers Squibb-Celgene en 2019 y AbbVie-Allergan en 2020, dijo que la acción de la FTC era necesaria desde hace mucho tiempo.

La fusión Horizon-Amgen “costaría a los consumidores precios más altos, menos opciones e innovación”, señaló. “La fusión habría dado a Amgen aún más herramientas para explotar a los consumidores y dañar la competencia”.

La FTC también anunció la ampliación de una investigación de un año sobre los PBM, indicando que se investigaban dos gigantescas empresas de compra de medicamentos, Ascent Health Services y Zinc Health Services. Los críticos afirman que los PBM crearon estas empresas para ocultar beneficios.

Cuando Amgen anunció la compra de Horizon en diciembre —la mayor operación biofarmacéutica de 2022— mostró especial interés por los medicamentos de Horizon para la enfermedad tiroidea ocular (Tepezza) y la gota grave (Krystexxa), por los que la empresa cobraba hasta $350,000 y $650,000, respectivamente, por un año de tratamiento. Según la demanda, la fusión perjudicaría a rivales biotecnológicos que tienen productos similares en fase avanzada de pruebas clínicas.

Según la FTC, Amgen podría promocionar los fármacos de Horizon a través de la “venta cruzada”. Esto significa exigir a los PBM que promocionen algunos de los medicamentos menos populares de Amgen —los productos Horizon, en este caso— a cambio de que Amgen ofrezca a los PBM grandes descuentos por sus superventas. Según la denuncia, Amgen tiene nueve medicamentos que el año pasado generaron más de $1,000 millones cada uno. El más popular es Enbrel, que trata la artritis reumatoide y otras enfermedades.

Los tres mayores PBM negocian los precios y el acceso al 80% de los medicamentos recetados en Estados Unidos, lo que les confiere un enorme poder de negociación. Su capacidad para influir en los medicamentos a los que tienen acceso los estadounidenses, y a qué precio, les permite obtener miles de millones en descuentos de los fabricantes.

“La posibilidad de que Amgen pudiera aprovechar su cartera de medicamentos superventas para obtener ventajas sobre sus rivales potenciales no es hipotética”, afirma la denuncia de la FTC. “Amgen ha desplegado esta misma estrategia para conseguir condiciones favorables de los pagadores y proteger así las ventas de los medicamentos de Amgen en dificultades”.

La denuncia señaló que la biotecnológica Regeneron demandó el año pasado a Amgen, alegando que la estrategia de reembolso de esta última perjudicó la capacidad de Regeneron para vender su medicamento competidor contra el colesterol, Praluent. Repatha, de Amgen, generó unos ingresos mundiales de $1,300 millones en 2022.

Según la demanda, “puede resultar completamente imposible” para los rivales más pequeños “igualar el valor de los reembolsos agrupados que Amgen podría ofrecer”, ya que aprovecha la colocación de los medicamentos de Horizon en los formularios de los planes de salud.

Los analistas de la industria se mostraron escépticos sobre el éxito de la acción de la FTC. Hasta ahora, la Comisión y el Departamento de Justicia han evitado cuestionar las fusiones farmacéuticas, un precedente difícil de superar.

Las investigaciones sobre el impacto de las fusiones han demostrado que a menudo benefician a los accionistas al aumentar el precio de las acciones; pero perjudican la innovación en el desarrollo de fármacos al recortar los proyectos de investigación y el personal.

Las olas de consolidación redujeron el número de empresas farmacéuticas líderes de 60 a 10 entre 1995 y 2015. Según Feldman, la mayoría de las fusiones de los últimos años se han producido entre “peces gordos que adquieren muchos peces pequeños”, como empresas de biotecnología con fármacos prometedores.

La gigantesca fusión Amgen-Horizon es una excepción obvia y, por tanto, una buena oportunidad para que la FTC demuestre la “teoría del daño” en las maniobras de consolidación de la industria farmacéutica con los PBM, dijo Aaron Glick, analista de fusiones de Cowen & Co.

Pero eso no significa que la FTC vaya a ganar.

Amgen puede incurrir o no en prácticas anticompetitivas, pero “otra cuestión es cómo encaja esta demanda en las leyes antimonopolio y los precedentes actuales”, señaló Glick. “Tal y como está configurada la ley hoy, parece poco probable que se sostenga en los tribunales”.

El argumento de la FTC sobre el comportamiento de Amgen con los productos Horizon es hipotético. La demanda pendiente de Regeneron contra Amgen, así como otras demandas que han prosperado, sugiere que existen normas para suprimir este tipo de comportamiento anticompetitivo cuando se produce, añadió Glick.

El juez que preside el caso en el Tribunal de Distrito de Estados Unidos en Illinois es John Kness, quien fue nombrado por el entonces presidente Donald Trump y es un ex miembro de la Federalist Society, cuyos miembros tienden a ser escépticos sobre los esfuerzos antimonopolio.

Es probable que el caso se resuelva antes del 12 de diciembre, fecha límite para que la fusión se lleve a cabo en los términos actuales.

Amgen trató de socavar los argumentos del Gobierno comprometiéndose a no agrupar los productos de Horizon en futuras negociaciones con los gestores de beneficios farmacéuticos (PBM). Esta promesa, aunque difícil de hacer cumplir, podría obtener una audiencia favorable en corte, apuntó Glick.

Sin embargo, incluso una derrota permitiría a la FTC arrojar luz sobre un problema en la industria y lo que considera una deficiencia en las leyes antimonopolio que quiere que el Congreso corrija, explicó.

Al día siguiente de ir a corte para detener la fusión, la FTC anunció que profundizaba en una investigación sobre los gestores de beneficios farmacéuticos que inició el pasado mes de junio. La agencia solicitó información a Ascent y Zinc, los dos llamados agregadores de reembolsos, organizaciones de compra de medicamentos creadas por los PBM Express Scripts y CVS Caremark.

En una audiencia celebrada el 10 de mayo, el CEO de Eli Lilly & Co., Dave Ricks, afirmó que la mayor parte de los $8,000 millones en cheques de reembolso que su empresa pagó el año pasado fueron a parar a los agregadores de reembolsos, en lugar de directamente a los PBM. Una “gran parte” de los $8,000 millones fue a parar al extranjero, indicó Ricks. Ascent tiene su sede en Suiza, mientras que Emisar Pharma Services, un agregador establecido por PBM OptumRx, tiene su sede en Irlanda. Zinc Health Services está registrada en Estados Unidos.

Los críticos afirman que los agregadores permiten a los PBM ocultar la cuantía y el destino de los reembolsos y otras comisiones que cobran como intermediarios en el negocio de los medicamentos.

Por su parte, los PBM aseguran que sus esfuerzos reducen los precios en el mostrador de la farmacia. Los testimonios en el Congreso y en las audiencias de la FTC del año pasado indican que, al menos en algunos casos, en realidad los aumentan.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

When the first Humira biosimilar — essentially a generic version — finally hit the market in January, it came with an unpleasant surprise. The biosimilar’s maker, Amgen, launched two versions of the drug, which treats a host of conditions including rheumatoid arthritis. They were identical in every way but this: One was priced at about $1,600 for a two-week supply, 55% off Humira’s list price. But the other was priced at around $3,300, only about 5% off. And OptumRx, one of three powerhouse brokers that determine which drugs Americans get, recommended option No. 2: the more expensive version.

As Murdo Gordon, an Amgen executive vice president, explained in an earnings call, the higher price enabled his company to give bigger rebates, or post-sale discounts, to Optum and other intermediaries. Most of that money would be passed on to insurers, and patients, he said. Gordon did not mention that the higher-priced option would leave some patients paying much more out-of-pocket, undermining the whole rationale for generic drugs.

The Optum-Amgen announcements perfectly elucidated why, after years of thundering against drugmakers, Congress and the administration have now focused on regulating the deal-makers known as pharmacy benefit managers, or PBMs. Sen. Bernie Sanders’ health committee grilled a panel of PBM and pharmaceutical executives Wednesday in preparation for a vote on PBM legislation, expected Thursday.

The three biggest PBMs — OptumRx, CVS Caremark, and Express Scripts — control about 80% of prescription drug sales in America and are the most profitable parts of the health conglomerates in which they’re nestled. CVS Health, the fourth-largest U.S. corporation by revenue on Fortune’s list, owns CVS Caremark and the insurer Aetna; UnitedHealth Group, a close fifth, owns Optum; and Cigna, ranking 12th, owns Express Scripts. While serving as middlemen among drugmakers, insurers, and pharmacies, the three corporations also own the highest-grossing specialty drug and mail-order pharmacies.

“John D. Rockefeller would be happy to be alive today,” said David Balto, a former Federal Trade Commission attorney who represents clients suing PBMs. “He could own a PBM and monopolize economic power in ways he never imagined.”

Drug manufacturers claim that exorbitant PBM demands for rebates force them to set high list prices to earn a profit. Independent pharmacists say PBMs are driving them out of business. Physicians blame them for unpredictable, clinically invalid prescribing decisions. And patients complain that PBMs’ choices drain their pocketbooks.

With PBMs driving prices, competition has had the opposite effect from what economic theory predicted Medicare patients would spend out-of-pocket on drugs, one large study showed. Over a five-year period, patients were paying 50% more for branded drugs that had competitors than for those that didn’t.

All this makes the PBMs ripe targets for politicians of both parties. Yet the complexity and obscurity of their role in the drug marketplace have skeptics wondering whether legislation advancing in the House and Senate will actually help patients or lower prices at the pharmacy counter.

“We may try to make things better and actually make things worse,” Sen. Rand Paul (R-Ky.) said at Wednesday’s hearing.

The PBMs pass along most of their rebates to health plans, which will bear a larger share of patient drug costs in coming years under Medicare changes that are part of the 2022 Inflation Reduction Act. It’s likely that pressure on insurers will be passed along to PBMs and result in even more aggressive limits on physician prescription decisions, said Troyen Brennan, an adjunct Harvard University professor who was chief medical officer for CVS Health from 2008 to 2022.

Several congressional bills target drug company rebates to PBMs and what’s known as “spread pricing” — the extra money PBMs collect from insurers over what they pay pharmacies for drugs.

But those aren’t the big PBM revenue sources anymore, Brennan said. PBMs today mostly make money by owning mail-order and specialty pharmacies and from the government’s 340B program, created to help hospitals that treat a disproportionately elderly and poor population. Medicare requires drugmakers to provide big discounts to participating hospitals and the growing rosters of affiliated physician groups they own, and some of those discounts end up with PBMs.

Employers and the federal government decide where most of the rebate money goes, PBM leaders testified Wednesday — and health plans decide what out-of-pocket costs their covered members will pay.

In other words, drug companies blame PBMs for high drug counter prices, PBMs blame insurers, and insurers blame the drug companies, all part of a health care system that hinges on an unspoken bargain: Make life comfortable for some — mostly the upper and middle classes — at the expense of lower-income and poorly insured people who get what they get.

 PBMs’ extraction of money from patients in the name of “copayments” at the pharmacy counter “reintroduces medical underwriting” that was stripped away by the Affordable Care Act, Craig Garthwaite, a health care researcher at Northwestern’s Kellogg School of Management, told a Senate panel last year. Insurers can no longer pick and choose whom to insure, as they could before the landmark 2010 health law. But they are finding ways to make the sickest pay.

“People with expensive conditions are paying more for insurance so healthy people can pay less,” he said.

PBMs Evolve From Minnows to Whales

In 1967, a year before the first PBM was founded, spending on prescription drugs outside of a hospital in the U.S. totaled around $3.3 billion, compared with more than $600 billion in net payments last year. By 2005, when Medicare expanded to include coverage of outpatient drugs, government and private insurers depended on PBMs’ negotiating power to keep rising drug prices in check.

The Federal Trade Commission and Justice Department allowed the largest PBMs to gobble up competitors and merge with insurers during the Bush and Obama administrations on the grounds that bolstering their powers might rein in prices. The FTC fought state investigations of anti-competitive behavior, saying that pressure on PBMs would benefit consumers.

The FTC under President Joe Biden has switched course, at least partly because of the arrival of Chair Lina Khan, a vigorous proponent of antitrust policy who launched an investigation of the PBMs last June.

It came partly at the request of independent pharmacists, who rely on PBM reimbursements for the drugs they purchase and provide consumers. Thousands of pharmacists complained to the FTC that PBMs force them to accept unfairly low reimbursements — then slam them with opaque rules requiring them to pay back some of the money months later. Pharmacists returned $12.6 billion to PBMs in 2021, according to a recent Medicare Payment Advisory Commission report.

During a recent week, said Ashley Seyfarth, who owns Kare Drug in Aztec, New Mexico, a PBM reclaimed money from one prescription because the paperwork was faxed. It clawed back cash from another sale because Kare had kept the drug on the shelf an extra day, beyond the PBM’s time limit, to accommodate a patient delayed getting to the store.

And her reimbursements are “beyond low,” Seyfarth said. She laughed when asked whether contract terms with the PBMs were negotiable. “You aren’t negotiating anything,” she said. “It’s take it or leave it.”

PBMs “have the right to audit whether contract terms are agreed to,” Angela Banks, vice president of policy at the Pharmaceutical Care Management Association, the PBM trade group, said at a recent conference. “A lot of the complaints about PBMs come from two parties from whom we are extracting money: manufacturers and pharmacists.”

PBM pricing decisions are often murky. According to a recent study, in 2018 Medicare spent $2.6 billion more through PBMs for a year’s worth of 184 generic drugs than they would have cost at Costco. Doctors and hospitals find PBM formularies baffling, with dozens of variations depending on a patient’s health plan.

When Philadelphia-area internist Amy Davis writes a prescription, she has no idea what the pharmacy will bill her patients, she said, or whether a PBM has decided the drug needs prior authorization. Sometimes she doesn’t find out until a patient returns months later saying they skipped the drug because it was too expensive.

“We physicians are completely in the dark,” she said. “And it’s designed that way.”

The PBMs’ growing use of proprietary pharmacies, including mail-order operations, can interfere with the care of patients like Jasmine St. Clair, a 45-year-old restaurant manager and mother of six in Mount Juliet, Tennessee.

In October 2021, St. Clair’s treatment for a rare, non-smoking-related lung cancer was delayed three weeks after PBM giant Express Scripts insisted her prescription be filled by Accredo, the mail-order pharmacy it owns.

In the meantime, her fatigue and lower-back and neck pain became so bad “I couldn’t pick up my daughter, who was 2,” St. Clair said. “And I was really getting scared.”

After St. Clair started the four-pills-twice-a-day regimen, her tumor rapidly shrank. But in January, her husband’s insurance changed and the medications didn’t arrive on time. When she called Accredo to see what was wrong, “they said, ‘You owe $8,000. Would you like to pay by card?’”

The pharmacy attached to her oncology practice straightened out the payment issue and ensured her continued use of the drug, St. Clair said. Her oncologist, Johnetta Blakely, said these are daily occurrences in her practice.

“The problem with the PBMs and the specialty pharmacies they own is that they are so complicated and intertwined it’s hard to figure out what the heck they are doing,” Blakely said. “All this bureaucratic stuff is a distraction and takes away from things I could be doing, like asking Jasmine about her kids.”

What’s the Remedy?

Bipartisan House and Senate bills would require PBMs to reimburse pharmacies serving Medicaid patients based on an authorized price list, rather than using standards that allegedly allow PBMs to lowball pharmacies. The Congressional Budget Office has estimated the bills would save the federal government $1 billion over 10 years. Another Senate bill would require PBMs to report more of their earnings to the FTC, and would ban deceptive and unfair fees.

