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Good morning. It’s Wednesday, which means it’a also “The Bear” season 3 premiere day. For my Boston readers, know that Ayo Edebiri has been thinking deeply about the tragedy of the Great Molasses Flood of 1919.

Read the rest…

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 unanimous Supreme Court turned back a challenge to the FDA’s approval and rules for the abortion pill mifepristone, finding that the anti-abortion doctor group that sued lacked standing to do so. But abortion foes have other ways they intend to curtail availability of the pill, which is commonly used in medication abortions, which now make up nearly two-thirds of abortions in the U.S.

Meanwhile, the Biden administration is proposing regulations that would bar credit agencies from including medical debt on individual credit reports. And former President Donald Trump, signaling that drug prices remain a potent campaign issue, attempts to take credit for the $35-a-month cap on insulin for Medicare beneficiaries — which was backed and signed into law by Biden.

This week’s panelists are Julie Rovner of KFF Health News, Anna Edney of Bloomberg News, Rachana Pradhan of KFF Health News, and Emmarie Huetteman of KFF Health News.

Panelists

Anna Edney
Bloomberg

@annaedney

Read Anna's stories.

Emmarie Huetteman
KFF Health News

@emmarieDC

Read Emmarie's stories.

Rachana Pradhan
KFF Health News

@rachanadpradhan

Read Rachana's stories.

Among the takeaways from this week’s episode:

• All nine Supreme Court justices on June 13 rejected a challenge to the abortion pill mifepristone, ruling the plaintiffs did not have standing to sue. But that may not be the last word: The decision leaves open the possibility that different plaintiffs — including three states already part of the case — could raise a similar challenge in the future, and that the court could then vote to block access to the pill.
• As the presidential race heats up, President Joe Biden and former President Donald Trump are angling for health care voters. The Biden administration this week proposed eliminating all medical debt from Americans’ credit scores, which would expand on the previous, voluntary move by the major credit agencies to erase from credit reports medical bills under $500. Meanwhile, Trump continues to court vaccine skeptics and wrongly claimed credit for Medicare’s $35 monthly cap on insulin — enacted under a law backed and signed by Biden.
• Problems are compounding at the pharmacy counter. Pharmacists and drugmakers are reporting the highest numbers of drug shortages in more than 20 years. And independent pharmacists in particular say they are struggling to keep drugs on the shelves, pointing to a recent Biden administration policy change that reduces costs for seniors — but also cash flow for pharmacies.
• And the Southern Baptist Convention, the nation’s largest branch of Protestantism, voted this week to restrict the use of in vitro fertilization. As evidenced by recent flip-flopping stances on abortion, Republican candidates are feeling pressed to satisfy a wide range of perspectives within even their own party.

Also this week, Rovner interviews KFF president and CEO Drew Altman about KFF’s new “Health Policy 101” primer. You can learn more about it here.

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

Julie Rovner: HuffPost’s “How America’s Mental Health Crisis Became This Family’s Worst Nightmare,” by Jonathan Cohn.

Anna Edney: Stat News’ “Four Tops Singer’s Lawsuit Says He Visited ER for Chest Pain, Ended Up in Straitjacket,” by Tara Bannow.

Rachana Pradhan: The New York Times’ “Abortion Groups Say Tech Companies Suppress Posts and Accounts,” by Emily Schmall and Sapna Maheshwari.

Emmarie Huetteman: CBS News’ “As FDA Urges Crackdown on Bird Flu in Raw Milk, Some States Say Their Hands Are Tied,” by Alexander Tin.

Also mentioned on this week’s podcast:

• Bloomberg News’ “Dozens of CVS Generic Drug Recalls Expose Link to Tainted Factories,” by Anna Edney and Peter Robison.
• KFF Health News’ “Biden Plan To Save Medicare Patients Money on Drugs Risks Empty Shelves, Pharmacists Say,” by Susan Jaffe.
• KFF Health News’ “More States Legalize Sales of Unpasteurized Milk, Despite Public Health Warnings,” by Tony Leys.

click to open the transcript

Transcript: SCOTUS Rejects Abortion Pill Challenge — For Now

KFF Health News’ ‘What the Health?’ Episode Title: ‘SCOTUS Rejects Abortion Pill Challenge — For Now’Episode Number: 351Published: June 13, 2024

[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.] 

Mila Atmos: The future of America is in your hands. This is not a movie trailer and it’s not a political ad, but it is a call to action. I’m Mila Atmos and I’m passionate about unlocking the power of everyday citizens. On our podcast “Future Hindsight,” we take big ideas about civic life and democracy and turn them into action items for you and me. Every Thursday we talk to bold activists and civic innovators to help you understand your power and your power to change the status quo. Find us at futurehindsight.com or wherever you listen to podcasts.

Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for 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, June 13, at 10:30 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 Anna Edney of Bloomberg News.

Anna Edney: Hi there.

Rovner: Rachana Pradhan of KFF Health News.

Rachana Pradhan: Hello.

Rovner: And Emmarie Huetteman, also of KFF Health News.

Emmarie Huetteman: Good morning.

Rovner: Later in this episode we’ll have my interview with KFF President and CEO Drew Altman, who I honestly can’t believe hasn’t been on the podcast before. He is here to talk about “Health Policy 101,” which is KFF’s all-new, all-in-one introductory guide to health policy. But first, this week’s news.

So, as we tape, we have breaking news from the Supreme Court about that case challenging the abortion pill mifepristone. And you know how we always say you can’t predict what the court is going to do by listening to the oral arguments? Well, occasionally you can, and this was one of those times the court watchers were correct. The justices ruled unanimously that the anti-abortion doctors who brought the suit against the pill lack standing to sue. So the suit has been dismissed, wrote Justice [Brett] Kavanaugh, who wrote the unanimous opinion for the court: “A plaintiff’s desire to make a drug less available for others does not establish standing to sue.” So, might anybody have standing? Have we not maybe heard the end of this case?

Edney: Yeah, I think certainly there could be someone else who could decide to do that. I mean, just quickly looking around when this came out, it seems like maybe state AGs [attorneys general] could take this up, so it doesn’t seem like it’s the last of it. I also quickly saw a statement from Sen. [Bill] Cassidy, a Republican, who mentioned this wasn’t a ruling on the merits exactly of the case, but just that these doctors don’t have standing. So it does seem like there would be efforts to bring it back.

Rovner: This is not going to be the last challenge to the abortion pill.

Edney: Yeah.

Pradhan: Just looking in my inbox this morning after the decision, I mean it’s clear the anti-abortion groups are really not done yet. So I think there’s going to be a lot of pressure, of course, from them. It is an election year, so they’re trying to get, notch wins as far as races go, but also to get various AGs to keep going on this.

Rovner: And if you listen to last week’s podcast, there are three AGs who are already part of this case, so they may take it back with the district court judge in Texas. We shall see. Anyway, more Supreme Court decisions to come.

But moving on to campaign 2024 because, and this seems impossible, the first presidential debate is just two weeks away.President [Joe] Biden is still struggling to convince the public that he’s doing things that they support. Along those lines, this week the administration proposed rules that would ban medical debt from being included in calculating people’s credit scores. I thought that had happened already. What would this do that hasn’t already been done?

Huetteman: Well, last year the big credit agencies volunteered to cut medical debt that’s below $500 from people’s credit reports. Of course, there’s a lot of evidence that shows that that’s not really the way that people get hurt with their credit scores, they get hurt when they have big medical bills. So this addresses a major concern that a lot of Americans have with paying for health care in the United States.

I oversee our “Bill of the Month” project with NPR and I can say that a lot of Americans will pay their medical bills without question, even for fear of harm to their credit score, even if they think that their bill might be wrong. Also, it’s worth noting also that researchers have found that medical debt does not accurately predict whether an individual is credit-worthy, actually, which is unlike other kinds of debt that you’d find on credit scores.

Rovner: So yeah, not paying your car payment suggests what you might or might not be able to do with a mortgage or a credit card. But not paying your surprise medical bill, maybe not so much?

Huetteman: Yes, exactly. Really, we can all end up in the emergency room with a big bill. You don’t get a big bill just because you have trouble meeting your credit card bills or you have trouble meeting your car payments, for example.

Rovner: We’ll see if this one resonates with the public because a lot of the things that the administration has done have not. Meanwhile, President [Donald] Trump, who presided over one of the most rapid and successful vaccine development projects ever, for the covid vaccine, now seems to be moving more firmly into the anti-vax camp, and it’s not just apparently anti-covid vaccine. Trump said at a rally last month that he would strip federal funding from schools with vaccine mandates — any vaccines apparently, like measles and mumps and polio — and he says he would do it by executive order. No legislation required. This feels like it could have some pretty major consequences if he followed through on this. Anna, I see you nodding. You have a toddler.

Edney: Right, right. I was just thinking about that going into kindergarten, what that could mean, and there’s just so many … I mean, even kids don’t have to get chickenpox nowadays. That seems like a really great thing. I don’t know. I mean, I had chickenpox. I think that it could take us backwards, obviously, into a time that we’re seeing pockets of as measles crops up in certain places and things like that. I’d be curious. What I don’t know is how much federal funding supports a lot of these schools. I know there’s state funding, county funding, how much that’s actually taking away if it would change the minds of certain ones. But I guess if you’re in maybe a state that doesn’t like vaccines in the first place, it’s a free-for-all to go ahead and do that.

Pradhan: One of the questions I have, too, is through the CDC [Centers for Disease Control and Prevention] we have the Vaccines for Children Program, which provides free immunizations to children for a lot of these infectious diseases, for children who are either uninsured or underinsured or low-income. And so that’s been a really long-standing program and I’m very curious as to whether they would try to maybe reduce or eliminate a bunch of the vaccines that are provided through that, which obviously could affect a significant number of children nationwide.

Rovner: Yeah, it’s funny, the anti-vax movement has been around for, I don’t know, 20, 25 years; whenever that Lancet piece that later got rescinded came out that connected vaccines to autism. It seems it’s getting a boost and, yes, that’s an intended pun right now. I guess covid, and the doubts about covid, is pushing onto these other vaccines, too.

Edney: I think that we’ve certainly seen that. Before covid, at least my understanding of a lot of the concerns around the behavioral issues and autism linked to vaccines or things like that was more of the left-wing, maybe crunchier people who were seeing it as not wanting to put, in their words, poison in their bodies. But now we’re seeing this also right-wing opposition to it, and I think that’s certainly linked to covid. Any mandate at this point from the government is pushed back against more so than before.

Rovner: Well, we have lots of news this week on drugs and drug prices. Anna, you have quite the story about how trying to save money by buying generic might not always be the best move? As I describe it: the scary story of the week. Tell us about it.

Edney: Yes. Yeah, thank you. Yeah, I did this data dive looking into store-brand medication. So when you go into CVS or Walgreens, for example, you can see the Tylenol brand name there, but next to it you’ve got one that looks a lot like it, but it’s got CVS Health or Walgreens on the name and it costs usually a few dollars less. What I found is that of those store brands, CVS has a lot more recalls than the rest, even though they’re selling these same store-brand drugs. So they have two to three times more recalls than Walgreens and Walmart. And what’s happening is they are more often going to shady contract manufacturers to make their generic products that they’re selling over the counter. I found one that was making kids’ medication with contaminated water. And then the really disturbing one that was nasal sprays for babies on the same machines that this company was using to make pesticides. And just wrote about a whole litany of these kinds of companies that CVS is hiring at a higher rate than the other two — Walgreens and Walmart — that I was able to do the data dive on.

And interestingly, these store brands have a loophole, so they’re not responsible for the quality of those medications, even though their name’s on it. They can just walk away and say, “Well, we put it on the shelves. We agree with that, but it’s up to these companies that are making it to verify the quality.” And so, that’s usually not how this works. Even if there’s contract manufacturers, which a lot of drugmakers use, they usually have to also verify the quality. But store brands are considered just distributors, and so there’s this separation of who even owns the responsibility for this drug.

Pradhan: Yeah, I think a collective reaction reading this. I know, how many people did I text your story to Anna, saying, “Yikes! … FYI.”

Rovner: So on the one hand, you get what you pay for. On the other hand, price is not the only problem that we find with drugs. A new study from the University of Utah Drug Information Service just found that pharmacists are reporting the largest number of drugs in shortage since the turn of the century. And my colleague Susan Jaffe has a story on how some shortages are being exacerbated at the pharmacy level by a new Medicare rule that was intended to lower prices for patients at the counter.

Anna, how close are we to the point where the drug distribution system is just going to collapse in on itself? It does not seem to be working very well.

Edney: Yeah, it does feel that way because I always think of that example of the long balloon and when you squeeze it at one end the other end gets bigger. Because when you’re trying to help patients at the counter, somebody’s taking that hit, that money isn’t just appearing out of thin air in their pockets. So the pharmacists are saying — and particularly smaller pharmacies, but also some of the bigger ones — are saying the way that these drugs are now being reimbursed, how that’s working under this new effort, is they don’t have as much cash on hand, so they’re having trouble getting these big brand-name drugs. It was a really interesting story that Susan wrote. Just shows that you can’t fix one end of it, you need to fix the whole thing somehow. I don’t know how you do that.

And shortages are another issue just of other kinds, whether it’s quality issues or whether it’s the demand is growing for a lot of these drugs, and depending even on the time of year. So I think we’re all seeing it just appear to be disintegrating and hoping that there’s just no tragedy or big disaster where we really need to rely on it.

Rovner: Yeah, like, you know, another pandemic.

Edney: Exactly.

Rovner: There’s also some good news on the drug front. An FDA [Food and Drug Administration] advisory committee this week recommended approval for yet another potential Alzheimer’s drug, donanemab, I think I’m pronouncing that right. I guess we’ll learn more as we go on. The drug appears to have better evidence that it actually slows the progression of the disease without the risks of Aduhelm, the controversial drug approved by the FDA that’s been discontinued by its manufacturer. This would be the second promising drug to be approved following Leqembi last year. When we first started talking about Aduhelm — what was that, two years ago — we talked about how it could break Medicare financially because so many people would be eligible for such an expensive drug. So now we’re looking at maybe having two drugs like this and I don’t hear people talking about the potential costs anymore.

Is there a reason why or are we just worried about other things?

Edney: Well, I think there’s a benefit that they seem to have proven more than Aduhelm. But there’s also still a risk of brain swelling and bleeding, and that I’m sure would factor into someone’s decision of whether they want to try this. So maybe people aren’t exactly flocking in the same way to want to get these drugs. As they’re used more, maybe that changes and we see more of “Can you spot the swelling? Can you stop it?” And things like that. But I think that there just seems to be a lot of questions around them. Also, Aduhelm was the biggest one, which obviously Medicare didn’t cover, and then they’re not even trying to sell anymore. But I think that there’s just always questions about how they’re tested, how much benefit really there is. Is a few months worth that risk that you could have a major brain issue?

Rovner: While we are on the subject of drugs and drug prices, we have “This Week in Misinformation” from former President Trump, who as we all know, likes to take credit for things that are not his and deflect blame from things that are. Now in a post on his Truth Social platform, he says that he is the one who lowered insulin copayments to $35 a month, and that President Biden “had nothing to do with it.” Yes, the Trump administration did offer a voluntary $35 copayment program for Medicare Part D plans, but it was limited. It was time-limited and not all the plans adopted it. President Biden actually didn’t do the $35 copay either, but he did propose and sign the law that Congress passed that did it. It was part of the Inflation Reduction Act. Ironically, President Biden didn’t get all he wanted either. The intent was to limit insulin copayments for all patients, but so far, it’s only for those on Medicare. I would guess that Trump is saying this to try to neutralize one of the few issues that maybe is getting through to the public about something that President Biden did.

Pradhan: Well, I mean, I think even during President Trump’s first term, I mean lowering drug prices, he made it very clear that that was something that was important to him. He certainly wasn’t following the traditional or older Republican Party’s friendliness to the pharmaceutical industry. I mean, he was openly antagonizing them a lot, and so it’s certainly something that I think he understands resonates with people. And it’s a pocketbook issue similar to what’s going on on medical debt that we talked about earlier, right? These new regulations that are being proposed — they may not be finalized, we’ll have to see about that because of the timing — but these are things that are, I think at the end of the day, of course, are very relatable to people. Unlike, perhaps, abortion is a big campaign issue, but it’s not necessarily going to resonate with people in the same way and certainly not potentially men and women in the same way. But I think that there’s much more broad-based understanding of having to pay a lot for medications and potentially not being able to afford it. Obviously, insulin is probably the best poster child for a lot of reasons for that. So no surprise he wants to take credit for it, and also perhaps that it’s not really what happened, so …

Rovner: If nothing else, I think it signals that drug prices are still going to be a big issue in this campaign.

Pradhan: For sure. And I mean Joe Biden has made it very clear. I mean the Inflation Reduction Act of course included other measures to lower people’s out-of-pocket costs for drugs, which he’s very eagerly touting on the trail right now to shore up support.

Rovner: Let’s move on from drugs to abortion via the FDA spending bill on Capitol Hill this week. The annual appropriations bills are starting to move in House committees, which is notable itself because this is when they are supposed to start moving if they’re going to get done by Oct. 1, the start of the next fiscal year. We haven’t seen that in a long time. So last year Republicans got hung up because they wanted their leaders to attach all manner of policy riders to the spending bills, most of them aimed at abortion, which can’t get through the Senate. Well in a big shift, Republicans appear to be backing off of that, and the current version of the bill that funds the Department of Agriculture, as well as the FDA, does not include language trying to ban or further restrict the abortion pill mifepristone. Of course, that could still change, but my impression is that the new [House] Appropriations chairman, [Rep.] Tom Cole, who’s very much a pragmatist, wants to get his bills signed into law.

