KFF Health News' 'What the Health?': The Struggle Over Who Gets the Last Word
The Host
Julie Rovner
KFF Health News
Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.
The Supreme Court in March will hear oral arguments in two very different cases that boil down to the same question: How much power do “experts” in health and science deserve? At stake is the future accessibility of the abortion pill mifepristone, and the ability of government officials to advise social media companies about misinformation.
Meanwhile, abortion opponents are preparing action plans in case Donald Trump retakes the White House. While it’s unlikely Congress will have enough votes to pass a national abortion ban, a president can take steps to make abortion far less available, even in states where it remains legal.
This week’s panelists are Julie Rovner of KFF Health News, Sandhya Raman of CQ Roll Call, Joanne Kenen of Johns Hopkins University and Politico Magazine, and Sarah Karlin-Smith of the Pink Sheet.
Panelists
Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico
Sarah Karlin-Smith
Pink Sheet
Sandhya Raman
CQ Roll Call
Among the takeaways from this week’s episode:
- Abortion opponents are preparing for the possibility of a second Trump presidency. Among ways the former GOP president could influence policy without Congress is by installing an activist secretary of Health and Human Services, possibly allowing a political appointee to overrule decisions made by FDA employees.
- While President Joe Biden is embracing abortion rights, Donald Trump is highlighting two conflicting truths: that he appointed the Supreme Court justices who helped overturn the constitutional right to an abortion and that embracing abortion restrictions could drive away voters.
- The federal government is making its initial offers on 10 expensive pharmaceuticals targeted for Medicare price negotiations. But the process is private, so it is unknown what those offers are.
- Two pharmaceuticals that have been in the headlines — the controversial Alzheimer’s disease drug Aduhelm and the insulin Levemir — will soon be pulled from the market. The decisions to discontinue them play into an ongoing debate in drug development: When is innovation worth the price?
- “This Week in Health Misinformation” features an article by KFF Health News’ Amy Maxmen about how what once were fringe views questioning science are now becoming more mainstream.
Also this week, Rovner interviews Samantha Liss, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” feature, about a husband and wife billed for preventive care that should have been fully covered. If you have an outrageous or confounding medical bill you’d like to share with us, you can do that here.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: ProPublica’s “Amid Recall Crisis, Philips Agrees to Stop Selling Sleep Apnea Machines in the United States,” by Debbie Cenziper, ProPublica, and Michael D. Sallah, Pittsburgh Post-Gazette.
Joanne Kenen: The New York Times’ “Elmo Asked an Innocuous Question,” by Callie Holtermann.
Sarah Karlin-Smith: The Texas Tribune’s “Texas Attorney General Requests Transgender Youths’ Patient Records From Georgia Clinic,” by Madaleine Rubin.
Sandhya Raman: The Associated Press’ “Community Health Centers Serve 1 in 11 Americans. They’re a Safety Net Under Stress,” by Devi Shastri.
Also mentioned on this week’s podcast:
- Politico’s “The Anti-Abortion Plan Ready for Trump on Day One,” by Alice Miranda Ollstein.
- The 19th’s “The Tools Trump Cold Use to Curb Abortion Access if He’s Elected,” by Shefali Luthra and Mel Leonor Barclay.
- The New York Times’ “How Trump Could Institute a Backdoor Federal Abortion Ban,” by Mary Ziegler.
- CQ Roll Call’s “GOP Pivots on Abortion Stance as 2024 Nears,” by Ariel Cohen and Sandhya Raman.
click to open the transcript
Transcript: The Struggle Over Who Gets the Last Word
KFF Health News’ ‘What the Health?’Episode Title: The Struggle Over Who Gets the Last WordEpisode Number: 332Published: Feb. 1, 2024
[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.]
Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News, and I’m joined by some of the best and smartest health reporters in Washington. We are taping this week on Thursday, Feb. 1, at 10 a.m. As always, news happens fast, and things might have changed by the time you hear this. So here we go.
We are joined today via video conference by Joanne Kenen of Johns Hopkins University and Politico Magazine.
Joanne Kenen: Good morning, everybody.
Rovner: Sandhya Raman of CQ Roll Call.
Sandhya Raman: Hello, everyone.
Rovner: And Sarah Karlin-Smith of the Pink Sheet.
Sarah Karlin-Smith: Morning.
Rovner: Later in this episode, we’ll have my interview with KFF Health News’ Samantha Liss, who reported and wrote the latest KFF Health News-NPR “Bill of the Month.” This month’s patient — actually, patients — got unexpected bills for care that should have been fully covered.
Before we get to this week’s news, it is February, so that means we want your health policy valentines. We will put a link to submit in our show notes. It’s on our web page at kffhealthnews.org. Show us, and your valentine, your affection for nerdy health policy topics. Winners will get read on the podcast and shared on our webpage and social media. The top poem will get its own illustration by our amazing in-house artist, Oona Tempest, so get those entries in.
OK, now the news. We will start this week in federal court where March is starting to look like “Health Policy Month.” At the 5th Circuit in New Orleans, judges will hear arguments in the case Braidwood v. Becerra, which challenges the very popular provision of the Affordable Care Act that requires insurers to cover a long list of preventive services at no out-of-pocket cost to patients. Fun fact: This is the provision in question in the latest “Bill of the Month,” which you will hear about in a few minutes. Another fun fact: The lower-court decision in this case came from Judge Reed O’Connor, whose name might sound familiar because he was the judge who tried to strike down the entire Affordable Care Act back in 2018. Somebody remind us why the plaintiffs here think the preventive services mandate is unlawful and should be stricken?
Raman: One of the issues that they have in this case is that certain types of this preventative care are in question — so, some of the things related to women’s health, vaccines, PrEP for preventing HIV, and just the moral issues that they have that those things do not necessarily need to be applied to under their plan. It’s some of those things in particular that come up.