But PBMs have shown themselves adept at finding ways around regulation. A federal rule scheduled to take effect next year would curtail PBM “clawbacks” on independent pharmacies. But PBM contracts sent out to pharmacies in recent weeks get around that by lowering reimbursement fees and putting a percentage of their payments to pharmacies into a kind of escrow, said Douglas Hoey, CEO of the National Community Pharmacists Association.

When the Trump administration considered banning brand-name drug rebates in 2017, PBMs set up companies in Ireland and Switzerland to take over the negotiations and purchases. Doing so offered a tax advantage and allowed the PBMs to avoid scrutiny of the quantity and nature of those deals. Recently, Express Scripts set up another company to purchase generic drugs, in the Cayman Islands.

And PBMs appear adept at moving money from one pocket to another. “Yesterday’s rebates are today’s fees and potentially tomorrow’s something else,” said John O’Brien, CEO of the pharmaceutical industry-funded research group, the National Pharmaceutical Council.

Every arrangement that PBMs make with manufacturers, employers, and insurers is secret and proprietary, said Barak Richman, a Duke University Law School professor. This makes it nearly impossible to examine what kind of deals PBMs are making.

Antitrust law could be brought to bear on the PBMs, Richman said. And the Biden administration has shown an eagerness to possibly reverse mergers that have increased PBM clout. The Justice Department has taken similar steps.

But federal officials will have to move fast to slow the PBMs. Insurers that don’t have PBMs as part of their business have been shrinking in recent years because of the growing clout and buying power of the companies.

“I predict that any health insurer that doesn’t have a PBM is going to disappear in 10 years,” said Neeraj Sood, a professor at the University of Southern California Sol Price School of Public Policy. “Otherwise, there is no way to compete with the big three.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

If Congress fails to raise the nation’s debt ceiling in the next few months, the U.S. could default on its debt for the first time in history. Republicans in Congress, however, say they won’t agree to pay the nation’s bills unless Democrats and President Joe Biden agree to deep cuts to health and other programs. Among the proposals in a bill House Republicans passed April 26 is the imposition of new work requirements for adults who receive Medicaid.

Meanwhile, many of the states passing restrictions on abortion are also passing bills to restrict the ability of trans people to get health care. The two movements — both largely aimed at conservative evangelicals, a key GOP constituency — have much in common.

This week’s panelists are Julie Rovner of KFF Health News, Jessie Hellmann of CQ Roll Call, Shefali Luthra of The 19th, and Sarah Karlin-Smith of the Pink Sheet.

Panelists

Jessie Hellmann
CQ Roll Call

@jessiehellmann

Read Jessie's stories

Shefali Luthra
The 19th

@Shefalil

Read Shefali's stories

Sarah Karlin-Smith
Pink Sheet

@SarahKarlin

Read Sarah's stories

Among the takeaways from this week’s episode:

• The Republican-controlled House’s proposal to raise the debt ceiling contains enough politically poisonous measures that the plan is a non-starter in the Senate. They include substantial funding cuts to major federal health programs, including the FDA and the National Institutes of Health — cuts that would force the federal government to cut back on grants and other funding.
• The proposal would also impose work requirements on adults enrolled in Medicaid — which covers low-income and disabled Americans, as well as pregnant women — and in the Supplemental Nutrition Assistance Program, which helps needy families buy food. Under the plan, the government would save money by cutting the number of people helped. But most beneficiaries cannot work or already do so. Experience shows the change would mostly affect people who struggle to report their work hours through what can be complicated online portals.
• Multiple congressional committees have released plans to fight high drug costs, promoting efforts to explore how pharmacy benefit managers make decisions about cost and access, as well as to encourage access to cheaper, generic drugs on the market. And during congressional testimony this week, the administrator of the Centers for Medicare & Medicaid Services, Chiquita Brooks-LaSure, said the agency would no longer issue warnings to hospitals that fail to comply with a law that requires them to post their prices, but instead would move directly to fining the holdouts.
• Also in news about cost-cutting legislation, a plan to address an expensive glitch in Medicare payments to hospital outpatient centers and physician offices is gaining steam on Capitol Hill. Hospital consolidation has helped increase costs in the health care system, and lawmakers are eager to keep health spending under control. But the hospital industry is ramping up advertising to make sure lawmakers think twice before legislating.
• In abortion news, it will likely be at least a year before the Supreme Court rules on whether the abortion pill mifepristone should remain accessible. Some justices suggested in last summer’s Dobbs decision, which overturned abortion rights, that they would leave further abortion questions to the states, yet the nation is finding that overturning a half-century of legal precedent is messy, to say the least. Meanwhile, reporting and polling are revealing just how difficult it is for doctors in states with abortion bans to determine what constitutes a “medical emergency” worthy of intervention, with a grim consensus emerging that apparently means “when a woman is near death.”

Also this week, Rovner interviews Renuka Rayasam, who wrote the latest KFF Health News-NPR “Bill of the Month” feature, about a pregnant woman experiencing a dangerous complication who was asked to pay $15,000 upfront to see one of the few specialists who could help her. If you have an outrageous or exorbitant medical bill you want to share with us, you can do that here.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: The Nation’s “The Poison Pill in the Mifepristone Lawsuit That Could Trigger a National Abortion Ban,” by Amy Littlefield.

Shefali Luthra: The Washington Post’s “The Conservative Campaign to Rewrite Child Labor Laws,” by Jacob Bogage and María Luisa Paúl.

Jessie Hellmann: Politico’s “Gun Violence Is Actually Worse in Red States. It’s Not Even Close,” by Colin Woodard.

Sarah Karlin-Smith: The Wall Street Journal’s “Weight-Loss Drugmakers Lobby for Medicare Coverage,” by Liz Essley Whyte.

Also mentioned in this week’s episode:

• In Oklahoma, a Woman Was Told to Wait Until She’s ‘Crashing’ for Abortion Care,” by Selena Simmons-Duffin.
• Anti-Trans Bills Have Doubled Since 2022. Our Map Shows Where States Stand,” by Annys Shin, N. Kirkpatrick, and Anne Branigin.

click to open the transcript

Transcript: Dancing Under the Debt Ceiling

KFF Health News’ ‘What the Health?’

Episode Title: Dancing Under the Debt Ceiling

Episode Number: 295

Published: April 27, 2023

[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]

Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, April 27, at 10 a.m. As always, news happens fast — really fast this week — and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Jessie Hellmann of CQ Roll Call.

Jessie Hellmann: Good morning.

Rovner: Sarah Karlin-Smith, the Pink Sheet.

Sarah Karlin-Smith: Hi, everybody.

Rovner: And Shefali Luthra of The 19th.

Shefali Luthra: Hello.

Rovner: Later in this episode, we’ll have our KFF Health News-NPR “Bill of the Month” interview with Renuka Rayasam. This month’s patient had a happy ending medically, but a not-so-happy ending financially. But first, the news. We’re going to start this week with the budget and, to be specific, the nation’s debt ceiling, which will put the U.S. in default if it’s not raised sometime in the next several weeks, not to panic anyone. House Republicans, who have maintained all along that they won’t allow the debt ceiling to be raised unless they get spending cuts in return, managed to pass — barely — a bill that would raise the debt ceiling enough to get to roughly the middle of next year. It has no chance in the Senate, but it’s now the Republicans’ official negotiating position, so we should talk about what’s in it. It starts with a giant cut to discretionary spending programs. In health care that includes things like the National Institutes of Health, most public health programs, and the parts of the FDA that aren’t funded by user fees. I mean, these are big cuts, yes?

Hellmann: Yeah, it’s about a 14% cut to some of these programs. It’s kind of hard to know exactly what that would mean. But yeah, it’s a big cut and there would have to be, like, a lot of changes made, especially to a lot of health care programs, because that’s where a lot of spending happens.

Rovner: Yeah, I mean, sometimes they’ll agree on cuts and it’ll be like a 1% across the board, which itself can be a lot of money. But I mean, these are, these are sort of really deep cuts that would seriously hinder the ability of these programs to function, right?

Karlin-Smith: NIH for a number of years was operating on only getting budget increases that were not keeping up kind of with inflation and so forth. And they just finally, over the last few years, got back on track. Even though their budget seemed like it was going up, really, if you adjusted for inflation, it had been going down. And then when you have an agency like FDA, which, the line is always that they do an incredible amount of work on really a shoestring budget for the amount they regulate, so they never get — NIH sometimes gets, you know, that bipartisan popularity and does get those bigger increases back, and they never really get those big increases, so I think it would be harder for them also to get that back later on if they did get such big cuts.

Hellmann: There are like also a lot of health programs that just operate on flat funding from year to year, like Title X.

Rovner: Yeah, the family planning program.

Hellmann: And so obviously, like HHS said last year, We are only able to fund a certain number of providers, like, less than previously, because of inflation, and stuff like that. So obviously if you take a 14% cut to that, it would make it even harder.

Rovner: All right. Another major proposal in the package would institute or expand work requirements for people on food stamps and on Medicaid. Now, we’ve had work rules for people on welfare since the 1990s, but most people on Medicaid and food stamps, for that matter, either already work or can’t work for some reason. Why are the Republicans so excited about expanding or instituting work requirements?

Hellmann: I think there are a few reasons. No. 1, it’s a big money saver. The CBO [Congressional Budget Office] came out with their analysis this week showing that it would save the federal government about $109 billion. A lot of that would be shifted to the states because the way the bill is written, states would still be allowed to cover these individuals if they can’t prove that they’re working. But they’d have to pick up the costs themselves, which, I’ve seen experts questioning if that would really happen, even in states like, you know, New York and California, who probably wouldn’t want these people to lose coverage. But I think an argument that you hear a lot too, especially during the Trump administration when they were really pushing these, is they say that work is what provides fulfillment and dignity to people. Former CMS [Centers for Medicare & Medicaid Services] administrator Seema Verma talked about this a lot. The argument I heard a lot on the Hill this week is that Medicaid and other — SNAP [Supplemental Nutrition Assistance Program], TANF [Temporary Assistance for Needy Families], programs like that — trap people in poverty and that work requirements will kind of give them an incentive to get jobs. But as you said, like, it wouldn’t apply to most — you know, most people are already working. And most people who lost coverage under some of the previous iterations of this just didn’t know about it or they were unable to complete the reporting requirements.

Rovner: And to be clear, the CBO estimate is not so much because people would work and they wouldn’t need it anymore. It’s because people are likely to lose their coverage because they can’t meet the bureaucratic requirements to prove that they’re working. Shefali, you’re nodding. We’ve seen this before, right?

Luthra: I was just thinking, I mean, the savings, yes, they come from people losing their health insurance. That’s very obvious. Of course, you save money when you pay for fewer people’s coverage. And you’re absolutely right: “This will motivate people to work” argument has always been a little bit — complicated is a generous word. I think you could even say it’s a bit thin just because people do already work.

Rovner: And they — many of them work, they don’t earn enough money, really, to bring them out of poverty. And they don’t have jobs that offer health insurance. That’s the only way they’re going to get health insurance. All right. Well, where do we go from here with the debt ceiling? So now we’ve got this Republican plan that says work — everybody has to work and prove that they work and we’re going to cut all these programs — and the Democrats saying this is not a discussion for the debt ceiling, this is a separate discussion that should happen down the road on the budget. Is there any sign that either side is going to give here?

Hellmann: It doesn’t seem like it. Democrats have been saying, like, this is a non-starter. The president has been saying, like, we’re not going to negotiate on this; we want a clean increase in the debt ceiling, and we can talk about some of these other proposals that you want to pursue later. But right now, it seems like both sides are kind of at a standstill. And I think Republicans see, like, passing this bill yesterday as a way to kind of strengthen their hand and show that they can get all on the same page. But I just do not see the Senate entertaining a 14% cut or, like, Medicaid work requirements or any of this stuff that is just kind of extremely toxic, even to some, like, moderate Democrats over there.

Rovner: Yeah, I think this is going to go on for a while. Well, so at this high level, we’ve got this huge partisan fight going on. But interestingly, this week elsewhere on Capitol Hill things seem surprisingly almost bipartisan, dare I say. Starting in the Senate, the chairman and the ranking member of the Health, Education, Labor and Pensions Committee, Democrat Bernie Sanders and Republican Bill Cassidy, announced that they’ve reached agreement on a series of bills aimed at reining in prescription drug costs for consumers, including one to more closely regulate pharmacy benefit managers and others to further promote the availability of generic drugs. Sarah, we’ve talked about the target on the backs of PBMs this year. What would this bill do and what are the chances of it becoming law?

Karlin-Smith: So this bill does three things: One is transparency. They want to pull back the cover and get more data and information from PBMs so that they can better understand how they’re working. So I think the idea would then be to take future policy action, because one of the criticisms of this industry is it’s so opaque it’s hard to know if they’re really doing the right thing in terms of serving their customers and trying to save money and drug prices as they say they are. The other thing is it would basically require a lot of the fees and rebates PBMs get on drug prices to be given back directly to the health plan, which is sort of interesting because the drug industry has argued that money should be given more directly to patients who are paying for those drugs. And when that has scored by the CBO, that often costs money because that leads to PBMs using less money to lower people’s premiums, and premiums are subsidized from the government. So I’m curious if the reason why they designed the bill this way is to sort of get around that, although then I’m not sure exactly if you get the same individual … [unintelligible] … level benefit from it. And then the third thing they do is they want to eliminate spread pricing, which is where — this is really a pharmacy issue — where PBMs basically reimburse pharmacies less than they’re charging the health plans and, you know, their customers for the drug and kind of pocketing the difference. So I think, from what I’m seeing on the Hill, there’s a ton of momentum to tackle PBMs. And like you said, it’s bipartisan. Whether it’s this bill or which particular bills it’s hard to know, because Senate Finance Committee is sort of working on their own plan. A number of committees in the House are looking at it, other parts of the Senate. So to me, it seems like there’s reasonable odds that something gets done maybe this spring or summer on PBMs. But it’s hard to know, like, the exact shape of the final legislation. It’s pretty early at this point to figure out exactly how it all, you know, teases out.

Rovner: We have seen in the past things that are very bipartisan get stuck nonetheless. Well, across the Capitol, meanwhile, the House Energy and Commerce Committee is also looking at bipartisan issues in health care, including — as they are in the Senate — how to increase price transparency and competition, which also, I hasten to add, includes regulating PBMs. But, Jessie, there was some actual news out of the hearing at Energy and Commerce from Chiquita Brooks-LaSure, who runs the federal Medicare and Medicaid programs. What did she say?

Hellmann: So they’ve instituted two fines against hospitals that haven’t been complying with the price transparency requirements. So I think that brings the number of hospitals that they’ve fined to, like, less than five. Please fact-check that, but I’m pretty sure that I can count it on one hand.

Rovner: One hand. They have, they have actually fined a small number of hospitals under the requirement. Yeah. I mean, we’ve known — we’ve talked about this for a while, that these rules have been in effect since the beginning of 2022, right? And a lot of hospitals have just been not doing it or they’re supposed to be showing their prices in a consumer-understandable way. And a lot of them just haven’t been. And I assume CMS is not happy with this.

Hellmann: Yeah, so Brooks-LaSure said yesterday that CMS is no longer going to issue warnings for hospitals that aren’t making a good-faith effort to comply with these rules. Instead, they’ll move straight to what’s called the corrective action phase, where basically hospitals are supposed to, like, say what they’re going to do to comply with these. And after that, they could get penalized. So we’ll see if that actually encourages hospitals to comply. One of the fines that they issued is like $100,000. And so I think some hospitals are viewing this, you know, as a cost of doing business because they think it would cost them more to comply with the price transparency rules than it would to not comply with them.