Pradhan: I do wonder, though, if because of the Supreme Court decision that just came out today, whether that will change the calculation, or at the very least, the pressure that he is under to include something in the FDA bill. But as you know, there’s plenty of time for abortion riders to make it in or out. I feel like this is, it’s like Groundhog Day. Usually something related to abortion policy will upend various pieces of legislation. So I’ll be curious to be on the lookout for that, whether it changes anything.

Rovner: Anna, were you surprised that they left it out, at least at the start?

Edney: Yeah, I think you’re just what we’ve seen with all of the rancor around abortion and abortion-related issues, I guess a little surprised. But also maybe it makes sense in just the sense that there are Republicans who are struggling with that issue and don’t want to have to keep talking about it or voting on it in the same way.

Rovner: Well, that leads right to my next subject, which is that the Senate is voting this afternoon, after we tape, on a bill that would guarantee access to IVF. Republicans are expected to block it as they did last week on the bill to guarantee access to contraception. But as of Wednesday, it’s going to be harder for Republicans to say they’re voting against the bill because no one is threatening to block IVF. That’s because the influential Southern Baptist Convention, one of the nation’s largest evangelical groups, voted, if not to ban IVF, at least to restrict the number of embryos that can be created and ban their destruction, which doctors say would make the treatments more expensive and less successful. It sounds like the rift among conservatives over contraception and IVF is a long way from getting settled here.

Huetteman: That certainly seems to be true. It’s also worth noting that there are a lot of influential members of Congress who are Baptist, of course, including House Speaker Mike Johnson. And I was refreshing my memory of the religious background of the current Congress with a Pew report: They say 67 members of this Congress are Baptist. Of course, Southern Baptist is the largest piece of that. And 148 are Catholic, which of course is another denomination that opposes IVF as well. So that’s a pretty big constituency that has their churches telling them that they oppose IVF and should, too.

Rovner: Yeah, everybody says they’re not coming for contraception, they’re not coming for IVF. I think we’re going to see a very spirited and continued debate over both of those things.

Well, speaking of the rift over reproductive health, former President Trump is struggling to please both sides and not really succeeding at it. He made a video address last week to the evangelical group, The Danbury Institute, which is a conservative subset of the aforementioned Southern Baptist Convention, in which former President Trump didn’t use the word abortion and skirted the issue. That prompted some grumbling from some of the attendees, reported Politico. Even as Democrats called him an anti-abortion radical for even speaking to the group, which has labeled abortion “child sacrifice.”

So far, Trump has gotten away with telling audiences what they want to hear, even if he contradicts himself regularly. But I feel like abortion is maybe the one issue where that’s not going to work.

Pradhan: Well, I think the struggle really is even if people are more forgiving of him saying different things, it puts a lot of down-ballot candidates in a really difficult position. And I know, Julie, you’d wanted to talk about this, but Republican candidates for U.S. Senate, I mean just how they have to thread the needle, and I don’t know that voters will be as forgiving about changes in their position. So I think they say it’s like, it’s not just about you. It’s like when two people get married, they’re like, “It’s not just about the two of you. It’s like your whole family.” This is like the family is your party and everyone down-ballot who has to now figure out what the best message is, and as we’ve seen, they’ve really struggled with “We’ve shifted now from being many candidates and Republican officeholders supporting basically near-total abortion bans, if not very early gestational limits, to the 15-week ban being a consensus position.” And now saying, well, Trump’s saying he’s not going to sign a national abortion ban, so let’s leave it to the states. I mean, it keeps changing, and I think obviously underscores the difficulty that they’re all having with this. So I don’t think it helps for him to be saying inconsistent things all the time because then these other candidates for office really struggle, I think, with explaining their positions also.

Rovner: So as I say every week, I’ve been covering abortion for a very long time, and before Roe [v. Wade] was overturned the general political rule is you could change positions on abortion once. If you were anti-abortion you could become pro-choice, and we’ve seen that among a lot of Democrats, Sen. [Bob] Casey in Pennsylvania, sort of a notable example. And if you supported abortion rights, you could become anti-abortion, which Trump kind of did when he was running the first time. Others have also as, there are … and again we’re seeing this more among Republicans, but not exclusively.

But people who try to change back usually get hammered. And as I say, Trump has violated every political rule about everything. So not counting him, I’m wondering about, as you say, Rachana, some of these Senate candidates, some of these down-ballot candidates who are struggling to really rationalize their current positions with maybe what they’d said before is something I think that bears watching over the next couple of months.

Huetteman: Absolutely. And we’re seeing candidates who will change their tone within weeks of saying something or practically days at this point. They’re really banking on our attention being pretty low as a public.

Rovner: Yeah. Although they may be right about that part.

Pradhan: Yeah, that’s true. And there’s a lot of time between now and November, but I think even the … just all the things, even this week of course, between now and November is an eternity. But we just talked about the Southern Baptist Convention stance on IVF. Of course, usually when these things happen, it prompts a lot of questions to lawmakers about whether they support that decision or not, whether they agree with it. And I think these court decisions … the Supreme Court, of course, will be out by the end of June, and so right now it might be fresh on people’s minds. But it’s hard to know whether September or October is the dominant or very prominent campaign issue in the same way.

Rovner: At the same time, we have a long way to go and a short way to go, so we will actually all be watching.

All right, well that is the news for this week. Now we will play my interview with Drew Altman and then we will come back and do our extra credits.

I am pleased to welcome to the podcast Drew Altman, president and CEO of KFF, and of course my boss. But lest you think that this is going to be a suck-up interview, you will see in a moment it’s also a shameless self-promotion interview. Drew, thank you so much for joining us.

Drew Altman: It’s great to be on “What the Health?” Thank you.

Rovner: I asked you here to talk about KFF’s new “Health Policy 101” project which launched last month, as a resource to help teach the basics of health policy. I know this is something you’ve been thinking about for a while. Tell us what the idea was and who’s the target audience here.

Altman: Well, since the Bronze Era, when I started KFF, faculty and students found their way to our stuff and they found it useful. It might’ve been a fact sheet about Medicaid or a policy brief about Medicare or a bunch of charts that we produced. But they’ve had to hunt and peck to find what they wanted and someone would find something on Medicaid or Medicare or the ACA [Affordable Care Act] or health care costs or women’s health policy or international comparisons or whatever it was. And for a very long time, I have wanted to organize our material about health policy for their world so that it was easy to find. It was one stop, and you could find all the basic materials that you wanted on the core stuff about health policy as a service to faculty and students interested in health policy because we don’t just analyze it and poll about it and report on it. We have a deep commitment. We really care about health policy and health policy education.

Rovner: You said those are the main topics covered. I assume that other topics could be added in the future? I mean, I could see a chapter on AI and health care.

Altman: Yes, and we’re starting with an introduction for me. There’s a chapter by Larry Levitt about challenges ahead. There’s a chapter by somebody named Julie Rovner on Congress and the agencies, who also wrote a book about all of that stuff, which is still available, folks.

Rovner: It desperately needs updating. So I’m pleased to be contributing to this.

Altman: But this is just the first year. And there were 13 chapters on the issues that I ticked off a moment ago and many more issues. And we’re starting the process of adding chapters. So the next chapter will probably be on LGBTQ issues, and then, though it’s not exactly the same thing as health policy, by popular demand, we will have a chapter on the basics of public health and what is the public health system, and spending on public health.

And I will admit, some of this also has origins in my own personal experience because before I was in government or in the nonprofit world or started and ran KFF, I was an academic at MIT [Massachusetts Institute of Technology] and I was fine when it came to big thoughts. And there I was and I’d written a book about health cost regulation. But what I didn’t know much about was how stuff really worked and the basics. And if I really needed to understand what was happening with regulation of private health insurance or the Medicaid program or the Medicare program, I didn’t really have any place to go to get basic information about the history of the program, or the details of the program, or a few charts that would give me the facts that I needed, or what are the current challenges. And when it really sunk in was when I left MIT and I went to work in what is now CMS [Centers for Medicare & Medicaid Services] and then was called the HCFA [Health Care Financing Administration], and boy on the first day did I realize what I did not know. It was only when I entered the real world of health policy that I understood how much I had to learn. So I wanted to bridge the two worlds a little bit by making available this basic “Health Policy 101.”

Rovner: I confess, I’m a little bit jealous that this hadn’t existed when I started to learn health policy because, like you, I had to ferret it all out, although thankfully KFF was there through most of it and I was able to find most of it along the way.

Altman: Exactly, and I think there’ll be other audiences for this because if you’re working on the Hill — but you don’t work full time on health — if you’re working in an association, if you’re working anywhere in the health care system, there’s lots of times when you really just need to understand. I just read about an 1115 waiver. What is that? Or what really is the difference between traditional Medicare and the Medicare Advantage plan? How is it that you get your drugs covered in the Medicare program? It seems to be lots of different ways. And just I’m confused. How does this actually work?

I’ll admit to you, also, I personally have an ulterior motive in all of this. And my ulterior motive is that it is my feeling now, and this has been a slowly creeping problem, that there isn’t enough what I would call health policy in health policy education. So that over time it has become more about what is fashionable now, which is delivery and quality and value.

And I won’t name names, but I spent a couple of days advising a health policy center at a renowned medical school about their curriculum in what they called health policy. And the draft of it had nothing in it that I recognized as health policy. Some of this is understandable. It’s because if you’re faculty with a disciplinary base — economics, political science, sociology, whatever — there’s no reason you would know a lot about what we recognize as the core of health policy. There has been a serious decline in faith in government, in young people taking jobs in certainly the federal government, but a little bit in state government as well. So the jobs now are all in the health care industry, they’re in tech, they’re in consulting firms. And so I think there’s just less of an incentive to learn a lot about Medicare, Medicaid, the ACA, the federal agencies, because you’re not going to go work in the federal agencies, at least as frequently as students did in my time. And so just to be blunt about it, I am, in my mind, trying to get more health policy back into health policy education.

Rovner: Well, as you know, I endorse that fully because that’s what we’re trying to do, too. One more question since I have you. I’ve been thinking about this a lot. When I started covering health policy shortly after you left HCFA, the big issue was people without insurance. And then throughout the early 2000s the big issue was spiraling costs. I feel like now the big issue is people who simply cannot navigate the system. The system has become so byzantine and complicated that, well, now there’s a “South Park” about it. I mean, it’s really to get even minor things dealt with is a major undertaking. I mean, what do you see as the biggest issue in policy for the next five or 10 years?

Altman: Well, I think the big issue for health care people used to be access to care. Now only about 8% of the population is uninsured. The big issue now is affordability, in my mind, and the struggles Americans are having paying their health care bills. It is an especially acute problem, virtually a crisis, for people with severe illnesses or people who are chronically ill. Fifty[%], 60% of those people really struggle to pay their medical bills. The crisis or the problem that isn’t discussed enough — because it isn’t a single problem it rears its head in so many ways — is the one you’re talking about: that is the complexity of the health care system. Just the sheer complexity of it; how difficult it is to navigate and to use for people who have insurance or don’t have insurance. Larry Levitt and I wrote a piece in JAMA about this, and we, all of us at KFF, are trying to focus more attention on that problem. Need to do more work on that problem and the many parts of it. It’s partly why we set up an entire program a couple of years ago on consumer and patient protection, where we intend to focus more on just this issue of the complexity of the system makes it hard to make it work for people. But especially for patients who are people who encounter the system because they need it.

Rovner: Well, we will both continue to try to keep explaining it as it keeps getting more byzantine. Drew Altman, thank you so much for joining us.

Altman: Thank you, Julie, very much.

Rovner: OK, we are back. 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. Emmarie, why don’t you go first this week?

Huetteman: Sure. My story comes from CBS [News]. The headline is “As FDA Urges Crackdown on Bird Flu in Raw Milk, Some States Say Their Hands Are Tied.” So the story says that there are three more states that have had their first reported cases of bird flu in the last month. And two of them don’t really have a way to conduct increased oversight of dairy cows and the industry that seems to be particularly having problems here. Wyoming and Iowa are those two states. Basically, these are states where raw milk is unregulated, so there’s no way for them to implement surveillance and restrictions on raw milk that might protect people from the fact that pasteurization appears to kill bird flu. But you don’t have pasteurization with raw milk, of course, that’s the definition.

Actually, this leads me to an extra, extra credit. KFF Health News’ Tony Leys wrote about the raw milk change in Iowa last year, and he was reporting on how Iowa only just changed their law, allowing legal sales of raw milk. And his story, among other things, pointed out that pasteurization helped rein in many serious illnesses in the past, including tuberculosis, typhoid, and scarlet fever. So unfortunately, this is a public health issue that’s been going on for a century or more, and we’ve got a method to deal with this, but not if you’re drinking raw milk. So that’s my story this week.

Rovner: Now people are going to drink raw milk and not get childhood vaccines. We’ll see how that goes. Sorry. Anna, you go next.

Edney: Yeah, mine is from Stat and it’s “Four Tops Singer’s Lawsuit Says He Visited ER for Chest Pain, Ended Up in Straitjacket.” It’s really scary, and maybe not totally surprising, unfortunately, that this is how an older Black man was treated when he went to the hospital. But this is Alexander Morris, a member of the Motown group The Four Tops. These are in the Rock & Roll Hall of Fame, The Four Tops, and he had chest pain and problems breathing and went to the hospital in Detroit and was immediately just assumed he was mentally ill, and he ended up quickly in a straitjacket. So he is suing this hospital. And I think he brought up in this article he’d seen people talk about driving while Black or walking while Black, and he essentially had become sick while Black. And he was able to prove he was a famous person and they took him out of the straitjacket. But how many other people haven’t had that ability, and just been assumed, because of the color of their skin, to not be having a serious health issue? So I think it’s worth a read.

Rovner: Yeah, it was quite a story. Rachana.

Pradhan: This week, I will take a story from The New York Times that is headlined “Abortion Groups Say Tech Companies Suppress Posts and Accounts.” It is basically an examination of how TikTok, Instagram, and others, how they moderate/remove content about abortion. What’s interesting about this is, so this is being told from the perspective of individuals who support access to abortion services. And it recounts some examples of Instagram suspending one group, it was called Mayday Health, which provides information about abortion pill access. There’s a telemedicine abortion service called Hey Jane, where TikTok briefly suspended them. What I thought was really interesting about this is anti-abortion groups have said for longer, actually, that technology companies have suppressed or censored information about crisis pregnancy centers, for example, that designed to dissuade women from having abortions. But I think it’s concerns about, broadly speaking, just what the policies are of some of these social media companies and how they decide what information is acceptable or not. And it details these examples of, again, women who support abortion access or posting TikToks that maybe spell abortion phonetically. Like “tion” is, instead of T-I-O-N, it’s S-H-U-N. Or they’ll put a zero instead of an O, and so it doesn’t get flagged in the same way. So yeah, definitely an interesting read.

Rovner: The fraughtness of social media moderation on this issue and many others. Well, my extra credit this week is from my fellow Michigan fan and sometime podcast guest Jonathan Cohn of HuffPost, and it’s called “How America’s Mental Health Crisis Became This Family’s Worst Nightmare.” And it’s basically the story of the entire mental health system in the United States over the last century, as told through the eyes of one middle-class American family, about one patient whose trip through the system came to a tragic end. Even if you think you know about this country’s failure to adequately treat people with mental illness, even if you do know about this country’s failures on mental health, you really do need to read this story. It is that good.

All right, that is our show. 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 technical guru, Francis Ying, and our doing-double-duty editor this week, Emmarie Huetteman. As always, you can email us your comments or questions. We’re whatthehealth, all one word, @kff.org. Or you can still find me at X, I’m @jrovner. Anna?

Edney: @annaedney.

Rovner: Rachana?

Pradhan: I’m @rachanadpradhan on X.

Rovner: Emmarie?

Huetteman: I’m lurking on X @EmmarieDC.

Rovner: We will be back in your feed next week. Actually, we’ll be coming to you from Aspen next week. But until then, be healthy.

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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.

It’s not surprising that the nursing home industry is filing lawsuits to block new Biden administration rules requiring minimum staffing at facilities that accept federal dollars. What is slightly surprising is the pushback against the rules from members of Congress. Lawmakers don’t appear to have the votes to disapprove the rule, but they might be able to force a floor vote, which could be embarrassing for the administration.

Meanwhile, Senate Democrats aim to force Republicans who proclaim support for contraceptive access to vote for a bill guaranteeing it, which all but a handful have refused to do.

This week’s panelists are Julie Rovner of KFF Health News, Rachel Cohrs Zhang of Stat, Alice Miranda Ollstein of Politico, and Sandhya Raman of CQ Roll Call.

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Rachel Cohrs Zhang
Stat News

@rachelcohrs

Read Rachel's stories.

Alice Miranda Ollstein
Politico

@AliceOllstein

Read Alice's stories.

Sandhya Raman
CQ Roll Call

@SandhyaWrites

Read Sandhya's stories.

Among the takeaways from this week’s episode:

• In suing to block the Biden administration’s staffing rules, the nursing home industry is arguing that the Centers for Medicare & Medicaid Services lacks the authority to implement the requirements and that the rules, if enforced, could force many facilities to downsize or close.
• Anthony Fauci, the retired director of the National Institute of Allergy and Infectious Diseases and the man who advised both Presidents Donald Trump and Joe Biden on the covid-19 pandemic, testified this week before the congressional committee charged with reviewing the government’s pandemic response. Fauci, the subject of many conspiracy theories, pushed back hard, particularly on the charge that he covered up evidence that the pandemic began because dangerous microbes escaped from a lab in China partly funded by the National Institutes of Health.
• A giant inflatable intrauterine device was positioned near Union Station in Washington, D.C., marking what seemed to be “Contraceptive Week” on Capitol Hill. Republican senators blocked an effort by Senate Majority Leader Chuck Schumer to force a vote on consideration of legislation to codify the federal right to contraception. Immediately after, Schumer announced a vote for next week on codifying access to in vitro fertilization services.
• Hospitals in London appear to be the latest, high-profile cyberattack victims, raising the question of whether it might be time for some sort of international cybercrime-fighting agency. In the United States, health systems and government officials are still in the very early stages of tackling the problem, and it is not clear whether Congress or the administration will take the lead.
• An FDA advisory panel this week recommended against the formal approval of MDMA, a psychedelic also known as ecstasy, to treat post-traumatic stress disorder. Members of the panel said there was not enough evidence to recommend its use. But the discussion did provide more guidance about what companies need to present in terms of trials and evidence to make their argument for approval more feasible.