Rovner: Yeah. I think in this case it seems to be mostly PrEP. It seems to be mostly about not wanting to encourage homosexual behavior, as the plaintiffs are saying, which is a rerun of what we had with the birth control cases, which went on, also for this provision of the ACA. No matter what happens in this case, Braidwood is sure to be appealed to the Supreme Court, which already has two health-related cases set for March oral arguments.
On March 18, the justices will hear Murthy v. Missouri, which challenges the government’s ability to coordinate with social media companies to downplay medical misinformation. The attorneys general of Louisiana and Missouri are arguing that the Biden administration essentially worked to censor conservative views. The Murthy in this case is Surgeon General Vivek Murthy, on whose behalf the Justice Department called the lower-court ruling seeking to bar communication between the White House and federal health agencies with social media companies, quote, “novel, unbounded, startling, radical, and ill-defined.” This could be a really important case for those trying to rein in medical misinformation, right? I mean, it’s obviously a really delicate thing. What serves as medical misinformation when the government gets to say, “Really, it should be at least de-algorithming,” if that’s a word, “this stuff because it’s not correct.”
Karlin-Smith: Right. I think one of the questions here is was the government collaborating and just sort of discussing and flagging these concerns to the companies, or did they exercise some sort of undue leverage here? Which is a big debate. Obviously, a private company has different ability to also regulate speech on its platform than the government does. So that’s another element to the case. I think sometimes people get confused about what your free speech rights are when you’re not directly dealing with the government in the U.S.
Rovner: Yes, there’s no guaranteed free speech in a private space like social media. I mean, they are not government-run. Although, I guess one of the arguments here is that they may be government-involved. I guess that’s what this case is supposed to try and create the guidelines for, but it’ll be … I’m looking forward to actually listening to these oral arguments.
Well, the following week, on March 26, the Supreme Court will hear the case FDA v. Alliance for Hippocratic Medicine, which is the one where conservative doctors challenged the original year 2000 approval of the abortion pill mifepristone. Technically, the justices are no longer considering canceling the original approval. They’re considering rolling back the FDA’s loosening of restrictions on the drug in 2016. But still, that alone could be a big deal, right? Sandhya, you’ve been following this, have you?
Raman: Yeah. Yeah. The Supreme Court decided at the end of last year that they would be taking up the case. So this week they set the actual oral arguments that we can look forward to. That’s going to be the first big abortion case that they’re going to hear since Dobbs. We have another abortion case coming up in April related to emergency health care. I think that it is interesting that it’s not over the full approval of the drug, it’s the regulations, but if you …
Rovner: Well, that’s because the 5th Circuit rolled back the original decision.
Raman: Yes. But I think that if you look at how much the regulations have changed since the original approval, there’s been a lot of expansion in just how it can be used, who can prescribe it, where it can be used, that kind of thing. So even if they were to rule to rescind some of those regulations and keep the original approval in place, that could have a huge effect in terms of who can get it. I mean, since the initial approval, we’ve been allowed to distribute it by mail, we’ve been allowed to do by telehealth to prescribe it. Just the length into pregnancy that it can be used, there’s been a lot of changes there. So we’ll have that to watch. The briefs have all started coming in, at least in favor of keeping the regulations as they are. We’ve had a huge lawmaker brief from a lot of Democrats. We had one from a lot of the pharmaceutical companies, including some big ones like Pfizer and Biogen.
Rovner: Yeah. I noticed in the PhRMA brief — or the pharmaceutical companies’ brief; I don’t believe it was from PhRMA the organization yet. But they did say that they were worried that if the court even were to uphold the 5th Circuit decision, which doesn’t cancel the approval but would cancel all of the changes since 2016, that that would basically freeze in place the use of drugs as we discover new uses for the same drugs. I mean, if you can’t relabel and put them out in a different way for different things, that would be a big hit to the drug industry, which, Sarah, spends a lot of time repurposing existing drugs, right? That’s a big part of drug development.
Karlin-Smith: Right. Improving upon a drug once it gets approved, expanding the label to treat different conditions is a big thing. The underlying tension for the pharmaceutical industry here is that there is a concern that this is the courts weighing in on sort of questioning the scientific judgment of the FDA in a way that would just make our whole drug approval regulatory system not function well for the industry, regardless of whether you’re talking about an abortion drug or a cancer drug or an arthritis drug. That’s really why there’s so much engagement from folks who are not necessarily here to argue about abortion politics. It’s just this concern that there’s certain scientific expertise and deference that we feel like the FDA should have, and that there’s concern that courts don’t really have that ability to accurately second-guess their judgments there.
Rovner: This really harkens back to what we’ve been talking about for the last couple of weeks with this big Supreme Court case on Chevron deference, which is basically the question of whether judges get to decide how to interpret federal laws or whether courts get to decide. This obviously would be a big deal because judges are not generally people with the expertise that doctors and scientists at the FDA have, right? Isn’t that sort of a big piece of this case too?
Kenen: Yes. We know that this particular court is anti-abortion. If they had just sort of a birthday cake wish, they would make the abortion pill go away. The question is where are they going to come down on who gets to decide? Is this an FDA decision or is this a legal decision elsewhere in the system? That’s the mystery. We really don’t know. In some ways, too, with the prior case we were just talking about, about preventive care, the USP has a lot of … the U.S. Preventive …
Rovner: Services Task Force.
Kenen: Who decides? What’s their authority? Which is part of the underlying legal battle in that case. So, are they anti-abortion? Yeah. Six, we know, are. Are they anti-FDA? Are they going to find some legal rationale for pulling this out of the FDA, with leaving other drugs in the FDA? That’s sort of part of what we’ll be watching for. Not just us. I mean, that’s what it comes down to.
Rovner: I was going to say, even the social media case, I mean, all of these cases are basically about scientific expertise and who gets to have the last say on questions of science and medicine. I mean, literally, all of these cases are about the same thing when you come right down to it.