Rovner: So transparency here is still a work in progress. There’s also a fight in the House over the very wonky-sounding site-neutral payment policy in Medicare, which, like the surprise bill legislation from a few years back, is not so much a partisan disagreement as a fight between various sectors in the health care system. Can you explain what this is and what the fight’s about?

Hellmann: So basically hospital outpatient departments or, like, physician offices owned by hospitals get paid more than, like, independent physician’s offices for providing things like X-rays or drug administration and stuff like that. And so this is —

Rovner: But the same care. I mean, if you get it in a hospital outpatient or a doctor’s office, the hospital outpatient clinic gets paid more.

Hellmann: Yeah. And there’s not much evidence that shows that the care is any different or the quality is better in a hospital. And so this has kind of been something that’s been getting a lot of attention this year as people are looking for ways to reduce Medicare spending. It would save billions of dollars over 10 years, I think one think tank estimated about 150 billion over 10 years. It’s getting a lot of bipartisan interest, especially as we talk more about consolidation in hospitals, you know, buying up these physician practices, kind of rebranding them and saying, OK, this is outpatient department now, we get paid more for this. There are fewer independent physician’s offices than there used to be, and members have taken a really big interest in how consolidation increases health care prices, especially from hospitals. So it does seem like something that could pass. I will say that there is a lot of heat coming from the hospital industry. They released an ad on Friday last week warning about Medicare cuts, so, they usually do whenever anyone talks about anything that could hurt their bottom lines. Very generalist ad and kind of those “Mediscare” ads that we’ve been talking about. So it’ll be interesting to see if members can withstand the heat from such a powerful lobbying force.

Rovner: As we like to say, there’s a hospital in every single district, and most of them give money to members of Congress, so anything that has the objection of the hospital industry has an uphill battle. So we’ll see how this one plays out. Let us turn to abortion. The fate of the abortion pill mifepristone is still unclear, although the Supreme Court did prevent even a temporary suspension of its approval, as a lower court would have done. Now the case is back at the 5th Circuit Court of Appeals, which has swiftly scheduled a hearing for May 17. But it still could be months or even years before we know how this is going to come out, right, Shefali?

Luthra: It absolutely could be. So the fastest that we could expect to see this case before the Supreme Court again, just — what from folks I’ve talked to is, I mean, we have this hearing May 17, depending on how quickly the 5th Circuit rules, depending on how they rule, there is a chance that we could see if we get, for instance, an unfriendly ruling toward mifepristone, the federal government could appeal to the Supreme Court this summer. We could see if the Supreme Court is willing to take the case. The earliest that means that they would hear it would be this fall, with a decision in the spring a year from now, but that would be quite fast. I think what’s striking about it is that we may all recall last year, when the Supreme Court issued its decision in the Dobbs case, they said this will put the issue of abortion back in the hands of the states, out of the judiciary, we will no longer be involved. And anyone at the time could have told you there’s no way that this would happen because it is too complicated of an issue, when you undo 50 years of precedent, to assume there will be no more legal questions. And here we are. Those critics have been proven right, because who could have seen that, once again, we’d have the courts being asked to step in and answer more questions about what it means when a 50-year right is suddenly gone?

Rovner: Indeed. And of course, we have the … [unintelligible] … This is going to be my next question, about whether this really is all going to be at the state level or it’s going to be at the state and the federal level. So as red states are rushing to pass as many restrictions as they can, some Republicans seem to be recognizing that their party is veering into dangerously unpopular territory, as others insist on pressing on. We saw a great example of this over the weekend. Former vice president and longtime anti-abortion activist Mike Pence formally split on the issue with former President Trump, with Pence calling for a federal ban and not just leaving the issue to the states. Nikki Haley, the former governor of South Carolina and the lone woman in the Republican field so far, managed to anger both sides with the speech she made at the headquarters of the hard-line anti-abortion group the Susan B. Anthony List. Haley’s staff had suggested ahead of time that she would try to lay out a middle ground, but she said almost nothing specific, which managed to irritate both full abortion abolitionists and those who support more restrained action. Is this going to be a full-fledged war in the Republican Party?

Luthra: I think it has to be. I mean, the anti-abortion group is still very powerful in the Republican Party. If you would like to win the nomination, you would like their support. That is why we know that Ron DeSantis pursued a six-week ban in Florida despite it being incredibly unpopular, despite it now alienating many people who would be his donors. This is just too important of a constituency to annoy. But unfortunately, you can’t really compromise on national abortion policy if you’re running for president. A national ban, no matter what week you pick, it’s not a good sound bite. We saw what happened last year when Sen. Lindsey Graham put forth his national 15-week ban: Virtually no other even Republicans wanted to endorse that, because it’s a toxic word to say, especially in this post-Dobbs environment, especially now that we have all of this polling, including NPR polling from yesterday, that showed us that abortion bans remain quite unpopular and that people don’t trust Republicans largely on this issue. I think this is going to be incredibly interesting because we are going to eventually have to see Nikki Haley take a stance. We will have to see Donald Trump, I think, frankly, be a bit more committal than he has been, because meanwhile, he has lately told people publicly that he would not issue any federal policy, would leave this up to the states, we also know that he has said different things in other conversations. And at some point those conflicts are going to come to a head. And what Republicans realize is that their party’s stance and the stance they need to take to maintain favor with this important group is just not a winning issue for most voters. People don’t want abortion banned.

Rovner: Yeah, it’s a real problem. And Republicans are seeing they have no idea how to sort of get out of this box canyon, if you will. Well, back in the states, things seem to be getting even more restrictive. In Oklahoma this week NPR has another of those wrenching stories about pregnant women unable to get emergency health care. This time, a woman, a mom of three kids already with a nonviable and cancerous pregnancy who was told literally to wait in the hospital parking lot until she was close enough to death to obtain needed care. And that case turned out not to be an outlier. A quote-unquote “secret shopper” survey of hospitals in Oklahoma found that a majority of the 34 hospitals contacted could not articulate what their policy was in case of pregnancy complications or how they would determine if the pregnant person’s life was actually in danger. I can’t imagine Oklahoma is the only state where this is the case. We have a lot of these bans and no idea where sort of the lines are, even if they have exceptions.

Luthra: We know that this is not isolated to Oklahoma. There is a lawsuit in Texas right now with a group of women suing the state because they could not access care that would save their lives. One of those plaintiffs testified in Congress about this yesterday. Doctors in virtually every state with an abortion ban have said that they do not know what the medical exceptions really are in practice other than that they have to wait until people are on death’s door because there isn’t — medical emergency isn’t really a technical term. These bills, now laws, were written without the expertise of actual physicians or clinicians because they were never really supposed to take effect. This really has been just another example of a way that the dog chased the car and now the dog has the car.

Rovner: And the dog has no idea what to do with the car. Well, meanwhile, in Iowa, the attorney general has paused the state’s policy of paying for abortions as well as emergency contraception for rape victims. This is where I get to rant briefly that emergency contraception and the abortion pill are totally different, that emergency contraception does not cause abortion — it only delays ovulation after unprotected sex and thus is endorsed for rape victims in Catholic health facilities across Europe. OK, end of rant. I expect we’re going to see more of this from officials in red states, though, right, with going — not just going after abortions, but going after things that are not abortion, like emergency contraception.

Luthra: And I mean, if we look at what many of the hard-line anti-abortion groups advocate, they don’t just want to get rid of abortion. They specifically name many forms of hormonal contraception, but specifically the emergency contraception Plan B, and they oppose IUDs [intrauterine devices]. It would just be so, so surprising if those were not next targets for Republican states.

Rovner: So abortion isn’t the only culture war issue being fought out in state legislatures. There’s also a parallel effort in lots of red states to curtail the ability of trans people, mostly but not solely teenagers, to get treatment or, in some cases, to merely live their lives. According to The Washington Post, as of the middle of this month, state legislators have introduced more than 400 anti-trans bills just since January. That’s more than the previous four years combined. Nearly 30 of them have become law. Now, I remember in the early aughts when anti-gay and particularly anti-gay marriage bills were the hot items in red states. Today, with some notable exceptions, gay marriage is as routine as any other marriage. Is it possible that all these attacks on trans people, by making them more visible, could have the same effect? In other words, could this have the opposite effect as the people who are pushing it intended? Or am I just looking for a silver lining here?

Luthra: I think it’s too soon to say. There isn’t incredible polling on this issue, but we do know that in general, like, this is not an issue that even Republicans pick their candidates for. It’s not like they are driven to the ballot box because they hate trans people this much. I wouldn’t at all be surprised if there is a backlash, just because what we are hearing is so, frankly, horrific. What I have been really struck by, in addition to the parallels to anti-gay marriage, have been the ways in which restrictions on access to health care for trans people really do parallel attacks to abortion in particular, thinking about, for instance, passing laws that restrict access to care for minors, passing laws that restrict Medicaid from paying for care, that restrict how insurance covers for care. It’s almost spooky how similar these are, because people often think minors are easier to access first. People often think health insurance is an easier, sort of almost niche issue to go for first. And what we don’t often see until afterward is that these state-by-state laws have made care largely inaccessible. The other thing that I think about all the time is that these are obviously, in both cases, forms of health care restriction that are largely opposed by the medical community, that are often crafted without the input of actual medical expertise, and that target health care that does feel incredibly difficult to extricate from the patient’s gender.

Rovner: Yeah. The other thing is that people are going from state to state, just like with abortion. In order to get health care, they’re having to cross state lines and in some cases move. I mean, we’re starting to see this.

Luthra: The high-profile example being Dwyane Wade, formerly of the Miami Heat, moving away from Florida because of his child.

Karlin-Smith: The other thing, Julie, you were saying in terms of how optimistic to be, in terms of maybe the other side of this issue sort of pushing back and overcoming it, is that Politico had this good story this week about doctors in states where this care is perfectly legal and permissible but they’re getting so many threats and essentially their health care facilities feel that they’re so much in danger that they are concerned about how to safely provide and help these people that they do want to help and give care, while also not putting their families and so forth in danger, which perhaps also has a parallel to some of how there’s tons of, like, constant protests outside abortion clinics. And people have volunteered for years just to kind of escort people so they can safely feel comfortable getting there, which of course is, you know, can be very traumatic to patients trying to get care.

Rovner: Yeah, the parallels are really striking. So we will watch that space too. All right. That is the news for this week. Now, we will play my “Bill of the Month” interview with Renuka Rayasam. Then we will come back and share our extra credit. We are pleased to welcome to the podcast Renuka Rayasam, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” story. Renu, welcome to “What the Health?”

Renuka Rayasam: Thanks, Julie. Thanks for having me.

Rovner: So this month’s patient was pregnant with twins when she experienced a complication. Tell us who she is, where she’s from, and what happened.

Rayasam: Sure. Sara Walsh was 24 weeks pregnant with twins — it was Labor Day weekend in 2021 — and she started to feel something was off. She had spent a long time waiting to have a pregnancy that made it this far — eight years, she told me. But instead of feeling excited, she started to feel really nervous and she knew something was off. And so on Tuesday, she went to her regular doctor. And then on Wednesday, after that Labor Day, she went to her maternal fetal specialist, who diagnosed her with a pretty rare pregnancy complication that can occur when you have twins, when you have multiple fetuses that share blood unevenly through the same placenta. And it’s called twin-to-twin transfusion syndrome. And, you know — and this was Wednesday — she went into the office in the morning and she waited a long time for the doctor to kind of come back with the results, she and her husband, and just kind of spent the morning sort of back-and-forth between her maternal fetal specialist and her OB-GYN. And they told her she needed to get treatment immediately, that if she didn’t have treatment that she could lose one or both twins, she herself could even die. She needed to keep her fluid intake low. So they referred her to a specialist about four hours away from where she was. She was in Winter Haven, Florida, and they referred her to a specialist near Miami. And the specialist there apparently does not contract with any private insurance. And so that afternoon, hours after her diagnosis, she was packing her bags; she was getting ready to go, figuring out a place to stay, a hotel room and all that. And she gets a call from the billing office of this specialist in Coral Gables, Florida, near Miami. And they said, “Listen, we don’t contract with private insurance. You have to pay upfront for the pre surgical consultation for the surgery and then the post-surgical consult. And you need to have that money before you show up tomorrow in our office at 8 a.m.”

Rovner: And how much money was it?

Rayasam: About $15,000 in total for the consultations and the surgery itself. She told me she burst into tears. She didn’t want to lose these twins. She wasn’t given any option of shopping around for another provider. And she spent some time trying to figure out what to do. She couldn’t get a medical credit card because I guess there’s a 24-hour waiting period and she didn’t have that long. And so finally, her mother let her borrow her credit card. She checked into a hotel at midnight and at 8 a.m. the next morning she handed over her credit card and her mother’s credit card before she could have the procedure — before she could even see the doctor, I should say.

Rovner: And the outcome was medically good, right?

Rayasam: Yeah. The provider who did her surgery is a pioneer in this field. And that was why those doctors sent Sara to this provider, Dr. Ruben Quintero. He came up with this staging system that helps assess the symptom’s severity and even pioneered the treatment for it. But he sort of used all that to kind of say, OK, you have to pay me; I’m not even going to deal with insurance in this case. And so that afternoon, it was that Thursday, the day after she was diagnosed, she had a procedure, it went well, she had a couple of follow-ups in the following weeks. And then five weeks later, she delivered premature but otherwise healthy twin girls.

Rovner: So is that even legal for a doctor to say, “I’m not even going to look at you unless you pay me some five-figure amount”?

Rayasam: Generally, no. We have the federal No Surprises Act, as you know, and that’s meant to do away with surprise billing. But that was really designed for kind of inadvertent medical bills or surprises. Things get really complicated when there’s this appearance of choice where, you know, she had time to call the insurer, she had time to call the provider. It wasn’t as if she was unconscious and sort of rushed to the nearest doctor. Technically, she had a choice here. She could have chosen not to get the procedure. She could have gone to a different state. But obviously, those are not real choices in her situation when she needed the procedure so urgently. And so in those cases, you know, the billing experts I spoke with said this is a real loophole in federal billing legislation and state surprise billing legislation because the bill wasn’t a surprise. She knew how much to expect upfront. And that’s what makes this situation tricky.

Rovner: And she knew that the doctor wasn’t in network.

Rayasam: Absolutely. She knew the doctor wasn’t in network, and she knew how much she had to pay, and she willingly forked over the money, of course, as anyone would have in that situation or tried to in that situation.

Rovner: So after the fact, she went back to her insurance company to see if they could work something out, since it was pretty much the only place she could have gone at that point to get the treatment. But that didn’t go so well.

Rayasam: That didn’t go so well, and it’s one complication in this story that I myself don’t know what to make of, but the provider does not contract with any insurer, I should say. But he did take her insurance card and — or, the billing person did — and they say that they bill as a courtesy to the patient. So they file the paperwork for the patient. They say, “OK, your insurer will reimburse you. We’re going to provide all the paperwork.” In Sara’s case, it took a long time for this doctor and his practice to get Blue Cross Blue Shield the paperwork they needed to kind of pay for her claim. And in addition to that, they didn’t really send over the right paperwork right away. So it took a long time. And eventually she got only $1,200 back and she ended up paying far more than that out-of-pocket.

