For years, Humira dominated the market for treating rheumatoid arthritis and other autoimmune disorders. In the process, it became the best-selling medicine in the world and generated billions of dollars in annual sales for AbbVie, which extended its monopoly time and again by filing dozens of patents that made it harder for would-be rivals to launch lower-cost biosimilar versions.

Continue to STAT+ to read the full story…

The Host

Julie Rovner
KHN

@jrovner

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

The abortion debate has changed dramatically in the seven months since the Supreme Court overturned Roe v. Wade and its nationwide right to abortion. Nearly half the states have banned or restricted the procedure, even though the public, at the ballot box, continues to show support for abortion rights.

In this special two-part podcast, taped the week of the 50th anniversary of the Roe decision, an expert panel delves into the fight, the sometimes-unintended side effects, and what each side plans for 2023.

This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Sandhya Raman of CQ Roll Call, and Sarah Varney of KHN.

Panelists

Alice Miranda Ollstein
Politico

@AliceOllstein

Read Alice's stories

Sandhya Raman
CQ Roll Call

@SandhyaWrites

Read Sandhya's stories

Sarah Varney
KHN

@sarahvarney4

Read Sarah's stories

Among the takeaways from this week’s episode:

• Exemptions to state abortion bans came into question shortly after the Supreme Court’s decision to overturn Roe, with national debate surrounding the case of a 10-year-old in Ohio who was forced to travel out of state to have an abortion — although, as a rape victim, she should have been able to obtain an abortion in her home state.
• The restrictions in many states have caused problems for women experiencing miscarriages, as medical providers fear repercussions of providing care — whether affecting their medical licenses or malpractice insurance coverage, or even drawing criminal charges. So far, there have been no reports of doctors being charged.
• A Christian father in Texas won a lawsuit against the federal government that bars the state’s Title X family-planning clinics from dispensing birth control to minors without parental consent. That change poses a particular problem for rural areas, where there may not be another place to obtain contraception, and other states could follow suit. The Title X program has long required clinics to serve minors without informing their parents.
• Top abortion opponents are leaning on misinformation to advance their causes, including to inaccurately claim that birth control is dangerous.
• Medication abortion is the next target for abortion opponents. In recent months, the FDA has substantially loosened restrictions on the “abortion pill,” though only in the states where abortion remains available. Some opponents are getting creative by citing environmental laws to argue, without evidence, that the abortion pill could contaminate the water supply.
• Restrictions are also creating problems for the maternal care workforce, with implications possibly rippling for decades to come. Some of the states with the worst maternal health outcomes also have abortion bans, leading providers to rethink how, and where, they train and practice.
• Looking ahead, a tug of war is occurring on state and local levels among abortion opponents about what to do next. Some lawmakers who voted for state bans are expressing interest in at least a partial rollback, while other opponents are pushing back to demand no changes to the bans. With Congress divided, decisions about federal government spending could draw the most attention for those looking for national policy changes.

Also this week, Rovner interviews Elizabeth Nash, who tracks state reproductive health policies for the Guttmacher Institute, a reproductive rights research group.

Click to open the transcript

Transcript: Part I: The State of the Abortion Debate 50 Years After ‘Roe’

KHN’s ‘What the Health?’Episode Title: Part I: The State of the Abortion Debate 50 Years After ‘Roe’Episode Number: 281Published: Jan. 26, 2023

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Julie Rovner: Hi! This is Julie Rovner from KHN’s “What the Health?” We’re doing a special episode this week trying to summarize the state of the abortion debate in the wake of the Supreme Court’s overturn of Roe v. Wade. We have the very best group of experts and reporters I could think of. And the conversation was so good and so long that for the first time we’re breaking it into two parts. So here’s Part I. 

Today we are joined via video conference by Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Good morning.

Rovner: Sandhya Raman of CQ Roll Call.

Sandhya Raman: Good morning.

Rovner: And my KHN colleague Sarah Varney.

Sarah Varney: Hey.

Rovner: We will actually get to our panel a little bit later. That’s because on this special episode of “What the Health?” we’re taking a deep dive into the state of abortion access on the 50th anniversary of Roe v. Wade. We’re going to get our bearings first by hearing from Elizabeth Nash of the Guttmacher Institute, a reproductive rights research group. As you’ll hear, Elizabeth is a walking encyclopedia of state abortion rules and regulations. So here’s the interview, and then we’ll be back for our group discussion. 

I am pleased to welcome to the podcast Elizabeth Nash, who tracks state legislative activity on reproductive health issues for the Guttmacher Institute. Elizabeth knows more than probably any other single person about the state of abortion laws and how they’ve changed over time and has been an invaluable resource for me over the many years I have covered this issue. I could think of no one better to kick off our special episode on the state of abortion rights in 2023. Elizabeth, welcome to “What the Health?”

Elizabeth Nash: Thank you. That is the most flattering introduction, and I am glad I have been able to help.

Rovner: Well, I can honestly say that I’ve given up on trying to keep track of where abortion is legal, illegal, or somehow restricted since Roe was overturned last June. Is it safe to say this is the most rapid change in state rules since you’ve been tracking this?

Nash: Yes, to put a point on that, I started tracking 1999. So I do have some sense of the longevity of what we’re talking about. And going back even further, the rules weren’t changing all that quickly in 1973 or ’5. I mean, they were changing somewhat quickly. But when we look at what is happening right now, it really is a sea change, right? We have a quarter of the states — so there are 14 states — where abortion is unavailable, right? In 12 of those states, that’s due to abortion bans. In two other states,it’s because of other things that have happened. And so you’re looking at, already, the South, the Plains, the Midwest … abortion access has been extremely difficult to come by. And then we’re seeing what’s happening in the progressive states, at the same time, to expand access. So it’s been on both ends of the spectrum, right? Expanding and restricting. And it literally is all over the map.

Rovner: Is there any way to divide them into categories that make it easier to track? I know in some states …  we all know about these six states where there were voter ballot measures. Some of them have been legislative issues and some of them are stuck in court on both sides, right?

Nash: Oh, yes, absolutely. So beyond these 14 states where abortion is unavailable … so you’re really thinking about the Texases, Louisianas, Mississippis, Arkansas, Oklahomas of the world. There’s another group of states where there are abortion bans that were enacted before the Dobbs [v. Jackson Women’s Health Organization] ruling and now are tied up in court. And we’re thinking about states like Utah, Wyoming, also Indiana, even though that one happened after the Dobbs ruling. They came into special session and passed an abortion ban and now it’s tied up in the courts. But we have a lot of pieces that are moving through the court system. And what is different now than before the Dobbs ruling in June is that most of these cases are in state court. And so we’re now having to rely on state constitutions to protect abortion rights. And in many of these states, the state constitutions haven’t been evaluated and tested in this way. So this is a whole brand-new batch, essentially, of court cases about what do we expect? What are the kinds of clauses that are being used to support abortion rights and to hopefully strike down these abortion bans?

Rovner: I know for years, even decades, anti-abortion groups were united in their desire to see Roe overturned. Now that it has been, are you surprised with how much farther some are trying to get states to go beyond just straight abortion bans?

Nash: You know, I think Dobbs came down and those … activists and advocates in the movement said they’re not going to stop here. And they haven’t, right? So the general public thought, oh, maybe this is settled. And those in the movement said, no, wait, this is one more step in the journey. Also, yes, we are seeing more efforts even in these states that have abortion bans that aren’t even implemented looking to pass more restrictions. And you’re like, what could they possibly do? Well, there’s been a real focus by abortion opponents on medication abortion. Because they know people are accessing medication abortion online, they want … abortion opponents want to try to hem that in and stop that from happening. So more restrictions on medication abortion, even potentially legislation that would prevent access to websites that have information about abortion on them. So looking at a range of types of policies around medication abortion, also seeing some more restrictions potentially that could prevent abortion funds and support organizations from doing their good work. ’Cause one of the conversations after the Dobbs ruling in June was, well, if people leave the state to access abortion, could we ban them from travel? Well, we probably won’t see a lot of legislation that specifically bans people from leaving the state for an abortion. But we will see some legislation around trying to give them fewer options, such as making it harder for abortion funds and practical support organizations to fulfill their mission or legislation that prevents businesses from supporting their employees to go to another state and access abortion.

Rovner: I was struck by a piece you wrote last month on exceptions to abortion bans, particularly for rape or incest or the life or health of the pregnant woman. I am old enough to remember the early 1990s when Congress spent several years debating whether to add back rape and incest exceptions to the federal “Hyde Amendment.” They had been there originally. They were dropped out in the 1980s and then there was a huge fight over getting them back. But you point out that for all the effort on the issue, these exceptions don’t actually mean very much. Why is that?

Nash: Well, to put it in a few words, abortion opponents see exceptions as loopholes, and they’re trying to narrow those so-called loopholes so that it’s impossible to access care. So I think the public generally had this sense that, oh, there must be exceptions if someone’s health is at risk, or their life is in danger and perhaps some other situations, right? So that just general understanding the public might have. Well, in fact, one, those kinds of health exceptions just really never existed at all. And the fight really was what you’re talking about, around rape and incest, maybe a genetic anomaly of the fetus. And on top of that, when they were added, they really are these incredibly narrowly worded exceptions that make it impossible for someone to get an abortion under them. A lot of times people would be required to report to the legal authorities. Well, that could be very traumatizing for a sexual assault survivor. They may not be there emotionally. They may be expecting additional blowback from the authorities. Unfortunately, that has been part of the history, right? And so, having to relive all of that is a problem. So really, these exceptions are basically meaningless. And yet we’re expecting to see fights over them in 2023. And particularly in some of these states where we’ve seen abortion bans. Tennessee is one example where there’s an abortion ban in effect and basically there is no access to abortion, in part because there’s a provision of that ban that says that the provider has to give out an affirmative defense if they provide an abortion. And, basically, that means that there will be no abortions provided in Tennessee.

Rovner: Because if you provide one, you’ll still end up in court, even if it’s legitimate.

Nash: Yes, you’ll end up in court. It’s a huge expense. And if you lose, you’ll have all of these penalties and, potentially, loss of license … there’s a lot at stake. And so in Tennessee, there is a potential of a debate around exceptions. And again, I think this is about abortion opponents trying to make their bans look less bad. Right? This is about, oh, well, we’ll add in some exceptions. People will think we’re doing something and, in effect, it means nothing. So really, where we need to start moving towards — and, of course, advocates are moving towards this — it’s more about how do you bring along the public and others who need to roll back abortion bans? They don’t serve any public health good.

Rovner: There seems to be this growing — I won’t even call it a rift yet, but a separation between a lot of Republicans who’ve traditionally voted for abortion bans because they knew they weren’t going to go into effect. So it looked good. And they have that section of their base that they make happy. Well, now that we’re shooting with real bullets, if you will, some of those Republicans seem to be getting a little antsy about some of the bans, particularly when they’re hearing about doctors who are afraid to provide not just abortion care, but sometimes routine or emergency care for women with problem pregnancies.

Nash: Yeah, it’s very true. And yes, Republicans in these states, particularly conservative states, are in a bit of a pickle. They’re trying to placate their base that has been arguing for abortion bans without any exceptions. And now they see their opportunity with the fall of Roe. And then you have the public, the much larger public that supports abortion access and, in fact, is getting more supportive of abortion access because the rubber has hit the road. We are seeing the impact of abortion bans, and it is around abortion access. It is also around what you’re seeing in maternal health care. And also in these conservative states, we’re seeing a conversation among providers that is, Do I stay in this state? Can I remain here knowing that I cannot provide all the care my patients need and deserve?

Rovner: That’s the big irony, is that banning abortion could end up having fewer rather than more pregnancies, because I know a lot of women who are afraid to get pregnant lest they have complications that they won’t be able to get treated.

Nash: Yeah, absolutely. And if patients are feeling supported and know that they can get the care that they need, then that can change the whole trajectory, at least for a few years of their life. Because people may decide, OK, I’m going to delay my childbearing until I feel comfortable and in a situation where I feel that my health will be taken care of.

Rovner: Well, I think there will be a lot more for you to follow this year and in the next couple of years. You’re going to have to make your spreadsheet bigger. I look forward to continuing to do this. Elizabeth Nash, thank you for your work, and thank you again for joining us.

Nash: Thank you so much for having me. It was a real treat to talk to you. I followed your work for forever.

Rovner: We will definitely have you back.

