Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Hello! Hope your weekend was a blissful one. Today, we talk about AbbVie’s outsize marketing spend, see how GLP-1s are impacting cancer rates, and more.

Read the rest…

The massive sum spent by AbbVie, the maker of the mega blockbuster anti-inflammatory drug Humira, is the most a pharmaceutical company has spent on marketing to doctors since such data became available in 2017. The figure includes compensation for consulting and other services like speaking fees, lodging and travel for doctors, and meals, as well as a small number of payments made directly to hospitals.

The payments, made public by the Centers for Medicare and Medicaid Services, provide an insight into AbbVie’s marketing in the immediate aftermath of the company losing its monopoly on Humira, which dominated the company’s balance sheets for the better part of the last two decades. The payments show that the company is being far more aggressive in targeting doctors than competitors of comparable size.

Continue to STAT+ to read the full story…

The agency sent a civil investigative demand requiring Teva to provide information related to the patents listed in the so-called Orange Book, which is maintained by the Food and Drug Administration. The move comes after the FTC late last year began warning Teva and several other companies that they should remove hundreds of “improperly or inaccurately” listed patents or face further action.

The FTC has argued Teva and these other companies listed patents in the Orange Book without properly claiming certain key information, such as a drug substance or method for using a drug. Industry critics say the tactic makes it harder for generic companies to sell lower-cost alternatives to Americans and has been blamed by several congressional lawmakers for keeping prices high.

Continue to STAT+ to read the full story…

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Good morning. Read on today for some exclusive hiring news and a retraction of a high-profile paper on cancer detection.

Read the rest…

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

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…

Patent and Trademark Office has proposed a new rule designed to stem the use of so-called patent thickets, which are wielded by pharmaceutical companies to delay the arrival of lower-cost generic medicines in the marketplace.

Essentially, thickets are collections of numerous patents that add only incremental changes to a drug and, therefore, produce little to no additional benefit to patients. Yet they extend precious monopolies for brand-name drugmakers and, consequently, are blamed for contributing to ongoing high drug costs for countless Americans.

To assemble a thicket, drug companies rely on a critical tool with a wonky name — a terminal disclaimer — which is the subject of the proposed rule. In short, a terminal disclaimer is a stipulation made by a drug company to the PTO that a continuation or follow-on patent — essentially, a minor patent that makes few substantive changes to a medicine — will expire at the same time as the original patent.

Continue to STAT+ to read the full story…

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.

Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

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

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

USE OUR CONTENT

This story can be republished for free (details).

The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

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

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.

Credits

Francis Ying
Audio producer

Rebecca Adams
Editor

To hear all our podcasts, click here.

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

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

USE OUR CONTENT

This story can be republished for free (details).

The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

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

The 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.

Panelists

Sarah Karlin-Smith
Pink Sheet

@SarahKarlin

Read Sarah's stories.

Alice Miranda Ollstein
Politico

@AliceOllstein

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.

Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

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

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

USE OUR CONTENT

This story can be republished for free (details).

And here is our regular feature in which we highlight a different person each week. This time around, we note that Recludix Pharma hired Ajay Nirula as executive vice president and head of R&D. Previously, he worked at Eli Lilly, where he was senior vice president and the immunology therapeutic area head.

But all work and no play can make for a dull head of R&D.

Continue to STAT+ to read the full story…