Rovner: And of course, the next obvious question is, doesn’t her insurance have an out-of-pocket maximum? How did she ever end up spending this much?

Rayasam: That’s a great question. We reached out to her insurer, and they didn’t really give us much of an explanation, but they, you know, on their billing statements and what they said to her was, “Hey, you went willingly out of network; this doesn’t qualify you for those out-of-pocket maximums.” They didn’t give us an explanation as to why. This seems to be a classic case of where those maximums should apply. But like I said, I think, you know, she had very little recourse. She tried to appeal the bills. She’s, you know, been on the phone with her insurer multiple times. The thing that makes this story more complicated is that it’s such a rare procedure and there aren’t that many providers in the country that even perform this procedure. So at first she was having to struggle with billing codes and all that with her insurance, so a lot of the people she was dealing with on the insurance side were really confused. It wasn’t something that they had a playbook for, knew what to do with, and that’s what made this a little bit more complicated.

Rovner: So what’s the takeaway here? I mean, obviously this was a rare complication, but if you multiply the number of rare complications of different things, you’re talking about a lot of people. Is there any way to get around this? I mean, it sounds like she did everything she could have in this case.

Rayasam: She did. In this case, it turns out there was another provider in Florida. There was no way for her to know that. Neither her OB-GYN nor the maternal fetal specialist told her about this other provider. I found out about it. I called around and did the reporter thing. And there are now four providers in Florida that will treat this. But of course, you know, if I was a patient, I wouldn’t shop around and risk my pregnancy either. So it’s unfortunate, in this case, there’s not much a person can do other than make sure that they’re keeping all the paperwork. And, you know, one thing that one of the billing experts I spoke with told me is that when you pay upfront, it makes things a lot harder. And in this case, like I said, she didn’t have a choice. But if there’s ever a way to get the bill on the back end, then there’s more of an incentive for the provider and the insurer to work together to get paid. But once the provider was paid, the insurer is not going to rush to reimburse the patient.

Rovner: And the provider is not going to rush to help the insurer figure out what to do. Ah well, another cautionary tale. Renu Rayasam, thank you so much.

Rayasam: Thank you.

Rovner: OK, we’re back and it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Sarah, why don’t you go first this week?

Karlin-Smith: Sure. I took a look at a story in The Wall Street Journal, “Weight-Loss Drugmakers Lobby for Medicare Coverage. Adding Ozempic, Mounjaro to federal plans could stoke sales.” It really documents well sort of the range of lobbying organizations and groups and where they’re sort of putting money to try and get Medicare to shift its policies and cover treatments for obesity, which was something that in the early creations of Part D was banned. And I think largely at that time it was because weight loss was seen as more of a cosmetic treatment than something that impacted health in the same way we appreciate now.

Rovner: And also, there wasn’t anything that worked.

Karlin-Smith: Right. The things that prior to this, the things that were available at different times were not very effective and in some cases turned out to be fairly unsafe. And of course, now we have treatments that seem to work very well for a number of people, but there’s a fear of just how much money it would cost Medicare. So the other interesting thing in this story is they talk about some lawmakers in Congress thinking about ways to maybe narrowly start opening the floodgates to access by potentially maybe limiting it to people with certain BMIs [body mass indexes] or things like that to maybe not have the initial cost hit they might be concerned about with it.

Rovner: And of course, whether Medicare covers something is going to be a big factor in whether private insurance covers something. So it’s not just the Medicare population I think we’re talking about here.

Karlin-Smith: Right. There’s already I know lobbying going on around that. My colleague wrote a story a few weeks ago about Cigna sort of pushing back about having those drugs be included potentially in, like, the essential health benefits of the ACA [Affordable Care Act]. So it’s going to be, yeah, a broader issue than just Medicare.

Rovner: Yeah, it’s a lot. I mean, I remember when the hepatitis C drugs came out and we were all so, you know, “Oh my God, how much this is going to cost, but it cures hepatitis C.” But I mean, that’s not nearly as many people as we’re talking about here. Jessie, why don’t you go next?

Hellmann: My stories from Politico. It’s called “Gun Violence Is Actually Worse in Red States. It’s Not Even Close.” It takes a weird twist that I was not expecting. Basically, the premise is about how gun deaths are actually higher in areas like Texas and Florida. They have higher per capita firearm deaths, despite messaging from some Republican governors that it’s actually, like, you know, cities like Chicago and New York that are like war zones, I think it’s the former president said. The author kind of makes an interesting argument I didn’t see coming about how he thinks who colonized these areas plays into kind of like the culture. And he argues that Puritans like had more self-restraint for the common good. And so areas like that have less firearm deaths where, you know, the Deep South people were — had like a belief in defending their honor, the honor of their families. So they were kind of more likely to take up arms. Not sure how I feel about this argument, but I thought it was an interesting story and an interesting argument, so —

Rovner: It is. It’s a really good story. Shefali.

Luthra: My story is from The Washington Post. It is called “The Conservative Campaign to Rewrite Child Labor Laws.” It’s a really great look at this Florida-based group called the Foundation for Government Accountability, which, despite its innocuous-sounding name, is trying to help states make it easier to employ children. This is really striking because we have seen, in states like Arkansas, efforts to make it easier to employ people younger than 16 in some cases, which is just really interesting to watch in these states that talk about protecting children and protecting life to, to then make it easier to, to employ kids.

Rovner: And in dangerous profess — in dangerous jobs sometimes. I mean, we’re not talking about flipping burgers.

Luthra: No, no. We’re talking about working in, like, in meat plants, for instance. But I think what’s also interesting is that this same organization that has made it easier to employ children has also tried to fight things like anti-poverty and try to fight things like Medicaid expansion, which is just sort of, if you’re thinking about it from an access-to-health standpoint, like, anti-poverty programs and Medicaid are shown to make people healthier. It’s sort of a really interesting look into a worldview that in many ways uses one kind of language but then advance the policy agenda that takes us in a different direction.

Rovner: Maybe we should go back to to Jessie’s story and depend on who settled that part of the country. We shall see. Speaking of history, my story’s from The Nation, and it’s called “The Poison Pill in the Mifepristone Lawsuit That Could Trigger a National Abortion Ban,” by Amy Littlefield. And it’s about the Comstock Act, which is a law from the Victorian era — it was passed in 1873 — that banned the mailing of, quote, “lewd materials,” including articles about abortion or contraception. A lot has been written about the Comstock Act of late because it was used to justify part of the opinion in the original mifepristone case out of Amarillo. But what this article makes clear is that reviving the law is actually a carefully calculated strategy to make abortion illegal everywhere. So this is not something that just popped up in this case. It’s a really interesting read. OK, that is our show. As always. if you enjoyed the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks, as always, to our ever-patient producer, Francis Ying. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me, at least for now. I’m @jrovner. Sarah?

Karlin-Smith: I’m @SarahKarlin.

Rovner: Jessie.

Hellmann: @jessiehellmann.

Rovner: Shefali.

Luthra: @Shefalil.

Rovner: We’ll be back in your feed next week. Until then, be healthy.

Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News’ ‘What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

The Host

Mary Agnes Carey
KFF Health News

@maryagnescarey

Read Mary Agnes' stories

Mary Agnes Carey, Partnerships Editor and Senior Correspondent, oversees placement of KFF Health News content in publications nationwide. She has covered health care policy and politics for KFF Health News, CQ, Dow Jones Newswires, and other news outlets.

Supreme Court justices could act at any moment on access to the abortion pill mifepristone. Beyond reproductive health, their ruling could carry significant implications for states’ rights and FDA independence and integrity. For now, though, observers are unsure what the court will do — or what exactly prompted justices to again delay their decision this week.

At the Capitol, lawmakers grumbled, scoffed, and bickered this week as House Speaker Kevin McCarthy revealed the Republican proposal to cut government spending. The package would be dead-on-arrival in the Democratic-controlled Senate. But of note is the pushback from within McCarthy’s own caucus, with some hard-right conservatives pressing to go further by demanding the repeal of the Inflation Reduction Act in exchange for raising the debt ceiling.

And President Joe Biden pursued new efforts to grant legal status to young immigrants living in the country illegally who were brought here as children, sometimes called “Dreamers,” as his administration announced a plan to grant them access to government-funded health coverage.

This week’s panelists are Mary Agnes Carey of KFF Health News, Rachel Cohrs of Stat, Sandhya Raman of CQ Roll Call, and Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico.

Panelists

Rachel Cohrs
Stat News

@rachelcohrs

Read Rachel's stories

Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico

@JoanneKenen

Read Joanne's stories

Sandhya Raman
CQ Roll Call

@SandhyaWrites

Read Sandhya's stories

Among the takeaways from this week’s episode:

• The Supreme Court extended its stay on the use of mifepristone through Friday, giving justices longer to act on a major, complicated case with nationwide implications for reproductive health. It is unclear what the court will do, though there are several actions it could take — including sending the case back to the lower courts or again extending the stay and buying justices even more time to come to agreement or pen dissents.
• GenBioPro, which produces the generic version of mifepristone, sued the FDA on Wednesday, attempting to preserve access to the drug. About two-thirds of the mifepristone currently used in the United States is generic.
• In congressional news, House Speaker McCarthy released what is effectively Republicans’ opening offer in the fight over raising the debt ceiling. The package includes GOP health priorities that would not garner needed support in the Senate, like work requirements for Medicaid and the clawback of unspent covid-19 pandemic funds.
• While health costs are high across government programs, Medicaid takes the big hit in the Republican proposal to cut federal spending. Republicans have embraced work requirements for government assistance since at least the 1980s, yet in Arkansas — a state that implemented work rules for Medicaid — it has proved challenging to verify that enrollees are meeting those requirements.
• The Senate Finance Committee, which has jurisdiction over much of federal health spending, revealed a package this week to tackle drug pricing. While the proposal is in the early stages, it seeks to incorporate bipartisan measures touching pharmacy benefit managers, insulin users, and more.
• And on the coverage front, the Biden administration announced that immigrant kids brought to the United States who remain here under the Deferred Action for Childhood Arrivals program will be able to apply for Medicaid and Affordable Care Act coverage. This eligibility expansion comes as states prepare to disenroll those who no longer qualify for Medicaid as the public health emergency’s coverage protections expire. Expect a fight from some states as they resist being forced to cover insurance for individuals living in the U.S. without legal permission.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Mary Agnes Carey: The New York Times’ “A Beauty Treatment Promised to Zap Fat. For Some, It Brought Disfigurement,” by Anna Kodé

Joanne Kenen: The New York Times’ “My Transplanted Heart and I Will Die Soon,” by Amy Silverstein

Sandhya Raman: ABC News’ “Puerto Rico’s Water Supply Is Being Depleted, Contaminated by Manufacturing Industry on the Island, Experts Say,” by Jessie DiMartino, Lilia Geho, and Julia Jacobo

Rachel Cohrs: The Wall Street Journal’s “‘I Hate You, Kathie Lee Gifford!’ Ozempic Users Report Bizarre Dreams,” by Peter Loftus

click to open the transcript

Transcript: Will They or Won’t They (Block the Abortion Pill)?

KFF Health News’ ‘What the Health?’Episode Title: Will They or Won’t They (Block the Abortion Pill)?Episode Number: 294Published: April 20, 2023

[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]

Mary Agnes Carey: Hello and welcome back to “What the Health?” I’m Mary Agnes Carey, partnerships editor for KFF Health News. I’m filling in this week for Julie Rovner, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, April 20, at 10 a.m. Eastern. As always, news happens fast and things might have changed by the time you hear this. So here we go. Joining us today by video conference are Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico.

Joanne Kenen: Hi, everybody.

Carey: Rachel Cohrs of Stat.

Cohrs: Morning, everyone.

Carey: And Sandhya Raman of CQ Roll Call.

Raman: Good morning.

Carey: Let’s start with the current court action on mifepristone. The Supreme Court was scheduled to rule yesterday on a decision from the U.S. Court of Appeals for the 5th Circuit that rolled back FDA action since 2016, allowing patients to get mifepristone through the mail, authorizing prescriptions by medical professionals other than doctors, and approving the drug’s use up to 10 weeks into a pregnancy instead of seven. Supreme Court Justice Samuel Alito Jr, who’d previously set Wednesday as the deadline for the court to act, extended that stay until Friday, and the justices could certainly act before they choose to —hopefully not while we’re taping. But I wanted to get everyone’s thoughts on why do you think the court didn’t act yesterday? Joanne, can I start with you?

Kenen: I mean, presumably they’re still hashing it out. There’re probably two or three judges who are still thinking about it or discussing it with their colleagues, or colleagues who want to think they can persuade them to their side. I mean, there’s something internal. On the other hand, I mean, they didn’t originally give themselves a lot of time to consider a complicated and historic case. We know there’s an anti-abortion majority. We know they’re not crazy about medical abortions any more than they are about surgical abortions. But this has large implications about states’ rights and about the sort of integrity of the FDA. So they may just wanted to sleep on it. They’re human, but the two sides are battling for two or three in the middle.

Carey: So what does this signal about how they might rule? I mean, to your point about the split, the battle, what are the options? What do you — Sandhya, what do you think about what they might —

Kenen: Well, if it was slam dunk, we’d have had it.

Carey: That is true. That is true. It is not a slam dunk.

Raman: And everyone that I have talked to in the last few weeks on this is just that there are so many different options, different permutations, that it’s difficult even for people that are experts on FDA policy, like expert lawyers, experts on abortion policy, to just kind of like predict the nuances. You know, they could let the stay expire. They could send it back to the 5th Circuit. They could decide to hold arguments and let it expire or not expire. They could decide something different than the 5th Circuit. You know, there’s so many different ways that things could happen that I think it makes it difficult. And then yesterday, the other manufacturer of mifepristone, GenBioPro, also filed suit against the FDA. So now we have, since Dobbs, like five different lawsuits related to mifepristone and three of them, post-Dobbs, are related to the FDA in particular. And I think it just gets very, very complicated to make a decision, even if ideologically some people might align with one way versus the other, given all of these different permutations and that we still have that Washington case that is attacking another part of this. So it’s just complicated to get people to do something. And the fact that this case has been moving so, so quickly.

Carey: Could we be in the same place on Friday? Could we get another stay? Could the justices certainly ask for more time, and are there any thoughts about the probability of that actually happening? Rachel, what are your thoughts?

Cohrs: I think they can do what they want.

Carey: That’s true.

Cohrs: They gave themselves time once more, and I think obviously there’s a benefit to having some certainty and predictability for people, for providers, but certainly they could stay again.

Carey: So, Sandhya, you just mentioned the Washington state case. So while this Texas ruling is before the Supreme Court, a federal district judge in Washington state issued a ruling in a separate case that instructed the FDA to not alter the current availability of the drug in 17 states and the District of Columbia. And as you just mentioned, a manufacturer of the generic version of the drug — the company’s name is GenBioPro; they make the generic version of mifepristone — they’re arguing that if the FDA implements a court order suspending approval of the drug, the agency would deprive the company of its rights to market the drug without due process of law. And as I understand, this company is a major manufacturer of the generic version of the drug, right? So let’s talk a bit more about this confusion of these split rulings. I mean, what is the public to make of it? What’s the reaction with facilities that are providing this medication or doctors who want to prescribe it or just the general public? The person who might be interested in this situation is very confused. I mean, talk a little bit about how people sort through it and what this means for them.