OK. We are back with Alice [Miranda] Ollstein, Sandhya Raman, and Sarah Varney. I’ve tried to order this discussion by topic, and while we won’t get to everything, I hope we’ll at least get a good idea of the landscape since the Supreme Court overturned Roe v. Wade last June. I want to start by talking about some of the immediate or almost immediate effects of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization on June 24. Abortion rights advocates had been arguing for years, in some cases decades, about some of the things that might happen if Roe was overturned. Mostly, they were told the equivalent of “Don’t worry your pretty little heads over those things; they won’t happen.” But in fact, a lot of them did, starting almost immediately with the case of a 10-year-old in Ohio who was raped and had to go to Indiana to end the resulting pregnancy. Abortion opponents first claimed it was made up. Then when it was proved true, the Indiana attorney general went after the doctor who treated the child. This whole fight is still actually going on, isn’t it? Alice, I see you nodding.

Ollstein: Yes. So there are not criminal charges against this doctor or, that we know of, any doctor yet. You know, that was one feared thing that has not materialized, mainly because doctors have proven very cautious and unwilling to even do anything that could be seen as violating these state bans. So what’s at issue in the Indiana case is around the medical licensing — so not criminal charges. But still it’s very intimidating for the doctor. Her name was dragged all over the news and she got lots of threats, etc. And I think what really jumped out most for me from that case is, theoretically, the child should have been able to get an abortion in Ohio under these purported exemptions to the state’s ban. And yet both the child and her caretakers thought it was necessary to go out of state. And that really shows how these exemptions may exist on paper but are really difficult and, in some cases, impossible to use in practice. 

Varney: And the other thing that that case I think shows was that the response from those who oppose abortion was sort of immediate, that this did not happen. This was made up. We saw Jim Jordan come out with some tweets essentially saying this was just a hoax. And then when they actually found this 27-year-old man and they DNA-tested him and they arrested him, there’s been crickets actually from that side. And I think that also indicated to us what we’ve been seeing now over the last couple of months. What I heard on Friday at the March for Life in Washington and again at the National Pro-Life Summit as well in Washington, just this absolute denial, really, that all of these things are happening. I brought specific cases to people that I interviewed, both the soldiers on the ground to leaders of the movement, to say, “Here’s what’s happening in Louisiana, this particular case in Texas.” And 2-to-1, they said, “This is not happening. This is made up. These physicians are just doing this because they want to send a message.” And then when you interview obstetricians and gynecologists who are opposed to abortion rights, they too say that, “Oh, this is all just made up, that the exceptions are very clear. We know what to do to save a woman’s life.” So I think this is a whole other front … this sort of misinformation campaign about the actual impact on the ground of these abortion bans.

Rovner: Yeah. And to follow up on that, I mean, another thing that was predicted is that the lives and health of pregnant women who were not seeking abortions but who experienced pregnancy complications could be negatively affected. And that is definitely happening, right? These are among the things that the anti-abortion movement says are not happening. But we’ve now seen story after story of women, particularly, whose water breaks too early for even premature infants to survive and who end up basically being stuck in this limbo because their doctor is worried about violating the law, but also worried about keeping the woman alive.

Raman: There are a number of doctors who’ve spoken up about some of the risks that they felt firsthand of defying some of these state bans, even when it’s a serious health or emergency risk or having to go through hospital lawyers before they can act. And I think there’ve been a lot of cases, especially in Missouri and Texas, and I think the Texas Medical Association last year even appealed to the state medical board because of the difficulty they had in treating some of these serious health issues for pregnant individuals because of the risk … that it just kind of creates this layered effect where, on one hand, some of these state laws don’t even exactly lay out what is an emergency, what isn’t an emergency, how do you define imminent death, how mental health fits in? Even though that can be, as we know, a serious health risk as well. And it just — a number of layers to figuring out an already tricky situation when dealing with an emergency health situation should be pretty straightforward.

Rovner: And yet … 

Varney: And it’s interesting, too, I also posed this exact question to marchers on Friday. And 2-to-1 they said, “Well, first of all, we don’t really understand pregnancy. We don’t understand fetal development. We certainly don’t understand fetal demise. We’re … none of us are doctors.” None of the people out there, most of them at least, were not doctors. But, you know, saying very specifically, that case in Louisiana that KHN and NPR reported about a woman who was … she had a 4-year-old. She wanted to be pregnant. She started hemorrhaging, was obviously miscarrying. She went to a hospital. She was turned away. She was bleeding profusely, in intense pain, went back to a second hospital, also turned away because they could still detect a faint fetal activity, fetal cardiac activity. And so when I posed this really specific question to some of the people at the march, they said, “Well, this is what God wants. God wants her to return to her home and let this baby die, or she should birth this baby and then bury it.” This sort of disconnect between what’s happening to a person who’s miscarrying and their religious beliefs about what should happen are completely far apart.

Ollstein: Yeah, what’s really come to the fore is that the treatment for a miscarriage or a pregnancy complication and an abortion medically are the same in so many cases. It’s the same drugs you take. It’s the same procedure to empty the uterus. And so restrictions on one will inevitably impact the other. And that’s what we’re really hearing from doctors who, again, because of the chilling effect created by these laws, are afraid to do things that would risk them getting charged, risk them losing their licenses, you know, issues with malpractice insurance. And so they are really erring on the side of not providing this care in a lot of circumstances.

Rovner: And sometimes there are women who are not even pregnant getting caught up in this. In Alabama, a woman was jailed for using illegal drugs that threatened her unborn child, except she’s now suing for false imprisonment because she was not pregnant. Some states are basically criminalizing every stage of pregnancy, right?

Ollstein: This has been an issue since before Dobbs, for sure. I mean, and it’s not just red states. In California, two women were incarcerated for taking drugs and having pregnancy loss. And so I think this has been exacerbated by the fall of Roe v. Wade and this new aggressive era with the anti-abortion officials becoming emboldened. But it’s certainly not the first time we’ve seen this happen.

Rovner: And Sarah, you were talking about Alabama, in particular?

Varney: Alabama has sort of perfected this. Steve Marshall, who’s their current attorney general, was a local prosecutor in a county that essentially came up with this notion that you could extend these chemical endangerment laws to pregnant women. There was a woman who was in prison for 10 years after she used drugs during her pregnancy and had a stillbirth. And it’s hard to say that these kinds of laws are helping these women or helping them with their addiction issues. And I think the thing that I’m really on the lookout for — and we’re all national reporters, but I’m sure, like many of you, I travel to these states — I think what’s difficult is that in a place like Alabama, this is really now up to local prosecutors. So, as we saw, that was a case where a family member called the police and reported this woman saying that she was using drugs and that she was pregnant. Now, did this family member actually know she was pregnant or not, or was she just trying to seek some sort of revenge? I have no idea. But you’re right. She was then jailed and then kept saying, “Give me a pregnancy test, I’ll take it!” And then, sure enough, she, of course, wasn’t pregnant. But, you know, it’s up to individual prosecutors in Idaho, in Alabama, in Texas. They can sort of do what they want now, and especially in these states that have fetal rights written into their constitutions. This is really the next front.

Rovner: Well, and of course, the biggest thing of all that we were told — insisted it was not going to happen — anti-abortion activists said they never intended nor wanted to limit birth control. But that really is starting to happen, isn’t it?

Raman: I mean, we could even see this last year. The House did their vote on a bill to codify contraception, and it did not get much bipartisan support. And of the eight Republicans then that voted for it, five of them are no longer in office. One of them, in particular, that is there of the three, Nancy Mace of South Carolina, spoke a lot when we had the recent abortion votes in the House about how she wanted there to be votes on things like birth control first, before they went to look at abortion. But it seems like there’s not as much an appetite among Republican lawmakers federally to do that right now.

Rovner: Yeah, I think Nancy Mace is trying to be the Lisa Murkowski of the House, trying to have it all ways.

Varney: I’m actually about to go to Texas to do a story for the NewsHour about this Title X lawsuit. So this was a father, you guys probably heard about this, but this is a Christian father of three daughters who sued to say — his lawyer is Jonathan Mitchell, who was the lawyer for the S.B. 8 case and is involved in a lot of anti-abortion conservative causes. And …

Rovner: S.B. 8, for those who don’t remember, it’s the Texas law that was in effect before Roe was overturned, that basically — the bounty to turn in somebody you think has something to do with abortion, and you can win money!

Varney: Correct. And was clearly in violation of Roe but was allowed to stand. Well, so, this lawyer, on behalf of this father and his children, has sued the federal government to the same federal judge that S.B. 8 went through. And they won. So now in Texas, if you are a minor, you cannot go into Title X clinics for the first time since the Nixon administration and get birth control. And if you live in a rural area like Amarillo, you really don’t have any other options. And of course, there’s lots of evidence that shows why parental consent actually is harmful when it comes to reproductive health, particularly for girls. So now we’re going to be shooting that story. But I think there’s a lot of concern among the Title X administrators in the different states where abortion is banned, and there are these very active anti-abortion groups, that they will essentially extend this Title X ruling to their other states without even having to go to the courts. They’ll just say, well, they did it in Texas, so we can now do it in Alabama.

Rovner: And funny, there was a giant fight about exactly this in the Reagan administration, which was before I started covering this. But I read about it. It was called the “Squeal Rule.” It was an effort to actually require parental involvement in girls getting birth control from Title X clinics. And it was struck down by a federal judge. Basically, it has been doctrine ever since, and law, that teens are allowed to go seek care from Title X clinics and they don’t have to tell their parents. Obviously, Title X clinics don’t provide abortions. They’re not allowed to by federal law. But teens are definitely, have been allowed to seek birth control without parental involvement. And if this lawsuit ends up getting upheld, that’s going to change, too.

Varney: I’ll be interested, though, if I can ask, because I’m curious about your opinions on all this, is that, again, when I was at the march and that summit, you know, I asked every single person I interviewed, well, OK, so you want to stop abortion? What about birth control? Knowing full well that for many of these people, most of them are deeply religious and they do not believe in birth control. But Kristan Hawkins, from the Students for Life, her line, which I have heard from others as well, is, quote, “Chemical birth control is dangerous to women.” So I will be curious to see how we as journalists confront the misinformation that has always been percolating in pro-life circles for many, many years. But how will we confront that misinformation in our stories? You know, I actually chose, in my reporting for the NewsHour over the weekend, not to use that clip, because I would then have to go into several paragraphs of, actually, that’s not the case. So I’m curious what we’re going to do about that, because they will make that claim. And then are we going to treat it in the same way that we treated, you know, Donald Trump when he would sort of make things up? 

Rovner: Well, there’s also the further complication — if you go back to the Hobby Lobby Supreme Court case in 2014 — is that some people and organizations oppose some types of birth control because they say — this is sort of famously with the IUD, the intrauterine device — that it can prevent the implantation of a fertilized egg, and therefore that’s a very early abortion, or some types of progesterone, [that] only birth control can prevent the implantation of a fertilized egg. It turns out in most cases that is not the case scientifically, but that is still their belief. And the Hobby Lobby case basically said, if you believe it, that’s your religion and you can have it that way. So it’s already a complicated case, and I’m sure we will see more of this going forward. But I want to drill a little bit deeper on the future of the abortion pill, mifepristone, which actually does end a pregnancy. It’s the first of a two-drug combination used for medication abortion. Both sides in the abortion debate seem to be zeroing in on medication abortion as the next big target: abortion rights forces, because the ability to end an early pregnancy without going to a physical abortion clinic or having surgery, it’s preferable for now a majority of people seeking abortions; anti-abortion forces are against it for pretty much the same reason. It’s a way for abortions to continue mostly out of public sight. So let’s start with the abortion rights side. What’s being done to make the pill more easily available? We’ve had a lot of activity on that front just in the last couple of weeks, right?

Ollstein: Yeah. So there’s been efforts for years now to petition the FDA to loosen the restrictions around who can get the pill, where they can get it, when they can get it. And that has slowly led to those rules being loosened over time. So a couple of years ago, the FDA moved to allow telemedicine prescriptions and patients being able to receive the pills by mail. At first, they said, OK, just during the pandemic because it’s too dangerous to go into a clinic. And then they said, OK, we looked at the data, and actually this is safe to do permanently. And then just very recently, they said that those prescriptions can also be sent to retail pharmacies. So you can pick them up at your local CVS or Walgreens. And that is broadening where and when and how patients can get these pills. But again, only in states where their use is not already banned or severely restricted, which is, you know, a lot of states right now. Some of those laws are blocked in court, so the exact count is always fluctuating. But it’s around 18 states where that is not … those options for obtaining the pills are not there for patients right now.