So while we are on the subject of abortion, former South Carolina governor and, still, Republican presidential candidate Nikki Haley has been dodging questions about a federal abortion ban by pointing out that if neither party has 60 votes in the Senate, nothing can pass. Which is true as long as there’s still a filibuster. Well, it seems that the anti-abortion movement took that as a challenge. Two of our podcast colleagues, Shefali Luthra and Alice [Miranda] Ollstein, have eye-opening stories this week about all the things that President Donald Trump could do, if he’s elected again, without Congress. Some of those are things that he did in his first term that President Biden reversed, but some are new ones too. They’re already vetting people to carry out those policies. It looks like they want to be ready on day one. At least the anti-abortion forces want to be ready on day one, to do kind of a full-court press on anything that they consider to be abortion related.
Raman: Yeah, I think there have been, in the past, some of these policies that have gone back and forth between each administration. So something like Title X, the family planning program. Depending on if we have a Democrat or a Republican in office, they change what some of the regulations are there, but then …
Rovner: They basically kick Planned Parenthood in or out.
Raman: Yeah, things like that. Or like the Mexico City policy, which does something in a similar … but for overseas funding. And we’ve had also a ton of different new regulations since the Dobbs decision, in the Biden administration making it a little easier if you are, in certain cases, needing an abortion and are in the VA, in the Defense Department, things like that, that have been big issues for a lot of Republicans. So they would also have to — it’s more of a new territory to figure out how to roll back some of those compared to some of the things that they have a standard plan on.
But if you look at both of our podcast colleagues’ stories, one that stuck out to me was just kind of how they would have the FTC [Federal Trade Commission] try to crack down on abortion by mail, which comes back to the court case we were just discussing, abortion medication, abortion. And just how you could reinterpret some of the existing regulations that we do have regardless of what happens at the Supreme Court.
Karlin-Smith: I was going to say one thing that really stuck out to me in one of The New York Times pieces about this was how even the Trump administration could basically have their HHS [Department of Health and Human Services] secretary override FDA decisions, because we sort of forget that, actually, the way Congress has written a lot of the laws, actually, the HHS secretary has that ultimate authority around drug approvals. We just sort of take it for granted, I think, that for the most part they delegate that to FDA and the political appointees stay out of it. That’s another thing they raise is you could have sort of a more activist HHS secretary that could interfere with what does or doesn’t get approved by FDA. So there’s some pretty norm-ending ideas there for the government.
Rovner: I will say that I do remember Kathleen Sebelius came in and overrode an FDA … about contraception coverage decision. President [Barack] Obama made it clear that he asked Secretary Sebelius to override the FDA, but I think that was more to protect the FDA. Made it clear that this was a policy decision, not a medical decision. I know that they struggled with that a lot. For exactly the reason that you’re saying, that they didn’t want this to become normal, to have the secretary override the decision of the FDA.
Kenen: But that was a big controversy and someone at the FDA quit over it. I think it was the women’s health person. In that case, it was narrow. It was about, if I’m remembering correctly, Julie has a, sometimes, better memory, it was under-18 access to the morning-after pill, right? It was about 10 or 12 years ago.
Rovner: It was 2011 because it was the night my dog had her leg surgery and I had to come back to the office at 1 in the morning because we didn’t think that the secretary was going to override this decision.
Kenen: No, I said 10 to …
Rovner: I remember it really vividly.
Kenen: … 10 to 12 years ago. Yes, it was, then, 12 years ago. There hasn’t been a high-level repetition of that that I can think — of a HHS override. I mean, that’s one reason why the former FDA commissioners maybe … Julie, you and I were both at Aspen that year. It was maybe eight years ago or nine years ago where all the former FDA commissioners came together and called for the FDA to become an autonomous agency, sort of like the SEC [Securities and Exchange Commission], which was a proposal that then fell in a pond and was never heard from again. But that would prevent that kind of political interference. I mean, I actually spoke to a former FDA commissioner sort of recently and said, “Whatever happened to that?” And he said, “Wait.” So apparently they haven’t totally forgotten. We’re going to see reiterations of this fight over absolutely everything for the indefinite future: Who gets to decide?
Rovner: Yeah, I do think, like I was saying, that this is basically all about who gets to make medical and scientific decisions and whose, quote-unquote, “opinion” holds. Well, before we get off of this totally, both Alice’s and Shefali’s story, and an op-ed by University of California-Davis law professor Mary Ziegler, who’s also been on this podcast, talk about the revival of the Comstock Act. We have talked about this before and we surely will again, but somebody remind us what this 1873 law does and how it could be applied to abortion.
Karlin-Smith: In simple terms, it’s to prevent sending what are considered, quote-unquote, “obscene materials” through the mail. What that can refer to has been interpreted in different ways over the years. I mean, some of the … when it’s from the 1800s, it’s before we had medication abortion. It’s before we had the internet and telemedicine and all of these things. So there’s a lot of room that people have seen for just how it can be reinterpreted now with a lot of different things in place compared to over a 100-and-some years ago, and just how that can work in certain favors.
Rovner: I think I’ve said this before, now that we’re talking about the Comstock Act again, I realize that Anthony Comstock, who it is named after, was not a member of Congress. He was just an anti-smut crusader, basically. I believe the phrase, “You can’t send anything lewd or obscene through the mail.” This would be how they could sort of use it to say that anything abortion or possibly even contraception could be lewd or obscene. With all of this, that the Republicans are getting ready, or at least the anti-abortion groups are getting ready to do, Sandhya, you have a story out this week pointing out that abortion is not something Republicans are emphasizing on the campaign trail. Why not? There seems to be an awful lot of enthusiasm on that side.
Raman: It is pretty interesting. I mean, even if at this point it’s looking like we’re going to have the Round Two of the Trump-Biden matchup, if you look at how Trump, and then even Nikki Haley, have been messaging, all their ads, all that, they have not been as strong on anti-abortion issues as they have in the past. They’re both people that — both of them I’ve covered addressing annual Susan B. Anthony List events. I’ve covered March for Life where Trump has addressed them. They’ve both been very strong on this issue. And then, as you look at it now, neither of them have been really strong on committing to signing a national ban. Haley has really sidestepped the issue in a lot of the interviews that she’s done, just because, like you said, the Senate filibuster. I think even Trump has … they’ve been messaging on him being the most pro-life president that they’ve had. He’s just kind of sidestepped it as well, just kind of emphasizing other things. If you look at the advertising they’ve been doing, it’s not focused on this. It’s such a stark contrast to what the Biden campaign has done, which has really gone all in on abortion rights. They even had an all-reproductive-rights-themed rally a couple weeks ago.