Raman: So the suit that was filed yesterday about the generic, they make two-thirds of the mifepristone that is used in the U.S. So if they were unable to be manufacturing theirs based on a ruling that only allowed the name-brand version of the drug, that’s a huge percentage of the market that is gone, and more than half of abortions are done through medication abortion. So that’s one thorn in it. And I think that another is that we have all of these states that have been stockpiling the drugs — several that have been, you know, in case they don’t know what is happening with the ruling. Washington is one of them. And there’s still not clarity depending on what happens with these cases of, you know, will they be able to use what that they have stockpiled? And then we have other states like New York and I think California that have been stockpiling misoprostol as another way to — in case there’s a court ruling that doesn’t go in their favor — to just give patients in their states access to medication abortion. I think that there are so many different permutations that it’s very difficult for even folks that are confident that the rule may go a different way to know what to predict, just because we’re in such uncertain territory, from all of the different former FDA officials that have said, “You know, this is a very different situation. We don’t even know, after decades of experience at the FDA, like, how this would play out, what it would mean, whether we’d have to pull everything off the market.” How it would play out, it’s just a lot of unknown territory given all of the different things going on.

Kenen: Well, also, whatever they do now isn’t necessarily the end of the story, right? I mean, if the court issues a stay, it will still go through the courts and it presumably ends up at the Supreme Court again. If they issue a stay pending full hearing of the case, it’ll be going on for months more. But either they issue a stay saying the 5th Circuit ruling, which did not totally — the lower federal court banned the use of the pill; the appeals court limited it to seven weeks instead of the FDA has ruled it’s for 10 weeks. So if they uphold the 5th Circuit Court of Appeals, there would still be use, but it would be limited. If they put a stay saying, “Yes, it can stay legal in the states that allow it for now,” then it would still be legal in those states but we’d still be back discussing what is the Supreme Court going to do a couple of months from now.

Carey: And how — where is the drug industry on this? I mean, this would have sweeping ramifications.

Kenen: They’re horrified. One of you might know the number — was it like 250 companies signed the brief that you’re going to have a court decide what drug is safe and what drug is not safe, rather than the FDA? I mean, the pharmaceutical company fights with the FDA all the time, but they need the FDA and they know they need the FDA and they admit they need the FDA. You know, you have one voice in this country saying a drug is safe or a drug is not safe or a drug is safe under the following conditions.

Raman: There have been hundreds of the drug companies that have spoken out against it, and PhRMA [Pharmaceutical Research and Manufacturers of America] more recently also finally came out against it. It’s been pretty uniform in a way that I have not really seen in the past where there have been, you know, the drug companies, the various people that have been regulators, the folks that are in favor of abortion rights, then just advocates — and just very unified in this response.

Carey: Rachel, what is the impact of the drug industry’s weighing in in this manner? How could that shape the decision? Was there anything surprising in how they worked together on this? I know you’ve done some reporting on this area.

Cohrs: Yes. Yeah. So I think certainly them actually filing briefs with the court will kind of help drive home the ramifications of this, just on a much larger scale. I mean, we’re not just talking about abortion now. We’re talking about any medication that could be at all controversial. You know, we’re talking PrEP for HIV. You know, there are so many areas where companies genuinely are concerned about lawsuits and about judges who aren’t experts. So I think this uniform voice will drive home the larger impacts here beyond this one issue. And also, I think, the drug industry has significant resources to invest. And I think, it took a little while, but the trade groups PhRMA and BIO [Biotechnology Innovation Organization] have said that they are willing to invest, and they haven’t made any specific commitments, but certainly I think down the line there could be legal challenges. And now that they have put themselves out there, they certainly are a significant player in the space, with resources.

Raman: The drug industry is also a huge player in, you know, donating to various campaigns and lobbying on the Hill. And it’s definitely going to be — put increasingly different folks in a tight spot if they are receiving a lot of backing from the pharmaceutical industry and if they’ve spoken out in favor of restricting the drug. And it’ll be interesting to see kind of as it goes on what happens there with some of these folks.

Carey: Sure. Well that’s a perfect segue way because we have lawmakers on Capitol Hill are also weighing in on this. About 150 Republicans are urging the Supreme Court to uphold the 5th Circuit’s ruling, while more than 250 Democrats have urged the court to not prevent access to mifepristone. Are Republicans taking a political risk here speaking out? Because I know it’s been talked about on the podcast before, about the abortion rights opponents have some splits on how far to go on some of these restrictions on abortion. You know, Republicans didn’t really seem eager to engage when the decision came out, but now they are. What does that mean? What do you make of it?

Raman: We’ve had that delay first that, you know, a lot of Republicans did not even comment on the case, which was kind of interesting, given that, you know, after a lot of these decisions, we see a lot from both sides kind of weighing in. And I think when you look at some of these briefs, they say a lot of the similar talking points as before, which is something that you can kind of look to. But I mean, the conversation is still moving, even on the Hill. Yesterday, Robert Califf from the FDA was facing questions about mifepristone from different Republicans, from Cindy Hyde-Smith, who had agreed with the lower court decision, from Susan Collins, who was kind of against the decision as one of the Republicans who generally supports abortion rights. And I think it’ll be very interesting if this gets taken up by a committee that has jurisdiction over the FDA, which we have not really seen a commitment to. Energy and Commerce [Committee] Democrats have asked for something on this to come up. But, you know, under Republican leadership, I don’t know that that would necessarily happen. The only committee that is really committed to looking at this issue has been, like, Senate Judiciary, which with Democratic control is going to look a different way. And they don’t really have the jurisdiction over FDA in the same way as some of the other committees do. So I think that’ll be interesting to look at if that changes.

Kenen: There is a divide in the Republican Party about how far to go. I mean, some are for rape and incest exceptions, some are not. Some are for six weeks, some are for 15 weeks, some are for zero weeks. This is reflecting those divisions. It also depends on the individual lawmaker’s district. You know, if you come from an extremely conservative district and you are an anti-abortion absolutist, then you’re going to speak out on this. But we’ve noted they don’t really want to antagonize pharma either. So you’ve seen, I guess it’s 150ish — you haven’t seen all of them. It’s a complicated issue for some of them, given the competing interests, you know. Is abolishing all abortions in the United States of America your top goal? In which case you’re going to want to support the lower court. If you have a more nuanced view, where you’re worried about precedent for overriding the FDA, you have competing — I mean, there are very few abortion rights Republicans, but they don’t all want to draw the line in the same place.

Carey: So while we’re on the subject of Capitol Hill, let’s talk about the debt ceiling. We have a little bit of action there this week. Speaker of the House Kevin McCarthy unveiled his plan to raise the debt ceiling. McCarthy and many Republicans have said they don’t want to raise the debt ceiling without spending cuts. President Biden and many Democrats are pushing for a clean debt ceiling increase. So among its provisions, Speaker McCarthy’s plan would cut federal spending by roughly $130 billion, and that would take spending back to fiscal 2022 levels. Health-related provisions include new work requirements for Medicaid and food stamp recipients, and the package would also claw back unspent covid aid funds. And there’s a bit of a twist on the work requirement proposals of the past: States could opt to keep those that don’t comply with the work rules covered under Medicaid, keep them on the rolls. But if they do, the state would bear the full cost of that coverage and forgo the federal money for those enrollees, right? The proposal also requires states to make use of existing resources like payroll databases, state health and human service agencies, to verify compliance with a work rule when possible. There’s a lot to unpack here. It’s pretty clear that, I mean, House Democrats aren’t going to vote for this. Does the speaker even have enough votes in his own caucus to pass it? I think he can only lose like four.

Kenen: TBD. But I don’t think the conventional wisdom is that he has the votes. You know, it’s a starting offer, but they can change, you know, has to go Rules [Committee]. They’ll change — you know, they could change things.

Carey: It is a starting offer. But your vote is next week and it’s Thursday. OK. Rachel, what’s your take on this?

Cohrs: Yeah, I think it was a bit of a roller coaster this week, as some members of the Freedom Caucus were demanding wholesale repeal of the Inflation Reduction Act around midweek, and they certainly backed off from that, especially the health care portion. So I think that is worth noting, at least right now. Again, unclear if he has the votes, or if the speaker has the votes, and then obviously Senate Democrats aren’t going to go for it and President Biden isn’t going to go for this. So I think, like Joanne said, it is kind of an opening offer here. And again, there isn’t a lot on Medicare in here. So I think we just, you know, finally, after so much rhetoric and so much back-and-forth, have some sort of tangible starting point from Republicans here, which is significant.

Kenen: But, you know, as soon as they made that pledge that we’re not going to touch Medicare, meaning traditional Medicare actually, and we’re not going to touch Social Security, we all knew that, Oh, that means that it’s all going to go to Medicaid. So this is a big Medicaid hit. And work rules have been something the Republicans have embraced at least since the Reagan era, maybe even before, but certainly since the 1980s. A few states tried them or at least said they were going to impose them under the Obama administration. At that point, the administration didn’t approve them and the courts didn’t uphold them. But we have a different court now. So I think this court would uphold; that’s likely. But this is not acceptable for Democrats, nor is it meant to be.

Raman: And when we had the various states propose these and in some cases implement them during the Trump administration, every single one of them was struck down by the court once, sometimes twice. You know, we had Arkansas, we had New Hampshire, we had Kentucky, we had Michigan. Every single time the judge at hand was, you know, “This is going against the function of Medicaid,” which — historically we’ve had work requirements in some of the other programs, but the way the Medicaid statute is written, it has been difficult to find a way to keep those in place. So if they were able to get that past, I mean, even the House, which seems like is a, is a question mark, I mean — whatever could get through would absolutely face court battles from some of the same folks that challenged them during the Trump administration.

Kenen: But I think the only one that actually went into effect was Arkansas. And in addition to it being thrown out by a court, it also just didn’t work. The mechanism didn’t work. It became really hard for people. The verification that you’re working, which this proposal actually addresses, that Mary Agnes just alluded to that, the verification was extraordinarily cumbersome. I mean, you had like lots of poor people in Arkansas — and rural Arkansas don’t have access to Internet — and you only had a few hours a day where you could use the portal and you have to leave work to go to the local library to prove that you were working. I mean, it was just — forget the ideology of it — the mechanics didn’t work, and people were thrown off even though they were compliant. And but this [is] just like a deep philosophical divide between the two parties, and they have compromised, and back in the Clinton years they compromised on welfare, what’s now called TANF [Temporary Assistance for Needy Families]. There’s work requirements for SNAP, for what we used to call food stamps. But Medicaid has been a red line for Democrats, that this is an entitlement based on health; it’s not like you deserve — some people deserve it and some people don’t. It’s been a philosophical, ideological, you know, something that Democrats feel very strongly about.

Cohrs: Oh, I just want to jump in on the covid money as well — much smaller deal, fewer impacts on patients — but it has been kind of interesting and over the last couple of weeks that the Biden administration has rolled out some new programs that cost quite a bit of money, as there’s this horizon, this call for Congress to claw back unspent covid funds. I mean, they’re spending $5 billion now on developing vaccines and therapeutics, $1 billion on vaccine access, when they said they didn’t have any money. So it’s just kind of interesting that, you know, when these funds are committed to a program legally, then Congress can’t claw them back. So I’m curious to see what else we’ll see as these negotiations solidify.

Carey: All right. We’ll keep our eye on it. And I want to just check in briefly on the Senate side. I know we’ve discussed these issues on the podcast before. The Senate Health, Education, Labor and Pensions Committee has been working on legislation focused on drug prices and pharmacy benefit managers. This morning we have a framework introduced from the Senate Finance Committee. It’s with Sen. Wyden, the chair from Oregon, who’s a Democrat, and Sen. Mike Crapo, Republican from Idaho, that also seeks to address PBMs in the prescription drug supply chain. We also have the moving, or maybe not moving, but introduce legislation, anything new there on insulin prices with Sen. Warnock and Sen. Kennedy to cap the out-of-pocket price at $35. Any movements there in the Senate, any insight you could offer?

Cohrs: On the Senate Finance [Committee] side, that is a very significant development, that they’ve decided to get in on the fun this week of putting together a package, just because their committees do have jurisdiction over so much federal spending. And Sen. Wyden has been involved in this issue. He’s put out — I found a package of bills from 2019, and, you know, he’s been on this issue a long time. So I think his team has proven they can craft big-picture, very impactful policy with the Inflation Reduction Act. So I think that’s certainly something to watch with that much federal spending on the line. And on insulin, you know, Sen. Schumer this week has committed to have some sort of insulin pricing provision in whatever package might come together — it’s still pretty amorphous — but it’s unclear what that’s going to look like. There is another proposal from Sen. Collins and Sen. Shaheen, two much more senior members of the caucus, and that mechanism works differently. For patients, it would look pretty similar. But on the back end, for insurers, for drugmakers, both of those programs would work differently. So they haven’t sorted that out yet. HELP hasn’t even picked a date for their hearing and formally announced it yet. So we are in early stages, but there’s certainly a lot swirling around.

Carey: Absolutely. And we’ll keep our eye on all of that as well. So I’d like to also chat a little bit about some ACA developments that happened this week. President Biden recently announced that hundreds of thousands of immigrants brought to the United States illegally as children will be able to apply for Medicaid and the Affordable Care Act’s health insurance exchanges. This allows participants in the Obama-era Deferred Action for Childhood Arrivals program, also known as DACA, to access government-funded health insurance programs. You can expect pushback from conservative leaders of states that have been reluctant to expand Medicaid, possibly also pushback from Republican members of the Hill on this provision. And then, in other ACA news, the administration has finalized new rules that are aimed at making it easier for consumers to sign up for ACA plans, in particular those who are losing their coverage through Medicaid or the Children’s Health Insurance Program. The Centers for Medicare & Medicaid Services, also known as CMS, will also give state marketplaces the option to hold a special enrollment period for people who lose their Medicaid or CHIP coverage. What could this possibly mean for enrollment in the program, right, to making it easier for DACA participants to enroll in the ACA or people losing their coverage through CHIP or Medicaid? I think it’s about 16 million people now in the program. Does this build more support for it? Are Republicans going to engage against it? Do they think that’s simply a losing battle because they’ve never agreed on an alternative?

Raman: I mean, right now, we’ve had historic levels of people in Medicaid and CHIP just because states have been unable to unenroll them from coverage during the public health emergency for covid. And now that states are starting to recheck their rolls and see who’s still eligible, who’s not eligible, we’ve been expecting just, you know, a big drop in different people that would be either getting uninsured or maybe moving to a different type of plan with a private or the exchanges. And I think it’s been something that, you know, states and the federal government have been working on for the entire time of just, you know, different ways to make sure that that drop-off in the number of uninsured folks doesn’t skyrocket as states are going through this process. And so I think the timing is important in that, you know, you’re trying to counteract the drop. And HHS [the U.S. Department of Health and Human Services] has been touting, you know, the high levels of uptake in the ACA and just like the low uninsured rate and this has been something they’ve just kind of been pushing, you know, month after month. This has been something that has been like a big achievement for them. And so now really like push comes to shove to say that, you know, it doesn’t drop off dramatically if you want to continue touting some of these achievements and making sure that people don’t drop off just because the emergency is ending and that guaranteed coverage isn’t there.

Kenen: So there are multiple issues in the question that are exposed, the DACA, which —

Carey: Of course it can’t be just one question I have to ask four at once.