Rovner: There’s also lawsuits challenging these bans, right? Sandhya, I see you nodding.

Raman: We have three main lawsuits that I think that we’re all watching right now. We have one from last year from anti-abortion groups that is challenging the 2000 approval of mifepristone, on the grounds of it should rescind the approval by the FDA. And so the next step is, as early as next month, the judge there in that case could issue a preliminary injunction that would mean that there wouldn’t be mifepristone nationwide, not just in that district. And the thing about that case that’s interesting is, I think, regardless of what we see happen there, it will get appealed and that would go to the 5th Court of Appeals, which is notorious for doing a lot of the Obamacare cases that we’ve seen in the health space over the past few years.

Rovner: And a lot of abortion cases over the years, too.

Raman: Yes, yes.

Rovner: Because it’s what Texas and the 5th Circuit in Texas and Louisiana and a couple of other Southern states. 

Raman: Yeah. And then the second two … came yesterday. And they’re interesting in that they’re on the state level in that one of the main manufacturers of mifepristone GenBioPro is suing in West Virginia over the fact that the state abortion laws that they say are at odds with mifepristone in the state due to the near-total ban. And then, in North Carolina, a physician is also suing saying that the state laws essentially are also at war with the federal jurisdiction over this.

Rovner: Yeah, basically, they’re saying that states can’t individually, basically, make unavailable a drug that’s been approved by the FDA because think of how that would be if every state could decide whether every drug was going to be legal in that state, we would have basically chaos with a lot more than just the abortion pill.

Ollstein: Arguably, we do, basically, have chaos right now.

Rovner: That is a fair point. There were cases in Massachusetts several years ago about a new opiate that eventually there’s a federal court that said, no, no, no, Massachusetts, we get what you’re trying to do, but you can’t overrule the FDA. Basically, if the FDA says this is safe and effective and it’s going to be available, then you have to abide by that. So we will see if that’s going to happen with the abortion pill.

Varney: Can I just add something? 

Rovner: Yes.

Varney: That I was just reading about abortion pill bans in different states, including South Dakota. And the targeted advertisement I got from Google was for a company called hims, which is for Viagra. So I’m reading here about how abortion pills are not allowed, abortion is illegal, and I hope this is a family podcast, but this is an advertisement that anybody can see. It says: Get hard, stay hard, and last longer. So this is the advertisement you get when you go to the AP and you read a story about abortion.

Rovner: Great. So the other side is also having some creative ways to go after the abortion pill. I don’t think it’s them who’s planting the advertisements for men. But Alice, you uncovered this story about some groups charging that the pill can cause environmental damage in wastewater, right?

Ollstein: Yes. So, look, anti-abortion groups know people are still obtaining these pills in states where they’re not allowed to do so. And so they are looking to, you know, whatever they can look at in order to block that from happening. And they’re trying to get really creative. And so one of the several new things they’re trying is they’re trying to cite environmental laws in order to get state lawmakers to pass new restrictions, in order to get state AGs to move in and do more enforcement actions to stop the use of these pills. So they are alleging that because people take the pills at home and have an abortion at home, that goes into the wastewater, that that is a risk to wildlife, livestock, humans. There is not evidence for this right now. I talked to people who study the effect of other pharmaceuticals in wastewater, and they say that this is just infinitesimal, but this is something they’re trying. Again, it’s not the only thing they’re trying. But, you know, it could have some legs. They’ve already convinced one state to introduce legislation specifically along these lines — West Virginia — saying that any doctor that prescribes the pill also has to give the patient a medical waste bag in order to bag the abortion and not have it go into the wastewater. They are trying to do this in other states. You know, the goal is, again, to stop the use of the pills altogether.

Varney: And when I was at the summit on Saturday, they had an hour-and-a-half-long session on this. And it was in this ballroom, and it was just packed with high school and college students primarily. And they plan on doing a taste-the-water challenge at different campuses; they’re starting in Texas. And they said very specifically, we are not going to have any signs that say anything about how we’re pro-life or opposed to abortion. We’re not going to have anything that says “fetus.” We’re just going to have glasses of water up on the table at these campuses and we’re going to invite students to step up and taste the water. And then we’re going to tell them that there is likely traces of the abortion pill in this water. And so they’re going to use high school students and college students to sort of run these taste-the-water challenges, to bring in this new idea and spread it around.

Rovner: Super. Can’t wait. All right. Well, moving on. One of the interesting outcomes of this decision is that it’s also affecting people who aren’t pregnant, don’t have anything to do with being pregnant. There have been a bunch of stories about women of childbearing age being unable to get medications for lupus and other conditions. How is that happening?

Ollstein: Well, again, you know, these things are not just used for one purpose. This actually came up pretty recently because some medical groups were petitioning the FDA to add more things to the abortion pill label so that they can be more legally protected in obtaining these medications for non-abortion purposes. Right now, the pill is only technically supposed to be prescribed for an abortion, but it’s used off-label for all of these other medical treatments. And so you have instances where pharmacists who are also newly empowered right now to deny prescriptions to people based on what they assume it’s being used for. And that’s leading to a lot of patients not being able to obtain prescriptions for other conditions.

Rovner: And for other drugs, right? I mean, drugs that can cause abortion, but aren’t the abortion pill. I’m thinking mostly of methotrexate, which is used for a lot of different conditions, but is also in some countries used as an abortion pill. And we’ve seen lots of cases where people are unable to get their methotrexate prescriptions refilled. People who have been using it for years. So that’s been complicated.

That’s it for Part I of our special, two-part podcast on the state of the abortion debate 50 years after Roe v. Wade. Don’t forget to download Part II, which will be right after this in your feed. It’s got the rest of our discussion, plus some very special extra credit. Thanks for listening.

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Having spent its entire first week choosing a speaker, the Republican-led U.S. House finally got down to legislative business, including passing two bills backed by anti-abortion groups. Neither is likely to become law, because they won’t pass the Senate nor be signed by President Joe Biden. But the move highlights how abortion is sure to remain a high-visibility issue in the nation’s capital.

Meanwhile, as open enrollment for the Affordable Care Act nears its Jan. 15 close, a record number of people have signed up, taking advantage of renewed subsidies and other help with medical costs.

This week’s panelists are Julie Rovner of KHN, Margot Sanger-Katz of The New York Times, Alice Miranda Ollstein of Politico, and Sarah Karlin-Smith of the Pink Sheet.

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Margot Sanger-Katz
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https://www.nytimes.com/by/margot-sanger-katz

Among the takeaways from this week’s episode:

• The House now has a speaker after 15 rounds of full-chamber roll call votes. That paved the way for members to be sworn in, committee assignments to be made, and new committee chairs to be named. Cathy McMorris Rodgers (R-Wash.) and Jason Smith (R-Mo.) will be taking the helm of major health committees.
• McMorris Rodgers will lead the House Energy and Commerce Committee; Smith will be the chairman of Ways and Means. Unlike McMorris Rodgers, Smith has little background in health issues and has mostly focused on tax issues in his public talking points. But Medicare is likely to be on the agenda, which will require the input of the chairs of both committees.
• One thing is certain: The new GOP-controlled House will do a lot of investigations. Republicans have already reconstituted a committee to investigate covid-19, although, unlike the Democrats’ panel, this one is likely to spend time trying to find the origin of the virus and track where federal dollars may have been misspent.
• The House this week began considering a series of abortion-related bills — “statement” or “messaging” bills — that are unlikely to see the light of day in the Senate. However, some in the caucus question the wisdom of holding votes on issues like these that could make their more moderate members more vulnerable. So far, bills have had mostly unanimous support from the GOP. Divisions are more likely to emerge on topics like a national abortion ban. Meanwhile, the Title X program, which pays for things like contraception and testing for sexually transmitted infections, is becoming a hot topic at the state level and in some lawsuits. A case in Texas would restrict contraception availability for minors through this program.
• It’s increasingly clear that abortion pills are going to become an even bigger part of the abortion debate. On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. The FDA puts these extra restrictions or safeguards in place for certain drugs to add additional protection. Some advocates say these pills simply do not bring that level or risk.
• Anti-abortion groups are planning protests in early February at large pharmacies such as CVS and Walgreens to try to get them to walk back plans to distribute abortion pills in states where they are legal.
• A growing number of states are pressuring the Department of Health and Human Services to allow them to import cheaper prescription drugs from Canada — or, more accurately, importing Canada’s price controls. While this has long been a bipartisan issue, it has also long been controversial. Officials at the FDA remain concerned about breaking the closed supply chain between drugs being manufactured and delivered to approved U.S. buyers. The policy is popular, however, because it promises lower prices on at least some drugs.
• Also in the news from the FDA: The agency granted accelerated approval for Leqembi for the treatment of Alzheimer’s disease. Leqembi is another expensive drug that appears to work, but also carries big risks. However, it is generally viewed as an improvement over the even more controversial Alzheimer’s drug Aduhelm. Still to be determined is whether Medicare — which provides insurance to most people with Alzheimer’s — will cover the drug.
• As the Affordable Care Act enrolls a record number of Americans, it is notable that repealing the law has not been mentioned as a priority for the new GOP majority in the House. Rather, the top health issue is likely to be how to reduce the price of Medicare and other health “entitlement” programs.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week that they think you should read, too:

Julie Rovner: The Washington Post’s “Social Security Denies Disability Benefits Based on List With Jobs From 1977,” by Lisa Rein

Margot Sanger-Katz: Roll Call’s “Providers Say Medicare Advantage Hinders New Methadone Benefit,” by Jessie Hellmann

Alice Miranda Ollstein: The New York Times’ “Grant Wahl Was a Loving Husband. I Will Always Protect His Legacy.” By Céline Gounder

Sarah Karlin-Smith: KHN’s “Hospitals’ Use of Volunteer Staff Runs Risk of Skirting Labor Laws, Experts Say,” by Lauren Sausser

Also mentioned in this week’s podcast:

• KHN’s “States Challenge Biden to Lower Drug Prices by Allowing Imports From Canada,” by Phil Galewitz
• Politico’s “Next Frontier in the Abortion Wars: Your Local CVS,” by Alice Miranda Ollstein and Lauren Gardner
• KFF’s “Millions of Uninsured People Can Get Free ACA Plans,” by Jared Ortaliza, Justin Lo, Gary Claxton, Krutika Amin, and Cynthia Cox

TRANSCRIPT

Click here for a transcript of the episode.

KHN’s ‘What the Health?’Episode Title: GOP House Opens With Abortion AgendaEpisode Number: 279Published: Dec. 12, 2023

Tamar Haspel: A lot of us want to eat better for the planet, but we’re not always sure how to do it. I’m Tamar Haspel.

Michael Grunwald: And I’m Michael Grunwald. And this is “Climavores,” a show about eating on a changing planet.

Haspel: We’re here to answer all kinds of questions. Questions like: Is fake meat really a good alternative to beef? Does local food actually matter?

Grunwald: You can follow us or subscribe on Stitcher, Apple Podcasts, Spotify, or wherever you listen.

Julie Rovner: Hello and welcome back to KHN’s “What the Health?” I’m Julie Rovner, chief Washington correspondent at Kaiser Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Jan. 12, at 10 a.m. As always, news happens fast, and things might have changed by the time you hear this. So here we go. Today we are joined via video conference by Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Good morning.

Rovner: Margot Sanger-Katz of The New York Times.

Margot Sanger-Katz: Hello.

Rovner: And Sarah Karlin-Smith of the Pink Sheet.

Sarah Karlin-Smith: Hi, everybody.

Rovner: So no interview this week, but lots of news, so we will get right to it. We’re going to start with the new Congress, where the House finally has a speaker after 15 rounds of full-chamber roll calls. Settling the speaker meant that the rest of the House could be sworn in and things like committee chairs elected. Two key health committees, Energy and Commerce and Ways and Means, will both have new chairs, not just new because they’re Republican, but new because they have not chaired the committee previously. Energy and Commerce will be headed by a woman for the first time, Cathy McMorris Rodgers of Washington state, who’s had a longtime interest in health policy and was also in the Republican leadership. Over at Ways and Means, the new chairman is Jason Smith of Missouri, who I confess I had never heard of before this. Does anyone know anything about him? And does he have any interest in health care?

Ollstein: Most of what he said about chairing the committee has been about things other than health care. It’s been a lot on taxes, for instance. The new House majority is very “exorcised” about the IRS funding that the previous Congress approved and trying to get rid of that. But he has shown some interest in some telehealth provisions. And so I think also I’m sure we’re going to discuss some interest in, shall we say, revisiting Medicare’s benefits and funding …

Rovner: Yeah, we’re going to get to that next.