Also this week, Rovner interviews KFF Health News’ Bram Sable-Smith, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” feature about a free cruise that turned out to be anything but. If you have an outrageous or baffling bill you’d like to send 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: Abortion, Every Day’s “EXCLUSIVE: Health Data Breach at America’s Largest Crisis Pregnancy Org,” by Jessica Valenti.
• Alice Miranda Ollstein: The Washington Post’s “Conservative Attacks on Birth Control Could Threaten Access,” by Lauren Weber.
• Rachel Cohrs Zhang: ProPublica’s “This Mississippi Hospital Transfers Some Patients to Jail to Await Mental Health Treatment,” by Isabelle Taft, Mississippi Today.
• Sandhya Raman: Air Mail’s “Roanoke’s Requiem,” by Clara Molot.

Click to open the transcript

Transcript: Nursing Home Staffing Rules Prompt Pushback

[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.] 

Mila Atmos: The future of America is in your hands. This is not a movie trailer, and it’s not a political ad, but it is a call to action. I’m Mila Atmos, and I’m passionate about unlocking the power of everyday citizens. On our podcast, Future Hindsight, we take big ideas about civic life and democracy and turn them into action items for you and me. Every Thursday we talk to bold activists and civic innovators to help you understand your power and your power to change the status quo. Find us at futurehindsight.com or wherever you listen to podcasts.

Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for 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, June 6, 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 Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Hello.

Rovner: Sandhya Raman of CQ Roll Call.

Sandhya Raman: Good morning.

Rovner: And Rachel Cohrs Zhang of Stat News.

Rachel Cohrs Zhang: Hi, everybody.

Rovner: Later in this episode, we’ll have my interview with KFF Health News’ Bram Sable-Smith, who reported and wrote this month’s KFF Health News/NPR “Bill of the Month.” It’s about a free cruise that turned out to be anything but. But first, this week’s news. We’re going to start this week with those controversial nursing home staffing rules.

In case you’ve forgotten, back in May, the Biden administration finalized rules that would require nursing homes that receive federal funding, which is basically all of them, to have nurses on duty 24/7/365, as well as impose other minimum staffing requirements.

The nursing home industry, which has been fighting this effort literally for decades, is doing what most big powerful health industry players do when an administration does something it doesn’t like: filing lawsuits. So what is their problem with the requirement to have sufficient staff to care for patients who, by definition, can’t care for themselves or they wouldn’t be in nursing homes?

Cohrs Zhang: Well, I think the groups are arguing that CMS [Centers for Medicare & Medicaid Service] doesn’t have authority to implement these rules, and that if Congress had wanted these minimum staffing requirements, Congress should have done that and they didn’t. So they’re arguing that they’re overstepping their boundaries, and we are seeing this lawsuit again in Texas, which is a popular venue for the health care industry to try to challenge rules or legislation that they don’t like.

So, I think it isn’t a surprise that we would see these groups sue, given the financial issues at stake, given the fearmongering about facilities having to close, and just the hiring that could have to happen for a lot of these facilities. So it’s not necessarily a surprise, but it will certainly be interesting and impactful for facilities and for seniors across the nation as this plays out.

Rovner: I mean, basically one of their arguments is that there just aren’t enough people to hire, that they can’t get the number of people that they would need, and that seems to be actually pretty persuasive argument at some point, right?

Cohrs Zhang: I mean, there is controversy about why staffing shortages happen. Certainly there could be issues with the pipeline or with nursing schools, education. But I think there are also arguments that unions or workers’ rights groups would make that maybe if facilities paid better, then they would get more people to work for them. Or that people might exit the industry because of working conditions, because of understaffing, and just that makes it harder on the workers who are actually there if their workloads are too much. Or they’re expected to do more work — longer hours or overtime — or their vacation is limited, that kind of thing.

So I think it is a surprisingly controversial issue that doesn’t have an easy answer, but that’s the perspectives that we’re seeing here.

Rovner: I mean, layering onto this, it’s not just the industry versus the administration. Now Congress is getting into the act, which you rarely see. They’re talking about using the Congressional Review Act, which is something that Congress can do. But of course, when you’re in the middle of an administration that’s done it, it would get vetoed by the president. So they can’t probably do anything. Sandhya, I see you nodding your head. These members of Congress just want to make a statement here?

Raman: Yeah. So Sen. James Lankford insured the resolution earlier this week to block the rule’s implementation, and it’s mostly Republicans that have signed on, but we also have [Sen.] Joe Manchin and [Sen.] Jon Tester. But the way it stands, it doesn’t have enough folks on board yet, and it would also need to be taken up. It faces an uphill climb like many of these things.

Rovner: Somebody actually asked me yesterday though, can they do this? And the answer is yes, there is the Congressional Review Act. Yes, Congress with just a majority vote and no filibuster in the Senate can overturn an administration rule. But like I said, it usually happens when an administration changes its hands because it does have to be signed by the president and the president can veto it.

If the president vetoes it, then they would need a veto override majority, which they clearly don’t seem to have in this case. But obviously there is enough concern about this issue. I think there’s been a Congressional Review Act resolution introduced in the House too, right?

Ollstein: It’s really tough because, like Rachel said, these jobs are low-paid. They’re emotionally and physically grueling. It’s really hard to find people willing to do this work. And at the same time, the current situation seems really untenable for patients. There’s been so many reports of really horrible patient safety and hygiene issues and all kinds of stuff in part, not entirely the fault of understaffing, but not helped by understaffing certainly.

I think, like, we see on so many fronts in health care, there are attempts to do something about this situation that has become untenable, but any attempt also will piss off someone and be challenged.

Rovner: Yeah, absolutely. And we should point out that nursing homes are staffed primarily not by nurses, but by nurses aides of various training levels. So this is not entirely about a nursing shortage, it is about a shortage of workers who want to do this, as you say, very grueling and usually underpaid work.

Well, speaking of controversial things, Dr. Tony Fauci, the now-retired head of the NIH’s National Institute of Allergy and Infectious Diseases, and currently the man most conspiracy theorists hold responsible for the entire covid-19 pandemic, testified before the House Select Committee on the pandemic Monday. And not surprisingly, sparks flew. What, if anything, did we learn from this hearing?

Cohrs Zhang: The interesting part of this hearing was watching how Dr. Fauci positioned himself in response to a lot of these criticisms that have been circulating. The committee has been going through different witnesses, and specifically it criticized one of his deputies, essentially, who had some unflattering emails released showing that he appeared to be trying to delete emails or use personal accounts to avoid public records requests from journalists or other organizations …

Rovner: I’m shocked, shocked that officials would want to keep their information away from prying reporters’ eyes.

Cohrs Zhang: It’s not surprising, but it is surprising to see it in writing. But this is, again, everyone is working from home and channels of communication were changing. But I think we did see Dr. Fauci pretty aggressively distancing himself, downplaying the relationship he had with this individual and saying that they worked on research together, but he wasn’t necessarily advising agency policy.

So that’s at least how he was framing the relationship. So he definitely downplayed that. And I think an interesting comment he made — I’m curious to see what you think about this, Julie — was that he didn’t say that the lab leak theory itself was a conspiracy, but his involvement and a cover-up was a conspiracy. And so it did seem that some of the rhetoric has at least changed. He seemed more open-minded, I guess, to a lab leak theory than I expected.

Rovner: I thought he was pretty careful about that. I think it was the last thing he said, which is that we’re never really going to know. I mean, it could have been a lab leak. It could have happened. It could have been an animal from the wet market. The Chinese have not been very forthcoming with information. I personally keep wondering why we keep pounding at this.

I mean, it seems unlikely that it was a lab leak and then a conspiracy to cover it up. It clearly was one or the other, and there’s a lot of differences of opinions. And that was the last thing he said is that it could have been either. We don’t know. That’s always struck me as the, “OK, let’s talk about something else.” Anyway, let’s talk about something else.

Raman: I was just going to add, we did see a personal side to him, which I think we didn’t see as much when he was in his official role when he was talking. It was about the death threats that he and his family have been receiving when responding to a lot of the misinformation going around about that. And I thought that was striking compared to, just juxtaposed, with a lot of the other [indecipherable] with [Rep.] Marjorie Taylor Greene saying, “Oh, you’re not a real doctor.” There’s a lot of colorful protesters. And I just thought that stood out, too.

Rovner: Yeah, he did obviously, I think, relish the chance to defend himself from a lot of the charges that have been leveled at him. And I think … his wife is a prominent scientist in her own right — obviously can take care of herself — but I think he was particularly angry that there had been death threats leveled toward his grown daughters, which probably a bit out of line. Alice, you wanted to add something.

Ollstein: Yeah, I think it’s also been interesting to see the shift among Democrats on the committee over time. I think they’ve gone from an attitude of Republicans are on a total witch hunt, this is completely political, this is muddying the waters and fueling conspiracy theories and will lead to worse public health outcomes. And I think based on some of the revelations, like Rachel said about emails and such, they have come to a position of, oh, there might be some things that need investigating and need accountability in here.

But I think their frustration seems to be what it’s always been in that how will this lead to making the country better prepared in the future for the next pandemic — which may or may not already be circulating, but certainly is inevitable at some point. Either way, it’s all well and good to hold officials accountable for things they may have done, but how does that lead to making the country more prepared, improving pandemic response in the future? That’s what they feel is the missing piece here.

Rovner: Yeah. I think there was not a lot of that at this hearing, although I feel like they had to go through this maybe to get over to the other side and start thinking about what we can do in the future to avoid similar kinds of problems. And obviously you get a disease that you have no idea what to do about, and people try to muddle through the best they can. All right, now we are going to move on and we’ll talk about abortion where there is always lots of news.

Here in Washington, there is a giant inflatable IUD flying over Union Station Wednesday to highlight what seems to be Contraception Week on Capitol Hill. Not coincidentally, it’s also the anniversary this week of the Supreme Court’s 1965 ruling Griswold v. Connecticut that created the right to birth control. Alice, what are Democrats, particularly in the Senate where they’re in charge, doing to try to highlight these potential threats to contraceptive access?

Ollstein: So this vote that happened that was blocked because only two Republicans crossed the aisle to support this Right to Contraception bill — it’s the two you expect, it’s [Sen.] Lisa Murkowski and [Sen.] Susan Collins — and you’re already seeing Democrats really make hay of this. Both Democrats and their campaign arms and outside allied groups are planning to just absolutely blitz this in ads. They’re holding events in swing states related to it, and they’re going hard against individual Republicans for their votes.

I think the Republicans I talked to who voted no, they had a funny mixed message about why they were voting no on it. They were both saying that the bill was this sinister Trojan horse for forcing religious groups to promote contraception and even abortion and also gender-affirming care somehow. But also, the bill was a pointless stunt that wouldn’t really do anything because there is no threat to contraception. But also Republicans have their own rival bill to promote access to contraception.

So access to contraception isn’t a problem, but please support my bill to improve access to contraception. It’s a tough message. Whereas Democrats’ message is a lot simpler. You can argue with it on the merits, but it’s a lot simpler. They point to the fact that Supreme Court Justice Clarence Thomas has expressed interest and actually called on the court to revisit precedents that protect the right to contraception.

Lots of states have thwarted attempts to enact protections for contraception. And a lot of anti-abortion groups have really made a big push to muddy the waters on medical understanding of what is contraception versus what is abortion, which we can get into later.

Rovner: Yes, which we will. Sandhya, did you want to add something?

Raman: Yeah, and I think that something that I would add to what Alice was saying is just how this is kind of at the same time a little bit different for the Democrats. Something that I wrote about this week was just that after the Dobbs [v. Jackson Women’s Health Organization] decision, we had the then-Democratic House vote on several different bills, but the Democrats have not really been holding this chamber-wide vote on bills related to abortion, contraception for the most part. And so this was the first time that they are stepping into that.

They’ve done the unanimous consent requests on a lot of these bills. And even just a couple months ago when talks are really heating up on IVF, there’s other things that we have to get to, appropriations and things like that, and this would just get bogged down. And they were shying away from taking floor time to do this. So I think that was an interesting move that they’re doing this now and that they’re going to vote on an IVF next week and whatever else next down the line.

Rovner: Yeah, I noticed that as soon as this bill went down, Sen. [Chuck] Schumer teed up the Right to IVF bill for a vote next week. But Alice, as you were alluding to, I mean, where this gets really uncomfortable for Republicans is that fine line between contraception and abortion. Our colleague Lauren Weber has a story about this this week [“Conservative Attacks on Birth Control Could Threaten Access,”], which is your extra credit, so why don’t you tell us about it?

Ollstein: Yeah. So she did a really great job highlighting how, especially at the state level where a lot of these battles are playing out, anti-abortion groups that are very influential are making arguments that certain forms of birth control are abortifacients. This is completely disputed by medical experts and the FDA [Food and Drug Administration] that regulates these products. They say, just to be clear about what we’re talking about, we’re talking about some forms of emergency contraception, which is taken after sex to prevent pregnancy. It is not an abortifacient. It won’t work if you’re already pregnant. It prevents pregnancy. It does not terminate a pregnancy. They are also saying this about some IUDs, intrauterine devices, and even about some hormonal birth control pills.

So there’s been pushback that Lauren detailed in her story, including from some Republicans who are trying to correct the record. But this misinformation is getting really entrenched, and I think it’s something we should all be paying attention to when it crops up, especially in the mouths of people in power.

Rovner: I mean, when I first started writing about it it was not entirely clear. There was thought that one of the ways the morning-after pill worked was by preventing implantation of a fertilized egg, which some people consider, if you consider that fertilization and not implantation, is the beginning of life. According to doctors, implantation is the beginning of pregnancy, among other things, because that’s when you can test for it.

But those who believe that fertilization is the beginning of life — and therefore something that prevents implantation is an abortion — were concerned that IUDs, and mostly progesterone-based birth control that prevented implantation, were abortifacients. Except that in the years since, it’s been shown that that’s not the case.

Ollstein: Right.

Rovner: That in fact, both IUDs and the morning-after pill work by preventing ovulation. There is no fertilized egg because there’s no egg. So they are not abortifacients. On the other hand, the FDA changed the labeling on the morning-after pill because of this. And yet the Hobby Lobby case [Burwell v. Hobby Lobby Stores Inc.] that the decision was written by Justice [Samuel] Alito, basically took that premise, that they were allowed to not offer these forms of contraception because they believed that they were acted as abortifacients, even though science suggests that they didn’t. It’s not something new, and it’s not something I don’t think is going to go away anytime in the near future.

Raman: I would add that it also came up in this week’s Senate Health [Committee] hearing, that line of questioning about whether or not different parts of birth control were abortifacients. Sen. [Patty] Murray did that line of questioning with Dr. Christina Francis, who’s the head of the anti-abortion obstetrician-gynecology group and went through on Plan B, IUDs and different things. And there was a back and forth of evading questions, but she did call IUDs as abortifacients, which goes back to the same thing that we’re saying.

Rovner: Right, which they have done all along.

Ollstein: Yeah. I mean, I think this really spotlights a challenge here, which is that Republicans’ response to votes like this week and things that are playing out in the state level, they’re scoffing and saying, “It’s absolutely ridiculous to suggest that Republicans are trying to ban birth control. This is completely a political concoction by Democrats to scare people into voting for them in November.”

What we’re talking about here are not bans on birth control, but there are policies that have been introduced at both the state and federal level that would make birth control, especially certain forms like we were just talking about, way harder to access. So there are proposals to carve them out of Obamacare’s contraception mandate, so they’re not covered by insurance.

That’s not a ban. You can still go pay out-of-pocket, but I remember all the people who were paying out-of-pocket for IUDs before Obamacare: hundreds and hundreds of dollars for something that is now completely free. And so what we’re seeing right now are not bans, but I think it’s important to think about the ways it would still restrict access for a lot of people.

Rovner: Before we leave the nation’s capital it seems that the Supreme Court’s upcoming decision on the abortion pill may not be the last word on the case. While it seemed likely from the oral arguments that the justices will agree that the Texas doctors who brought the case don’t have standing, there were three state attorneys general who sought to become part of the case when it was first considered back in Texas. So it would go back to Judge [Matthew] Kacsmaryk, our original judge who said that the entire abortion pill approval should be overturned. It feels like this is not the end of fighting about the abortion pill’s approval at the federal level. I mean, I assume that that’s something that the drug industry, among others, won’t be happy about.

Ollstein: Courts could find that the states don’t have standing either, that this policy does not harm them in any real way. In fact, Democratic attorneys general have argued the exact opposite, that the availability of mifepristone helps states: saves a lot of money; it prevents pregnancy; it treats people’s medical needs. So obviously, Kacsmaryk has a very long anti-abortion record and has sided with these challenges in a lot of cases. But that doesn’t mean that this would necessarily go anywhere.

But your bigger point that the Supreme Court’s upcoming ruling on mifepristone is not the end, it certainly is not. There’s going to be a lot more court challenges, some already in motion. There’s going to be state-level policy fights. There’s going to be federal-level policy fights. If Trump is elected, groups want him to do a lot of things through executive order to restrict mifepristone or remove it from the market entirely through the FDA. So yes, this is not going to be over for the foreseeable future.