Kenen: When Trump did the town hall on Fox, two, three weeks ago, whenever that was, he had it both ways, which meant that there’s a film clip to use whoever you’re advertising to. Within a minute and a half or two minutes or whatever it was, Trump took credit for knocking down Roe. He took credit for … “I accomplished that.” In other words, he appointed the justices or some of the justices that voted for that. So he took credit for finally being the one to get rid of abortion after 50 … get rid of Roe after 50 years. He was very …
Rovner: Which is true.
Kenen: It’s true. Well, both things he said were true because he took credit for that. So there’s your film clip one for that ad, or that message, or that social media, or whatever, direct mail. Whatever you want to use it for. It’s “I am the one.” And it’s true. And then, in the next breath, he said, “But we have to win elections.” He’s also said he’s for a … is it rape and incest or just rape? I think it was both. He’s for that exception. And then he talked about, “Face reality, we have to win.” Which is also a true statement if you’re running for president. You have to win or you don’t get to do these things that you’ve promised. So, I mean, he’s not the first politician or the last to try to have it both ways. It was interesting that he had it both ways, both accurately, in a two-minute conversation.
Rovner: Not that uncommon for him, though …
Kenen: No, but …
Rovner: To take both sides of an issue at the same time.
Kenen: He was so unabashed about it, it was sort of interesting that, “I did this, but maybe I won too much. Maybe it wasn’t …” I mean, at the polls, abortion has won.
Rovner: Yeah.
Kenen: Anytime there’s been a single-issue vote on abortion, the pro-choice people have won every ballot initiative since Dobbs.
Rovner: Yeah. And yet the other ironic thing, I mean, Sandhya, you already mentioned this, that the Biden administration is going all in on abortion because they know that Democratic women and independent women in most polls are supportive of abortion rights and not supportive of the Dobbs decision. On the other hand, Biden himself is an unlikely messenger for this. He’s a Catholic man of a certain age. He’s always been uncomfortable with this issue. He was pro-life early in his career. There was a joke that he didn’t even say “abortion,” I think, until a year into his presidency. There was an actual website that said, “Has Joe Biden said the word abortion yet?” So is he going to be able to bring along all of these people because they’re just going to, “If you support abortion rights, you’ll just vote for anybody not named Donald Trump”?
Raman: I mean, I think that we’ve already seen some of these different abortion-oriented groups really mobilize or kind of illustrate, commit how much money they’re going to spend, all the on-the-ground stuff they’re going to do to get him reelected. They have called out some of the things that he’s done, some of the regulations we’ve already talked about, that kind of thing. But I do get the sense that some of them are frustrated that we haven’t done enough. But I mean you could say the same for the other side. There’s always more that people want. Given the limitations of government when you don’t have the trifecta, and even when you do have the trifecta, if you don’t have enough of a majority to get some of your golden-ticket items done. So I think that it will be interesting to watch. I mean, we even, going forward, for the State of the Union coming up, they’ve already announced that they’re going to have … one of the guests is Kate Cox, the Texas woman who had to travel when she wasn’t able to get the court order to get the emergency abortion.
Rovner: Yeah.
Kenen: I mean, it’s a turnout issue. We know that voters are not enthusiastic about either candidate. We know that, right? I mean, will that change as the election gets closer? Who knows? But right now, many polls are finding that America’s not crazy about this particular rematch. So what are the issues that motivate people who are lukewarm to actually vote? This is going to be on both sides. This is going to be an issue, but the intensity in many ways is going to be on the Democratic side because they’re, just like it used to be, the one fighting for change. The one on the out is the one more likely to have that voter intensity. For 50 years, it was the Republicans. For the last 18 months, it’s been the Democrats. Vice President [Kamala] Harris has been talking about this. A lot of the other surrogates are talking about this. So this is a “Will this make you get out of whatever else you were going to do that Tuesday, or early vote, and actually vote?” It’s going to be one of the key issues in turnout.
Karlin-Smith: I think that’s a great point, that that is another reason why there’s so much Republican messaging on some of these other issues, on immigration, on crime and things like that. Because when it’s not a single-issue thing like the ballot — they’re still winning tons of races for governor and things like that. Maybe focusing on those issues might be good for them to boost some of the turnout.
Rovner: Well, another big issue that voters care about is drug prices. We actually have a lot of drug news this week. The federal government, just this morning, sent out its first set of proposed prices for the 10 drugs they have selected for Medicare price negotiation. Of course, they’re not telling us those prices because this is a private negotiation. But Sarah, did anything jump out at you from what they’ve said about kicking off this process?
Karlin-Smith: I think right now what the Biden administration is trying to do is just sort of publicize that this process is happening. Because again, this is a big political issue, an election thing that they’re hoping will motivate voters. But at the same time, it’s a little bit of a dud in some ways because the government can’t say what they’re offering and the companies don’t necessarily seem inclined to put out any information on this yet. So it’s going to be a pretty private process, potentially all the way up until this fall, in September, when we’ll get some public information. But I think the Biden administration just wants to keep ramming it into voters’ heads that, “Hey, we’re doing work to try and lower drug prices for people as much as we can.”
Rovner: Of course, the drug industry still hopes that some court will overrule and stop this whole thing, right?
Karlin-Smith: Right. There was actually oral arguments yesterday in one of the challenges from AstraZeneca to … that they’re hoping courts will intervene. I think some of the initial reporting from that was that the judge was fairly skeptical of some of AstraZeneca’s arguments, such as that there’s sort of a due process or taking of property that the government is not allowed to do here. The judge was basically saying, “Well, nobody is forcing you to participate in the Medicare program and sell your drugs there.” So some initial, at least, positive signs for the government in those oral arguments.