Ollstein: So there could be some things, but it doesn’t seem that he’s been a big health care guy or will be a big health care guy going forward.

Rovner: In the olden days, when I started covering this, the chairman of the Ways and Means Committee frequently did not have either an interest or an expertise in health care. But the chairman of the Ways and Means health subcommittee did. That’s where pretty much everything came from. Do we know yet who is going to chair the Ways and Means health subcommittee …? We do not. So we’ll wait to see that. But yes …. even though I read Chairman Smith’s little introduction about what he’s interested in — and I know he mentioned rural health — but he did not anywhere mention Medicare. And of course, the Ways and Means Committee has jurisdiction over most of Medicare in the House. It is going to come up, as far as we can tell, right?

Sanger-Katz: One imagines so because some of the promises that leadership has made to its members to think about how to balance the budget in the long term, to consider entitlement reform, whatever that may mean. And, you know, Medicare is where the money is. So you would think that the Ways and Means Committee would want to be looking seriously at how to reform the program, if that’s the interest of leadership on this policy area.

Rovner: And they’ve already said that they want to tie any debt ceiling vote, which [is] one of those things that Congress absolutely has to do to reforms, quote-unquote, of the Medicare and Social Security programs. Because, again, as Margot said, that’s where the money goes. So we expect to see Medicare as an issue, regardless of what the Ways and Means Committee does, right?

Ollstein: That’s right. There were a lot of calls for Democrats to address the debt ceiling issue during their final months in power. They did not do so. That means that it’s going to be a big, messy fight this year. One of the biggest things to watch. This is an instance where the Republican House majority will be able to flex its muscles even though they don’t have the Senate and White House, because they can trigger a budget standoff that puts the faith and credit of the country in jeopardy and demand concessions, including cuts to Medicare. So we’ll see how that goes.

Rovner: Although I will say, Sen. Brian Schatz of Hawaii was on Twitter, and he didn’t ask me anything much to the horror of his communications staff. But one of the questions that somebody asked him was, “Why didn’t you do the debt ceiling?” And he just said: We didn’t have the votes. So that at least answers the question of why didn’t they take care of this before the Republicans took the majority back? Well, one thing we do know is going to happen is that the new Republican-controlled House is going to do a lot of investigations. Indeed, one of the first orders of business in the new Congress was the re-establishment of a committee on the covid pandemic with a new focus on investigating the origins of the virus and the government’s response to it. What are we expecting out of that?

Karlin-Smith: As you said, Julie, I think two of the things is, one, they’re going to do more investigation into the origin of the virus. Republicans have pushed the potential theory that this was borne out of a lab in China, not necessarily something more naturally occurring. And I think a lot of scientists have said this theory has been fairly close to disproven and find that the focus on it distracts from really dealing with the current pandemic. But I think we should expect a lot of that. And that will include, I think, a lot of relitigation of Anthony Fauci and his particular role in the NIH [National Institutes of Health] and funding different types of research on viruses, both in the U.S. and abroad. The second thing I think they’re going to look very closely at is how the U.S. has spent the covid funding that Congress has doled out and appropriated. That’s certainly a lot of money. And I think, again, oversight is always probably … it’s a good thing to see if Congress gives money, are we spending it? … Does it actually get to where it needs to go? Does it go to where it’s supposed to go? I think that … in general, I think most people think that’s a good thing. Sometimes what ends up happening is it gets taken a little bit to …  this disingenuous step forward in Washington, where everything gets questioned or they pick on jurisdictions for not spending the money fast enough when it’s just not realistic. So you have to read between the lines really carefully when you’re looking at some of the findings from that type of work. Because sometimes, again, when you give a state $1,000,000 to do something, they’re not often able to make that change in two months.

Rovner: And then if they do, they get criticized for spending it on the wrong thing, so …

Karlin-Smith: Right.

Sanger-Katz: But I will say, speaking as a journalist, not as a congressional investigator, I do think that the covid funding is really ripe for a lot of investigation. There’s already been very good reporting that a lot of the small-business programs were broadly defrauded. I think there was a real emphasis by Congress and — in a bipartisan way, Republicans obviously voted for these bills as well. But I think there was a real emphasis on just getting money out the door. People were so scared of a catastrophic economic collapse that, unlike a lot of programs that Congress designs that fund various things, there weren’t a lot of initial safeguards, there wasn’t a lot of process or administrative burden associated with getting money. And so that means it really is valuable to look and see where did it go, who may have defrauded the program, what are ways that in the next crisis it might be possible to do these kinds of programs in a way that is more efficient. You know, it occurs to me that in addition to the small-business money, hospitals got a whole lot of money as part of these programs. And again, there’s been some journalism about this, but I do think I’m all for more oversight, trying to learn some real lessons. I agree with Sarah that there is probably some of this that’s going to veer into the disingenuous and kind of “gotcha.” But there may be some useful and interesting findings as a result of this process as well.

Rovner: And as we saw with the Jan. 6 committee, Congress has powers that journalists don’t. As we know, the Justice Department has powers that Congress doesn’t. But Congress has pretty good investigatory powers. They can subpoena things when they need to. So, yes, I imagine we’re going to learn something about the fate of all of those dollars that went out the door.

Ollstein: Just to be fair, Republicans have sort of claimed that the Democrat-led effort to investigate covid didn’t have any financial accountability aspect. That’s not true. It did. They really scrutinized a lot of government contracts — like no-bid government contracts that funneled lots and lots of money to things that did not pan out or help anybody. There has been some of that already. But I agree that there’s definitely more to look at.

Rovner: And there … obviously, there was a Republican and a Democratic administration handling the covid pandemic. So one presumes there are things to investigate on both sides. Well, even while the House committees are gearing up, Republicans are bringing “statement” bills to the floor, bills that we know the Senate won’t take up and the president won’t sign. And despite the fact that abortion rights drove a lot of the midterm elections in the other direction, two of the first bills brought to the floor by the new Republican majority seek to do the bidding of anti-abortion groups. This, apparently, making Republican moderates, particularly those in swing districts, not so happy. Alice, are we looking at pretty much the same split in the Republicans in the House as in a lot of states — the people who think that the Republicans didn’t do well because they should have done more and people who think the Republicans didn’t do well because they should have done less?

Ollstein: Yeah, absolutely. And there’s a split on how to talk about it or whether to talk about it as well. It’s not just the actions, it’s the messaging in addition. And so, yes, there are some in the House who are, like, why are we doing this? Why are we taking these votes that have no chance of becoming law? It just puts our members from swing districts in a more vulnerable position. The things they voted on so far this week have pretty unanimous support on the Republican side, I would say. I think where you could start to see some bigger divides are when they get into votes on an actual national abortion restriction that would put a gestational limit on the procedure, or something like that, which absolutely some members want to do and want to take a vote on. I think that’s where you could start to see some Republicans being, like, wait, wait, wait, wait, why are we doing this? But the things so far are, like you said, they’re “messaging” bills, but they’re ones that have pretty broad support on the conservative side.

Rovner: And we should mention, I mean, one of them was just a sense of Congress that, you know, that bombing pregnancy crisis centers is bad. Or that violence against pregnancy centers …

Sanger-Katz: I’m not going to give credit for this correctly, but I saw a tweet on this topic last week when the list of demands and the list of these bills that we’re going to get a vote on was released where someone asked, Oh, did D-Triple-C [the Democratic Congressional Campaign Committee] co-author this list? Where I do think there is an interesting tension, as Alice said, where the particular message bills that the most conservative members of the House Republican caucus want to vote on are those issues where we see in public opinion polling, where we see in the last election that the majority of Americans are not really with those most conservative Republicans. And I think a lot of moderate Republicans would just prefer not to vote on those issues, particularly because they know that they can’t make them policy. And we were talking about changes to Medicare and Social Security, and I think that also falls very much in that category where there might be a situation in which if Republicans really thought that they could reform these programs, maybe they would want to take the political risk, because I do think it’s an important long-term goal of many Republicans. But I think there’s also a frustration, you know, why would we take all these votes on something that is generally unpopular? Everyone knows that both Social Security and Medicare are really, really popular programs and people are very wary of changes to them. There is a political risk in taking a bunch of votes saying that you want to pull money out of those programs or change them structurally when you can’t even achieve it.

Rovner: Yeah. Well, speaking of that, during Wednesday’s abortion debate on the House floor, Republican moderate Nancy Mace of South Carolina kept saying to any cable outlet that would put a microphone in front of her that Congress should be making birth control more widely available instead of voting on abortion. But we are also seeing the first shots fired in an effort to restrict birth control. Well, last month, a Trump-appointed judge ruled that the Title X family planning program is illegally providing contraception to minors. Now, this is a fight that dates back to even before I started covering it. It was called “the Squeal Rule” in the early 1980s, an effort by the Reagan administration to require parental involvement before teens could use Title X family planning services. It was eventually struck down in federal court, but now it’s back. Is this where we’re headed?

Ollstein: I think it’s really important to watch things in law and policy that are just directed at minors because inevitably it does not stop there. Like, that’s sort of the testing ground. It’s where people are more comfortable with more restrictions and more hoops to jump through. But as we’ve seen with gender-affirming care, it doesn’t stop there. What’s tested out as a policy for minors is inevitably proposed for adults as well, and so …

Sanger-Katz: What’s the adult version of this, Alice? Like who? Like spousal consent?

Rovner: Yes, there had been — I was just going to say — not so much in contraception, although originally it was, but also on abortion that, yeah, if there’s a partner that the partner would have to consent.

Ollstein: But there’s also been spousal consent stuff for more permanent … getting your tubes tied, those kinds of things. That’s been a debate as well. And, I mean, in the abortion space we’ve seen this for, in terms of like traveling across state lines for an abortion. That’s been a restriction for minors that’s also been proposed for adults. So it’s just this phase we should absolutely watch — as well as Title X program continues to be a space for proposed restrictions. It’s a lever that they’re able to hold because it does have federal funding and it does have constraints that other pots of money don’t have.

Rovner: My favorite piece of trivia is that the Title X program has not been reauthorized since 1984 because Congress has never been able to find the votes. You know, when the Democrats were in charge and wanted to do it, the Republicans would have all of these amendments that the Democrats probably couldn’t fight off. The Republicans wanted to do it and put all these stringent rules that the Democrats wouldn’t have. So, literally, this program has been … it gets funded every year, but it’s been marching along for now several decades without Congress having formally reauthorized it.

Ollstein: Yeah, that’s why you keep seeing different presidential administrations trying to put their stamp on it through rulemaking, which, of course, can be rolled back by the subsequent president, as we’ve seen with [Donald] Trump and [Joe] Biden. And so it just keeps going back and forth. And these clinics that are out there getting this funding, which, again, can’t be used for abortion, for contraception, STD testing, fertility stuff, all kinds of stuff, but not abortion. But they keep having to comply with these wildly different rules. It’s really difficult.

Rovner: Yeah, it is. All right. Well, last week we talked about the Biden administration’s effort to make abortion pills more available through both pharmacies and the mail. On the one hand, some abortion rights advocates say that the FDA is still overregulating the abortion pill by requiring extra hoops for both pharmacies and doctors to jump through in order to offer or write prescriptions for a medication that’s proved safe and effective over two decades. On the other hand, we now have the specter of abortion opponents protesting at CVSes or Walgreens near you. And Alice, they’re already planning to do that, right?

Ollstein: Yeah, that’s right. They would have done it sooner, but they didn’t want to step on the March for Life, which is coming up in a couple of weeks. And so they’re planning these protests at CVS and Walgreens around the country for early February, trying to pressure the company to walk back its announcement that they will participate in the distribution of abortion pills in states where they remain legal, which is, by our count, currently 18 can’t do this either because abortion is banned entirely or because there are laws specifically restricting how people get the pills.

Rovner: Sarah, I want you to talk about some of these extra hoops that have to be jumped through because a lot of people think it’s just for this pill and it’s not. This is something that the FDA has for any drug that’s potentially abusable, right?