Kenen: The DACA, which is also known as the Dreamers, Biden is trying to cover them. Democrats have been trying to give them legal status and got nowhere. In fact, they’re probably further away from that than they were five or six years ago. But to get them health coverage is something the Democrats — it’s like the least they can do to this population. But I can’t imagine there’s not going to be a political and/or a legal fight from the states who are going to have to pay for their share of it, right? I mean, Medicaid is a state-federal joint expenditure, and the states that don’t want to cover these people will well resist or sue. Or, I mean, everything ends up in court; I would imagine this will, too, or baked into the debt ceiling — you know, one more thing to fight about with the debt ceiling. So that’s one issue. I mean, the other issue is this unwinding of this huge Medicaid population. Most of these people are going to be eligible for some kind of coverage. Some of them are still going to be eligible for Medicaid. Some of them are going to be eligible for very good deals for sort of low-income working people on the ACA. And some have jobs that they can get insured through — theirs or a partner or a family member. But really, the only ones who are ineligible for anything would be those in the remaining Medicaid gap states. But that’s like theoretically, if we did everything right, the only people that would be ineligible are the Medicaid gap population, which is now down to about 10 states, assuming North Carolina, you know, finalizes their approval or, you know, enacts their expansion. But like, that’s the perfect world, and we don’t live in a perfect world. I mean, some of these people are going to get lost in the shuffle. And in fact, maybe several million; their estimates are like maybe 6 million, you know, no one knows. But, you know, our health care system is complicated. You know, getting a letter in the mail saying, you know, “Sayonara, Medicaid,” is not all of them will know how to negotiate new coverage even when they’re eligible, and we’re going to have to do a really good job of helping them. And that has to be from the federal government, from the state governments, from the health system itself, from advocates, from Congress. You know, everyone’s going to have to pitch in to get these people what they’re eligible for. And I don’t see that as an overnight success story. I think that there are people who should be covered and can be covered who won’t be covered. Eventually we’ll probably catch up and most of them enrolled. But I think that some of them have periods of uninsurance.

Carey: It’s absolutely a major undertaking. I know we’ll all be watching closely. OK, that’s the news for this week. Now it’s time for our extra credit segment. That’s when we each recommend a story we read this week and think you should read it too. As always, don’t worry if you miss it. We’ll post the links on our podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device.

Kenen: I actually want to read the first sentence of this piece. This is a guest essay in The New York Times by Amy Silverstein. She’s a heart transplant recipient. She’s, I guess, about 60 now, and she’s about to die, not because her heart, her transplanted heart is failing — she writes about how she kept that in pristine condition — but because she’s got cancer. And it’s called “My Transplanted Heart and I Will Die Soon,” and it begins, “Today, I will explain to my healthy transplanted heart why, in what may be a matter of days or weeks at best, she — well, we — will die.” And in addition to being just a heart-tugger, I did not know a lot of what she explores about transplant medicine, that we think of transplants as medical miracles — and they are; you know, she had like an extra 35 years of life — but they’re also, transplant medicine itself hasn’t really, according to what she writes, transplant medicine itself — the drugs, the care they get, these heavy-duty drugs haven’t improved in 40 years. While she has a healthy heart, she has metastatic lung cancer because of these drugs. The medical care around transplant can be quite dangerous. And I knew nothing about that, and I’ve covered health for a long time. So it’s a tragic story and it’s also a scientific failure or a medical system or a medical research failure story that I hope a lot of people who have the power to change it read.

Carey: Sandhya, what’s your extra credit?

Raman: So my extra credit is from ABC News. It’s called “Puerto Rico’s Water Supply Is Being Depleted, Contaminated by Manufacturing Industry on the Island, Experts Say.” It’s a triple byline from Jessie DiMartino, Lilia Geho, and Julia Jacobo. And I thought their story was really interesting because it looks at the effects of the manufacturing industry on the water supply in Puerto Rico. The manufacturing there is, in Puerto Rico, is really high because there used to be a tax incentive that’s now lapsed to create a huge boom in manufacturing in the ’60s and ’70s. And kind of looking at the impacts of that, and over time and to the environment, and pharma manufacturing in particular, is 65% of what has been the industrial groundwater withdrawals. So in areas that rely heavily on groundwater on an island, this is felt especially hard. And so they go through a lot of the implications of some of that and how the manufacturing affects it, especially in an island with a finite water supply.

Carey: Rachel.

Cohrs: Mine is, the headline is, “‘I Hate You, Kathie Lee Gifford!’ Ozempic Users Report Bizarre Dreams,” in The Wall Street Journal and by Peter Loftus. Our newsroom has been covering the weight loss drug explosion this year, and I think this story was just so colorful and just a great example of reporting on the side effects that emerge when so many people are interested or want to take a drug. And I think there is certainly a public service to people understanding what they’re getting into and just hearing from all sorts of people, because certainly there are agencies who are supposed to be doing that. But I think there’s also just a lot of buzz that’s fascinating. The writing was just so rich and bizarre. And yeah, it was a great read and a great illustration on it, too.

Carey: Well, speaking of weight loss and getting fat out of our bodies, my story is from The New York Times, called “A Beauty Treatment Promised to Zap Fat. For Some, It Brought Disfigurement,” by Anna Kodé, and I hope I’m pronouncing your name correctly. You might have heard or seen all these ads about the treatment called CoolSculpting. It uses a device on a targeted part of the body to freeze fat cells. Patients typically undergo multiple treatments in the same area, and in successful cases, the cells die and the body absorbs them. “But for some people,” Anna writes, “the procedure results in severe disfigurement. The fat can grow, harden and lodge in the body, sometimes even taking on the shape of the device’s applicator.” The manufacturer says this is a rare side effect, but a Times investigation that drew on internal documents, lawsuits, medical studies, and interviews indicates the risk to patients may be considerably higher. So that’s our show. As always, if you enjoyed the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left a review; that helps other people find us too. Special thanks, as always, to our ever-patient producer, Francis Ying. And as always, you can email us with your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me @maryagnescarey. Rachel?

Cohrs: @rachelcohrs.

Carey: Joanne?

Kenen: @JoanneKenen.

Carey: Sandhya.

Raman: @SandhyaWrites.

Carey: We’ll be back in your feed next week. Until then, be healthy.

Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News’ ‘What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

The abortion pill mifepristone is now ground zero in the abortion debate. Late Wednesday night, the 5th Circuit Court of Appeals said the drug should remain on the market but under restrictions on distribution that were in effect before 2016, which ban prescribing by mail or by telemedicine. The restrictions would make it even more difficult for patients in states where abortion is illegal or widely unavailable.

The decision comes in response to a ruling last week out of Texas, where a federal judge, as was widely expected, found that the FDA should not have approved the drug more than 22 years ago and ordered it, effectively, unapproved.

Complicating matters further still, in a separate case filed by 18 attorneys general in states where abortion is largely legal, last week a federal district judge in Washington state ordered the FDA not to reinstate any of the old restrictions.

This week’s panelists are Julie Rovner of KFF Health News, Victoria Knight of Axios, Shefali Luthra of The 19th, and Sarah Karlin-Smith of the Pink Sheet.

Panelists

Sarah Karlin-Smith
Pink Sheet

@SarahKarlin

Read Sarah's stories

Victoria Knight
Axios

@victoriaregisk

Read Victoria's stories

Shefali Luthra
The 19th

@Shefalil

Read Shefali's stories

Among the takeaways from this week’s episode:

• A late-night decision by the appeals court preserves access to mifepristone while the legal battle continues. But it also resurrects outdated limitations on the drug, meaning mifepristone can be used only up to seven weeks into a pregnancy, among other restrictions.
• While it is expected that the U.S. Supreme Court will ultimately decide the drug’s fate, some providers and state officials are rushing to stockpile it. Cutting off access to the abortion pill puts extra pressure on clinics in states where abortion remains legal, which are also serving women from so-called prohibition states and could see an influx of patients as mifepristone becomes difficult — or impossible — to get.
• Republicans largely have remained quiet about the ruling overturning mifepristone’s FDA approval. While many in the party support banning the drug, they likely recognize the political risks of broadcasting that stance. Meanwhile, the Biden administration moved to strengthen privacy protections for patients and providers related to abortion, offering some reassurance to those who fear they could be prosecuted under their home state laws for seeking abortions elsewhere.
• As Southern states have whittled away at abortion access, Florida, with its 15-week abortion ban, had emerged as a hub for patients across the region. This week the state moved to restrict the procedure to six weeks, a change that could send many patients scrambling north to states like Virginia and New York for care. And in Idaho, a new law makes “abortion trafficking” — or transporting a minor to have an abortion without parental consent — a crime.
• Congress is exploring new drug pricing measures, particularly aimed at increasing transparency around pharmacy benefit managers and capping insulin costs. Lawmakers are also watching the approach of the debt ceiling threshold; in the mix of budgetary pressure valves are Medicaid and, potentially, work requirements to receive Supplemental Nutrition Assistance Program benefits.
• Congress continues to show little appetite for addressing a different, intensifying public health crisis: gun violence. A new poll from KFF shows startlingly high numbers of Americans — especially people of color — have directly experienced gun violence and live with that threat every day.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week they think you should read, too:

Julie Rovner: The Washington Post’s “To Comply With a New Sesame Allergy Law, Some Businesses Add — Sesame,” by Karen Weese.

Shefali Luthra: KFF Health News’ “For Uninsured People With Cancer, Securing Care Can Be Like Spinning a Roulette Wheel,” by Charlotte Huff.

Victoria Knight: The Washington Post’s “Research With Exotic Viruses Risks a Deadly Outbreak, Scientists Warn,” by David Willman and Joby Warrick.

Sarah Karlin-Smith: NBC News’ “Conspiracy Theorists Made Tiffany Dover Into an Anti-Vaccine Icon. She’s Finally Ready to Talk About It,” by Brandy Zadrozny.

Click to open the transcript

Transcript: The Confusing Fate of the Abortion Pill

KFF Health News’ ‘What the Health?’Episode Title: The Confusing Fate of the Abortion PillEpisode Number: 293Published: April 13, 2023

[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]

Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We are taping this week on Thursday, April 13, at 10 a.m. As always, news happens fast —really fast this week — and things might have changed by the time you hear this. So here we go. We are joined today by video conference by Victoria Knight of Axios.

Victoria Knight: Good morning.

Rovner: Sarah Karlin-Smith of the Pink Sheet.

Sarah Karlin-Smith: Hi, Julie.

Rovner: And Shefali Luthra of The 19th.

Shefali Luthra: Hello.

Rovner: Well, no interview this week, but spring is busting out all over with health news, so we will get right to it. We will begin in Texas with that court case that we’ve been saying for the last few weeks we hadn’t gotten a decision in. Well, we got a decision last Friday night around dinnertime and then very early this morning — that’s Thursday — we got an appeals court decision, too. But let’s take them one at a time. Last Friday night, in an opinion that was shocking but not surprising, as many people put it, Trump-appointed federal District Judge Matthew Kacsmaryk effectively rolled back the Food and Drug Administration’s 22-plus-year-old approval of mifepristone; that’s the first of two pills used for medication abortion early in pregnancy. Literally within the hour, federal District Judge Thomas Rice in Spokane, Washington, ruled in a separate case — brought by a group of about a dozen and a half state attorneys general — basically the opposite, ordering the FDA not to alter the current availability of the drug. Judge Kacsmaryk in Texas very kindly stayed his stay until this Friday to allow the Biden administration to appeal to the also very conservative 5th Circuit Court of Appeals. And in the wee hours of today, Thursday, an appeals court panel ruled that, while this lawsuit proceeds, mifepristone can continue to be sold, but only under the extremely onerous restrictions that were in effect until 2016. Shefali, where does that leave us? It’s kind of a mess, isn’t it?

Luthra: It is a huge mess, and the implications will be really significant. In particular, the 2016 restrictions on mifepristone don’t allow telemedicine. You have to go in person to a doctor to get the medication, and you can only use it up to seven weeks of pregnancy, when all of the evidence we have, including from the World Health Organization, says 10 weeks, sometimes maybe even 11. And I mean, we know realistically that people are taking mifepristone far later in pregnancy now because they can’t access legal abortion. And what this is going to do if it takes effect is it’s going to put a real strain on abortion clinics in states that have become destinations, right? The ones that are seeing so many out-of-state patients that largely do medication abortions because it’s easier, it’s faster, it pays a little bit better — all of these reasons that you do it —and that have really come to rely on telemedicine: Either they will have to take much longer to do this process and only do it for a handful of the patients they’re seeing, or they’ll switch to what we’ve talked about before, the misoprostol-only regimen, which is more painful, which is less effective. Still very good at terminating a pregnancy, but has a higher failure rate. And what clinics have told me is very often they expect that patients, when they hear that these are their options, will opt for a procedural abortion instead because that they know will absolutely work and they have to go home. They don’t worry about coming back to the clinic and worrying that they need an abortion again.

Karlin-Smith: I just want to put in the caveat that, you know, off-label use, which is where doctors prescribe a drug for use not approved for FDA, is something they do have sort of the discretion to do in practice of medicine once the product’s available. So the rollback is significant, but practically a lot of doctors will have the flexibility to still treat patients up to the longer timeframe. And people have pointed out this morning that, actually, many doctors were doing that prior to FDA formally expanding the approval.

Luthra: And to your point, many states have been stocking up on mifepristone in particular, and so have many abortion clinics, and they plan to use it as long as they can. The real challenge, I think, will be if there are supply issues at some point or other sorts of decisions from the Supreme Court, etc., or enforcement actions that essentially don’t allow telemedicine anymore.

Rovner: What it looks like the 5th Circuit has done is made it much harder for people in states where there are abortion bans to go to other states or to not go to another state but get the abortion pill, because they’ve banned it by mail; they’ve basically stopped in its tracks what we’ve been talking about for weeks — the ability of pharmacies to start to distribute it — because until 2016 you had to go — the doctor had to physically hand you the pill, which is what we are back to, and there have to be three visits in order to complete a medication abortion. These were all sort of the pre-2016 requirements. And the big question, though, is in Washington state, the requirement was that the FDA not change any of the relaxed restrictions. And now the 5th Circuit has said, yes, you will. So this still is on a fast track to the Supreme Court, right?

Luthra: It feels very like this is going to be decided by the Supreme Court. I mean, I wouldn’t be surprised if we hear about an appeal today. I wouldn’t be surprised if we hear about it tomorrow. It feels like really this could have changed between us taping and the podcast releasing.

Rovner: I think that’s entirely possible. So one of the things we thought Judge Kacsmaryk might do was order the FDA to basically restart its approval process for mifepristone, since his reasoning for rescinding essentially the drug’s approval is that the FDA violated its own procedures. Ironically, this decision came in a week when the FDA did withdraw the approval of a drug, a medication to prevent preterm birth called Makena. Sarah, what’s this drug and why is the FDA pulling it off the market? And this is how it’s supposed to work, right?

Karlin-Smith: Yes — supposed to work maybe is a stretch, depending on how some people felt about Makena; they felt it took way too long for FDA to withdraw it. So two sides of a coin, I suppose. But after a very long process, FDA finally pulled a drug that is given to women with the idea that it might help them deliver later, once their baby was full term, and prevent complications that come from having a premature birth. Unfortunately, over the years, as more clinical research was done on the drug, it appeared that it was not actually doing that. And as like all drugs, there are some side effects. And FDA basically ended up deciding, you know, absent any benefit, all you have is risk and this drug should not be pulled off the market. So it was finally pulled off the market after quite a lengthy process this week, right? It was still this week, or was it — no, it was last week.

Rovner: I think it was last week.

Karlin-Smith: Time. Time —

Rovner: Time is a very flat circle right now.