Rovner: Yeah. Although, as we know, they have a long way to go. In the individual-drug news category, remember when we were talking all about the controversial Alzheimer’s drug, Aduhelm, pretty much every week? Well, it is back and it’s sort of gone, or going, at least. Drug company Biogen is giving up ownership and prematurely ending a trial that was supposed to confirm the drug’s effectiveness in treating early Alzheimer’s. Sarah, you followed this from the very beginning. What do you take away from this whole saga? I mean, at one point, Aduhelm was going to be the answer, and then it was going to break Medicare because it costs so much. And then it was going to make people sick because it had side effects. And now it’s just going away.
Karlin-Smith: There’s so many layers to this story, but the quick version of it is, basically, FDA sort of controversially approved this drug over a lot of skepticism of whether it was actually going to be beneficial to patients. They use sort of a controversial measure that the drug reduced these amyloid plaques in the brain, but there were a lot of questions, including by outside scientists and so forth, as to whether this would actually improve the lives of patients with Alzheimer’s in terms of helping them function and memory. There’s a lot of side effects to the drug. Of course, the third layer of this is it was priced quite costly. What ended up happening was Medicare said, “We will only cover this drug at this point in time if it’s used in a clinical trial.” Part of what happened, I think in large part because of that, is there was no uptake of this product, no sales. That’s really why Biogen has pulled the plug here. The other element of this is that Biogen also has another Alzheimer’s drug that was approved fairly shortly thereafter that actually has better data to show there’s some benefit in actually improving people’s cognition. So again, they’re not necessarily invested in pushing forward a drug where they face all these payment challenges and have less solid data. The question now becomes, what does FDA do here? Do they officially go through the process and make sure … force Biogen to pull it off the market? What do they do about this clinical trial that they were supposed to be conducting to confirm the benefit? And what does science lose if that just gets stopped? I’m not sure if anyone will feel like there’s a need to complete that at this point. But it does raise interesting questions to me because I think about 1,500 or something patients were actually already enrolled in participating in that study.
Rovner: But I do think it’s important to emphasize that since Aduhelm was sort of all the rage, the big debate, we actually are finally seeing some drugs that do appear to have more benefit than cost for early Alzheimer’s. I mean, not a cure, but at least a slowing of the deterioration, right?
Karlin-Smith: I guess I think people are sort of cautiously optimistic about these drugs. They’re excited. Nobody thinks these are the holy grail yet of Alzheimer’s treatments. I think even some of the CEOs of the companies working on them have acknowledged that, but they do seem to offer some benefit. Again, there’s still a lot of these brain-swelling safety events that can be fairly devastating. So I think people are going to be watching really closely. Because usually what we know when a drug is initially approved is a fraction of what we end up knowing over time. So I think it’s still early days, but there is some hope that we finally sort of maybe cracked the code on some of the mechanisms of action of how to treat Alzheimer’s.
Kenen: Like with other drugs in cancer, elsewhere, sometimes you just need the first-draft drug. Hopefully, this isn’t the best we’re going to get. These new drugs that are showing some promise and some slowing down is sort of a proof of concept. Yes, you can make a drug that works. In other fields, too, you ended up … the first drug wasn’t a great drug, but it was a leap ahead in terms of understanding the science. So the fact that we have anything that does anything, scientists do consider that they don’t really understand Alzheimer’s, but it matters that there’s some effect. It’s not next week or next year, but there’s a goal that you can see. I think if you’re an Alzheimer’s researcher who’s spent their life not seeing a lot of tangible results, this is like a glimmer. Maybe more than a glimmer. I mean, this is like, “OK, we’re learning how to do this.”
Karlin-Smith: That was actually one of Biogen’s arguments, I think, for why Aduhelm should have been approved in the first place. Maybe even some folks at the FDA basically saying, “Look, we know this maybe isn’t the home run, but if you don’t approve these products, people are just going to leave this space and not invest in it and not keep trying to bring forth drugs.” I mean, there are people that vehemently disagree with that argument, that that’s the best way to encourage the right innovation for this country, but that wasn’t an argument you saw from industry and even some at the FDA, I think.
Kenen: But I wasn’t talking about Aduhelm specifically. I mean, the other ones that are in the pipeline that are coming out. I mean, it’s new and we don’t really know much about them yet. But the past Alzheimer’s drugs were basically useless or really limited use. These might be what we will later look back on as the first draft as opposed to another failure.
Rovner: I want to move on to another drug that’s being discontinued. European mega drugmaker Novo Nordisk has announced its ending production of a long-acting insulin, Levemir — I think that’s how you pronounce it — that, coincidentally, is one of the insulins that it slashed prices on last year under pressure from lawmakers. The announcement came the same week the company announced it would double the availability in the U.S. of its blockbuster weight loss drug, Wegovy, and the same week that the company hit $500 billion in market value. While there are substitutes for the insulin, for Levemir, many of its patients say this particular product is the best one for them, and there isn’t a one-to-one substitute. I guess this is a reminder that for drug companies, the prime goal is turning profits for their shareholders. I mean, they’re making a lot more money off of these weight loss drugs than they are off their diabetes drugs. We know that the weight loss drugs were in shortage because they couldn’t make enough of them. So you don’t have to be really good at math to kind of put two and two together here, right?
Raman: Right. I’m not sure they’re necessarily even hiding that fact, to some degree. They basically lowered the prices of a lot of these insulin products because of changes in the Medicaid rebate program, where because these products had their prices raised so much over the years, they were going to be subject to new inflation penalties, where they’d essentially owe Medicaid money if they didn’t lower the price. So now you have these older insulin products with lower prices that don’t make them as much money. And Novo Nordisk, in the insulin space, has innovated over the years and made some improvements. So they want to focus on selling their insulin products that they can sell at a higher price point. But again, you get patients who say, “Look, this older drug, actually, I personally, think works better.” And there’s a benefit to patients that it’s cheaper. This is, I think, an old story in the pharmaceutical space that sometimes is looked upon by lawmakers, which is, they innovate and they push patients onto newer products, but is the innovation really worth the price or should people have some way to choose the older product for the lower price if they think it works fine for them?