Karlin-Smith: Yeah, I wouldn’t say abusable is the right word, but basically people call this a REMS. It stands for risk evaluation and mitigation strategy. And it’s actually an authority Congress gave the FDA to — we use this term “safe and effective,” but we know all drugs, even when we say that “safe” term, will come with risks. And the idea here is that when the benefit-risk balance would be … so that it would be … FDA might say, OK, this is actually too risky to approve. However, we think we could make it kind of safe enough if we put in a little extra safeguards instead of just letting it go out there. Here’s a drug, doctors, you can prescribe it, follow the normal pathway, which is that the federal government, or at least the FDA, doesn’t really have a lot of say in exactly how the practice of medicine works. That’s left up to states. And, you know, doctors individually. They implement other practices to help ensure that safety balance is there. So one famous example is Accutane, which is an acne drug. It’s incredibly harmful to a developing fetus and birth defects. So women of pregnancy, bearing age are usually required to take regular pregnancy tests and so forth and monitor the status of that. And you’re not supposed to use the drug while pregnant because of the incredible harm you do to a baby. So there’s everything from things like that to just simply more written literature might be provided for certain drugs. Sometimes in the cases of the abortion pill, you know, who could actually dispense it and when was restricted. Sometimes there are particular sorts of trainings doctors have to take to get that extra authority to prescribe the drug. And again, the idea is that just to provide a little extra safeguard. Again, the controversy over the years with this pill is that people feel like it doesn’t meet that standard to have a REMS, that it can be safe and effective through our normal prescribing systems. Actually, Stat this week had an interesting interview with Jane Henney, who was the FDA commissioner when they first approved this drug. And she …

Rovner: Yeah, in the year 2000.

Karlin-Smith: Right. Which is actually …

Rovner: Right at the end of the Clinton administration.

Karlin-Smith: Actually predates this formal REMS authority. But there were others, different authorities that then evolved into REMS. But she said she thought that a lot of these restrictions would be gone by now and that what, at the time, what they were waiting for was more U.S.-specific experience with the drug, because what they were basing the original approval on was a lot of use of the drug in France, which had such a different health system than the U.S., they were a little bit uncomfortable, I guess, opening the floodgates in a way. So I thought that was an interesting historical point that came out this week.

Rovner: But clearly, Alice, I mean, this is going to be the next big fight in abortion, right, is trying to restrict the abortion pill?

Ollstein: Absolutely. I’ve been writing about this since before Roe v. Wade was overturned. The pills were already becoming one of the most popular and now are the most popular way to terminate a pregnancy in the U.S., which makes sense. You can take them in the comfort of your home with the people that you want to be with you, not in a scary medical environment. It’s also a lot cheaper than having a surgical procedure. So but then, of course, with the pandemic, people started using them even more because it was more dangerous to go to a clinical setting. And so this has been a big focus of both sides of this fight for a long time: either how to increase access to the pills or restrict them. Also, now that Roe v. Wade has been overturned, the pills and the ability to order them online from overseas in this legal gray area, that’s been a major way people have been getting around state bans, and the anti-abortion groups know that. And so they want to look at any way they can to crack down on this. And so with the Biden administration opening up a new potential pathway with these local retail pharmacies, they’re of course going to try to crack down on that as well.

Karlin-Smith: I mean, we talked about this before in the podcast, but I think this issue of federal preemption, if it gets teed up, is going to be a big thing that’s beyond just abortion, in terms of when does FDA’s approval of a drug trump state regulations around how it’s going to be used? And, you know, I feel like some people have not been satisfied on the … who want more access to abortion drugs in terms of how FDA has handled the rollback of the REMS. But you also have to wonder if they’re operating in this setting where, again, if you push things too far and you get a legal challenge, given how our courts are, right? And how politically it can backfire. And so it’s a complicated balance there.

Rovner: Well, speaking of drugs that are in gray areas that people order online, my KHN colleague Phil Galewitz reports that four states — Florida, Colorado, New Hampshire, and New Mexico — are now pressuring the Biden administration to allow them to import prescription drugs from Canada in an effort to reduce the cost of drugs for their residents. Now, despite the fact that this has been and remains a very bipartisan ask, the FDA, under both Republican and Democratic commissioners, has strongly objected to it over the years. Somebody remind us why this is so controversial.

Karlin-Smith: I think the big thing FDA has objected to is that when you allow importation in the way states have often asked for it, you basically often give up the supply chain oversight that we have in the U.S. that ensures people are not getting drugs that are counterfeit and have somehow been tampered with as they’ve gotten through the supply chain. And so, actually, I was refreshing my memory, and I can’t believe how long ago it is. When the Trump administration first became the first administration to say, Oh, actually, OK, we are going to agree that we think this could be come safely. Then they put out regulations that tried to … basically like made it so that to do importation, you would almost have to mimic the same supply-chain safety measures we already have for the FDA. So it became this double-edged sword of, sure, you can do the importation, but you’re going to have to jump to this level of hurdles that then makes it unusable. And so I think that’s the key barrier here, is that can a state actually propose a program that would get sign-off? And I think it’s not really surprising to me that the Trump team tried to thread the needle in that way of giving people the win of saying, Oh, we’ll allow it without actually making it feasible.

Sanger-Katz: I think it also highlights what a weird ask this is in some ways because what the states are looking to do is they are not looking to import drugs from other countries because they think that other countries have better manufacturing, have better safety protocols, have different drugs. They just want to import the lower prices that other countries pay for the same drugs. And so this is, in some ways, a very cludgy workaround that the states are basically asking for price regulation of drugs. But that obviously is a very difficult political act. So instead they’re saying, well, can we just import the prices that some other country has negotiated. And then it raises all these other issues about, Well, you know, there is like a reason why, in general, the United States has regulatory control over the drug supply.

Rovner: Also, Canada doesn’t have enough drugs to serve all of these states. I mean, that’s the thing that I’ve never managed to get over. And, in fact, Canada has said that they’re not anxious to do this because they don’t have enough drugs to serve both Canada and the United States. I mean, it also seems just literally impractical.

Sanger-Katz: I mean, we are seeing, of course, like in the Inflation Reduction Act, there were new measures that would allow Medicare, in particular, to start negotiating for lower prices for certain drugs. Obviously, that policy has a fair number of limitations, including that it’s only for Medicare, it’s only for certain drugs, and it’s not going to be instant. But while we did get some new timeline from the Biden administration this week, and it looks like that policy is going to start rolling out. So I think states are asking for this now because they want to import prices from other countries. But also, for the first time, Medicare, or the federal government is starting to take on drug prices directly. And we’re going to see how that looks relatively soon.

Rovner: Yes, this ship turns very slowly, but it does seem to be turning a little bit. Well, as we previewed last week, the FDA has approved another controversial Alzheimer’s disease drug, Leqembi. I think that’s how you say it, which has a Q without a U. Sarah, you’ve been following this. Are we headed down potentially the same road we traveled with Aduhelm? It feels kind of familiar. It’s a drug that we think works, but we don’t really know, and it has some big risks and will be expensive.

Karlin-Smith: Yeah, I mean, similar, but slightly different. And perhaps the analogy that things slowly make their way in a different direction is also right here. This drug, I think most people see it as an improvement on Aduhelm because it has, in one major clinical trial, shown some benefit on people’s cognitive decline slowing a bit. However, the big debate there is that … how meaningful the change that was seen in the trial is. Is it really going to be meaningful in people’s lives and is that worth the price? The company is … actually a similar company is involved here, but they priced it quite a bit lower than the original Aduhelm price, even lower than the price of Aduhelm now. It’s still seen as on the very high end of what a lot of cost-effective watchdogs say is a fair price. And as of right now, CMS [the Centers for Medicare & Medicaid Services] or Medicare is not going to be covering it at all because right now the drug only has what’s known as an accelerated approval. So we’re going to, over the next probably less than a year, in about nine months or so, FDA will have to weigh in on whether it gives the drug a full formal approval. And at that point, we’ll see if Medicare also gives the sign-off that they think this drug might actually be effective for people and are willing to pay for it. I think my bottom line on this drug is, you know, it provides some hope and some improvement for people, but it looks like to be a small clinical benefit for a big trade-off in risks. So I think as more data comes out over time, we’ll see again if that benefit-risk trade-off for most people falls on the right side of the coin.

Rovner: And we’ll watch this whole process go forward again. All right. Finally this week, but not least, there’s also news on the health insurance coverage front. With the end of open enrollment for the Affordable Care Act coverage rapidly approaching in most states, by Jan. 15, officials at the Department of Health and Human Services this week reported that enrollment is already up 13% from last year to almost 16 million people, including about 3.1 million people who are new enrollees. In the meantime, though, my colleagues over the firewall at KFF report that some 5 million more uninsured Americans are actually eligible for free health care coverage under the ACA. It feels ironic because this is not the first year of expanded subsidies and there’s been relatively little media coverage of open enrollment. Is it just that it takes time for knowledge of these offers to trickle down to people? Or that the Biden administration put a lot more effort into outreach this year?

Sanger-Katz: I think it’s all of the above. I think for the first few years of the Obamacare program, there were a lot of complaints that this insurance really wasn’t affordable enough for people. And, obviously, that’s why Congress, first in part of the pandemic stimulus bill and now again in the Inflation Reduction Act, really jacked up the subsidies and made the plans cheaper and, in many cases, have more wraparound benefits so that low-income people could get insurance that was either free or relatively low-premium and also didn’t ask them to pay a lot out-of-pocket for their own care. And we can see also that the Biden administration did a lot of outreach. I mean, it’s definitely the case that they both, through Congress, made the plans cheaper and also, through various administrative actions, made the plans more widely publicized. And I just want to highlight, I think last year was the record year for Obamacare enrollment. And now we’re seeing this huge increase on top of a record year. So these things seem to matter. I think the affordability of plans, the availability of free plans for a lot of uninsured Americans is very appealing. And yet the people who are uninsured and poor, I think, are difficult to reach. There is a lot of long-standing opposition to Obamacare. There are a lot of places where there are a lot of uninsured Americans, where there’s not particularly effective and robust outreach. People don’t know how to find these things, how to sign up. And it is really administratively complex to sign up for these plans. I mean, I don’t know how many of our listeners have tried to do it. It’s not impossible. It is on the internet. You know, anyone can do it. And you don’t have to have someone holding your hand. But I think in many cases you probably do want someone holding your hand if it’s your first time doing it. There are, in many markets, lots of choices. It’s confusing. It’s hard to know what the best option is, sometimes it’s a little bit hard to figure out what it’s going to cost you until you enter in a lot of information about your income. And you might also be scared that if you’re not sure or you put something in wrong, you could get in trouble. So I think this is just an ongoing challenge of getting all these people who are now eligible for these really low-cost plans to actually interact with the system and get insurance.

Rovner: One thing I guess bears mentioning is that with the Republicans just, you know, plan to do all of these things like try to repeal the Inflation Reduction Act because they don’t like the drug price provisions … [but] they are not talking about repealing the Affordable Care Act anymore, right? Have we finally come to the end of that particular fight?

Sanger-Katz: It sure looks that way.

Ollstein: Yeah. The right the writing has been on the wall in terms of the lack of that talk on the campaign trail for a few years now. I was joking with some colleagues that, you know, the “repeal Obamacare” is tired; the “repeal the drug price negotiation provisions” is wired. That’s the new talking point, although that’s not going to happen either, obviously, because of the control of the Senate and because of how insanely expensive it would be to repeal that. But the Republicans definitely have moved on to other targets.

Sanger-Katz: Although I will say, you know, once again, the fact that House leadership has committed to proposing cuts to health entitlement programs, the fact that they have committed to proposing a budget that balances in 10 years means that, I think, it will be extremely difficult for them to avoid talking about particular cuts or changes to Affordable Care Act programs. You know, again, it’s just like this is where the dollars are. They can take a lot of dollars out of Medicare, that is very politically unpopular. They can take some dollars out of Medicaid, you know, the largest expansion of which is part of ACA. They can take money out of these subsidies, which, you know, have been supercharged in recent years beyond even what Congress initially passed in 2010. And I do think, as Alice said, you know, this is not a popular talking point. I don’t think Republicans, by and large, want to be talking about repealing Obamacare anymore. And yet I think they are backed into this corner where they’re going to have to make and propose specific modifications and cuts to these programs in order to achieve these high-level philosophical goals that they’ve signed up for. And so I think it will be interesting to see what does it look like, maybe they’re not going to call it Obamacare repeal anymore, but they might still be sucking $1,000,000,000,000 out of Medicaid, like some of the Trump administration budgets did.