Karlin-Smith: Yeah, and so unfortunately it was really the only approved product that could possibly prevent preterm birth. And FDA really tried to recognize that and understand that people would be frustrated without options. But they tried to really emphasize the point that having an ineffective option is not the answer to that problem. The answer there is sort of push for more research on other products or even on this product to figure out if there’s a population of women it might benefit.

Rovner: So I wanted to mention that, because obviously the mifepristone ruling has the impact to affect much, much more than just abortion drugs. Individual drug companies are, to use the vernacular, freaking out about the idea that they could spend millions of dollars to shepherd a drug through clinical trials and the FDA approval process, only to see it banned because some small group of people object to it for some non-medical reason. Sarah, you cover the FDA. Is this freakout warranted right now?

Karlin-Smith: I do think most people think it is. And, you know, even in my preliminary look at what the 5th Circuit did this morning, I think that freakout is still going to continue because they seem to still give like this wide breadth that would allow many people to have the ability to challenge FDA approval decisions for any drug and then let judges weigh in who may not have the expertise and based on the science and all that other stuff that FDA has. So I think as this case has proceeded there’s still this underlying threat to the FDA’s authority and how they make decisions. Again, in the Texas case, he wasn’t trying to push it back to FDA and say, “OK, FDA, you go review this drug and decide again whether it needs to do it,” and then, you know, set them up for a Makena-like process where they would have to go through it. You know, they were trying to fast-track and overrule FDA’s authority. And if you read some of the details of the brief, you can really understand why it freaks out pharma and the FDA so much, because you can just tell how little the judge gets about how drugs are approved, the science, the regulatory process, and so forth.

Rovner: And basically that you have judges who are making medical and scientific decisions for which they are observably not qualified.

Karlin-Smith: Right, and I mean if nothing else industries likes stability, they like predictability, so there’s just this element of incredible unpredictability when you would have all these judges and potential legal cases throughout the country that would make it hard for them to deal with — and figuring out how to defend their products.

Rovner: So the FDA is obviously in an impossible situation here. They cannot satisfy both the Washington decision and the Court of Appeals decision because one says you can’t roll it back and one says you have to roll it back. Do we have any idea what the FDA is going to do here?

Luthra: I don’t know that we do. I mean, the Biden administration has said that they will follow the court orders, but the court orders are in conflict. So it seems like there should be some more clarity, perhaps, that we get. We, as of taping, haven’t gotten any statement from the president or the vice president or HHS, so we’ll keep an eye out and see if they have even just words of wisdom to offer about what this means or how they feel about the decision. But at this point, a lot is still quite confusing.

Rovner: So the Biden administration did take other action on abortion this week, in some separate steps. It announced Wednesday a series of new privacy protections for women and providers seeking or giving reproductive health care. How big a deal are these new rules, which sort of expand the HIPAA privacy rules? And why did it take them almost a year to do this? Hadn’t they been talking about this like right after the Dobbs ruling?

Luthra: They had been talking about this for a while. And what they said was that they believed that the guidance they had given to providers was sufficient to protect patient privacy. That has clearly not been the case, because we have continued to hear from people seeking abortions and from the health care providers giving them that they do not feel safe, right? They constantly have this fear that if I put something in someone’s medical record about an abortion, someone else might see it and it could get reported. So this should make that very clear beyond the guidance that was given out last summer — should make very clear that if you get an abortion, your doctor does not have to and should not tell any law enforcement about what happened. I think this has the potential to be really significant because one thing that we hear constantly from the people who are traveling out of state is they are terrified that they are breaking the law and that someone is going to find them, even though —

Rovner: That they’re breaking the law of their home state.

Luthra: Mm-hmm. Even though, of course, the home state laws do not criminalize the people who are seeking abortion.

Rovner: Yes. Well, I want to turn to the politics before we leave all of this. Democrats at all level of government were quick to decry this decision as wrong, anti-democratic, small d, and various other things. Republicans were a lot slower to react. How big a problem is abortion becoming for the Republican Party? They seem to be getting even more split on, “Gee, we thought that maybe overturning Roe was what we wanted and we were going to leave it at that.” And apparently anti-abortion activists are not leaving it at that.

Luthra: I mean, I think a great example of how Republicans are trying to navigate this problem is Congresswoman Nancy Mace, who, we may all recall, the day that Roe was overturned, put out a statement, like so many Republicans, saying that this was a great decision, very good for the country, the right step forward — and has since then tried very deliberately to walk away from that and to recalibrate her image on abortion and was one of the ones to come out this week and denounce the opinion from the District Court in Texas. Republicans who are willing to praise the decision in particular to take medication abortion off the market or to further restrict it, which is so unpopular, are finding themselves in a really tough spot. This is a winning issue for them and all they can really hope, and what we saw in the midterms, is to not talk about and to try and change the subject to something else.

Knight: I think important to note also that there were a good number of Republicans in Congress — think it was 69 — that signed on to an amicus brief both supporting the original lawsuit, this Texas lawsuit, and then also this decision when it came out.

Rovner: Right. This is an amicus brief to the Court of Appeals urging them to uphold the original decision.

Knight: Yeah. There were two amicus briefs , and a good number of congressional Republicans. — yeah, first for the original court case and then for the Appeals. But it was very noticeable that most of the Republican offices did not issue any kind of statement when this decision came out last week. So they’re fine supporting, putting documentation forward, supporting it, but they’re not broadcasting it, if that makes sense. And so I think that was very telling. It really was only Sen. Cindy Hyde-Smith, who is the Senate lead of the Pro-Life Caucus, that put something out. But it was very quiet among the rest of the Republicans, yeah.

Rovner: I noticed with that amicus brief, it’s like, OK, they’re going to say on the down-low to the anti-abortion activists, “We’re with you, but we really don’t want to publicize this because it’s not terribly popular with a lot of people.”

Luthra: To build on that, one example of someone who is really trying to walk that line and seems like is maybe facing challenges is Ron DeSantis, right? The person who did this compromise ban last year, the 15-week abortion ban, and now has clearly realized that if you want to be a nationally prominent Republican with support from the very powerful anti-abortion movement, you can’t do that; you need to be more overt in your disapproval of abortion and willingness to restrict access. But at the same time —

Rovner: Well, you’re anticipating my next question, which is that there is other abortion news this week. And in Florida, the legislature seems like it’s on the cusp of approving a six-week abortion ban to supplant the 15-week abortion ban it passed last year. And the aforementioned governor DeSantis says he will sign that if it comes to him. But Shefali, you’ve written about this. This could impact a lot more than just the people of Florida, right?

Luthra: I think it’s really important to note that Florida is the third-biggest state in the country and currently the biggest state in the eastern south part of the country where abortion is legal, even if it is only available up to 15 weeks. I have been to the clinics in Florida. It is stunning how crowded they are. There are people coming from all over the South. People are working until midnight to try and see every patient they can. And without Florida, the options are North Carolina and South Carolina. South Carolina clinics, there are very few of them, and they don’t go very far, not because of current state laws, but just because of the providers in the state. North Carolina is also looking likely to have some kind of abortion ban passed this year and again has way fewer clinics than Florida. If Florida is banning abortion after six weeks, a very, very large chunk of the country is going to be almost entirely displaced. The math just doesn’t really work. And we don’t know where people will be able to get abortions other than traveling, frankly, to Virginia, to D.C., to New York, and to all the places that so far, data shows, haven’t been as affected by out-of-state travelers.

Rovner: And of course, with the Court of Appeals decision basically saying that you can’t mail the abortion pills and that you can’t do it by telemedicine, I mean — which is not to say that people aren’t going to continue to get them by mail. It’s just that it won’t be FDA-sanctioned the way it was going to be. So Idaho is also making abortion news. This this feels like an afterthought, even though last week it seemed like a big deal. They have enacted a bill there creating the crime of abortion trafficking, which is the act of any adult transporting a minor for an abortion without her parent’s consent. Now, in the late 1990s and the early aughts, Republicans in the U.S. Congress tried unsuccessfully to pass something called the Child Custody Protection Act, which would have criminalized taking a minor across state lines for an abortion. But Idaho can’t do that. Only the federal government can regulate interstate travel. So this Idaho law just applies to the in-state portion of the trip. But it could still be a big deterrent, right? Unless you live right on the border. If you’re trying to take somebody out of state, you’re going to have to do part of it in state.

Luthra: I mean, of course. And I mean, Julie, I wanted to ask you about this because this is not actually a new kind of restriction. There are a bunch of states that have passed these, quote-unquote, “child trafficking laws” that restrict minors traveling out of state for abortion. Idaho is the first one to do it post-Dobbs. But for some reason, the anti-abortion movement has always had far more success in restricting access to minors. I think we’re all paying more attention now because we realize that this could in fact be the first step toward that thing that Justice Kavanaugh said would not happen, right? The larger-scale restriction of travel out of state for abortions.

Rovner: Yes. Restricting abortion for minors has been sort of the soft spot for the anti-abortion movement, really from the very beginning, because even people who consider themselves in favor of abortion rights, as we’ve seen this year with books — you know, parents are really like, “We want to be in charge of our daughters, and if my daughter needs my permission to get her ears pierced, she should need my permission to get an abortion or, God forbid, travel out of state or get contraception.” This is actually — it’s the minor issue that’s the reason that the Title X, the Family Planning Program, has not been reauthorized by Congress since 1984, which was before I started covering it. Oh, it’s my favorite piece of reproductive health trivia, because every time Congress tried to do it they got hung up over this question of should minors be able to get contraception without their parents’ approval. It is a continuing thing, but I think Idaho probably got more attention because they call this “abortion trafficking,” so we have a new law. All right. Well, there actually is other news this week that does not have to do with abortion. Congress next week will return from its two-week Easter/Passover break. And apparently at the top of the agenda in the Senate is a bill focusing on drug prices and particularly on pharmacy benefit managers. Even the Republican-led House is looking at PBM legislation. Sarah, remind us, what are PBMs and why are they so very unpopular among both Democrats and Republicans?

Karlin-Smith: So PBMs are companies contracted by your health insurance company or now, at this point, often owned by your health insurance company, that administer your pharmacy benefits, and they create the formularies that decide what drugs are covered and how much you are going to pay for them. And then they negotiate deals with pharmaceutical companies to try and lower the prices of drugs. And they also have to work with the pharmacies. So they’re called middlemen, often in a not very nice way. The drug industry has definitely tried to paint them as the key reason prices are too high, saying they give them discounts but they’re not passing them on to patients. It’s a bit more complicated than that. PBMs essentially say they do pass on that money to patients in the U.S. system but it ends up lowering everybody’s premiums, so not necessarily the person who’s paying for the high-cost drug. Of course, it’s a lot more complicated, because this is an industry, I think, surrounded by a lack of transparency. So it’s been hard for people, I think, to verify who’s getting that money and is it all really going to patients? And then, like I mentioned, this consolidation with health insurance companies, with parts of the pharmacy system as well, has started to raise a lot of kind of antitrust concerns and, again, that they may not be working in patients’ best interests.

Rovner: And a lot of this legislation is about transparency, right? It’s about sort of opening the black box of how PBMs set drug prices and negotiate with drug companies and pass these things along to insurers. I see you nodding, Victoria.

Knight: Yeah, and there’s a lot of different bills floating out there. There’s some that have passed out of committee in previous Congress that passed out of committee again, most notably a Senate Commerce bill — Chuck Grassley and Maria Cantwell — and that just passed out of committee, and that would implement some transparency measures, also ban the practice of spread pricing. There is some talk that Schumer may put a health package on the floor sometime soon, and so PBMs are going to potentially be a big part of that. There’s also supposed to be a markup sometime this month out of the Health, Education, Labor, Pensions Committee, where they also are talking about PBMs. So it’s interesting that there is a real movement on both sides of the aisle, also in the House, on PBMs. So they want to put some blame on high drug prices on someone. And right now it seems to be PBMs.

Rovner: And it looks like they’re going to go after insulin again, too, right? In the bill that passed last year they managed to cap insulin costs at $35 a month, but only for people on Medicare. So I guess this is the attempt to come back and require lower insulin prices for others. We will point out that many of the companies have voluntarily lowered some insulin prices, but looks like Congress not done with this yet, right?

Knight: No, it’s not done with it yet. Bernie Sanders is apparently going to haul some insulin execs in to have to testify, even though some of them have committed to lowering prices. And it’s also mentioned in the potential Schumer package, that $35 cap for everyone is supposed to be a part of it. And there’s also a lot of insulin $35-cap bills floating around. There is some Republican support in the Senate for that. There were some Republicans last year that voted for that. But I think the House will be the bigger issue, because there doesn’t seem to be as much Republican support in the House for a cap that extends to everyone.

Rovner: Yeah, but I mean, when we said sort of back in January that there might be some things that they could do on a bipartisan basis, it sounds like we’re starting to see some of them — now that it’s spring — blooming. So anything else that you are looking for this next session between, you know, Easter and Memorial Day?

Knight: I think also, I don’t know how much people are paying attention to this, but there is going to be one of those select subcommittee covid hearings next week and they’re bringing in some intelligence officials to talk about covid origins. So I think this is the first hearing with actual, like, intelligence officials. So I think it’ll be interesting to see what comes out of that. And obviously, there’s a lot of talk around, like, that practical policy implications are that Congress could kind of restrict NIH [National Institutes of Health] funding or how NIH gives out research funding because of all this talk around gain-of-function research in regards to covid origins. So I think that’s what we’re watching for rather than just the rhetoric around it, like what are the actual — how could it play out in regards to NIH funding? And then of course, can’t forget debt ceiling negotiations and work requirements are still very much being talked about.

Rovner: For Medicaid.

Knight: For Medicaid and also SNAP [Supplemental Nutrition Assistance Program] potentially. So there was reporting this morning from Punchbowl saying that work requirements are very much still in the proposals that are being kicked around. So, another thing to watch.

Rovner: May is traditionally a very busy month on Capitol Hill, particularly May of the odd-numbered year, the first year of a Congress, so I imagine we’ll see a lot. One last thing I want to talk about this week, and we haven’t talked about it for a while, but the toll of gun injuries just continues to mount. In the past three weeks, we’ve had mass shootings with multiple fatalities in Tennessee, Kentucky, and Florida. In Louisville, in fact, the mayor, who himself survived a mass shooting last year, lost a close friend in the shooting this week. So it’s not all that surprising that a new poll from my colleagues over the editorial firewall at KFF found that gun violence is so common that more than one in five Americans say they have personally been threatened by a gun. Nearly as many say a family member has been killed by a gun; 17% say they have personally witnessed someone being shot. The numbers are even worse for people of color. Nearly a third of Black adults have witnessed someone being shot, and more than a third have lost a family member to gun violence. We seem to have acknowledged finally that gun violence is a public health problem. Yet that hasn’t brought us any closer as a society to solving it. I mean, we were just talking about the things that Congress might be looking at in terms of health care in the spring. But gun violence isn’t really one of them, is it?

Knight: Yeah. I think you’ve seen from the Biden administration and acknowledgment from both sides of the aisle in Congress that the bipartisan bill that passed last year, which gave a lot of money towards mental health funding and also allowed states the option to implement red flag laws and some other smaller gun safety things. They kind of acknowledged that’s as far as they’re going to be able to go in the current makeup of this Congress. So it seems like a stalemate and it’s kind of like now on a state level. And there was some talk from Tennessee’s governor about doing some small things, perhaps after the shooting in Nashville, but it doesn’t seem like there is much movement.