Rovner: Well, meanwhile, in a case that might be over for the foreseeable future, the Texas Supreme Court last week officially rejected the case brought by 20 women who nearly died when they were unable to get timely care for pregnancy complications. The justices said in their ruling that while the women definitely did suffer, the fault lay with the doctors who declined to treat them rather than the vagueness of the state’s abortion ban. So where does that leave the debate about medical exceptions?

Ollstein: So anti-abortion groups’ response to a lot of the challenges to these abortion bans and stories about women in medical emergencies who are getting denied care and suffering real harm as a result, their response has been that there’s nothing wrong with the law. The law is perfectly clear, and that doctors are either accidentally or intentionally misinterpreting the law for political reasons. Meanwhile, doctors say it’s not clear at all. It’s not clear how honestly close to dead someone has to be in order to receive an abortion.

Rovner: And it’s not just in Texas. This is true in a bunch of states, right? The doctors don’t know …

Ollstein: In many states.

Rovner: … right? …

Ollstein: Exactly.

Rovner: … when they can intervene.

Ollstein: Right. And so I think the upcoming Supreme Court ruling on EMTALA [Emergency Medical Treatment and Active Labor Law], which we’ve talked about, could give some indication either way of what doctors are and are not able to do, but that won’t really resolve it either. There is still so much gray area. And so patients and doctors are going to state courts to plead for clarity. They’re going to their legislatures to plead for clarity. And they’re going to state medical boards, including in Texas, to plead for clarity. And so far, they have not gotten any.

Most legislatures have been unwilling to revisit their bans and clarify or expand the exceptions even as these stories play out on the ground of doctors who say, “I know that providing an abortion for this patient is the right thing medically and ethically to do, but I’m so afraid of being hit with criminal charges that I put the patient on a plane out of state instead.” Yeah, it’s just really tough.

And so what we wrote about it is we keep talking about doctors being torn between conflicting state and federal law, and that’s absolutely true, but what we dug into is that the state law just looms so much larger than the federal laws. So when you’re weighing, should I maybe violate EMTALA or should I maybe violate my state’s ban, they’re not going to want to violate their state’s ban because that means jail time, that means losing their license, that means having their freedom and their livelihood taken away.

Whereas an EMTALA violation may or may not mean a fine somewhere down the road. The enforcement has not been as aggressive at the federal level from the Biden administration as a lot of doctors would like it to be. And so, in that environment, they’re really deferring to the state law, and that means some people are not getting care that they maybe need.

Rovner: I say in the meantime, we had yet another jury just last week about a woman who had a miscarriage and could not get a D&C [dilation and curettage procedure] basically. When she went in there was no fetal heartbeat, but she ended up miscarrying at home and almost dying. She was sent away, I believe, from three different facilities. This continues to happen because doctors are concerned about when it is appropriate for them to intervene. And they seem, you’re right, to be leaning towards the “let’s not get in trouble with the state” law, so let’s wait to provide care as long as we think we can.

Well, moving on, we have two stories this week about efforts to treat post-traumatic stress disorder, particularly in military veterans. On Tuesday, an FDA advisory committee recommended against approval of the psychedelic MDMA, better known as ecstasy, for the treatment of PTSD. My understanding is that the panel didn’t reject the idea outright that this could be helpful, only that there isn’t enough evidence yet to approve it. Was I reading that right? Rachel, you guys covered this pretty closely.

Cohrs Zhang: Yes. Yeah, my colleagues did cover this. Certainly I think what’s a discouraging sign, I don’t think there’s any way around it, for some of these companies that are looking at psychedelics and trying to figure out some sort of approval pathway for conditions like PTSD.

One of my colleagues, Meghana Keshavan, she chatted with a dozen companies yesterday and they were trying to put a positive spin on it, that having some opinion or some discussion of a treatment like this by the advisory committee could lay out more clear standards for what companies would have to present in order to get something approved. So I think obviously they have a vested interest in spinning this positively.

But it is a very innovative space and certainly was a short-term setback. But it certainly isn’t a long-term issue if some of these companies are able to present stronger evidence or better trial design. I think there were some questions about whether trial participants actually could figure out whether they were placebo or not, which if you’re taking psychedelic drugs, yeah, that’s kind of a challenge in terms of trial design.

So I think there are some interesting questions, and I am confident that this’ll be something the FDA and industry is going to have to figure out in a space that’s new like this.

Rovner: Yeah, it’s been interesting to follow. Well, in something that does seem to help, one of the first controlled studies of service dogs to treat PTSD has found that man’s best friend can be a therapist as well. Those veterans who got specially trained dogs showed much more improvement in their symptoms than those who were on the doggy wait list as determined by professionals who didn’t know who had the dogs and who didn’t. So pet therapy for the win here?

Raman: I mean, this is the biggest study of this kind that we’ve had so far, and it seems promising. I think one thing will be interesting is if there’s more research, if this would change policy down the line for the VA [Department of Veterans Affairs] or other agencies to be able to get these kinds of service dogs in the hands of more vets.

Rovner: Yeah, I know there’s a huge demand for these kinds of service dogs. I know a lot of people who basically have started training service dogs for veterans. Obviously they were able to do this study because there was a long wait list. They were able to look at people who were waiting but hadn’t gotten a dog yet. So at least in the short term, possibly some help for some people.

Finally this week, in a segment I’m calling “Misery Loves Company,” it’s not just the U.S. where big health systems are getting cyberhacked. Across the pond, quoting here from the BBC, major hospitals in London have declared a critical incident after a cyberattack led to operations being canceled and emergency patients being diverted elsewhere. This sounds painfully familiar.

Maybe we need an international cybercrime fighting agency. Is there one? Is there at least, do we know, is there a task force working on this? Obviously the bigger, more centralized your health care system, the bigger problem this becomes, as we saw with Change Healthcare belonging to United[Healthcare], and this is now … I guess it’s a contractor that works for the NHS [National Health Service]. You can see the potential for really bad stuff here.

Cohrs Zhang: That’s a good question about some international standards, Julie, but I think what we have seen is Sen. Ron Wyden, who leads the Senate Finance Committee, did write to HHS [Department of Health and Human Services] this week and asked HHS to add to multiple-factor authentication as a condition of participation for some of these facilities to try to institute standards that way.

And again, I think there are questions about how much HHS can actually do, but I think it’s a signal that Congress might not want to do anything or think they can do anything if they’re asking the administration to do something here. But we’re still in the very early stages of systems viewing this as worthy of investment and just education about some of the best practices here.

Yeah, certainly it’s going to be a business opportunity for some consulting firms to help these hospitals increase their cybersecurity measures and certainly will be a global market if we see these attacks continue in other places, too.

Rovner: Maybe our health records will be as protected as our Spotify accounts. It would apparently be a step forward. All right, well, that is the news for this week. Now we will play my “Bill of the Month” interview with Bram Sable-Smith, and then we will come back and do our extra credits.

I am pleased to welcome back to the podcast my KFF Health News colleague Bram Sable-Smith, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” about a free cruise that turned out to be anything but. Welcome back to the podcast, Bram.

Bram Sable-Smith: Thanks for having me.

Rovner: So tell us about this month’s patient, who he is, and what happened to him. This is one of the wilder Bills of the Month, I think.

Sable-Smith: Right. So his name is Vincent Wasney. He lives in Saginaw, Michigan. Never been on an airplane before, neither had his [fiancée], Sarah. But when they bought their first house in 2019, their Realtor, as a gift, gifted them tickets for a cruise. My Realtor gave me a tote bag. So, what a Realtor, first of all! What an incredible gift.

Rovner: My Realtor gave me a wine opener, which I do still use.

Sable-Smith: If it sailed to the Caribbean, it’d be equivalent. So their cruise got delayed because of the pandemic, but they set sail in December 2022. And they were having a great time. One of the highlights of their trip was they went to this private island called CocoCay for Royal Caribbean guests, and it included an excursion to go swimming with pigs.

Rovner: Wild pigs, right?

Sable-Smith: Wild pigs, a big fancy water park, all kinds of food. They were having a great time. But it’s also on that island that Vincent started feeling off. And so in the past, Vincent has had seizures. About 10 years earlier, he had had a few seizures. They decided he was probably epileptic, and he was on medicine for a while. He went off the medicine because they were worried about liver damage, and he’d been relatively seizure-free for a long time. It’d been a long time since he’d had a seizure.

But when he was on that island having a great time, it’s when he started to feel off. And when they got back on the cruise ship for the last full day of the cruise, he had a seizure in his room. And he was taken down to the medical center on the cruise ship and he was observed. He was given fluids for a while, and then sent back to his room, where he had a second seizure. Once again, went down to the medical center on the ship, where he had a third seizure. It was time to get him off the boat. He needed to get onto land and go to a hospital. And so they were close enough to land that they were able to do the evacuation by boat instead of having to do something like a helicopter to do a medevac that way. And so a rescue boat came to the ship. He was lowered off the ship. He was in a stretcher and it was lowered down to the rescue boat by a rope.

His fiancée, Sarah, climbed down a rope ladder to get into the boat as well to go with them to land. And then he was taken to land in an ambulance ride to the hospital, et cetera. But, before they were allowed to disembark, they were given their bill and told “It’s time to pay this. You have to pay this bill.”

Rovner: And how much was it?

Sable-Smith: So the bill for the medical services was $2,500. This was a free cruise. They had budgeted to pay for internet, $150 for internet. They had budgeted to pay for their alcoholic drinks. They had budgeted to pay for their tips. So they had saved up a few hundred dollars, which is what they thought would be their bill at the end of this cruise. Now, that completely exploded into this $2,500 bill just for medical expenses alone.

And as they’re waiting to evacuate the ship, they’re like, “We can’t pay this. We don’t have this money.” So that led to some negotiations. They ended up basically taking all the money out of their bank accounts, including their mortgage payment. They maxed out Vincent’s credit card, but they were still $1,000 short. And they later learned once they were on land that Vincent’s credit card had been overdrafted by $1,000 to cover that additional expense.

Rovner: So it turns out that he was uninsured at the time, and we’ll talk about that in a minute. But even if he had had insurance, the cruise ship wasn’t going to let him off the boat until he paid in full, even though it was an emergency? Did I read that right?

Sable-Smith: That’s certainly the feeling that they had at the time. When Vincent was short the $1,000, eventually they were let off the ship, but they did end up, as we said, getting that credit card overdrafted. But I think what’s important to note here is that even though he was uninsured at the time, even if he had had insurance, and even if he had had travel insurance, which he also did not have at the time, which we can talk about, he still would’ve been required to pay upfront and then submit the receipts later to try to get reimbursed for the payments.

And that’s because on the cruise’s website, they explain that they do not accept “land-based health insurance plans” when they’re on the vessel.

Rovner: In fact, as you mentioned, a lot of health insurance doesn’t cover care on a cruise ship or, in fact, anywhere outside the United States. So lots of people buy travel insurance in case they have a medical emergency. Why didn’t they?

Sable-Smith: So travel insurance is often purchased when you purchase the tickets. You’ll buy a ticket to the cruise and then it will prompt you, say, “Hey, do you want some travel insurance to protect you while you’re on this ship?” And that’s the way that most people are buying travel insurance. Well, remember, this cruise was a gift from their realtors, so they never bought the ticket. So they never got that prompting to say, “Hey, time to buy some travel insurance to protect yourself on the trip.”

And again, these were inexperienced travelers. They’d never been on an airplane before. The furthest either one of them had been from Michigan was Vincent went to Washington, D.C., one time on a school trip. And so they didn’t really know what travel insurance was. They knew it existed. But as Vincent explained, he said, “I thought this was for lost luggage and trip cancellations. I didn’t realize that this was something for medical expenses you might incur when you’re out at sea.”

Rovner: And it’s really both. I mean, it is for lost luggage and cancellation, right?

Sable-Smith: And it is for lost luggage and cancellation. Yeah, that’s right.

Rovner: So what eventually happened to Vincent and what eventually happened to the bill?

Sable-Smith: Well, once he got taken to the hospital, he got an additional bill, or actually several additional bills, one from the hospital, two from a couple doctors who saw him at the hospital who billed separately, and also one from the ambulance services. As we know, he had already drained his bank account and maxed out his credit card and had it overdrafted to cover the expenses on the ship. So he was working on paying those off. And then for the additional bills he incurred on land, he had set up payment plans, really small ones, $25, $50 a month, but going to four separate entities.

He actually missed a couple payments on his bill to the hospital, and that ended up getting sent to collections. Again, none of these are charging interest, but these are still quite some burdens. And so he was paying them off bit by bit by bit. He set up a GoFundMe campaign, which is something that a lot of people end up doing who never expect to have to cover these kinds of emergency expenses, or reach out publicly for help like that. And they got quite a bit of help from family and friends. Including, Vincent picked up Frisbee golf during the pandemic, and he’s made quite a lot of good friends that way. And that community really came through for them as well. So with those GoFundMe payments, they were able to make their house payment. It was helpful with some of these bills that they had lingering leftover from the cruise.

Rovner: So what’s the takeaway here, other than that nothing that seems free is ever really free?

Sable-Smith: Yeah, right. Well, the takeaway is to be informed before you leave about a plan for how are you going to cover medical expenses when you’re going traveling. I think this is something that a lot of people are going to be doing this summer, going on vacations. I’ve got vacations planned. What’s your plan for covering medical expenses? And if you’re leaving the country, if you’re going on a cruise, someplace where your land-based American health insurance might not cover you, you should consider travel insurance.

And when you’re considering travel insurance, they come in all sorts of varieties. So you want to make sure that they’re going to cover your particular cases. So some plans, for example, won’t cover pre-existing conditions. Some plans won’t cover care for risky activities like rock climbing. So you want to know what you’re going to be doing during your trip, and you want to make sure when you’re purchasing travel insurance to find a plan that’s going to cover your particular needs.

Rovner: Very well explained. Bram Sable-Smith, thank you very much.

Sable-Smith: Always a pleasure.

Rovner: And 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 kffhealthnews.org and in our show notes on your phone or other mobile device.  Alice, you’ve gone already. Sandhya, why don’t you go next?

Raman: So my extra credit is “Roanoke’s Requiem,” and it’s an Air Mail from Clara Molot. And this is a really interesting piece. So at least 16 alumni from the classes of 2011 to 2019 of Roanoke have been diagnosed with cancer since 2010, which is a much higher rate when compared to the rate for 20-somethings in the U.S. and 15-times-higher mortality rate. And so the piece does some looking at some of the work that’s being done to uncover why this is happening.

Rovner: It’s quite a scary story. Rachel?

Cohrs Zhang: Yes. So the story I chose, it was co-published by ProPublica in Mississippi Today. The headline is “This Mississippi Hospital Transfers Some Patients to Jail to Await Mental Health Treatment,” by Isabelle Taft. And I mean, truly such a harrowing story of … obviously we know that there’s capacity issues with mental health treatment, but the idea that patients would be involuntarily committed, go to a hospital, and then be transferred to a jail having committed no crime, having no recourse.

I mean, some of these detentions happened. It was like two months long where these patients who are already suffering are then thrown out of their comfortable environments into jail as they awaited county facilities to open up spots for them. And I think the story also did a good job of pointing out that other jurisdictions had found other solutions to this other than placing suffering people in jail. So yeah, it just felt like it was a really great classic example of investigative journalism that’ll have an impact.

Rovner: Local investigative journalism — not just investigative journalism — which is really rare, yet it was a really good piece. Well, my extra credit this week is from Jessica Valenti, who writes a super-helpful newsletter called Abortion, Every Day. Usually it’s an aggregation of stories from around the country, but this week she also has her own exclusive [“EXCLUSIVE: Health Data Breach at America’s Largest Crisis Pregnancy Org,”] about how Heartbeat International, which runs the nation’s largest network of crisis pregnancy centers, is collecting and sharing private health data, including due dates, dates of last menstrual periods, addresses, and even family living arrangements.

Isn’t this a violation of HIPAA, you may ask? Well, probably not, because HIPAA only applies to health care providers and insurers and the vast majority of crisis pregnancy centers don’t deliver medical care. You don’t need a medical license to give a pregnancy test or even do an ultrasound. Among other things, personal health data has been used for training sales staff, and until recently was readily available to anyone on the web without password protection. It’s a pretty eye-opening story.

All right, that is our show. 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 technical guru, Francis Ying, and our fill-in editor this week, Stephanie Stapleton. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X, I’m at @jrovner. Sandhya?

Raman: @SandhyaWrites.

Rovner: Alice?

Ollstein: @AliceOllstein.

Rovner: Rachel?

Cohrs Zhang: @rachelcohrs.

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

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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.

June means it’s time for the Supreme Court to render rulings on the biggest and most controversial cases of the term. This year, the court has two significant abortion-related cases: one involving the abortion pill mifepristone and the other regarding the conflict between a federal emergency care law and Idaho’s near-total abortion ban.

Also awaiting resolution is a case that could dramatically change how the federal government makes health care (and all other types of) policies by potentially limiting agencies’ authority in interpreting the details of laws through regulations. Rules stemming from the Affordable Care Act and other legislation could be affected.

In this special episode of “What the Health?”, Laurie Sobel, an associate director for women’s health policy at KFF, joins host Julie Rovner for a refresher on the cases, and a preview of how the justices might rule on them. 

The cases highlighted in this episode:

• Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce, about how much discretion federal agencies should have in interpreting laws passed by Congress.
• U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, about whether the FDA exceeded its authority in relaxing restrictions on the abortion pill mifepristone.
• Moyle v. United States and Idaho v. United States, about whether the federal Emergency Medical Treatment and Labor Act requirement for hospitals participating in Medicare to provide needed medical care overrides Idaho’s near-total abortion ban in emergency cases.