Rovner: Speaking of drug company profits, the CEOs of Merck and Johnson & Johnson have voluntarily agreed to testify before the Senate Health Committee — meaning that Chairman Bernie Sanders won’t have to subpoena them after all. The hearing is scheduled for Feb. 8. But it’s not about any specific legislation, this is just a chance for Sanders to lecture the CEOs about their high prices, Sandhya?
Raman: Essentially, yes. I think, also, it’s been such a big issue for him. Even if you look back when we had the various nominees, that they wanted to … that would go through his committee where he said that he really wanted more action on this. So I think it’ll be interesting what he brings up, and if there’s a clear pathway of something to move forward since this has been such a big issue for him for a while.
Rovner: Well, he successfully made me want to watch this hearing. We’ll see how it goes. All right. Well, let us turn to “This Week in Health Misinformation.” In addition to that case that the Supreme Court will hear, that we talked about at the top, we have a story from my new KFF Health News colleague, Amy Maxmen, about how what used to be fringe anti-science views are now mainstream among Republicans in general. Vaccine hesitancy has gone up. And that’s hesitancy even to long-proven childhood vaccines, not just the covid vaccine. While trust in science in general has dropped, according to numerous polls. In Florida, Gov. Ron DeSantis has made public health conspiracies part of his platform. And as a presidential candidate, he said he would’ve considered nominating noted conspiracy theoretician and anti-vaxxer Robert F. Kennedy Jr. to run the CDC [Centers for Disease Control and Prevention]. I’ve certainly seen more pushback in my reporting of things that people used to agree on. I assume you guys have too. I mean, it harkens right back to our original theme of who gets trusted when they talk about science and medicine.
Karlin-Smith: I think one of the interesting things that Amy’s story really points out very well, that people have been talking about a lot since the beginning of the covid era, is that this anti-science or anti-vaccine attitude has really become embedded in people’s personal identity and personal politics in a new way. Once it becomes part of your political identity, the experts are saying, it becomes much harder to change people’s views. That’s seen as one of the key problems right now, because, again, providing facts or just rebutting the information doesn’t seem to work when you’re basically sort of attacking somebody’s core identities and beliefs.
Rovner: Yeah, it’s an interesting subject, how we’re sort of freezing a lot of these things in place.
Kenen: Well, it’s also tied up with liberty and freedom in a way that has been part of the anti-vax movement for a long time, but it was a much smaller thread. Right now, this individual liberty or medical freedom, “You don’t have the right to mandate anything,” that “It’s my body.” Now, that’s fine if it’s really only your body, but when you’re talking about infectious diseases, it’s everybody’s bodies. Anti-vaxxing is across the … there are people on both the left and right who are against vaccination. That has changed in the intensity and the politicization on the right, during covid and since covid, and this medical freedom movement, which is sort of a subsection of libertarianism. We tend to talk about anti-vaxxers and anti-vaccination because that’s the most salient thing in the last few years, but there is a broader distrust of expertise, period. Scientific expertise, medical expertise, everything. I mean, some of you know I’m writing a book. We turned in the first draft this very morning. Misinformation is part of the book, and disinformation. This decline, when I was researching … it wasn’t that America was a really trusting society. I was surprised. Going back in history, we’ve always [had] pretty high distrust rates of many major institutions, but it’s much higher in health, medicine, science, public health right now.
Rovner: It’s not just the U.S. We’re seeing this around the world, basically, since the pandemic.
Kenen: It’s tied into the pandemic. It’s tied into the research of populism, a right-wing form of populism. It’s tied into a whole anxiety. The last few years have been really hard on people. Science didn’t have the answers and quick fixes that people wanted, because science is incremental, and people wanted instantaneous fixes. They didn’t understand the incremental changing nature of science, and scientists didn’t always explain it well enough. So it’s here to stay for the near future. It’s pretty insidious because it’s way beyond vaccines.
Rovner: I’m sure we will talk about it more. Well, that is this week’s news. Now we will play my “Bill of the Month” interview with Samantha Liss, and then we will come back with our extra credits.
I am pleased to welcome to the podcast my colleague Samantha Liss, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” installment. Thanks for joining us, Sam.
Samantha Liss: Hi.
Rovner: So, this month’s patients, a husband and wife, got some mysterious bills for preventive care that they thought should have been free. Tell us who they are and what they got.
Liss: Yeah. So this month we bring you Chantal Panozzo and her husband. They live outside Chicago. And they underwent their first colonoscopies last year, after turning 45.
Rovner: Then, as we say, the bill came. Now, colonoscopies are very much on the list of preventive services that are supposed to be available at no out-of-pocket cost to patients. So there really shouldn’t even have been a bill. How much was the bill and what was it for?
Liss: Yeah. So their insurance company paid for the screening, but there was a separate $600 charge for something called “surgical trays.” Supplies you’d expect to be covered.
Rovner: Yeah. It’s like saying, “We’re going to charge you rent for lying on our table.”
Liss: Exactly.
Rovner: Chantal Panozzo knew that there shouldn’t be a charge. After getting no good explanation from her insurer or the gastroenterology practice, she went to complain. She went pretty much everywhere she could, right?
Liss: Yeah. Chantal is a savvy consumer, and she was furious. She lodged an appeal with her insurer, she filed a formal complaint with state regulators in Illinois, and she wrote to her elected officials.
Rovner: So what eventually happened?
Liss: She won, but she’ll tell you she did not feel victorious. Her insurer waived the bills for her and her husband, and they didn’t owe anything, but it was a months-long slog. I think seven months in total.
Rovner: Just to be clear, it was actually the insurer that she appealed to, and she won that appeal.
Liss: Yeah. I think part of what helped push that appeal along was her complaint to the Illinois Department of Insurance.
Rovner: So, doing all of those things apparently helped. It turns out that the couple uncovered quite the loophole in the preventive services mandate. What is that and how can others avoid falling into the same trap?