Rovner: And of course, in Tennessee, it was fighting about not doing anything about guns that erupted in that whole conflagration with people getting —

Knight: — expelled —

Rovner: —evicted from the Tennessee state legislature and then reappointed and yeah, I mean, that — people may not remember, that’s actually over a gun demonstration or a lack-of-gun-legislation demonstration. So who knows whether anyone will find something to do about it. All right. That is the news for this week. Now it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at khn.org and in our show notes on your phone or other mobile device. Sarah, why don’t you go first this week?

Karlin-Smith: Sure. I looked at an NBC News story called “Conspiracy Theorists Made Tiffany Dover Into an Anti-Vaccine Icon. She’s Finally Ready to Talk About It.” This was a nurse who was one of the first people to receive a covid vaccine when it first became available. And apparently, I guess, this is something that’s been a problem for her, she says, throughout her whole life. Sometimes with certain pain reactions she faints. And the story also talks about how she hadn’t really eaten lunch that day. But basically it was filmed and shared quite widely, including all over social media, and anti-vaccine activists basically took it and were using it sort of as proof of the harm caused by the vaccines. And the reaction to that from the hospital, and herself to some degree, was basically to just kind of keep quiet and not respond. There was very little pushback, yet — the idea was kind of if we ignore it, it will go away. But that just kept fueling everything. And basically people thought she might have even been dead and no one was telling. They thought the hospital was using her co-worker as sort of a body double to show proof of life. And a couple of years later, she’s finally trying to talk about what that experience was like and make clear again: She was fine, she was healthy, you know, she was more than happy to get the vaccine, you know, would do it again and stuff. But it’s a really interesting story because I think the journalists sort of go through again how we’ve been sort of grappling as a society with how to respond to this type of misinformation and how some of the normal kind of PR playbook strategies are actually hurting, not helping, public health. So we need to kind of shift to figure out how to handle that.

Rovner: And there are lots and lots and lots of these stories about people who, you know, quote-unquote, “died” when they got the vaccine, who are perfectly fine and walking around. It was — it was a really well done story. It’s just — it’s really kind of scary. Victoria.

Knight: Victoria, my extra credit this week is a story in The Washington Post by David Willman and Joby Warrick. It’s called “Research With Exotic Viruses Risks a Deadly Outbreak, Scientists Warn.” And so it’s basically kind of an in-depth look at how, over the years, the U.S. has funded virus research where — in other countries — where people go out into like forests and wildlife areas and collect bat samples, collect samples from different animals to try to kind of predict the next pandemic. And it profiles this one team in Thailand who has said, “We’re not accepting U.S. funds anymore.” They told the U.S. in 2021 after covid, “This feels too risky for us.” And we — they have been doing this research funded by the U.S. for four years, and they really felt like they hadn’t found much tangible benefit out of it either. So they’re kind of like, “It’s not worth the risk to our employees and potentially creating another pandemic on our own.”

Rovner: And and just to be clear, this isn’t gain-of-function research.

Knight: This is not even gain-of-function research.

Rovner: This is a different kind of potentially dangerous research.

Knight: Yeah, this is really just going out in the wild and collecting samples from animals that are out there already. But yeah, it’s not doing research in a lab that’s like altering a virus necessarily. So yeah, and so the story is kind of reckoning — like what is the balance between wanting to do scientific research and needing that knowledge for the future and the safety of employees and the general public. So, and it talked about how there is like — the U.S. does fund quite a bit of this kind of research around the world, and the pace of that has not always kept up with regulation and oversight. And so just kind of probing questions, especially as I talked about earlier — Congress does look into this issue of gain-of-function research and just the NIH funding research around the world in general.

Rovner: I feel like this whole week has been, where do government and science cross? Shefali.

Luthra: My story is from the well-named KFF Health News. It is called “For Uninsured People With Cancer, Securing Care Can Be Like Spinning A Roulette Wheel.” It’s by Charlotte Huff. It’s a really, really great look at what happens when you get cancer and in particular live in a state that didn’t expand Medicaid. Charlotte just does a really great job looking at the experiences that this woman has when she develops skin cancer and is recommended all these treatments that she can’t afford. She lives in South Carolina. She’s not eligible for Medicaid because they didn’t expand eligibility. And what it really gets into is the idea that there are a couple of cancers where you will get treatment, but for most of them, you will not get coverage; you have to pay thousands, sometimes tens of thousands out-of-pocket. And it’s a really well done, devastating look at what health care costs mean in our system and how much access really is for so much of health care based on where you happen to live.

Rovner: Yeah, it really is — really wonderful story. Well, my story, it’s also from The Washington Post, and it’s called “To Comply With a New Sesame Allergy Law, Some Businesses Add — Sesame,” by Karen Weese. So back in 2004, I covered the deliberation and passage of the Food Allergen Labeling and Consumer Protection Act, which for the first time required companies to put on the label in plain English if their products contained any of the eight major food allergens, which are milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. It was an enormous relief, particularly to parents of young children with allergies and to anyone with a food allergy that could be fatal. So, the law also required food companies to label whether there was a chance that the product could have been cross-contaminated with one of those allergens. That’s why you sometimes see on a label, you know, quote, “This product was produced in a facility that also makes milk products or that uses nuts” or some such thing. The law has worked pretty well, say those who fought for it, and in 2021 Congress added sesame to the list of allergens that had to be labeled. Except that this time something weird happened. Many food companies, rather than carefully cleaning and monitoring their plants to ensure there would be no cross-contamination with sesame, instead are basically evading the law’s intent by adding small amounts of sesame flour to their products and then putting on the label that “This product contains sesame.” It’s dangerous for a lot of reasons but mainly because for people with sesame allergies who have eaten certain products without problems for years, they may not realize that, to them at least, a poison has been added to their favorite bread or roll or whatever kind of product. So this is something that I imagine Congress is going to want to go back and take a look at. All right. Before we go this week, you may have noticed that the introduction to the podcast has been tweaked. That’s because we have a new name. Kaiser Health News has been retired as of this week. We are KFF Health News to reflect that we are an editorially independent program of KFF, also a new name, and that neither of us is connected in any way to that big HMO [health maintenance organization] Kaiser Permanente. I hope you will bear with us as we all get used to the change. OK, that is our show. As always, if you enjoyed the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks, as always, to our ever-patient producer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me, at least for the moment. I am still @jrovner. Victoria?

Knight: @victoriaregisk.

Rovner: Sarah?

Karlin-Smith: @SarahKarlin.

Rovner: Shefali.

Luthra: @shefalil.

Rovner: We will be back in your feed next week. Until then, be healthy.

Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News’ ‘What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).

[UPDATED on April 18]

The new drug looked so promising — except for that one warning sign.

At the American College of Rheumatology’s annual meeting in 2008, Duke University’s Dr. John Sundy proudly announced that pegloticase, a drug he’d helped develop, was astoundingly effective at treating severe gout, which affects perhaps 50,000 Americans. In about half of those who had taken it, the drug melted away the crystalline uric acid deposits that encrusted their joints to cause years of pain, immobility, or disfigurement.

But Sundy also disclosed an unsettling detail: In one clinical trial, patients who got the drug were more likely to develop heart problems than those who didn’t. The day after Sundy’s talk, the stock price of Savient Pharmaceuticals, which developed the drug with Duke scientists, plunged 75%.

That danger signal would disappear in later studies, and the FDA approved pegloticase, under the trade name Krystexxa, two years later. But the small biotech company never recovered. In 2013, Savient was sold at auction to Crealta, a private equity venture created for the purpose, for $120 million.

Two years later, a young company now called Horizon Therapeutics bought Crealta and its drug portfolio for $510 million.

Even at that price, it proved a good deal. Krystexxa brought in $716 million in 2022 and was expected to earn $1 billion annually in coming years.

Although Horizon says it now has 20 drugs under development, in its 15 years of existence it has yet to license a product it invented. Yet the company has managed to assemble a war chest of lucrative drugs, in the process writing a playbook for how to build a modern pharmaceutical colossus.

As the White House and both parties in Congress grapple with reining in prescription drug prices, Horizon’s approach reveals just how difficult this may be.

Horizon’s strategy has paid off handsomely. Krystexxa was just one of the many shiny objects that attracted Amgen, a pharmaceutical giant. Amgen announced in December that it intends to buy Horizon for $27.8 billion, in the biggest pharmaceutical industry deal announced in 2022.

Horizon’s CEO, Tim Walbert, who will reportedly get around $135 million when the deal closes, has mastered a particular kind of industry expertise: taking drugs invented and tested by other people, wrapping them expertly in hard-nosed marketing and warm-hued patient relations, raising their prices, and enjoying astounding revenues.

He’s done this with unusual finesse — courting patients with concierge-like attention and engaging specialist clinicians with lunches, conferences, and research projects, all while touting his own experience as a patient with a rare inflammatory disease. Walbert’s company has been particularly adept at ensuring that insurers, rather than patients, bear the costly burdens of his drugs.

A federal prosecutor in 2015 began examining allegations that Horizon’s patient assistance program had worked with specialty pharmacies to evade insurers’ efforts to shun Horizon’s expensive drugs. A separate probe opened in 2019 over alleged kickbacks to pharmacy benefit managers, companies that negotiate to get Horizon’s drugs covered by insurers. Those investigations appear to be no longer active, Horizon spokesperson Catherine Riedel said. The company this year disclosed a third probe, concerning methods the company allegedly used to get prior authorization of its drugs. Justice officials did not respond to requests for comment on the investigations.

An Injection of Marketing

To help sell its drugs, Horizon blankets specialist physicians with marketing and peer-to-peer appeals. Its payments to physicians for things like consulting, speeches, and meals totaled $8.7 million in 2021, compared with the $10 million it paid them for research, federal records show. By contrast, Seagen, a biotech company of roughly the same size, paid doctors a total of $116 million, with nearly $112 million of that pegged for research. Riedel said Horizon’s marketing and educational approaches were “necessarily unique” because of the challenges of treating rare and neglected diseases.

Walbert launched Horizon in 2008 in the Chicago area by combining and refashioning generic drugs into single pills. Duexis, Horizon’s first drug, is a mixture of generic Motrin and Pepcid. Its Vimovo combines generic Aleve and Nexium. In a 2017 article, a ProPublica reporter described being prescribed Vimovo for a shoulder injury. It cost him nothing, but his insurer was billed $3,252 for pills that together cost about $40 for a month’s supply in generic form. Horizon sold more than $57 million worth of Vimovo that year.

In 2014 and 2015, respectively, Horizon picked up two relatively new drugs that had no generic versions: the immunosuppressant Actimmune and Ravicti, which treats a rare genetic disorder. Soon Horizon was charging more than $50,000 a month for each, placing Actimmmune fourth and Ravicti second on GoodRx’s 2020 list of the most expensive U.S. drugs.

Horizon’s net sales soared from $20 million in 2012 to $981 million in 2016; Walbert’s pay package followed suit, topping an astronomical $93.4 million in 2015 in salary and stock. Stock analysts questioned the long-term soundness of a strategy of simply selling old drugs for mind-boggling prices, but Walbert was using the cash to refashion the company as a rare-diseases franchise.

His approach would make Walbert a darling of pharmaceutical investors and his board, which lavished him with over $20 million in compensation each of the past three years. While most biotechs and startups borrow heavily from venture capital to do science and have no idea how to develop and market a drug, Walbert got cash coming in quickly. “He did it backwards,” said Annabel Samimy, an analyst at Stifel Financial Corp. “Horizon built commercial platforms before they got into drug development.”

Generating “robust sales of what sounded like not very interesting drugs” allowed Walbert “to start a company on not very much,” said Oppenheimer analyst Leland Gershell. All the while, Horizon funded and cultivated the patient advocacy groups that can help lobby for a drug to be approved by the FDA and placed on insurers’ formularies, the lists of drugs health plans cover for patients.

Speaking From Experience

As Walbert and his spokespeople often point out, Walbert and his youngest son suffer from a rare disease, and Walbert also has an autoimmune disease. Walbert won’t name the diseases, but has said he’s taken the anti-inflammatory injectable Humira since 2003 — the year he led that drug’s commercial launch as a vice president at Abbott Laboratories. Humira has become the bestselling drug in history, with about $200 billion in all-time global sales.

In 2014, Walbert moved Horizon’s headquarters to Ireland, which nearly halved its tax rate. A year later it gained control of Krystexxa, and in 2017 it bought, for $145 million, a failing company that produced Tepezza, a drug for thyroid eye disease, which causes unsightly eye bulging and pain.

Tepezza quickly became a blockbuster, with $3.6 billion in total sales in 2021 and 2022. The company conducted additional clinical research on both Tepezza and Krystexxa, but it also spent heavily promoting these and other drugs to specialists who could prescribe them.

All the while it steadily raised prices. Savient put Krystexxa on the market in 2011 at $2,300 per injection. Horizon charges roughly 10 times as much. Six months of Tepezza treatment can run more than $400,000.

Horizon’s publicity emphasized the company’s sensitivity to patients, and its constant contact with disease advocates.

“Our scientists are attuned to the unmet needs of patients, their diagnostic and therapeutic journey,” Bill Rees, Horizon’s vice president for translational sciences, told KFF Health News. “It’s the marrying of the basic clinical science with a focus on the needs of the patient that differentiates us.”

To make sure patients keep using its drugs, clinicians say, Horizon staffers negotiate with insurance carriers, and the company offers drug discounts to lower-income patients while swaddling them with attention from its medical staff.

“Horizon has a nurse talk to each and every patient before every appointment,” said Dr. Brigid Freyne, who treats around half a dozen patients each year with Krystexxa at her Murrieta, California, rheumatology clinic. “The patients who come in here are highly motivated to get their IV. They get the message that it’s very important and they are fortunate to get the medicine.”

None of the manufacturers of her other infusion drugs shower patients with this kind of attention, she said.

While at Abbott, Walbert pioneered direct-to-consumer advertising for specialty drugs like Humira, a trend that aggravated insurers, who anticipated, correctly, that they would soon be shelling out billions for expensive drugs.

Horizon’s marketing plan for Krystexxa includes direct-to-consumer ads aimed at driving patients to specialists. The drug is designed for recalcitrant gout patients, who often have large lumps on their fingers, feet, and kidneys. Many, though not all, are heavy drinkers of beer or soda sweetened with high-fructose corn syrup, which can increase the buildup of uric acid, the cause of gout, said Dr. Robert McLean of Yale University.

While Krystexxa can help patients with advanced gout, the American College of Rheumatology views it as a drug of last resort, with plenty of cheaper, early intervention alternatives available.

“I prescribe it maybe once a year,” McLean said. “From a cost-effectiveness standpoint, it warrants questioning.”

Horizon recently started a publicity campaign addressed to all gout sufferers, urging them to see a rheumatologist or a nephrologist — the specialists it has targeted with Krystexxa educational materials — before the disease does too much harm.

“Horizon would like you to say, ‘Everyone with serious gout should be started on Krystexxa,’” said Dr. James O’Dell, a rheumatologist at the University of Nebraska Medical Center. The Horizon pitchmen he deals with are “nice guys, but we don’t believe that’s the best way.”

The company defends its marketing practices. “We learn what matters most to patient communities and act. This approach has been validated by independent third-party research,” said Riedel.

The Federal Trade Commission said in January it was seeking more information on the Amgen-Horizon merger. Sen. Elizabeth Warren (D-Mass.), citing high prices for Horizon and Amgen drugs, urged the agency to nix the deal.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

USE OUR CONTENT

This story can be republished for free (details).