Previous “What the Health?” coverage of these cases:

• KFF Health News' 'What the Health?': Abortion — Again — At the Supreme Court

  Apr 24, 2024

• KFF Health News' 'What the Health?': The Supreme Court and the Abortion Pill

  Mar 28, 2024

• KFF Health News' 'What the Health?': Health Enters the Presidential Race

  Jan 25, 2024

• KFF Health News' 'What the Health?': The Supreme Court vs. the Bureaucracy

  Jan 18, 2024

Where to find Supreme Court opinions as they are announced:

• The Supreme Court’s official website
•  The SCOTUSblog (not an official government website but run by lawyers and journalists)

Click to open the Transcript

Transcript: Waiting for SCOTUS

[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.] 

Mila Atmos: The future of America is in your hands. This is not a movie trailer, and it’s not a political ad, but it is a call to action. I’m Mila Atmos and I’m passionate about unlocking the power of everyday citizens. On our podcast “Future Hindsight,” we take big ideas about civic life and democracy and turn them into action items for you and me. Every Thursday we talk ato bold activists and civic innovators to help you understand your power and your power to change the status quo. Find us at FutureHindsight.com or wherever you listen to podcasts.

Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News. We’re taping this week on Wednesday, May 29, at 1 p.m. As always, news happens fast and things might’ve changed by the time you hear this. So here we go.

Because it’s a holiday week and health news is a little bit slow, we’re going to do something a little different. It’s about to be June, and that means the Supreme Court is going to issue opinions in some of the biggest cases argued this past term, including two abortion-related cases and one that could literally disrupt the way the entire federal government operates. I’m not sure I remember all the details of these cases, even though we have talked about them all on the podcast. So I’ve asked someone here to remind us what they’re about and give us a preview of how the court might rule in some of them. Laurie Sobel is associate director for women’s health policy here at KFF, and one of our top in-house legal experts. Laurie, welcome to “What the Health?” Thanks for joining us.

Laurie Sobel: Hi, Julie. It’s great to be here.

Rovner: So I thought we’d take the cases in the order they were argued before the court, although I know that’s not necessarily the order that we will see the opinions issued in. First up: In January, the justices heard arguments in two cases about, of all things, herring fishing. Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce. But these cases are about a lot more than herring and could affect a lot more than the Department of Commerce, right?

Sobel: Absolutely. These cases are about what’s called the Chevron doctrine [deference], which requires courts to defer to an agency’s interpretation of a law when the law is silent or ambiguous and the agency’s interpretation is reasonable.

Rovner: And what would an example of that be?

Sobel: Oh, there’s many, many examples. Essentially, Congress doesn’t fill in the details of many laws, and they rely on agencies to fill in those details, assuming that the agency has the expertise to figure out what those details might be. And also, many times the details change as new scientific evidence becomes available or there’s changed circumstances, or there’s a pandemic or something in which the agency needs to respond to.

Rovner: This is basically the entire federal regulatory process we’re talking about here, right?

Sobel: That’s correct.

Rovner: And in health care, there’s a lot of places that regulation affects.

Sobel: Absolutely. So Congress relies on the agencies to implement laws, the ACA [Affordable Care Act], Medicare, Medicaid, CHIP [Children’s Health Insurance Program]. So there’s a lot in health care. In addition, Title X is regulated by the Office of Population Affairs, and those also have regulations. So overturning Chevron would make it very difficult for Congress to continue to rely on agencies to fill in these gaps and to react to real-time situations.

Rovner: And there’s private entities that get regulated, are freaked out by the possibility that they won’t be able to rely on the agencies either.

Sobel: Absolutely. So everything from payment rates to providers and hospitals to negotiating prescription drug prices for the Medicare program. The ACA, I think, has probably more regulations than most laws. And relationship — we’ll talk about the FDA [Food and Drug Administration] in the next case, but the FDA also sets out regulations as does CDC [Centers for Disease Control and Prevention], and we really rely on those agencies to have the scientific expertise to react to the situation. So if Congress has to either fill in all the gaps, which is by most people’s assessment impossible, it might really stall how things get implemented and/or create a whole lot of new litigation.

Rovner: And I would say it would give courts a whole lot more authority than they have now, right?

Sobel: Certainly. So right now, the rule is that the agency’s interpretation stands as long as the law is ambiguous or silent and the agency’s interpretation is reasonable. This would give that power back to the courts to then guess what Congress meant or to interpret what Congress meant.

Rovner: Somebody I was talking to about this case suggested that, I hadn’t really thought about before, that if Chevron were to get struck down, that those who had sued over regulations and lost might be able to go back and reopen those cases. I mean, it could just be a flood of litigation.

Sobel: Absolutely. And that came up during oral argument about what would that mean for all the settled cases. And both sides offered different interpretations with the solicitor general arguing that it would really open up this can of worms to tons of litigation, and the plaintiffs essentially saying, “No, no, no, we could let those all stand and just going forward, the Chevron deference would be undone.” And there were some hints that maybe some compromises like that between the justices as they were talking.

Rovner: Exactly. You’re anticipating my next question, which is did we get any hints from the oral arguments about where they might be going with this case? It’s hard to imagine them just completely overturning Chevron.

Sobel: It is hard to imagine, but there are some justices that have been known to wanting to overturn Chevron for quite some time. So in that category I would put Justices [Clarence] Thomas and [Samuel] Alito, as well as [Neil] Gorsuch, as justices that have really been critical of the Chevron deference. Justice [Brett] Kavanaugh highlighted that the rules change when administrations change, and so he tried to counter the argument that there’s a reliance on Chevron for stability. He said, “Wait, wait, wait a minute. Every time there’s a new president, the rules change. So what kind of stability is that?”

Chief Justice [John] Roberts and [Justice Amy Coney] Barrett were really harder to read, and that might be where the decision relies on, where they come out and whether or not they’re able to forge a compromise with the three liberal justices who indicated support for keeping Chevron; both because of precedent, as well as they pointed out examples where they said, “We’re not subject matter experts here. We don’t want to be making these decisions.” Justice [Elena] Kagan was talking about AI and how that would change, and “we really don’t want to be in the position of Justice Kagan figuring out how that should be regulated.”

Rovner: Well, that seems to be an excellent segue to the next case, which is an abortion case concerning the availability of the abortion pill mifepristone. The case, which was argued in March, is called Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. Let’s start, because it’s about to become important, with what is the Alliance for Hippocratic Medicine? And what did their members have against the abortion pill?

Sobel: Well, the Alliance for Hippocratic Medicine is a newly formed anti-abortion advocacy coalition. It was formed specifically for this litigation. And they contend that they have members, which are doctors and organizations and associations, in Texas and around the country, who have treated and will continue to treat people who have experienced a complication from medication abortion. So to be clear, none of their members prescribe mifepristone. They don’t believe in abortion. They don’t want to have anything to do with abortion. But their contention is that they are injured based upon having to divert their time and resources away from their regular patients when they have to treat somebody who has had a side effect from mifepristone. Similarly, the association and organizations contend that they’ve had to divert their time to educate people about the dangers of medication abortion.

Rovner: So those are the plaintiffs. And, as you mentioned, some of them are in Texas and they sued in Texas very specifically to get a certain judge, right?

Sobel: Yes, to get Judge [Matthew] Kacsmaryk, who is known for being friendly to these types of cases.

Rovner: So Judge Kacsmaryk, who as you say, is known to be friendly to these types of cases, originally ruled that mifepristone’s entire approval should be rescinded. It was approved in the year 2000, so it’s been on the market for quite a long time. But that’s actually not what’s on the table at the moment before the justices. Explain how we got there.

Sobel: So that decision was then appealed to the 5th Circuit, and the 5th Circuit said, “We’re not going to roll back the original approval of mifepristone to the year 2000, but instead we’ll roll back the requirements to 2011 and say that those are the rules that should be enforced, and that the FDA exceeded their authority in changing the rules since 2011.”

Rovner: And some of those changed rules basically made it easier to get, and you could use it a little bit later into pregnancy because it was found to be safe, right?

Sobel: Exactly. So what those new rules have done is said that you can use it up to 10 weeks instead of seven weeks, that you don’t have to be in person to receive it. So the newest rules have opened up the possibility of using it for telehealth abortion, and also for pharmacists prescribing it. And so if the Supreme Court were to affirm the 5th Circuit’s decision, that would eliminate these new protocols the FDA has established in removing the in-person dispensing requirement, permitting telehealth abortions, and establishing the process for pharmacies to become certified to dispense mifepristone. In addition, it would roll back the gestational ages you just said, from 10 weeks to seven weeks, which is significant because, according to the CDC data, more than 4 in 10 medication abortions occur at seven weeks or later.

Rovner: I was going to say, and yeah, this could be super disruptive. I mean medication abortion is now more than half of all abortions in this country.

Sobel: Oh, it’s two-thirds.

Rovner: So without banning it, making it harder to get could have a big impact.

Sobel: Oh, absolutely. Medication abortion now accounts for nearly two-thirds of all abortions, and telehealth abortions have become very common, from the latest data that we have from WeCount, 1 in 5 abortions was provided via telehealth in December of 2023. So that’s one in all abortions, not one in medication abortions. So that’s quite a big number.

Rovner: Now, this case, even though it could be very disruptive to abortion, is about a whole lot more than abortion. Drugmakers in general seem pretty concerned by the idea of judges making scientific decisions that overrule the FDA. This hearkens back to the last case we talked about, right?

Sobel: Oh, absolutely. So this is the first case to ask the Supreme Court to overrule an FDA decision that a drug is safe and effective. So the outcome of this case could really have very far-reaching implications for the FDA’s authority to continue to regulate not only mifepristone, but a wide range of other drugs. And most likely the other drugs that are perceived to be controversial — gender-affirming care or PrEP — those are the drugs that are most likely to be litigated if this door is opened.

Rovner: And I know that there’s nothing that makes drugmakers … I mean, patent issues and drugmakers and court issues are hard enough, the idea that they could be granted approval by the FDA and then somebody could just come in and sue and make that go away.

Sobel: Oh, absolutely. This got the attention of the entire industry. There were many, many amicus briefs that were filed.

Rovner: So normally you can’t really tell from the oral arguments, as we said, how the justices are leaning. But in this case, the justices seemed fairly transparent about where we think they’re going to go. What are we expecting here?

Sobel: Yes. I mean, as I said before, it’s always dangerous to read the tea leaves too much, but this did seem more transparent than most, and that most justices seemed not convinced that the plaintiffs in this case have legal standing, which requires that you have an injury and that injury can be addressed by what the court decides. So even assuming that the plaintiffs have an injury, the question is what would happen if we roll back the rules that the FDA has back to 2011? Does that make it more or less likely that these plaintiffs would see people with side effects of mifepristone? It’s not really clear. In addition, many of the justices, including Justice Barrett, really pushed back on the lawyer representing the Alliance for where in the doctors’ affidavits it said they were actually participating in something they objected to. Notably, not really about necessarily this case, but about what might come up in the future, both Justice Thomas and Alito did bring up the Comstock Act and signaled that they would uphold the enforcement of the Comstock Act, pretty much inviting a future case or a future administration to enforce the Comstock Act.

Rovner: As much as we’ve talked about it, remind us again what the Comstock Act is.

Sobel: Sure. So it’s a law from 1873, which was an anti-obscenity law, and as part of it, it banned the mailing of any drug or device or instrument that could be used for abortion.

Rovner: Well, I guess during the entirety of Roe [v. Wade], it was irrelevant, right? Because abortion was legal,

Sobel: Right. And it’s been dormant. I mean, we can’t find any enforcement in any modern era.

Rovner: Yes, so it goes back a long ways, but it’s top of mind for a lot of people.

All right, moving on to our last case. On April 24, the court heard Idaho v. United States and Moyle v. United States, both of which challenged the federal government’s interpretation of the Emergency Medical Treatment and Active Labor Act, EMTALA, to override Idaho’s near-complete abortion ban, at least in medical emergencies. Let’s start by explaining what EMTALA is and how it relates to abortion?

Sobel: Sure. So EMTALA requires hospitals that participate in Medicare, which is pretty much every acute hospital, to provide stabilizing treatment within the hospital’s capability when there’s an emergency medical condition, which includes when the absence of immediate medical attention could reasonably be expected to place the health of the individual in serious jeopardy or serious impairments of bodily functions. So it was really intended as an anti-dumping law initially so that people who were uninsured weren’t just transferred or sent away to another hospital because they didn’t have the capacity to pay.

Idaho’s abortion ban only has an exception for life. It doesn’t have an exception to preserve the health of the pregnant person. And so the Biden administration sued Idaho and said this law then, essentially, puts these hospitals that have this requirement, because they accept Medicare payments, to stabilize patients. And when that care includes abortion care, they’re required to provide that under federal law. So the question is, does the EMTALA preempt the Idaho abortion ban?

It’s clear from the oral argument that Idaho’s position is that there is no conflict because they read into the EMTALA law that “within the hospital’s capability” includes the laws of Idaho and that Idaho gets to set the standard of care, and that that’s up to states, not up to the federal government. Whereas the federal government, the Biden administration’s position, is that, no, EMTALA specifically was an antidumping law, and that includes stabilizing all patients regardless of the care. And we don’t have to say including abortion in order for it to include abortion, it includes all care that’s required to stabilize patients.

Rovner: Of course, a lot of anti-abortion activists will say that the only time abortion is medically necessary is when it threatens life and that would be covered. But we’re seeing that that’s not necessarily the case, right? I mean, we’re seeing individual instances of this these days.

Sobel: Yeah. I mean, we know from Idaho that many patients have been helicoptered out of the state into nearby states that also have some abortion restrictions but just aren’t as restrictive as Idaho is, because they’re going to become septic or they’re going to lose kidney function, or they’re going to lose their reproductive organs. So they’re not in danger of losing their life immediately, but they’re in danger of losing serious bodily functions.

The other question that came up during oral argument was about just how imminent the life needs to be. And this comes down to how this is putting doctors in a pretty uncomfortable place. So yes, the doctors are permitted to provide abortion care in Idaho when they can certify in good faith that without the abortion care, the person’s life is endangered. But they’re concerned that, after the fact, attorneys for the state could come back and say, “Oh, wait a minute, that wasn’t your really good-faith decision and we’re going to prosecute you and we’re going to bring in our own expert.” And the question is really, how much should doctors have on the line? It’s a criminal statute, so there’s jail time involved. Of course, there’s a loss of license. And so how far out should doctors be required to go? And this is, again, it’s making people really uncomfortable, and there are anecdotes of people leaving the state because of this and not feeling comfortable practicing there.

Rovner: More than anecdotes of people leaving the state, there are people who come forward and said they’re leaving the state. And as a result, some hospitals are having to shut down their OB services. I mean, because when the doctors, OB-GYNs who are leaving, so in the ironic position of people who are having babies not being able to find someone who can deliver their baby at the same time.

Sobel: Right, right.

Rovner: That’s obviously one ramification within Idaho, but there could be ramifications outside just on the idea: Isn’t federal law supposed to trump state law? Isn’t that sort of a basic foundation of how we work?

Sobel: Yes. The supremacy clause is pretty basic when you go to law school. So yes. And I think how they word this decision will be very interesting to see because it’s a question of, is there a conflict or is there not? And the attorneys for Idaho were basically suggesting that there’s no conflict. So you don’t even need to say that there’s a preemption. You just have to find that there’s no conflict between Idaho law and EMTALA.

However they rule, if they rule for Idaho and say that you’re allowed to continue having this abortion ban that only has a life exception with no health exception, immediately, there’s four additional states with abortion bans that do not make exceptions for health as well. And those states are Arkansas, Mississippi, Oklahoma, and South Dakota. So in those states, like Idaho, a hospital cannot legally provide an abortion as stabilizing treatment when a person presents with a health endangerment and not a life endangerment. And so again, those risks can include sepsis, kidney failure, loss of fertility, they’re serious risks, even though they may not be life-threatening at the moment.

And even in the states that do have exceptions for health, we have seen that those exceptions are often very narrow and vague and hard to be implemented in real time. So pregnant people can still be denied emergency abortion care that’s needed to preserve their health, even in states that have a health exception. And if EMTALA doesn’t act as a backstop to say, “But wait, hospital, you’re violating this federal law,” then people are stuck with the state law that is narrow and vague.

Rovner: So I mean, overturning Roe, the justices says, “Oh, great, we won’t have to deal with abortion anymore. It’s all about the states.” But as we can see, it’s not all about the states. The Supreme Court is going to have to continue to deal with this issue.

Sobel: Right. Definitely.

Rovner: All right, well, finally, just a couple of housekeeping issues. We don’t actually know when these decisions will come, right? People who don’t follow the court on a regular basis often think that opinions are scheduled the same way oral arguments are, but it’s always a surprise.

Sobel: Unfortunately, they are not. Right now, the court lists their decision days on their website, which is on their calendar. Right now Thursdays seem to be the popular day, they have Thursdays through June listed. They most likely will add more decision days. On decision days, they start posting decisions at 10 a.m. Eastern Time, and you can follow along either on the Supreme Court’s website or many people go to SCOTUSblog, which also has a live blog that interprets some of what’s happening for people who are new to the court.

Rovner: And I will put both of those links in the show notes. Laurie Sobel, this has been so helpful. Thank you so much for joining us.

Sobel: Thank you for having me, Julie.

Rovner: OK, that is our show. 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 technical guru, Francis Ying, and our fill-in editor this week, Rebecca Adams. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X @jrovner. We will be back in your feed next week with the news. Until then, be healthy.

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According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by KFF Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later.

That inspection found that the Indiana dental device manufacturer didn’t require all customer complaints to be investigated and the company did not investigate some complaints about people being hurt by products, including the AGGA, the FDA documents state. The FDA requires device companies to investigate complaints and forward them to the agency. Johns Dental had “never” alerted the FDA to any such complaints, according to the documents.