Liss: Yeah. Under the law, the insurer bears the legal burden to pay for preventative care. There’s no requirement on providers to bill a certain way. So I think as we tell all our folks who read and listen to our “Bill of the Month” series, never pay the first bill. Wait until you get your explanation of benefits, and if something doesn’t feel right, ask questions.
Rovner: So basically, people can go in and get care that they expect and should be free and get random charges, and they can complain about those, right?
Liss: Exactly. And I think Chantal’s example shows sometimes you have to fight so hard and for so long to get something waived that you shouldn’t have been charged for to begin with. It’s maddening and it ticks people off.
Rovner: And if all else fails, you can send your bill to us.
Liss: Yes, please do.
Rovner: Sam Liss, thank you very much.
Liss: Thanks.
Rovner: OK, we’re back. It’s time for our extra-credit segment. That’s when we each recommend a story we read this week we think you should read, too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Joanne, you have my favorite this week, why don’t you go first?
Kenen: I told Julie that Elmo didn’t want her to get sad if I was going to do this one, and she didn’t. I’m sure almost everybody saw the Elmo phenomenon this week. The particular story that I’m referring to is by Callie Holtermann in The New York Times, “Elmo Asked an Innocuous Question.” And then there’s this wonderful sub-headline, “Elmo was not expecting it to open a yawning chasm of despair.” Elmo tweeted or X’ed, whatever you call it … I mean, it wasn’t really Elmo, it was his human. Elmo is just checking in, “How is everybody doing?” There were tens of thousands of views. Last time I looked, there were more than 16,000 responses. I did not read all 16,000, but people really are not happy. And they told Elmo that. It just became this sort of mass confessional to Elmo of all the things that people were feeling despair about. And then Elmo ended up saying something like, “Wow, Elmo is glad he asked.” So I don’t know if Elmo has now become our national shrink, but to a certain extent this week, he was.
Rovner: Absolutely. Sarah?
Karlin-Smith: I looked at a piece from The Texas Tribune about not quite an amazing topic, maybe. The “Texas Attorney General Requests Transgender Youths’ Patient Records From Georgia Clinic,” by Madaleine Rubin. It basically looks at a trend where Texas seems to be trying to not only control what is happening to the care of transgender children within their state, but trying to maybe intimidate or prevent care from happening out of state by going after telehealth providers, but maybe even trying to request records related to people that have traveled outside of the state to get care because they can’t get it in the state. It reminds me a bit of some of what some of these states are also trying to do in the abortion space as well, but raises interesting questions about whether the state really has the authority to interfere here and so forth.
Rovner: Yeah, Texas is obviously fighting this border issue, too, with the federal government. So Texas is trying to basically see how far it can press its authority, in general. Sandhya?
Raman: My pick this week is called “Community Health Centers Serve 1 in 11 Americans. They’re a Safety Net Under Stress.” It’s from Devi Shastri at The AP. I just thought it was a great look at some of the challenges, some new, some evergreen for the 1,400 federal community health centers that provide medical care, social services, and so much for so many folks in the country. It just looks at some of the issues. In Congress, there’s always the periodic federal funding drama of just, “When will community health centers get funded?” And, “They can’t long-term plan on that.” That and just how the staffing concerns, whether it’s money or quality of life, or just how they can address new health equities and things like that.
Rovner: It was a really good story. My extra credit this week is from ProPublica. It’s a coda to a series of stories that they’ve been working on, and we’ve been talking about over the past several years, after reporters at our fellow nonprofit newsroom helped uncover serious defects in the CPAP breathing machines manufactured by Philips Respironics, and the company’s failure to report complaints about the foam in those machines crumbling and getting into patient’s lungs. The company finally issued a recall. Then, apparently, the replacement foam also started to deteriorate, which also became a subject of the series. Now the GAO is investigating the FDA’s oversight of medical devices, and a federal criminal probe is being sought for Philips. And now, at least, the company will stop selling the machines in the United States. So journalism works, particularly when reporters keep at it. And boy, did they keep at it on this story.
OK, that is our show. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left a review; that helps other people find us, too. Special thanks, as always, to our technical guru, Francis Ying, and our editor, Emmarie Huetteman. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X, @jrovner, or @julierovner at Bluesky and @julie.rovner at Threads. Joanne, where are you hanging out these days?
Kenen: I’m mostly on Threads @joannekenen1.
Rovner: Sarah?
Karlin-Smith: I am @SarahKarlin or @sarahkarlin-smith.
Rovner: Sandhya?
Raman: I’m still with X and on Bluesky, @Sandhya@Writes.
Rovner: We will be back in your feed next week. Until then, be healthy.
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KFF Health News' 'What the Health?': Health Enters the Presidential Race
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Julie Rovner
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Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.
Based on the results of the first-in-the-nation primary in New Hampshire, it appears more likely than ever before that the 2024 presidential election will be a rerun of 2020: Joe Biden versus Donald Trump. And health is shaping up to be a key issue.
Trump is vowing — again — to repeal the Affordable Care Act, which is even more popular than it was when Republicans failed to muster the congressional votes to kill it in 2017. Biden is doubling down on support for contraception and abortion rights.
And both are expected to highlight efforts to rein in the cost of prescription drugs.
This week’s panelists are Julie Rovner of KFF Health News, Alice Miranda Ollstein of Politico, Anna Edney of Bloomberg News, and Jessie Hellmann of CQ Roll Call.
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Alice Miranda Ollstein
Politico
Anna Edney
Bloomberg
Jessie Hellmann
CQ Roll Call
Among the takeaways from this week’s episode:
- Trump had a strong showing in the New Hampshire GOP primary. But Biden may be gathering momentum himself from an unexpected source: Drug industry lawsuits challenging his administration’s Medicare price negotiation plan could draw attention to Biden’s efforts to combat rising prescription drug prices, a major pocketbook issue for many voters.