Rovner: Yeah. And it’s important to mention, again, I mean, the Republicans talk about all these things they’re going to do and people are thinking, Oh, my God, if they vote for this balanced budget, in 10 years it’s going to happen. They can’t do most of these things without the Senate and/or the president unless they have two-thirds to override, which they don’t. The one place that we do think they could exercise some leverage, obviously, is this debt ceiling vote where the Congress has to vote to raise the debt ceiling or the U.S. will default on things that it has already bought but not paid for — basically paying the credit card bill. And that, certainly, they’re going to try to make some entitlement changes. But all of these other things that they say they’re, quote-unquote, “going to do,” they’re mostly just quote-unquote, “making political statements,” right?

Sanger-Katz: But they’re going to have to talk about them. They’re going to have to write things down. They’re going to have to have specific dollars attached to this. I do think that it will be politically salient and that it will create some visibility into, like, well, how do you balance the budget in 10 years? What does entitlement reform look like? And they’re not saying Obamacare repeal anymore and they don’t want to, they understand that they don’t want to. And yet I think they’re going to be in this position where they’re going to effectively have to lay out something that looks like Obamacare repeal, something that looks like Social Security reform, something that looks like big changes to Medicare. And we will have a political debate about that because Democrats are just salivating to have those conversations. I think they feel like that is very strong political ground on them. They think that voters trust them to protect those very popular programs if they’re under assault. And, you know, which is very similar to the political dynamic we saw when Republicans were really trying in earnest, when they had full control of government and wanted to repeal Obamacare.

Rovner: Yes. And I would say, as we absolutely saw in 2017, when they failed to repeal it, Republicans very much agree on their goals, but they very much disagree on how to get there. There is no unified Republican plan for either reforming, you know, the Affordable Care Act or Medicare or Medicaid, I mean, except for basically cutting money out of it. So I will be interested, as Margot says, to see what they actually put down on paper.

Sanger-Katz: And, sorry, just one more thing on this point, which is, again, I think that the kinds of show votes that the Republican House leadership is going to have to put on these issues are probably not going to be particularly politically productive and may be politically damaging to them. But I do think, setting that aside for the moment, I do think we are entering in an environment of much higher interest rates, of really more accelerating federal debt. You know, there are a lot of conditions right now that are potentially ripe for thinking about government spending and particularly thinking about these big categories of government spending that are our federal health care programs. I think the last few years there’s been this sense that, you know, debt is free and the deficit doesn’t matter. And I think inflation is high, interest rates are rising. I do think that we’re in a moment where there may be a greater sense of a need to confront this problem. And I’m interested in what that conversation looks like, which may be a little bit different than the kind of highly ideological conversation that we’re going to see in the very near term.

Rovner: I was going to say that that would require actually having substantive talks about what might work, which we don’t know is going to happen, but we can cross our fingers and hope. All right. That is the news for this week. Now it is time for our extra-credit segment where we each recommend a story we read this week we think you should read, too. Don’t worry if you miss it; we will post the links on the podcast page at khn.org and in our show notes on your phone or other mobile device. Sarah, why don’t you go first this week?

Karlin-Smith: Sure. I took a look at a story by Kaiser Health News’ Lauren Sausser: “Hospitals’ Use of Volunteer Staff Runs Risk of Skirting Labor Laws, Experts Say.” I thought this was a fascinating story about hospitals’ reliance on volunteers, not for the types of activities I usually associate hospital volunteers with, which would be …

Rovner: Like candy stripers.

Karlin-Smith: Right. Like light … I don’t know, “light” is not the right word, but, you know, visiting people, comforting them in some way, providing added benefit of sorts. And this is really people that are being asked to do medical care and the basics, some of the basic care you need when you are in a hospital. And I think her story cites about $5 billion maybe in the U.S. of free labor through these types of volunteers. And the question becomes, you know, is this violating labor laws? And should these people be getting paid for the work, or should they … are they basically, because they’re using volunteers, taking money and job opportunities away from other people? And I thought it was a fascinating story just because I had no idea of all of this, you know, volunteer labor was being used and the impacts on these hospitals during the pandemic, when they couldn’t have volunteers. And just, I think, important to think about, too, how this impacts the quality of care as well people receive.

Rovner: Hospitals are very clever. Margot.

Sanger-Katz: I wanted to recommend an article from Jessie Hellman at Roll Call called “Providers Say Medicare Advantage Hinders New Methadone Benefit.” And I’ve been doing a lot of reporting on the Medicare Advantage program lately. And so I was a little bit jealous of this story. Congress just recently required Medicare to pay for methadone. You know, a very evidence-based treatment for opioid addiction that it hadn’t been covering before. And what this article found is that these Medicare Advantage plans, or private competitors to the government Medicare program, have been enacting a lot of roadblocks that make it hard for people to get this treatment. So they technically cover it, but they require often what’s called prior authorization, where you have to … doctors and others have to jump through a lot of hoops to prove that the person really needs it. And when I saw this article, I put out a bat signal on my Twitter and I said, Can anyone think of the medical reason why you would want to have … restrict access to methadone treatment? And, you know, this is just a Twitter poll, but no one could come up with the reason. They could think of lots of reasons why the insurance company might not want to cover it, because it’s expensive, because patients who have opioid addiction probably are pretty expensive in general. And so, you know, this could be a way to avoid paying for a complex treatment or a way to discourage patients who have complex health care needs from choosing a Medicare Advantage plan. Anyway, so just a good story and just, you know, another illustration of, you know, even after Congress does something like add a new benefit, there’s always value in doing oversight to see how is that actually working in the real world and is it giving patients the care that was intended?

Rovner: Yes. And we will be talking, I think, much more about Medicare Advantage this year. Alice.

Ollstein: So I have a very sad piece to recommend. It is an op-ed by Céline Gounder, who is a public health expert that we all know well, as well as the widow of Grant Wahl, the soccer journalist who died covering the World Cup. And she wrote about how her husband’s death has been co-opted by anti-vax conspiracy theorists who are trying to draw some connection to what happened to him and being vaccinated for covid. But she really smartly walks through the misinformation playbook because it is a very sort of predictable playbook with very predictable points and, you know, dismantles them one by one. And I think it’s really helpful for the inevitable next time we see this come up to be prepared in advance and be able to refute those points. Very tragic but very helpful thing to know.

Rovner: Yeah. Céline is our colleague now at KHN, in addition to everything else that she does, and I can just say to these trolls: Don’t mess with Céline. It really was a very good piece. Well, my extra credit this week is from The Washington Post, and it’s a great story that ran in the dead week between Christmas and New Year’s. So I … gave it an extra week. It’s called “Social Security Denies Disability Benefits Based on List With Jobs From 1977,” by Lisa Rein. And while I’ve known for a long time that the Social Security disability program has a multiyear backlog, one thing I didn’t know until I read this story is that a lot of otherwise likely eligible people get their benefits denied because they could theoretically do jobs that largely no longer exist. Among the jobs the government says people who are disabled might be able to do are nuts sorter, dowel inspector, or egg processor. That’s because the last time the labor market data used to determine if a disabled person might be able to do a job was last updated 45 years ago. The agency has been working since 2012 to update its listing of jobs that could be done by sedentary individuals. But somehow the new directory of jobs has not made it into use yet. Meanwhile, thousands of people deserving of disability benefits are being steered to jobs that are now largely automated, offshored, or otherwise obsolete, something that clearly needs to be fixed.

OK, that is our show for this week. As always, if you enjoy the podcast, you could subscribe wherever you get your podcasts. We’d appreciate it if you’ve left us a review — that helps other people find us, too. Special thanks, as always, to our ever-patient producer, Francis Ying. As always, you can email us your comments or questions. We’re at whatthehealth — all one word — @kff.org. Or you can tweet me. I’m still at Twitter for now: @jrovner. Sarah?

Karlin-Smith: I’m @SarahKarlin

Rovner: Margot?

Sanger-Katz: @sangerkatz

Rovner: Alice.

Ollstein: @AliceOllstein

Rovner: We will be back in your feed next week. In the meantime, be healthy.

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AbbVie, which for years has fought off competition for its blockbuster autoimmune drug Humira — the world’s top-selling medicine before Pfizer’s Covid-19 vaccine hit the market — has been the target of congressional hearings and legislation aimed at so-called patent thickets that can stall rival products.

Continue to STAT+ to read the full story…

To bring a new drug to market, the FDA requires pharmaceutical firms to perform extensive studies to demonstrate safety and efficacy, which are often expensive and time-consuming to conduct to the agency’s specifications. Getting a drug to market a few months sooner and for less expense than usual can translate into millions in profit for the manufacturer.

That is why a private equity-backed startup like Headlands Research saw an opportunity in creating a network of clinical sites and wringing greater efficiency out of businesses, to perform this critical scientific work faster. And why Moderna, Pfizer, Biogen, and other drug industry bigwigs have been willing to hire it — even though it’s a relatively new player in the field, formed in 2018 by investment giant KKR.

In July 2020, Headlands announced it won coveted contracts to run clinical trials of covid-19 vaccines, which would include shots for AstraZeneca, Johnson & Johnson, Moderna, and Pfizer.

In marketing its services, Headlands described its mission to “profoundly impact” clinical trials — including boosting participation among racial and ethnic minorities who have long been underrepresented in such research.

“We are excited,” CEO Mark Blumling said in a statement, to bring “COVID-19 studies to the ethnically diverse populations represented at our sites.” Blumling, a drug industry veteran with venture capital and private equity experience, told KHN that KKR backed him to start the company, which has grown by buying established trial sites and opening new ones.

Finding and enrolling patients is often the limiting and most costly part of trials, said Dr. Marcella Alsan, a public policy professor at Harvard Kennedy School and an expert on diverse representation in clinical trials, which have a median cost of $19 million for new drugs, according to Johns Hopkins University researchers.

Before covid hit, Headlands acquired research centers in McAllen, Texas; Houston; metro Atlanta; and Lake Charles, Louisiana, saying those locations would help it boost recruitment of diverse patients — an urgent priority during the pandemic in studying vaccines to ward off a disease disproportionately killing Black, Hispanic, and Native Americans.

Headlands’ sites also ran, among other things, clinical studies on treatments to combat Type 2 diabetes, postpartum depression, asthma, liver disease, migraines, and endometriosis, according to a review of website archives and the federal website ClinicalTrials.gov. But within two years, some of Headlands’ alluring promises would fall flat.

In September, Headlands shuttered locations in Houston — one of the nation’s largest metro areas and home to major medical centers and research universities — and Lake Charles, a move Blumling attributed to problems finding “experienced, highly qualified staff” to carry out the complex and highly specialized work of clinical research. The McAllen site is not taking on new research as Headlands shifts operations to another South Texas location it launched with Pfizer.

What impact did those sites have? Blumling declined to provide specifics on whether enrollment targets for covid vaccine trials, including by race and ethnicity, were met for those locations, citing confidentiality. He noted that for any given trial, data is aggregated across all sites and the drug company sponsoring it is the only entity that has seen the data for each site once the trial is completed.

A fragmented clinical trials industry has made it a prime target for private equity, which often consolidates markets by merging companies. But Headlands’ trajectory shows the potential risks of trying to combine independent sites and squeeze efficiency out of studies that will affect the health of millions.

Yashaswini Singh, a health economist at Johns Hopkins who has studied private equity acquisitions of physician practices, said consolidation has potential downsides. Singh and her colleagues published research in September analyzing acquisitions in dermatology, gastroenterology, and ophthalmology that found physician practices — a business with parallels to clinical trial companies — charged higher prices after acquisition.

“We’ve seen reduced market competition in a variety of settings to be associated with increases in prices, reduction in access and choice for patients, and so on,” Singh said. “So it’s a delicate balance.”

Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, called private equity involvement in trials “concerning.”

“We need to make sure that patients” know enough to provide “adequate, informed consent,” he said, and ensure “protections about the privacy of the data.”

“We don’t want those kinds of things to be lost in the shuffle in the goals of making money,” he said.

Blumling said trial sites Headlands acquired are not charging higher prices than before. He said privacy “is one of our highest concerns. Headlands holds itself to the highest standard.”

Good or bad, clinical trials have become a big, profitable business in the private equity sphere, data shows.

Eleven of the 25 private equity firms identified by industry tracker PitchBook as the top investors in health care have bought stakes in clinical research companies, a KHN analysis found. Those companies have been involved in studies ranging from covid vaccines to treatments for ovarian cancer, Parkinson’s disease, and Alzheimer’s.

Contracted firms also analyze patient data and prepare materials to secure approval from regulatory agencies, in hopes of getting more drugs to market faster. And a big draw for investors: Clinical research companies make money whether or not a drug succeeds, making it less risky than investing in a drug company.