The AGGA, which its inventor testified has been used on more than 10,000 patients, was promoted by dentists nationwide, some of whom said it could “grow” or “expand” an adult’s jaw without surgery and treat common ailments like sleep apnea. But these claims were not backed by peer-reviewed research, and Johns Dental has settled lawsuits from 20 patients who alleged the AGGA caused them grievous harm. The company has not admitted liability.

Two former FDA officials said the AGGA was likely able to stay on the market — and off the FDA’s radar — for so long because of the lack of inspections and investigations at Johns Dental. Madris Kinard, a former FDA manager who founded Device Events, which analyzes FDA data, said it defies belief that Johns Dental never received a complaint worthy of relaying to the FDA.

“That’s a red flag for me. If I don’t see a single report to the FDA, I typically think there is something going on,” Kinard said. “When they don’t report, what you have is devices that stay on the market much longer than they should. And patients get harmed.”

Johns Dental Laboratories declined to comment when reached by phone and its lawyers did not respond to requests for an interview. The family-owned company, which has operated since 1939 in the western Indiana city of Terre Haute, sells dozens of products to dentists and makes hundreds of retainers and sleep apnea appliances each month, according to its website.

Twelve of Johns Dental’s products are registered with the FDA as Class II medical devices, meaning they carry at least a moderate risk, and some have been featured on the company website for at least two decades, according to screen captures preserved by the Internet Archive.

The AGGA, which was invented by Tennessee dentist Steve Galella in the 1990s, was not registered with the FDA like Johns Dental’s other devices. Company owner Jerry Neuenschwander has said in sworn court depositions that Johns Dental started making the AGGA in 2012 and became Galella’s exclusive manufacturer in 2015 and that at one point the AGGA was responsible for about one-sixth of Johns Dental’s total sales revenue.

In another deposition, Johns Dental CEO Lisa Bendixen said the company made about 3,000 to 4,000 AGGAs a year and paid Galella’s company a “royalty” of $50 to $65 for every sale.

“We are not dentists. We do not know how these appliances work. All we do is manufacture to Dr. Galella’s specifications,” she said, according to a deposition transcript.

The FDA’s lack of knowledge about the AGGA likely contributed to its loose oversight of Johns Dental. When asked to explain the lack of inspection, the FDA said that, based on what it knew at the time, it was not required to inspect Johns Dental until 2018 when the company registered as a “contract manufacturer” of other medical devices. Prior to 2018, the FDA was only aware of Johns Dental operating as a “dental laboratory,” which normally do not manufacture their own products and only modify devices made by other companies to fit dentists’ specifications. The FDA does not regularly inspect dental labs, although it can if it has concerns or gets complaints, the agency said.

Kinard said that based on her experience at the FDA she believes the agency prioritizes medical devices over dental devices, which may have contributed to the lack of inspections at Johns Dental.

“There hasn’t been much attention to dental devices in the past,” Kinard said. “Hopefully that’s going to change because of dental implant failures, as well as this device, which has quite obviously had serious issues.”

The AGGA resembles a retainer and uses springs to apply pressure to the front teeth and upper palate, according to a patent application. Last year, the KFF Health News-CBS News investigation revealed the AGGA was not backed by any peer-reviewed research and had never been submitted to the FDA for review. At the time, at least 20 patients had alleged in lawsuits that the AGGA had caused grievous harm to their teeth, gums, and bone — and some said they’d lost teeth. Multiple dental specialists said in interviews that they had examined AGGA patients whose teeth had been shoved out of position by the device, sometimes causing tens of thousands of dollars in damage.

“The entire concept of this device, of this treatment, makes zero sense,” said Kasey Li, a maxillofacial surgeon who published research on AGGA patients that appeared on a National Institutes of Health website. “It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.

Johns Dental and Galella have negotiated out-of-court settlements with the original 20 AGGA plaintiffs without publicly admitting fault. At least 13 more AGGA patients have filed similar lawsuits since the KFF Health News-CBS News investigation. Johns Dental and Galella denied wrongdoing or have not yet responded to the allegations in the newer lawsuits.

Galella declined to be interviewed in 2023 and neither he nor his attorneys responded to recent requests for comment. One of his attorneys, Alan Fumuso, said in a 2023 statement that the AGGA “is safe and can achieve beneficial results” when used properly.

In the wake of the KFF Health News-CBS News report, Johns Dental abruptly stopped making the AGGA, according to the newly released FDA documents. The Department of Justice soon after opened a criminal investigation into the AGGA that was ongoing as of December, according to court filings. No charges have been filed. A DOJ spokesperson declined comment.

Spurred by the March 2023 news report, the FDA inspected Johns Dental in July. The FDA’s website shows that Johns Dental was issued seven citations, but the substance of the agency’s findings was not known until the inspection report was obtained this year.

FDA investigator David Gasparovich wrote in that report that he arrived unannounced at Johns Dental last July and was met by five attorneys who instructed employees not to answer any questions about the AGGA or the company’s complaint policies. Neuenschwander was told by his attorney not to talk to the inspector, the report states.

“He asked if he could photograph my credentials,” Gasparovich wrote in his report. “This was the last conversation I would have with Mr. Neuenschwander at the request of his attorney.”

The FDA requires device companies to investigate product complaints and submit a “medical device report” to the agency within 30 days if the products may have contributed to serious injury or death. Gasparovich’s inspection report states that Johns Dental had “not adequately investigated customer complaints,” and its complaint policies were “not adequately established,” allowing employees to not investigate if the product was not first returned to the company.

Johns Dental received four complaints about the AGGA after the KFF Health News-CBS News report, including one that came after the FDA announced “safety concerns” about the device, according to the inspection report.

“Zero (0) out of the four (4) complaints were investigated,” Gasparovich wrote in the report. “Each complaint was closed on the same day it was received.”

In the months after Gasparovich’s inspection, Johns Dental sent letters to the FDA saying it revised its complaint policies to require more investigations and hired a consultant and an auditor to address other FDA concerns, according to the documents obtained through FOIA.

Former FDA analyst M. Jason Brooke, now an attorney who advises medical device companies, said the FDA uses an internal risk-based algorithm to determine when to inspect manufacturers and he advises his clients to expect inspections every three to five years.

Brooke said the AGGA is an example of how the FDA’s oversight can be hamstrung by its reliance on device manufacturers to be transparent. If device companies don’t report to the agency, it can be left unaware of patient complaints, malfunctions, or even entire products, he said.

When a company “doesn’t follow the law,” Brooke said, “the FDA is in the dark.”

“If there aren’t complaints coming from patients, doctors, competitors, or the company itself, then in a lot of ways, there’s just a dearth of information for the FDA to consume to trigger an inspection,” Brooke said.

CBS News producer Nicole Keller contributed to this article.

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.

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Las pruebas han detectado el virus en el ganado en nueve estados, principalmente en Texas y Nuevo México, y más recientemente en Colorado, dijo Nirav Shah, director principal adjunto de los Centros para el Control y Prevención de Enfermedades (CDC), en un evento del 1 de mayo.

Otros animales, y al menos una persona en Texas, también se infectaron con el H5N1. Pero lo que más temen los científicos es si el virus se propagara de manera eficiente de persona a persona. Eso no ha sucedido y podría no suceder. Shah dijo que los CDC consideran que el brote de H5N1 “es un riesgo bajo para el público en general en este momento”.

Los virus evolucionan y los brotes pueden cambiar rápidamente. “Como con cualquier brote importante, esto se mueve a la velocidad de un tren bala”, dijo Shah. “De lo que hablamos ahora es de un instantánea de ese tren que se mueve rápidamente”. Lo que quiere decir es que lo que hoy se sabe sobre la gripe aviar H5N1 seguramente cambiará.

Con eso en mente, KFF Health News explica lo que se necesita saber ahora.

¿Quién contrae el virus que causa la gripe aviar?

Principalmente las aves. Sin embargo, en los últimos años, el virus de la gripe aviar H5N1 ha estado saltando cada vez más de las aves a los mamíferos en todo el mundo. La creciente lista, de más de 50 especies, incluye focas, cabras, zorrinos, gatos y perros salvajes en un zoológico en el Reino Unido. Al menos 24,000 leones marinos murieron en brotes de gripe aviar H5N1 en Sudamérica el año pasado.

Lo que hace que el brote actual en el ganado sea inusual es que se está propagando rápidamente de vaca a vaca, mientras que los otros casos, excepto las infecciones de leones marinos, parecen limitados. Los investigadores saben esto porque las secuencias genéticas de los virus H5N1 extraídos de las vacas este año eran casi idénticas entre sí.

El brote de ganado también preocupa porque agarró al país desprevenido. Los investigadores que examinan los genomas del virus sugieren que originalmente se transmitió de las aves a las vacas a finales del año pasado en Texas, y desde entonces se ha propagado entre muchas más vacas de las que se han examinado.

“Nuestros análisis muestran que esto ha estado circulando en vacas durante unos cuatro meses, bajo nuestras narices”, dijo Michael Worobey, biólogo especializado en evolución de la Universidad de Arizona en Tucson.

¿Es este el comienzo de la próxima pandemia?

Aún no. Pero es algo que vale la pena considerar porque una pandemia de gripe aviar sería una pesadilla. Más de la mitad de las personas infectadas por cepas anteriores del virus de la gripe aviar H5N1 de 2003 a 2016 murieron.

Incluso si las tasas de mortalidad resultan ser menos severas para la cepa H5N1 que circula actualmente en el ganado, las repercusiones podrían implicar muchas personas enfermas y hospitales demasiado abrumados para manejar otras emergencias médicas.

Aunque al menos una persona se infectó con el H5N1 este año, el virus no puede provocar una pandemia en su estado actual.

Para alcanzar este horrible estatus, un patógeno necesita enfermar a muchas personas en varios continentes. Y para lograrlo, el virus H5N1 necesitaría infectar a toneladas de personas. Eso no sucederá a través de saltos ocasionales del virus de los animales de granja a las personas. Más bien, el virus debe adquirir mutaciones para propagarse de persona a persona, como la gripe estacional, como una infección respiratoria transmitida principalmente por el aire cuando las personas tosen, estornudan y respiran.

Como aprendimos de covid-19, los virus transmitidos por el aire son difíciles de frenar.

Eso aún no ha sucedido. Sin embargo, los virus H5N1 ahora tienen muchas oportunidades para evolucionar a medida que se replican dentro de los organismos de miles de vacas. Como todos los virus, mutan a medida que se replican, y las mutaciones que mejoran la supervivencia del virus se transmiten a la próxima generación. Y debido a que las vacas son mamíferos, los virus podrían estar mejorando en reproducirse dentro de células más cercanas a las nuestras que las de las aves.

La evolución de un virus de gripe aviar listo para una pandemia podría facilitarse por una especie de superpoder que poseen muchos virus. Es decir, a veces intercambian sus genes con otras cepas en un proceso llamado recombinación.

En un estudio publicado en 2009, Worobey y otros investigadores rastrearon el origen de la pandemia del virus de la gripe porcina H1N1 en eventos en los que diferentes virus que causaban esta gripe, la gripe aviar y la gripe humana mezclaban y combinaban sus genes dentro de cerdos que se estaban infectando simultáneamente. Los cerdos no necesitan estar involucrados esta vez, advirtió Worobey.

¿Comenzará una pandemia si una persona bebe leche contaminada con el virus?

Aún no. La leche de vaca, así como la leche en polvo y la fórmula infantil, que se venden en tiendas se consideran seguras porque la ley requiere que toda la leche vendida comercialmente sea pasteurizada. Este proceso de calentar la leche a altas temperaturas mata bacterias, virus y otros microorganismos.

Las pruebas han identificado fragmentos de virus H5N1 en la leche comercial, pero confirman que los fragmentos del virus están muertos y, por lo tanto, son inofensivos.

Sin embargo, la leche “cruda” no pasteurizada ha demostrado contener virus H5N1 vivos, por eso la Administración de Drogas y Alimentos (FDA) y otras autoridades sanitarias recomiendan firmemente a las personas que no la tomen, porque podrían enfermarse de gravedad o algo peor.

Pero, aún así, es poco probable que se desate una pandemia porque el virus, en su forma actual, no se propaga eficientemente de persona a persona, como lo hace, por ejemplo, la gripe estacional.

¿Qué se debe hacer?

¡Mucho! Debido a la falta de vigilancia, el Departamento de Agricultura (USDA) y otras agencias han permitido que la gripe aviar H5N1 se propague en el ganado, sin ser detectada. Para hacerse cargo de la situación, el USDA recientemente ordenó que se sometan a pruebas a todas las vacas lecheras en lactancia antes que los ganaderos las trasladen a otros estados, y que se informen los resultados de las pruebas.

Pero al igual que restringir las pruebas de covid a los viajeros internacionales a principios de 2020 permitió que el coronavirus se propagara sin ser detectado, testear solo a las vacas que se mueven entre estados dejaría pasar muchos casos.

Estas pruebas limitadas no revelarán cómo se está propagando el virus entre el ganado, información que los ganaderos necesitan desesperadamente para frenarlo. Una hipótesis principal es que los virus se están transfiriendo de una vaca a la siguiente a través de las máquinas utilizadas para ordeñarlas.

Para aumentar las pruebas, Fred Gingrich, director ejecutivo de la American Association of Bovine Practitioners, dijo que el gobierno debería ofrecer fondos a los ganaderos para que informen casos y así tengan un incentivo para hacer pruebas. De lo contrario, dijo, informar solo daña la reputación por encima de las pérdidas financieras.

“Estos brotes tienen un impacto económico significativo”, dijo Gingrich. “Los ganaderos pierden aproximadamente el 20% de su producción de leche en un brote porque los animales dejan de comer, producen menos leche, y parte de esa leche es anormal y no se puede vender”.

Gingrich agregó que el gobierno ha hecho gratuitas las pruebas de H5N1 para los ganaderos, pero no han presupuestado dinero para los veterinarios que deben tomar muestras de las vacas, transportar las muestras y presentar los documentos. “Las pruebas son la parte menos costosa”, explicó.

Si las pruebas en las granjas siguen siendo esquivas, los virólogos aún pueden aprender mucho analizando secuencias genómicas del virus H5N1 de muestras de ganado. Las diferencias entre las secuencias cuentan una historia sobre dónde y cuándo comenzó el brote actual, el camino que recorre y si los virus están adquiriendo mutaciones que representan una amenaza para las personas.

Sin embargo, esta investigación vital se ha visto obstaculizada porque el USDA publica los datos incompletos y con cuentagotas, dijo Worobey.

El gobierno también debería ayudar a los criadores de aves de corral a prevenir brotes de H5N1, ya que estos matan a muchas aves y representan una amenaza constante de potenciales saltos de especies, dijo Maurice Pitesky, especialista en enfermedades de aves de la Universidad de California-Davis.

Las aves acuáticas como los patos y los gansos son las fuentes habituales de brotes en granjas avícolas, y los investigadores pueden detectar su proximidad mediante el uso de sensores remotos y otras tecnologías. Eso puede significar una vigilancia rutinaria para detectar signos tempranos de infecciones en aves de corral, usar cañones de agua para ahuyentar a las bandadas migratorias, reubicar animales de granja o llevarlos temporalmente a cobertizos. “Deberíamos estar invirtiendo en prevención”, dijo Pitesky.

Bien, no es una pandemia, pero ¿qué podría pasarle a las personas que contraigan la gripe aviar H5N1 de este año?

Realmente nadie lo sabe. Solo una persona en Texas fue diagnosticada con la enfermedad este año, en abril. Esta persona trabajaba con vacas lecheras, y tuvo un caso leve con una infección en el ojo. Los CDC se enteraron de esto debido a su proceso de vigilancia. Las clínicas deben alertar a los departamentos de salud estatales cuando diagnostican a trabajadores agrícolas con gripe, utilizando pruebas que detectan virus de la influenza en general.

Los departamentos de salud estatales luego confirman la prueba y, si es positiva, envían una muestra de la persona a un laboratorio de los CDC, donde se verifica específicamente la presencia del virus H5N1. “Hasta ahora hemos recibido 23”, dijo Shah. “Todos menos uno resultaron negativos”.

Agregó que funcionarios del departamento de salud estatal también están monitoreando a alrededor de 150 personas que han pasado tiempo alrededor de ganado. Están en contacto con estos trabajadores agrícolas con llamadas telefónicas, mensajes de texto o visitas en persona para ver si desarrollan síntomas. Y si eso sucede, les harán pruebas.

Otra forma de evaluar a los trabajadores agrícolas sería testear su sangre en busca de anticuerpos contra el virus de la gripe aviar H5N1; un resultado positivo indicaría que podrían haberse infectado sin saberlo. Pero Shah dijo que los funcionarios de salud aún no están haciendo este trabajo.

“El hecho de que hayan pasado cuatro meses y aún no hayamos hecho esto no es una buena señal”, dijo Worobey. “No estoy muy preocupado por una pandemia en este momento, pero deberíamos comenzar a actuar como si no quisiéramos que sucediera”.

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.

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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 national abortion landscape was shaken again this week as Florida’s six-week abortion ban took effect. That leaves North Carolina and Virginia as the lone Southern states where abortion remains widely available. Clinics in those states already were overflowing with patients from across the region.

Meanwhile, in a wide-ranging interview with Time magazine, former President Donald Trump took credit for appointing the Supreme Court justices who overturned Roe v. Wade, but he steadfastly refused to say what he might do on the abortion issue if he is returned to office.

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

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Sarah Karlin-Smith
Pink Sheet

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Alice Miranda Ollstein
Politico

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Read Alice's stories.

Rachana Pradhan
KFF Health News

@rachanadpradhan

Read Rachana's stories.