The number of clinical trials has exploded to more than 434,000 registered studies this year as of late November, more than triple the number a decade ago.

Still, most trial sites are physician practices that don’t consistently perform studies, according to a presentation by Boston-based investment firm Provident Healthcare Partners.

“Independent sites are being purchased by private equity, and they’re moving into larger site groups of 30, 40, and then their game plan is to roll that up into a business and then sell it again,” said Linda Moore Schipani, CEO of Clinical Research Associates, a Nashville-based company that worked on covid vaccine trials for AstraZeneca, Novavax, and Pfizer. “That’s kind of the endgame.”

Headlands is a prime example. It announced in November 2019 that it would acquire six centers in the U.S. and Canada, including three sites in Texas and Louisiana owned by Centex Studies that would help improve participation among Hispanics and African Americans.

It has made other acquisitions since then and opened new sites in areas with “extremely limited trial options,” something Blumling says distinguishes his company.

“I’m not an evangelist for private equity,” Blumling said. “The ability of KKR to be willing to invest in something that is a three- to five-year return versus a one- to two-year return is something that you won’t see out there.”

A research center in Brownsville, Texas — a stone’s throw from the U.S.-Mexico border and where 95% of the population is Hispanic or Latino — is one of several where it is partnering with Pfizer to boost patient diversity.

To recruit patients, Headlands “is really going beyond what a lot of sites do, which is social media,” Blumling said in an interview. “It’s going within churches, community fairs, really getting out into as much as possible the broader community.”

Headlands closed the Houston and Lake Charles sites because of staffing issues, Blumling said, and finished or moved their studies elsewhere. Blumling said the decision to close those locations “did not have anything to do with the speed of trials.”

Similarly, he said, Headlands is moving the McAllen site’s operations to Brownsville “because it had a larger population of trained personnel.”

“We want to continue to grow sites and do great work,” Blumling said. “If we can’t find the people in order to do that at the quality that we demand, which is at the highest level, then it doesn’t make sense to keep those sites.”

‘The Writing to Me Was on the Wall’

In 2006, Devora Torrence co-founded Centex Studies, which she described as “my little mom and pop business” in a 2021 podcast about female entrepreneurs in science. She said a flurry of interest from private equity came at the end of 2018. The appeal was evident: Drug companies were relying on bigger clinical trial networks.

“The thing is speed, getting it to market. With a bigger network, you get that speed,” Torrence said on the podcast. “The writing to me was on the wall that either I get some outside investment and scale up myself, or kind of listen to these guys and see if maybe now would be the right time to exit.”

Joining Headlands had its benefits during the pandemic because she could “lean on” its other sites with experience running vaccine trials. “Had we not gotten those … we may not still be here,” Torrence said.

Torrence, whose LinkedIn profile said she left the company in 2021, didn’t respond to messages from KHN.

Lyndon Fullen, a health care consultant and former Centex employee, said private equity provides funding that allows companies to add study sites.

“I completely support it,” he said. “If it’s about reaching that large patient population, it’s of course better to have larger groups with that funding.”

Opportunity in Long Covid

Contract research organization Parexel saw opportunity in the covid pandemic — millions of people were developing long covid after infection and there were few, if any, meaningful treatment options.

The company, which employs more than 19,000 people, was acquired in 2021 by EQT Private Equity and Goldman Sachs’ private equity arm for $8.5 billion, billions more than the $4.5 billion that private equity firm Pamplona Capital Management paid when it took Parexel private in 2017.

A growing body of research shows the debilitating effects of long covid, including a recent study of tens of thousands of patients in Scotland where nearly half had not fully recovered months later. But treatments addressing its root causes could be years away. “It’s a huge number of people,” said Dr. Nathalie Sohier, who leads Parexel’s infectious diseases and vaccines franchise. “There’s a lot of need.”

Long covid represents the promise and peril of the work to develop new drugs: Millions of patients create a potentially lucrative market for drug companies, and yet researchers and industry experts say they are reluctant to jump in. In part, that’s because “it’s not a well-defined disease, and that really makes it highly risky for companies to invest in research,” said Cecil Nick, a vice president for Parexel.

“How are we going to be able to tell the FDA that our drug works? We can’t count the number of people who died; we can’t count the number of people in the hospital,” said Dr. Steven Deeks, a University of California-San Francisco professor who is running an observational study on long covid patients.

As of August, among more than 4,400 covid studies, only 304 focused on long covid. A third of those were related to drug development, Sohier said.

Sohier said “there are few” companies in its long covid program. That hasn’t stopped Parexel from pitching itself as the ideal partner to shepherd new products, including by doing regulatory work and using remote technology to retain patients in trials. Parexel has worked on nearly 300 covid-related studies in more than 50 countries, spokesperson Danaka Williams said.

Michael Fenne, research and campaign coordinator with the Private Equity Stakeholder Project, which studies private equity investments, said Parexel and other contract research organizations are beefing up their data capacity. The aim? To have better information on patients.

“It kind of ties into access and control of patients,” Fenne said. “Technology makes accessing patients, and then also having more reliable information on them, easier.”

KHN senior correspondent Fred Schulte and Megan Kalata contributed to this report.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

Envy for-profit US healthcare? Check out this MD whose wife is a medical billing expert who spent over a year challenging an egregious billing error. After it all they still paid $1200. These are resourceful knowledgeable people who got taken for a ride. https://t.co/fnlUz3KTJb

— Raghu Venugopal MD (@raghu_venugopal) October 26, 2022

— Dr. Raghu Venugopal, Toronto

A Plea for Sane Prices

I just read your story about the emergency room billing for a procedure that was not done (“A Billing Expert Saved Big After Finding an Incorrect Charge in Her Husband’s ER Bill,” Oct. 25). We too had a similar experience with an emergency room and a broken arm that was coded at a Level 5, and it was a simple break. No surgery needed, and it took them only 10 minutes to set and wrap the broken arm but charged us over $9,000. I disputed the charges, and it took six months to get them to reduce the bill but they never admitted that they coded a simple break incorrectly to jack up the price of the bill. If it had been a Level 5 issue, we would not have sat in the waiting room for six hours before being seen. It was a horrible experience, and I think ERs all over the nation are doing this to make up for the non-payers they treat every day. It is robbery.

— Terrence Campbell, Pocatello, Idaho

It would be great if the vaulted @KHNews would clearly distinguish between the ED pro fee billing & hospital charges as it is not entirely clear here w/ in network svs.—Billing Expert Saved Big After Finding an Incorrect Charge in Her Husband’s ER Bill https://t.co/jRFAYb5F0P

— Ed Gaines (@EdGainesIII) October 25, 2022

— Ed Gaines, Greensboro, North Carolina

As you said, CPT codes should always be examined. This case is probably more than “just an error.” As a retired orthopedic surgeon, chief of surgery, and chief of staff at a North Carolina hospital, I have seen care such as this coded exactly like this with the rationale that, “Hey, this was a fractured humerus and it was manipulated and splinted.” 24505 is correct IF that is the definitive treatment, which it was not here. Even code 24500 would indicate definitive treatment without manipulation. This was just temporary care until definitive care could be done later. It should be billed as a visit and a splint. The visit for this, if it was an isolated problem (no other injury or problems), would qualify only as a Level 2 visit. That frequently gets upcoded as well by adding a lot of non-pertinent family, medical, and social history and a complete physical exam (seven systems at least) and a whole lot of non-pertinent “medical decision making.” All of that should be documented in the medical records even if the hospital stonewalls on the CPT codes.

Look closely at medical records and you will find frequent upcoding, if you are familiar with the requirements for different levels of treatment.

— Dr. Charles Beemer, Arvada, Colorado

Never attribute to Baumol's cost disease that which is adequately explained by malice. https://t.co/RbKOlBgCmp

— Shashank Bhat (@shashank_ps) October 26, 2022

— Shashank Bhat, San Francisco

A number of years ago, I was billed using a code that described a treatment that was not carried out. In similar fashion, I talked with my insurance company, which basically said it did not care whether the treatment took place or not as all it required was for a valid code to appear. I also contacted the Virginia Bureau of Insurance, which approves the various policies, and it said it had no jurisdiction over claims. I decided to let the hospital sue me for the disputed amount and defended myself in district court. Despite their attorney and four “witnesses,” the case was thrown out because the hospital was both unwilling and unable to justify the charges to the satisfaction of the judge. They did not want anybody in power to testify because of the questions they would have been asked, so they left it to people who were completely clueless. The takeaways from this were:

• Hospitals make up the numbers and leave them grossly inflated so they can claim that they are giving away care when they give discounts on the made-up numbers.
• Hospitals turn employees into separate billing entities so they can double-charge.
• Hospitals open facilities such as physical therapy in hospital locations because insurance companies will pay higher amounts when treatment is carried out in a hospital environment.
• Insurance companies and state insurance agencies do not act as gatekeepers to protect their clients/taxpayers.
• The insurance companies and the providers have a shared interest in the highest possible ticket prices and outrageous charges because the providers get to claim how generous they are with “unremunerated care,” and if the prices were affordable then they could not justify the high prices for insurance premiums and the allowed administration/profit share of 20% would be based on a far smaller amount.

In any other industry, this would have resulted in multiple antitrust suits. U.S. health care is a sad example of government, health care industry, and insurers all coming together against the interests of consumers. After this court case, I wanted to form a nonprofit to systematically challenge every outrageous charge against people who, unlike myself, did not believe or know how to defend themselves. If hospitals and other providers were forced to go to court to justify their charges on a systematic basis, pricing sanity would eventually prevail.

— Philip Solomon, Richmond, Virginia

The obvious solution to prosecute the hospital for fraud followed by a civil suit"A hospital charged nearly $7,000 for a procedure that was never performed" https://t.co/wPNNZ5cZey

— Barry Ritholtz (@ritholtz) October 31, 2022

— Barry Ritholtz, New York City

Patients as Watchdogs

Thank you for the article on Lupron Depot injections (Bill of the Month: “$38,398 for a Single Shot of a Very Old Cancer Drug,” Oct. 26). Last year, I was diagnosed with prostate cancer, though my case is not anywhere as severe as that experienced by Mr. Hinds.

Last month my urologist scheduled an MRI update for me at a facility owned by Northside Hospital Atlanta. At the suggestion of my beloved wife, I called my insurance company, UnitedHealthcare, to make sure the procedure was covered. Fortunately, it was. That being said, the agent from UnitedHealthcare mentioned that Northside Hospital’s fee was “quite a bit higher than the average for your area.” It was. Before insurance, the charge for an MRI at Northside was $6,291. I canceled the appointment at Northside and had the MRI done by a free-standing facility. Their charge, before insurance, was $1,234.

Every single encounter that I have with the health care system involves constant vigilance against price-gouging. When I have a procedure, I have to make sure that the facility is in-network,. that each physician is in-network, that any attending specialist such as an anesthesiologist or radiologist is in-network (and their base-facility as well). If I have a blood test, I have to double-check if the cost is included in a procedure or if it is separate. If it is a separate fee, I have to ensure that the analysis is also covered, and, if it is not, that it is not done through a hospital-owned facility but instead through a free-standing operation.

I have several ongoing conditions in addition to my prostate cancer — Dupuytren’s contracture, a rare bleeding disorder similar to thrombocytopenia, and arthritis. Needless to say, navigating our byzantine, inefficient, and profit-driven health care system is a total nightmare.

Health care in the United States has become so exceedingly outrageous. I cannot understand why it is not an issue that surfaces during election years or something that Congress is willing to address.

Again, thank you for your excellent reporting.

— Karl D. Lehman, Atlanta

Why capitalism without guardrails is a pipedream. Own the patent, control the pricing, and this is the result: $38,398 for a Single Shot of a Very Old Cancer Drug https://t.co/BLes77QN7F via @khnews

— Brian Murphy (@NorwoodCDI) October 26, 2022

— Brian Murphy, Austin, Texas

I was a medical stop-loss underwriter and marketer for over 30 years. Most larger (company plans for 100-plus employees) are self-funded, meaning the carrier — as in this case, UnitedHealthcare — is supplying the administrative functions and network access for a fee, while using the employer’s money to pay claims.

Every administrator out there charges a case management fee, either as a stand-alone charge or buried in their fees. Either way, they all tout how they are looking out for both the employer and the patient.

Even if this plan was fully insured, wouldn’t it have been in the best interest of all parties when they became aware of the patient’s treatment (maybe after the first payment) to reach out to the patient and let them know there are other alternatives?

The question in these cases is who is minding the store for both the patient and the employer. The employer, the insurer, and the patient could have all saved a lot of money and pain, if someone from case management had actually questioned the first set of charges.

— Fred Burkacki, Sarasota, Florida 

I did a few rounds of Lupron in my 20s for severe #endometriosis, and I had to fight my insurance company to get approved. Now, this is how much it costs for some people. https://t.co/UlB1TTtW40 #healthcare #prostatecancer

— Amanda Oglesby 🌊 (@OglesbyAPP) October 26, 2022

— Amanda Oglesby, Neptune, New Jersey

‘Bill of the Month’ Pays Off

I received a $1,075 refund on a colonoscopy bill I paid months earlier after listening to the KHN-NPR “Bill of the Month” segment “Her First Colonoscopy Cost Her $0. Her Second Cost $2,185. Why?” (May 31) and finding out the procedure should be covered under routine health care coverage. Thank you!

— Cynthia McBride, University Place, Washington

We have to close legal loopholes to make sure that cancer diagnostic procedures have the same insurance coverage as screening. Colonoscopies must be fully covered whether a polyp is found or not #ACA #colorectalcancer #CancerScreening https://t.co/slE6p3FvHe

— Erica Warner, ScD (@ewarner_12) May 31, 2022

— Erica Warner, Boston

Removing Barriers to Benefits

In the story “People With Long Covid Face Barriers to Government Disability Benefits” (Nov. 9), you stated: “Many people with long covid don’t have the financial resources to hire a lawyer.” This is incorrect. When applying for disability, you don’t need financial resources. There are law firms that specialize in disability claims and will not charge you until you win your claim. And, according to federal law, those law firms can charge only a certain percentage of the back pay you would get once the claim has been won. Also, if you lose the claim, and the law firm has appealed as many times as possible, you don’t owe anything. Please don’t make it more difficult for those who are disabled with misinformation.

— Lorrie Crabtree, Los Angeles

People unable to work due to Long Covid are facing barriers to obtaining government disability benefits.https://t.co/zWQfW5CkOS

— Ron Chusid (@RonChusid) November 10, 2022

— Ron Chusid, Muskegon, Michigan

Vaccine Injuries Deserve Attention, Too

I read your long-covid article with interest because many of the barriers and some of the symptoms faced by people with long covid are similar to those experienced by people with vaccine injuries. I’m really concerned about how there is even less attention and support for people who suffered adverse vaccine reactions.

Long covid and vaccine injuries are both issues of justice, mercy, and human rights as much as they are a range of complex medical conditions.

It’s nearly 20 months since someone I know sustained a serious adverse reaction, and it is heartbreaking how hard it has been for her to find doctors who will acknowledge what happened and try to help. There’s no medical or financial support from our government, and the Countermeasures Injury Compensation Program is truly a dead end, even as other countries such as Thailand, Australia, and the United Kingdom have begun to acknowledge and financially support people who sustained vaccine injuries.

I’ve contacted my congressional representatives dozens of times asking for help and sharing research papers about vaccine injuries, but they have declined to respond in meaningful ways. Similarly, my state-level representatives ignore questions about our vaccine mandate, which remains in place for state employees, despite at least one confirmed vaccine-caused fatality in a young mother who fell under the state mandate in order to volunteer at school.

There have been a few articles, such as …

• Why Is It So Hard to Compensate People for Serious Vaccine Side Effects?
• Feds Pay Zero Claims for Covid-19 Vaccine Injuries/Deaths
• Covid Vaccine Injury Plaintiffs Face Long Odds in U.S. Compensation Program
• Covid-19: Is the US Compensation Scheme for Vaccine Injuries Fit for Purpose?

… but no new ones have come to my attention recently, and it is concerning that the media and our political and public health leaders seem OK with leaving people behind as collateral damage.

Please consider writing a companion piece to highlight this need and the lack of a functional safety net or merciful response. My hope is that if long covid and vaccine injuries were both studied vigorously, new understanding would lead to therapeutics and treatments to help these people.

— Kathy Zelenka, Port Angeles, Washington

Given how long it took Congress to eventually approve "Agent Orange" and "Burn Pit" benefits for disabled veterans, it is at least a 15-20 year time frame and they don't have the backing or societal standing that veterans do. https://t.co/idt6tSioHc

— Matthew Guldin (@MRG_1977) November 11, 2022

— Matthew Guldin, West Chester, Pennsylvania

More on Mammograms

The article “Despite Katie Couric’s Advice, Doctors Say Ultrasound Breast Exams May Not Be Needed” (Oct. 28) does a disservice to women and can cause harm. An ultrasound is saving my life. I had two mammograms with ultrasounds this year. Although the first mammogram showed one cyst that was diagnosed as “maybe benign,” I knew it wasn’t. Why? Because I could feel the difference. I insisted on a second, and sure enough a large-enough cyst that’s definitely malignant was found. I had breast surgery on Oct. 31, followed by radiation treatment and, if needed, chemotherapy later. This article will deprive other, less aggressive and experienced women who do not have health care credentials or a radiologist for a husband to be harmed by being lulled into complacency.

— Digna Irizarry Cassens, Yucca Valley, California

Why do some women with dense breasts get additional screening while others do not? ⁦@CNN⁩ explains. ⁦@IronwoodCancer⁩ https://t.co/uFZZKo6RO4

— Patricia Clark (@patriciaclarkmd) October 27, 2022

— Patricia Clark, Scottsdale, Arizona

Your article on breast cancer screening neglected to present the supplemental option of Abbreviated Breast MRI (AB-MRI). The out-of-pocket cost at many clinics ranges from $250 to $500. For a national listing of clinics that offer this supplemental screening option, please go to https://timetobeseen.org/self-pay-ab-mri. For benefits, just Google “Abbreviated Breast MRI.”

— Elsie Spry, Wexford, Pennsylvania

Why didn’t more #SeniorCitizens leave for safer havens during Hurricane Ian as recommended? ⁦@judith_graham⁩ rightfully suggests that learning why is critical as the population of older people grows and #NaturalDisasters become more frequent. https://t.co/7k8bvNQxug

— Donald H. Polite (@DonaldPolite) November 2, 2022

— Donald H. Polite, Milwaukee

Preparation Plans for Seniors: All for One and One for All

At least 120 people died from Hurricane Ian, two-thirds of whom were 60 or older. This is a tragedy among our most vulnerable population that should have been prevented (“Hurricane Ian’s Deadly Impact on Florida Seniors Exposes Need for New Preparation Strategies,” Nov. 2).

Yes, coming together and developing preparedness plans is one way to protect seniors and avoid these kinds of tragedies in the future, but since this is not a one-size-fits-all situation, organizations that help seniors across the country must first look internally and be held accountable by making sure their teams always have a plan in place and are prepared to activate them at a moment’s notice.

During Hurricane Ian, I saw firsthand what can happen when teamwork and effective planning come together successfully to protect and prepare seniors with chronic health conditions like chronic obstructive pulmonary disease who require supplemental oxygen to breathe.

Home respiratory care providers and home oxygen suppliers worked tirelessly to ensure our patients received plenty of supplies to sustain them throughout the storm, and when some patients faced situations where their oxygen equipment wasn’t working properly inside their homes, staff members were readily available to calmly talk the patient through fixing the problem. After the winds receded, mobile vans were quickly stationed in safe spaces for patients or their family members to access the oxygen tanks and supplies they needed. If patients were unable to make it to these locations, staff members were dispatched to deliver tanks to their homes personally and check in on the patient.

Patients were also tracked down at shelters, and a team of volunteers was formed around the country to find patients who could not be reached by calling their emergency backup contacts, a friend, or family member. Through these established systems, we were able to remain in contact with all of our patients in Ian’s path to ensure their care was not impeded by the storm.

Organizations should always be ready and held accountable for the seniors they care for in times of disaster. I know my team will be ready. Will yours?

— Crispin Teufel, CEO of Lincare, Clearwater, Florida

Understanding the impact of #Climatechange on older people is critically important as the population expands and #naturaldisasters become more frequent and intense.https://t.co/RKB7pA28nr

— Ashley Moore, MS, BSN Health Policy (@MooreRNPolicy) November 2, 2022

— Ashley Moore, San Francisco

The Tall and the Short of BMI

I am amazed that in your article about BMI (“BMI: The Mismeasure of Weight and the Mistreatment of Obesity,” Oct. 12) you never mentioned anything about the loss of height. If a person goes from 5-foot-2 to 4-foot-10, the BMI changes significantly.

— Sue Robinson, Hanover, Pennsylvania

I've been against this since after gastric bypass surgery I got down to 164 pounds but at 5'7" BMI still considered me overweight. How an overreliance on BMI can stand between patients and treatment https://t.co/OawzhO0aOk

— Steve Clark (@blindbites) October 10, 2022

— Steve Clark, Lee’s Summit, Missouri

Caring for Nurses’ Mental Health

During the pandemic, when I read stories about how brave and selfless health care heroes were fighting covid-19, I wondered who was taking care of them and how they were processing those events. They put their own lives on the line treating patients and serving their communities, but how were these experiences affecting them? I am a mother of a nurse who was on the front lines. I constantly worried about her as well as her mental and physical well-being (“Employers Are Concerned About Covering Workers’ Mental Health Needs, Survey Finds,” Oct. 27). I was determined to find a way to honor and support her and her colleagues around the country.

I created a large collaborative art project called “The Together While Apart Project” that included the artwork of 18 other artists from around the United States. It originated during the lockdown phase of the pandemic, a time when we were all physically separated yet joined by a collective mission to create one amazing art installation to honor front-line workers, especially nurses. Upon its completion, this collaboration was recognized by the Smithsonian Institute, Channel Kindness (a nonprofit co-founded by Lady Gaga) and NOAH (National Organization of Arts in Medicine). After traveling around the Southeast to various hospitals for the past year on temporary exhibit, the artwork now hangs permanently in the main lobby at the University of Virginia Medical Center in Charlottesville, Virginia.

I wanted to do something philanthropic with this art project to honor and thank health care heroes for their dedication over the past two years. It was important to find a way to help support them and to ensure they are not being forgotten. Using art project as my platform, I partnered with the American Nurses Association and created a fundraiser. This campaign raises money for the ANA’s Well-Being Initiative programs, which support nurses struggling from burnout and post-traumatic stress disorder and who desperately need mental and physical wellness care. Fighting covid has taken a major toll on too many nurses. Some feel dehumanized and are not receiving the time off or the mental and physical resources needed to sustain them. Many are suffering in silence and have to choose between caring for themselves or their patients. They should not have to make this choice. Nurses are the lifeline in our communities and the backbone of the health care industry. When they suffer, we all suffer. Whether they work in hospitals, doctors’ offices, assisted living facilities, clinics or schools, every nurse has been negatively impacted in some way by the pandemic. They are being asked to do so much more than their jobs require in addition to experiencing greater health risks, less pay, and longer hours. Nurses under 35 and those of color are struggling in larger numbers.

The American Nurses Foundation offers many forms of wellness care at no charge. They rely heavily on donations to maintain the quality of their offerings as well as the ability to provide services to a growing number of nurses. I am an artist, not a professional fundraiser, and I have never raised money before. But I feel so strongly about ensuring that nurses receive the support and care they deserve, that I am willing to do whatever it takes to advocate and elevate these health care heroes.

The Together While Apart Project’s “Thank You Nurses Campaign” goal is $20,200, an amount chosen to reflect the numbers 2020, the year nurses became daily heroes. So far, I have raised over $15,500 through gifts in all amounts. For example, a $20 donation provides a nurse with a free one-hour call with a mental health specialist. That $20 alone makes a big difference and can change the life of one nurse for the better. The campaign has provided enough funding (year to date) to enable 940 nurses to receive free one-hour wellness calls with mental health specialists.

The online fundraiser can be found at https://givetonursing.networkforgood.com/projects/159204-together-while-apart-fundraiser.

— Deane Bowers, Seabrook Island, South Carolina

CEAPs, is it time to offer more #mentalhealth services? Nearly 1/2 of employers (w/ 200 workers) report a growing share of workers using mental health services. Yet 56% report they lack #behavioralhealth providers for employees to access to timely care. https://t.co/Vpkkwlq6C6

— EAPA (@EAPA) October 27, 2022

— Employee Assistance Professionals Association, Arlington, Virginia

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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This story can be republished for free (details).