Among the takeaways from this week’s episode:

• Florida’s new, six-week abortion ban is a big deal for the entire South, as the state had been an abortion haven for patients as other states cut access to the procedure. Some clinics in North Carolina and southern Virginia are considering expansions to their waiting and recovery rooms to accommodate patients who now must travel there for care. This also means, though, that those traveling patients could make waits even longer for local patients, including many who rely on the clinics for non-abortion services.
• Passage of a bill to repeal Arizona’s near-total abortion ban nonetheless leaves the state’s patients and providers with plenty of uncertainty — including whether the ban will temporarily take effect anyway. Plus, voters in Arizona, as well as those in Florida, will have an opportunity in November to weigh in on whether the procedure should be available in their state.
• The FDA’s decision that laboratory-developed tests must be subject to the same regulatory scrutiny as medical devices comes as the tests have become more prevalent — and as concerns have grown amid high-profile examples of problems occurring because they evaded federal review. (See: Theranos.) There’s a reasonable chance the FDA will be sued over whether it has the authority to make these changes without congressional action.
• Also, the Biden administration has quietly decided to shelve a potential ban on menthol cigarettes. The issue raised tensions over its links between health and criminal justice, and it ultimately appears to have run into electoral-year headwinds that prompted the administration to put it aside rather than risk alienating Black voters.
• In drug news, the Federal Trade Commission is challenging what it sees as “junk” patents that make it tougher for generics to come to market, and another court ruling delivers bad news for the pharmaceutical industry’s fight against Medicare drug negotiations.

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

Julie Rovner: ProPublica’s “A Doctor at Cigna Said Her Bosses Pressured Her To Review Patients’ Cases Too Quickly. Cigna Threatened To Fire Her,” by Patrick Rucker, The Capitol Forum, and David Armstrong, ProPublica.

Alice Miranda Ollstein: The Associated Press’ “Dozens of Deaths Reveal Risks of Injecting Sedatives Into People Restrained by Police,” by Ryan J. Foley, Carla K. Johnson, and Shelby Lum.

Sarah Karlin-Smith: The Atlantic’s “America’s Infectious-Disease Barometer Is Off,” by Katherine J. Wu.

Rachana Pradhan: The Wall Street Journal’s “Millions of American Kids Are Caregivers Now: ‘The Hardest Part Is That I’m Only 17,” by Clare Ansberry.

Also mentioned on this week’s podcast:

• Time’s “How Far Trump Would Go,” by Eric Cortellessa.
• NPR’s “Why Is a 6-Week Abortion Ban Nearly a Total Ban? It’s About How We Date a Pregnancy,” by Selena Simmons-Duffin.
• NPR’s “’Sicko’s’ Peeno Sees Few Gains in Health Insurance,” by Julie Rovner.
• CNN’s “Walmart Will Close All of Its Health Care Clinics,” by Nathaniel Meyersohn.

Click to open the Transcript

Transcript: Abortion Access Changing Again in Florida and Arizona

[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.]

Mila Atmos: The future of America is in your hands. This is not a movie trailer, and it’s not a political ad, but it is a call-to-action. I’m Mila Atmos, and I’m passionate about unlocking the power of everyday citizens. On our podcast “Future Hindsight,” we take big ideas about civic life and democracy, and turn them into action items for you and me. Every Thursday, we talk to bold activists and civic innovators to help you understand your power and your power to change the status quo. Find us at futurehindsight.com or wherever you listen to podcasts.

Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for 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 2, 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 Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Hello.

Rovner: Sarah Karlin-Smith of the Pink Sheet.

Sarah Karlin-Smith: Hi, everybody.

Rovner: And my KFF Health News colleague Rachana Pradhan.

Rachana Pradhan: Hello.

Rovner: No interview this week, but more than enough news to make up for it, so we will dig right in. We will start, again, with abortion. On Wednesday, Florida’s six-week abortion ban took effect. Alice, what does this mean for people seeking abortions in Florida, and what’s the spillover to other states?

Ollstein: Yeah, this is a really huge deal not only because Florida is so populous, but because Florida, somewhat ironically given its leadership, has been a real abortion haven since Roe vs. Wade was overturned. A lot of its surrounding states had near-total bans go into effect right away. Florida has had a 15-week ban for a while, but that has still allowed for a lot of abortions to take place, and so a lot of people have been coming to Florida from Alabama, Louisiana, those surrounding states for abortions. Now, Florida’s six-week ban is taking effect and that means that a lot of the patients that had been going there will now need to go elsewhere, and a lot of Floridians will have to travel out of state.

And so there are concerns about whether the closest clinics they can get to, in North Carolina and southern Virginia, will have the capacity to handle that patient overload. I talked to some clinics that are trying to staff up. They’re even thinking about physical changes to their clinics, like building bigger waiting rooms and recovery rooms. This is going to cause a real crunch, in terms of health care provision. That is set to not only affect abortion, but with these clinics overwhelmed, that takes up appointments for people seeking other services as well. My colleagues and I have been talking to people in the sending states, like Alabama, who worry that the low-income patients they serve who were barely able to make it to Florida will not be able to make it even further. Then, we’ve talked to providers in the receiving states, like Virginia, who are worried that there just are simply not enough appointments to handle the tens of thousands of people who had been getting abortions in Florida up to this point.

Rovner: Of course, what ends up happening is that, if people have to wait longer, it pushes those abortions into later types of abortions, which are more complicated and more dangerous and more expensive.

Ollstein: Yes. While the rate of complication is low, the later in pregnancy you go, it does get higher. That’s another consideration as well.

I will flag, though, that restrictions on abortion pills in North Carolina, which is now one of the states set to receive a lot of people, those did get a little bit loosened by a court ruling this week so people will not have to have a mandatory in-person follow-up appointment for abortion pills like they used to have to have. That could help some patients who are traveling in from out of state, but a lot of restrictions remain, and it’ll be tough for a lot of folks to navigate.

Rovner: While we think of that, well there’s at least, you can get abortions up to six weeks, my friend Selena Simmons-Duffin over at NPR had a really good explainer about why six weeks isn’t really six weeks, because of the way that we measure pregnancy, that six weeks is really two weeks. It really is a very, very small window in which people will be able to get abortions in Florida. It’s not quite a full ban, but it is quite close to it.

Well, speaking of full bans, after several false starts, the Arizona Senate Wednesday voted to repeal the 1864 abortion ban that its Supreme Court ruled could take effect. The Democratic governor is expected to sign it. Where does that leave abortion law in the very swing state of Arizona? It’s kind of a muddle, isn’t it?

Ollstein: It is. The basics are that a 15-week ban is already in place and will continue to be in place once this repeal takes effect. What we don’t know is whether the total ban from before Arizona was even a state will take effect temporarily, because of the weird timing of the court’s implementation of that old ban, and the new repeal bill that just passed that the governor is expected to sign very soon. The total ban could go into effect, at least for a little bit over the summer. Planned Parenthood is positioning the court to not let that happen, to stay the implementation until the repeal bill can take effect. All of this is very much in flux. Of course, as we’ve seen in so many states, that leads to patients and providers just being very scared, and not knowing what’s legal and what’s not, and folks being unable to access care that may, in fact, be legal because of that. Of course, this is all in the context of Arizona, as well as Florida, being poised to vote directly on abortion access this fall. If the total ban does go into effect temporarily, it’s sure to pour fuel on that fire and really rile people up ahead of that vote.

Rovner: Yeah, I was going to mention that. Well, now that we’re talking about politics. This week, we heard a little bit more about how former President Trump wants to handle the abortion issue, via a long sit-down interview with Time magazine. I will link to that interview in the show notes. The biggest “news” he made was to suggest that he’d have an announcement soon about his views on the abortion pill. But he said that would come in the next two weeks, the interview was of course more than two weeks ago. They did a follow-up two weeks later and he still said it was coming. In the follow-up interview, he said it would be next week, which this has already passed. Do we really expect Trump to say something about this, or was that just him deflecting, as we know he is wont to do?

Pradhan: Well, I’m sure that he’s getting pressure to say something, because as people have noted now quite widely, regardless of individual state laws, there are certainly conservatives that are pushing for him and his future administration to ban the mailing of abortion pills using the Comstock Act from the 1800s, which would basically annihilate access to that form of terminating pregnancies.

Rovner: There are also some who want him to just repeal the FDA approval, right?

Ollstein: Right. Of course, the Biden administration has made it easier for folks to get access to those, to mifepristone, in particular, one of two pills that are used in medication abortion. But yeah, will it be two weeks? I think he obviously knows that this is a potential political liability for him, so whether he’ll say something, I’m sure he will get competing advice as to whether it’s a good idea to say something at all, so we’ll have to see.

Rovner: Well, speaking of Trump deflecting, he seemed to be pretty disciplined about the rest of the abortion questions — and there were a lot of abortion questions in that interview — insisting that, while he takes credit for appointing the justices who made the majority to overturn Roe, everything else is now up to the state. But by refusing to oppose some pretty-out-there suggestions of what states might do, Trump has now opened himself up to apparently accepting some fairly unpopular things, like tracking women’s menstrual periods. Lest you think that’s an overstatement, the Missouri state health director testified at a hearing last week that he kept a spreadsheet to track the periods of women who went to Planned Parenthood, which, according to The Kansas City Star, “helped to identify patients who had undergone failed abortions.” Yet, none of these things ever seem to stick to Trump. Is any of this going to matter in the long run? He’s clearly trying to walk this line between not angering his very anti-abortion base and not seeming to side too much with them, lest he anger a majority of the rest of the people he needs to vote for him.

Ollstein: Well, he’s also not been consistent in saying it’s totally up to states, whatever states want to do is fine. He’s repeatedly criticized Florida’s six-week ban. He refused to say how he would vote on the referendum to override it. He has criticized the Arizona ruling to implement the 1864 ban. This isn’t a pure “whatever states do is fine” stance, this is “whatever states do, unless it’s something really unpopular, in which case I oppose it.” That is a tough line to walk. The Biden administration and the Biden campaign have really seized on this and are trying to say, “OK, if you are going to have a leave-it-to-states stance, then we’re going to try to hang on you every single thing states do, whether it’s the legislature, or a court, or whatever, and say you own all of this.” That’s what’s playing out right now.

Rovner: I highly recommend reading the interview, because the interviewer was very skilled at trying to pin him down. He was pretty skilled at trying to evade being pinned down. Well, meanwhile, Republican attorneys general from 17 states are suing the Equal Employment Opportunity Commission from including abortion in a list of conditions that employers can’t discriminate against and must provide accommodations for, under rules implementing the Pregnant Workers Fairness Act. The new rules don’t require anyone to pay for anything, but they could require employers to provide leave or other accommodations to people seeking pregnancy-related health care. The EEOC has included abortion as pregnancy-related health care. This is yet another case that we could see making its way to the Supreme Court. Ironically, the Pregnant Workers Fairness Act was a very bipartisan bill, so there are a lot of anti-abortion groups that are extremely angry that this has been included in the regulation. This is one of those abortion-adjacent issues that tends to drag abortion in, even when it was never expected to be there. And we’re going to see more of these. We’re going to get back into the spending bills, as Congress tries to muddle its way through another session.

Pradhan: I think, when I think about this, even though there’s a regulatory battle and a legal one now, too, like in the immediate aftermath of the Dobbs [v. Jackson Women’s Health Organization] decision, when there were employers, I think about it more practically. Which is that there were employers that were saying, “We would cover expenses.” Or they would pay for people to travel out of state if that was something that they needed. I wonder how many people would actually do it, even if it exists, because that’s a whole other … Getting an abortion, or even things related to pregnancy, are incredibly private things, so I don’t know how many women would be willing to stand up and say, “Hey, I need this accommodation and you have to give it to me under federal regulations.” In a way, I think it’s notable both that the EEOC put out those regulations and that there’s litigation over it, but I wonder if it, practically speaking, just how much of an impact it would really have, just because of those privacy and practical hurdles associated with divulging information in that regard.

Rovner: As we were just talking about, somebody in Alabama, the closest place they can go to get an abortion is in North Carolina or Virginia, and go, “Hey, I need three days off so I can drive halfway across the country to get an abortion because I can’t get one here.” I see that might be an awkward conversation.

Pradhan: Just like any sensitive medical- or health-related needs, it’s not like people are rushing to tell their employers necessarily that it’s something that they’re dealing with.

Rovner: That’s true. It doesn’t have anything to do with privacy. Most people are not anxious to advertise any health-related issues that they are having. Speaking of people and their sensitive medical information, that Change Healthcare hack that we’ve been talking about since February, well the CEO of Change’s owner, UnitedHealth Group, was on Capitol Hill on Wednesday, taking incoming from both the Senate Finance Committee in the morning, and the House Energy and Commerce Committee in the afternoon. Among the other things that Andrew Witty told lawmakers was that the portal that was hacked did not have multifactor authentication and he confirmed that United paid $22 million in bitcoin to the hackers, although as we discussed last week, they might not have paid the hackers who actually had possession of the information. Nobody actually seemed to follow up on that, which I found curious. My favorite moment in the Senate hearing was when North Carolina Republican Thom Tillis offered CEO Witty a copy of the book “Hacking For Dummies.” Is anything going to result from these hearings? Other than what it seemed a lot of lawmakers getting to express their frustration in person.

Pradhan: Can I just say how incredible it is to me that a company that their net worth is almost $450 billion, one of the largest companies in the world, apparently does not know how to enforce rules on two-factor authentication, which is something I think that is very routine and commonplace among the modern industrialized workforce.

Rovner: I have it for my Facebook account!

Pradhan: Right. I think everyone, even in our newsroom, knows how to do it or has been told that this is necessary for so many things. I just find it absolutely unbelievable that the CEO of United would go to senators and say this, and think that it would be well-received, which it was not.

Rovner: I will say his body language seemed to be very apologetic. He didn’t come in guns blazing. He definitely came in thinking that, “Oh, I’m going to get kicked around, and I’m just going to have to smile and take it.” But obviously, this is still a really serious thing and a lot of members of Congress, a lot of the senators and the House members, said they’re still hearing from providers who still can’t get their claims processed, and from people who can’t get their medications because pharmacies can’t process the claims. There’s a lot of dispute about how long it’s going to take to get things back up and running. One of the interesting tidbits that I took away is that, as much of health care that goes through Change, it’s like 40% of all claims, it’s actually a minimum part of United’s health claims. United doesn’t use Change for most of its claims, which surprised me. Which is maybe why United isn’t quite as freaked out about this as a lot of others are. Is there anything Congress is going to be able to do here, other than say to their constituents, “Hey, I took your complaints right to the CEO?”

Karlin-Smith: I think there’s two things they may focus on. One is just cybersecurity risks in health care, which is broader than just these incidents. In some ways, it could be much worse, if you think about hospitals and medical equipment being hacked where there could be direct patient impacts in care because of it. The other thing is, United is such a large company and the amount of Americans impacted by this, but also the amount of different parts of health care they have expanded into, is really under scrutiny. I think it’s going to bring a light onto how big they’ve become, the amount of vertical integration in our health system, and the risks from that.

Rovner: We went through this in the ’90s. Vertical integration would make things more efficient, because everybody would have what they called aligned incentives, everybody would be working towards the same goal. Instead, we’ve seen that vertical integration has just created big, behemoth companies like United. I don’t know whether Congress will get into all of that, but at least it brought it up into their faces.

There’s lots of regulatory news this week. I want to start with the FDA, which finalized a rule basically making laboratory-developed tests medical devices that would require FDA review. Sarah, this has been a really controversial topic. What does this rule mean and why has there been such a big fight?

Karlin-Smith: This rule means that diagnostic tests that are developed, manufactured, and then actually get processed, and the results get processed at the lab, will now no longer be exempted from FDA’s medical device regulations and they’ll have to go through the process of medical devices. The idea is to basically have more oversight over them, to ensure that these tests are actually doing what they’re supposed to do, you’re getting the right results and so forth. Initially, over the years, the prevalence of these tests has grown, and what they’re used for, I think, has changed and developed where FDA is more concerned about the safety and the types of health decisions people may be making without proper oversight of the tests. One, I think, really infamous example that maybe can people use to understand this is Theranos was a company that was exempted from a lot of regulations because of being considered an LDT. The initial impact is going to be interesting because they’re actually basically exempting all already-on-the-market products. There’s also going to be some other exemptions, such as for tests that meet an unmet medical need, so I think that will have to be defined. There is a reasonable chance that there’s going to be lawsuits challenging whether FDA can do this on their own or need Congress to write new legislation. There have been battles over the years for Congress to do that. FDA, I think, has finally gotten tired of waiting for them to lead. I think initially, we’re going to see a lot of battles going forth and FDA also just has limited capacity to review some of this stuff.

Rovner: We already know that FDA has limited capacity on the medical device side. I was amused to see, oh, we’re going to make these medical devices, where there’s already a huge problem with FDA either exempting things that shouldn’t really be exempt, or just not being able to look at everything they should be looking at.

Karlin-Smith: Right. They’re going to take what they call a risk-based approach, which is a common terminology used at the FDA, I think, to focus on the things where they think there’s the most risk of something problematic happening to people’s health and safety if something goes wrong. It’s also an admission, to some extent, of something that’s not necessarily their fault, which is they only have so much budget and so many people, and that really comes down to Congress deciding they want to fix it. Now, FDA has user-fee programs and so forth, so perhaps they could convince the industry to pony up more money. But as you alluded to early on, one of the fights over this has been their different segments of companies that make these tests that have different feelings about the regulations. Because you have more traditional, medical device makers that are used to dealing with the FDA that probably feel like they have this leg up, they know how to handle a regulatory agency like FDA and get through. Then you have other companies that are smaller, and do not have that expertise, maybe don’t feel like they have the manpower and, just, money to deal with FDA. I think that’s where you get into some of these business fights that have also kept this on the sidelines for a while.

Pradhan: Well, also I wonder, hospitals also use laboratory developed tests, too, and they develop them. I feel like, and Sarah, correct me if I’m wrong, but I think previously when there was debate over whether FDA was going to do this, I think hospitals were pretty critical of any move of FDA to start regulating these more aggressively, right? Because they said for tests used for cancer detection or other health issues, I think that they were not thrilled at the idea. I don’t know that they’ve had to really deal with FDA in this regard either when it comes to devices.

Karlin-Smith: Yeah. I know one big exemption that people were looking for was whether they were going to exempt academic medical centers, and they did not. We’ll see what happens with that moving forward. But obviously, again, the older ones will have this exemption.

Rovner: Well, speaking of controversial regulations, the administration has basically decided that it’s not going to decide about the potential menthol ban that we’ve been talking about on and off. There was a statement from HHS [Department of Health and Human Services] last week that just said, “We need to look at this more.” Somebody remind us why this is so controversial. Obviously, health interests say, really, we should ban menthol, it helps a lot of people to continue smoking and it’s not good for health. Why would the administration not want to ban menthol?

Pradhan: It’s controversial because, I’ll just say, that it’s an election year and they are worried about backlash from Black voters not supporting President Biden in his reelection campaign, because they do this.

Karlin-Smith: It’s a health versus criminal justice issue, because the concern is that yes, in theory, if Black people make up the majority of people who use menthol cigarettes, you’re obviously protecting their health by not having it. But the concern has been among how this would be enforced in practice and whether it would lead to overpolicing of Black communities and people being charged or facing some kind of police brutality for what a lot of people would consider a minor crime. That’s where the tension has been. Although notably, some groups like the NAACP and stuff have been gotten on board with banning menthol. It’s an interesting thing where we’re trying to solve a policing or criminal justice problem through a health problem, rather than just solving the policing problem.

Ollstein: Like Sarah said, you have civil rights groups lined up on both sides of this fight. You have some saying that banning menthol cigarettes would be racist because they’re predominantly used by the Black population. But then you have people saying, well it’s racist to continue letting their health be harmed, and pointing out that those flavored cigarettes have been targeted in their marketing towards Black consumers, and that being a racist legacy that’s been around for a while. There’s these accusations on both sides and it seems like the politics of it are scaring the administration away a little bit.

Rovner: Well, just speaking of things that are political and that people smoke, the Drug Enforcement Administration announced its plan to downgrade the classification of marijuana, which until now has been included in the category of most dangerous drugs, like heroin and LSD, to what’s called Schedule III, which includes drugs with medicinal use that can also be abused, like Tylenol with codeine. But apparently, it could be awhile before it takes effect. This may not happen in time for this year’s election, right?

Karlin-Smith: Right. They have to release a proposed rule, you got to do comments, you got to get to the final rule. OMB [Office of Management and Budget] even. It’s supposedly at OMB now. OMB could hold it up for a while if they want to. As anybody who follows health policy in [Washington] D.C. knows, nothing moves fast here when it comes to regulations.

Rovner: Yes. A regulation that we thought was taken care of, but that actually only came out last week would protect LGBTQ+ Americans from discrimination in health care settings. This was a provision of the Affordable Care Act that the Trump administration had reversed. The Biden administration announced in 2021 that it wouldn’t enforce the Trump rules. But this is still a live issue in many courts and it’s significant to have these final regulations back on the books, yes?

Pradhan: It is. I think this is one of the ACA regulations that has ping-ponged the most, ever since the law was passed, because there have been lawsuits. I want to say it took the Obama administration years to even issue the first one, I think knowing how controversial it was. I believe it was the second, I think it was his second term and it was when there was no fear of repercussions for his reelection. Yeah, it’s been a very, very long-fought battle and I imagine this is also not the end of it. But no, it is very significant, the way that they defined the regulations.

Rovner: I confess, I was surprised when they came out because I thought it had already happened. I’m like, “Oh, we were still kicking this around.” So, now they appear to be final.

Well, finally this week, lots of news in health business. First, an update from last week. The Federal Trade Commission is challenging so-called junk patents from some pretty blockbuster drugs, charging that the patents are unfairly blocking generic competition. Sarah, what is this and why does it matter?

Karlin-Smith: FDA has what’s known as an orange book, as a part of a very complicated process set up by the 1984, I believe, Hatch-Waxman Act that was a compromise between the brand and the generic drug industries to get generic drugs to market a bit faster. FTC has been accusing companies of improperly listing patents in the orange book that shouldn’t be there, and thus making it harder to get generic products on the market. In particular, they’ve been actually going against drugs that have a device component, basically saying these components’ patents are not supposed to be in the orange book. They are basically asking the companies to delist the patents. They actually have gotten some concessions so far, from some of the other products they’ve targeted.

The idea would be this should help speed some of the generic entrants. It’s not quite as simple, because you do have lots of patents covering these drugs, so it does make it a little bit easier, but it’s not like it automatically opens the door. But it is unique and interesting that they have focused in on these targets because, typically, what are sometimes known as complex generics, are a lot harder for companies to make and get into the market because of the devices. Because for safety reasons FDA wants the devices to be very similar. If you pick up your product at the pharmacy, you have to be able to just know how to use it, really, without thinking about it, even if it’s a …

Rovner: Obviously, this covers things like inhalers and injectables.

Karlin-Smith: Right. The new weight loss drugs everybody is focused on, inhalers has been a big one as well. Things like an EpiPen, or stuff like that.

I think it’s been interesting because it does seem like FTC’s had more immediate results, I guess, than you sometimes see in Washington. [Sen.] Bernie Sanders has piggybacked on what they’re doing and targeted these companies and products in other ways, and gotten some small pricing cost concessions for consumers as well. But it will take a little bit of time for, even if patents get delisted, for generic drugmakers to actually then go through the whole rigamarole of getting cheaper products to market.

Rovner: Yes. This is part of what I call the “30 Years War,” to do something about drug prices. Before we leave drug prices, we’re still fighting in court about the Medicare drug negotiation, right? There, the drug industry continues to lose. Is that where we are?

Karlin-Smith: Correct. They have their fourth negative ruling this week. Basically, in this case, the judge ruled on two main arguments the industry was trying to push forward. One is that the drug negotiation program would constitute a takings violation under the Fifth Amendment. One of the main reasons the judge in this district in New Jersey said no is because they’re saying basically participation in Medicare and this drug price negotiation program are voluntary, the government is not forcibly taking any of your property, you don’t have to participate.

Another big ruling from this judge was that this program does not constitute First Amendment violations. What’s happening here is a regulation of conduct, not speech. One of the more amusing things in the decision to me, that I enjoyed, is the industry has argued that they’re basically being forced under this program to say, “Oh, this is … when CMS [Centers for Medicare & Medicaid Services]” … and then work out a price, that the price they work out is the maximum fair price because that’s the technical terminology used in the law, that they’re then somehow making an admission that any other price that they’ve charged has not been fair. The judge basically said, “Well, this is a public relations problem, not a constitutional problem. Nobody is telling you you can’t go out and publicly disagree with CMS about this program and about their prices that you end up having to enter into.”

It’s another blow. They have a lot of different legal arguments they’re trying out in different cases. As I said, they’ve thrown a lot of spaghetti at the wall. So far, other arguments have failed. Some of the cases are stalled on more technicalities, like the districts they’ve filed in. There was another case that was heard, an appeal was heard yesterday, in PhRMA, the main trade group’s case, where they’re trying to push on because of that. There’s going to be a lot of more action, but so far, looks good for the government.

Pradhan: When this was first rolling out, including when CMS announced the initial 10 drugs that would first be on the list, lawyers that I talked with at the time said that the arguments that the industry was making, it was a reach, to be diplomatic about it. I don’t think anyone really thought that they would be successful and it seems like that is, at least to date, that’s how it’s playing out.

Rovner: I’ll repeat, it’s a good time to be a lawyer for the drug industry, at least you’re very busy.

All right, well, finally this week, we spend so much time talking about how big health care is getting, Walmart this week announced that it’s basically getting out of the primary care business. It’s closing down its two dozen clinics and ending its telehealth programs. This feels like another case of that, “Wow, it looked so easy to make money in health care.” Until you discover that it’s not.

Pradhan: Right. I think making money in primary care, certainly that’s not where the people say, “Oh, that’s a real big cash cow, let’s go in there.” It’s other parts of the health care industry.

Karlin-Smith: One thing that struck me about a quote in a CNN article from Walmart was how they were focusing on they wanted to do this, but they found it wasn’t a sustainable business model. To me, that then just brings up the question of “Should health care be a business?” and the problems. There’s a difference between being able to operate primary care and make enough money to pay your doctors and cover all your costs, and a big company like Walmart that wants to be able to show big returns for their investors and so forth. There’s also that distinction that something that’s not attractive for a business model like that can still be viable in the U.S.

Rovner: This reminds me a lot of ways of the ill-fated Haven Healthcare, which was when Amazon and JPMorgan Chase and Berkshire Hathaway all thought they could get together because they were big, smart companies, could solve health care. They hired Atul Gawande, he was one of the biggest brains in health care, and it didn’t work out. We shall continue.

Anyway, 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 kffhealthnews.org and in our show notes on your phone or other mobile device.

Rachana, why don’t you go first this week?

Pradhan: This story that I’m going to suggest, [“Millions of American Kids Are Caregivers Now: ‘The Hardest Part Is That I’m Only 17.”] it’s in The Wall Street Journal, depressing like most health care things are. It’s about how millions of children, I think it’s over 5 million children under the age of 18, are providing care to siblings, grandparents, and parents with chronic medical needs, and how they are becoming caregivers at such young ages. In part, because it is so hard to find and afford in-home care for people. That is my extra credit.

Rovner: Right, good story. Sarah?

Karlin-Smith: I looked at a piece in The Atlantic by Katherine J. Wu, “America’s Infectious-Disease Barometer Is Off.” It’s focused on our initial response in this country to bird flu, and maybe where the focus should and shouldn’t be. It has some interesting points about repeat mistakes we seem to be making, in terms of inadequate testing, inadequate focus on the most vulnerable workers, and what we need to do to protect them in this crisis right now.

Rovner: Alice?

Ollstein: I chose [“Dozens of Deaths Reveal Risks of Injecting Sedatives Into People Restrained by Police“] an AP investigation, collaborating with Frontline, about the use of sedatives when police are arresting someone. This is supposed to be a way to safely restrain someone who’s combative, or maybe they’re on drugs, or maybe they’re having a mental health episode, and this is supposed to be a nonlethal way to detain someone. It has led to a lot of deaths, nearly 100 over the past several years. These drugs can make someone’s heart stop. The reporting shows it’s not totally clear if just the drugs themselves are what is killing people, or if it’s in combination with other drugs they might be on, or it’s because they’re being held down in a way by the cops that prevent them from breathing properly, or what. But this is a lot of deaths of people who have received these injections and is leading to discussions of whether this is a best practice. Pretty depressing stuff, but important.

Rovner: Yeah. It was something that was supposed to help and has not so much in many cases. My story this week is from ProPublica. It’s called “A Doctor at Cigna Said Her Bosses Pressured Her To Review Patients’ Cases Too Quickly. Cigna Threatened To Fire Her.” It’s by Patrick Rucker and David Armstrong. It’s about exactly what the headline says. A doctor who spent too much time reviewing potential insurance denials because she wanted to be sure the cases were being decided correctly. It’s obviously not the first story of this kind, but I chose it because it so reminded me of a story that I did in 2007, which was about a physician who worked for a managed-care company, it was Humana in that case, who was pushed to deny care and first testified to Congress about it in 1996. I honestly can’t believe that, 28 years later, we are still arguing about pretty much the exact same types of practices at insurance companies. At some point you would think we would figure out how to solve these things, but apparently not yet.

OK, that is our show. 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 technical guru, Francis Ying, and our editor, Emmarie Huetteman. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X @jrovner.

Rachana, where are you hanging these days?

Pradhan: I am also on X, @rachanadpradhan.

Rovner: Sarah?

Karlin-Smith: I’m at @SarahKarlin or @sarahkarlin-smith on Bluesky.

Rovner: Alice?

Ollstein: @AliceOllstein on X, and @alicemiranda on Bluesky.

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

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Hello! Today, we discuss how the FDA is holding firm in how it handles non-compliant trial sponsors and investigators, how PhRMA is rebuilding its ranks, and offer up a fabulous podcast.

The need-to-know this morning

• Advisers to the European Medicines Agency recommended the approval of Qalsody, a treatment for ALS from Biogen.

What do CEOs owe the world?

Did Humira break the system? And can you CRISPR a fetus? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast.

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The FDA conducted an investigation into morel mushrooms after the severe illness outbreak linked to Dave’s Sushi in Bozeman in late March and April. The investigation found that undercooked or raw morels were the likely culprit, and it led the agency to issue its first guidelines on preparing morels.

“The toxins in morel mushrooms that may cause illness are not fully understood; however, using proper preparation procedures, such as cooking, can help to reduce toxin levels,” according to the FDA guidance.

Even then, a risk remains, according to the FDA: “Properly preparing and cooking morel mushrooms can reduce risk of illness, however there is no guarantee of safety even if cooking steps are taken prior to consumption.”

Jon Ebelt, spokesperson for Montana’s health department, said there is limited public health information or medical literature on morels. And samples of the morels taken from Dave’s Sushi detected no specific toxin, pathogen, pesticide, or volatile or nonvolatile organic compound in the mushrooms.

Aaron Parker, the owner of Dave’s Sushi, said morels are a “boutique item.” In season, generally during the spring and fall, morels can cost him $40 per pound, while morels purchased out of season are close to $80 per pound, he said.

Many highly regarded recipe books describe sauteing morels to preserve the sought-after, earthy flavor. At Dave’s, a marinade, sometimes boiling, was poured over the raw mushrooms before they were served, Parker said. After his own investigation, Parker said he found boiling them between 10 and 30 minutes is the safest way to prepare morel mushrooms.

Parker said he reached out to chefs across the country and found that many, like him, were surprised to learn about the toxicity of morels.

“They had no idea that morel mushrooms had this sort of inherent risk factor regardless of preparation,” Parker said.

According to the FDA’s Food Code, the vast majority of the more than 5,000 fleshy mushroom species that grow naturally in North America have not been tested for toxicity. Of those that have, 15 species are deadly, 60 are toxic whether raw or cooked — including “false” morels, which look like spongy edible morels — and at least 40 are poisonous if eaten raw, but safer when cooked.

The North American Mycological Association, a national nonprofit whose members are mushroom experts, recorded 1,641 cases of mushroom poisonings and 17 deaths from 1985 to 2006. One hundred and twenty-nine of those poisonings were attributed to morels, but no deaths were reported.

Marian Maxwell, the outreach chairperson for the Puget Sound Mycological Society, based in Seattle, said cooking breaks down the chitin in mushrooms, the same compound found in the exoskeletons of shellfish, and helps destroy toxins. Maxwell said morels may naturally contain a type of hydrazine — a chemical often used in pesticides or rocket fuel that can cause cancer — which can affect people differently. Cooking does boil off the hydrazine, she said, “but some people still have reactions even though it’s cooked and most of that hydrazine is gone.”

Heather Hallen-Adams, chair of the toxicology committee of the North American Mycological Association, said hydrazine has been shown to exist in false morels, but it’s not as “clear-cut” in true morels, which were the mushrooms used at Dave’s Sushi.

Mushroom-caused food poisonings in restaurant settings are rare — the Montana outbreak is believed to be one of the first in the U.S. related to morels — but they have happened infrequently abroad. In 2019, a morel food poisoning outbreak at a Michelin-star-rated restaurant in Spain sickened about 30 customers. One woman who ate the morels died, but her death was determined to be from natural causes. Raw morels were served on a pasta salad in Vancouver, British Columbia, in 2019 and poisoned 77 consumers, though none died.

Before the new guidelines were issued, the FDA’s Food Code guidance to states was only that serving wild mushrooms must be approved by a “regulatory authority.”

The FDA’s Food Code bans the sale of wild-picked mushrooms in a restaurant or other food establishment unless it’s been approved to do so, though cultivated wild mushrooms can be sold if the cultivation operations are overseen by a regulatory agency, as was the case with the morels at Dave’s Sushi. States’ regulations vary, according to a 2021 study by the Georgia Department of Public Health and included in the Association of Food and Drug Officials’ regulatory guidelines. For example, Montana and a half-dozen other states allow restaurants to sell wild mushrooms if they come from a licensed seller, according to the study. Seventeen other states allow the sale of wild mushrooms that have been identified by a state-credentialed expert.

The study found that the varied resources states use to identify safe wild mushrooms — including mycological associations, academics, and the food service industry — may suggest a need for better communication.

The study recognized a “guidance document” as the “single most important step forward” given the variety in regulations and the demand for wild mushrooms.

Hallen-Adams said raw morels are known to be poisonous by “mushroom people,” but that’s not common knowledge among chefs.

In the Dave’s Sushi case, Hallen-Adams said, it was obvious that safety information didn’t get to the people who needed it. “And this could be something that could be addressed by labeling,” she said.

There hasn’t been much emphasis placed on making sure consumers know how to properly prepare the mushrooms, Hallen-Adams said, “and that’s something we need to start doing.”

Hallen-Adams, who trains people in Nebraska on mushroom identification, said the North American Mycological Association planned to update its website and include more prominent information about the need to cook mushrooms, with a specific mention of morels.

Montana’s health department intends to publish guidelines on morel safety in the spring, when morel season is approaching.

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.

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Hello from ASH! Writing this Readout from a press room at the annual hematology confab here in San Diego. Today’s edition is chockfull of Vertex content, plus some extras from ASH and elsewhere.

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