- Biden’s drug pricing efforts also include using the government’s so-called march-in rights on pharmaceuticals, which could allow the government to lower prices on certain drugs — it’s unclear which ones. Meanwhile, Sen. Bernie Sanders of Vermont is calling on his committee to subpoena the CEOS of two drugmakers in the latest example of lawmakers summoning Big Pharma executives to the Hill to answer for high prices.
- More than a year after the Supreme Court overturned the constitutional right to an abortion, abortion opponents gathered in Washington, D.C., for the March for Life rally, looking now to continue to advance their priorities under a future conservative presidency.
- One avenue that abortion opponents are eying is the 19th-century Comstock Act, which could not only prohibit the mailing of abortion pills to patients, but also prevent them from being mailed to clinics and medical facilities. Considering the abortion pill is now used in more than half of abortions nationwide, it would amount to a fairly sweeping ban.
- And state legislators continue to push more restrictive abortion laws, targeting care for minors and rape exceptions in particular. The ongoing quest to winnow access to the procedure amid public reservations reflected in polling and ballot initiatives highlights that, for at least some abortion opponents, fetuses are framed as an oppressed minority whose rights should not be subject to a majority vote.
Also this week, Rovner interviews Sarah Somers, legal director of the National Health Law Program, about the potential effects on federal health programs if the Supreme Court overturns a 40-year-old precedent established in the case Chevron USA v. Natural Resources Defense Council.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: Health Affairs’ “‘Housing First’ Increased Psychiatric Care Office Visits and Prescriptions While Reducing Emergency Visits,” by Devlin Hanson and Sarah Gillespie.
Alice Miranda Ollstein: Stat’s “The White House Has a Pharmacy — And It Was a Mess, a New Investigation Found,” by Brittany Trang.
Anna Edney: The New Yorker’s “What Would It Mean for Scientists to Listen to Patients?” by Rachael Bedard.
Jessie Hellmann: North Carolina Health News’ “Congenital Syphilis — An Ancient Scourge — Claimed the Lives of Eight NC Babies Last Year,” by Jennifer Fernandez.
Also mentioned on this week’s podcast:
Stat’s “Pharma’s Attack on Medicare Drug Price Negotiation Might Benefit Biden,” by John Wilkerson.
click to open the transcript
Transcript: Health Enters the Presidential Race
KFF Health News’ ‘What the Health?’Episode Title: Health Enters the Presidential RaceEpisode Number: 331Published: Jan. 25, 2024
[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.]
Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Jan. 25, at 10 a.m. As always, news happens fast, and things might’ve changed by the time you hear this. So here we go. We are joined today via video conference by Alice Miranda Ollstein of Politico.
Alice Miranda Ollstein: Good morning.
Rovner: Jessie Hellmann of CQ Roll Call.
Jessie Hellmann: Hi there.
Rovner: And Anna Edney of Bloomberg News.
Anna Edney: Hello.
Rovner: Later in this episode we’ll have my interview with Sarah Somers of the National Health Law Program. She’s going to explain what’s at risk for health care if the Supreme Court overturns the Chevron doctrine, and if you don’t know what that is, you will. But first, this week’s news. We’re going to start this week with politics. To absolutely no one’s surprise, Donald Trump won the first-in-the-nation New Hampshire primary, and even though he wasn’t even on the ballot, because Democrats no longer count New Hampshire as first, President [Joe] Biden handily won a write-in campaign.
Since it seems very likely at this point that the November ballot will pit Trump versus Biden once again, I thought we’d look, briefly at least, at both of their health agendas for now. Trump has once again vowed to try and repeal the Affordable Care Act, which not only didn’t go well in 2017, we learned this week that the federal marketplace enrolled a record 21.3 million people for this year. In 2017, that number was 12.2 million. Not to mention there are now a half a dozen more states that have expanded Medicaid to low-income childless adults.
So with so many more millions of Americans getting coverage via Obamacare, even if Trump wants to repeal and replace it, is there any chance Republicans would go along, even if he wins back majorities in the House and the Senate? They have seemed rather unwilling to reopen this box of worms.
Edney: I mean, certainly, I think that currently they’re unwilling. I don’t want to pretend that I know what the next several months will hold until November, but even before they’re willing or not, what would the plan be? We never saw one, and I don’t anticipate there would be any sort of real plan, particularly if it’s the Trump White House itself having to put the plan together to repeal Obamacare.
Rovner: Yes. How many times did he promise that “we’ll have a plan in two weeks” throughout most of his administration? Alice, you were saying?
Ollstein: Yes. I think what we should be thinking about, too, is this can happen not through Congress. There’s a lot of President Trump could do theoretically through the executive branch, not to repeal Obamacare, but to undermine it and make it work worse. They could slash outreach funding, they could let the enhanced tax credit subsidies expire — they’re set to expire next year. That would also be on Congress. But a president who is opposed to it could have a role in that; they could slash call center assistance. They could do a lot. So I think we should be thinking not only about could a bill get through Congress, but also what could happen at all of the federal agencies.
Rovner: And we should point out that we know that he could do some of these things because he did them in his first term.
Ollstein: He did them the first time, and they had an impact. The uninsured rate went up for the first time under Trump’s first term, for the first time since Obamacare went into effect. So it can really make a difference.
Rovner: And then it obviously went down again. But that was partly because Congress added these extra subsidies and even the Republican Congress required people to stay on Medicaid during the pandemic. Well, I know elsewhere, like on abortion, Trump has been all over the place, both since he was in office and then since he left office. And then now, Alice, do we have any idea where he is on this whole very sensitive abortion issue?
Ollstein: He has been doing something very interesting recently, which is he’s sort of running the primary message and the general message at the same time. So we’re used to politicians saying one thing to a primary audience. These are the hard-core conservatives who turn out in primaries and they want to hear abortion is going to be restricted. And then the general audience — look at how all of these states have been voting — they don’t want to hear that. They want to hear a more moderate message and so Trump has been sort of giving both at once. He’s both taking credit for appointing the Supreme Court justices, who overturned Roe v. Wade. He has said that he is pro-life, blah, blah, blah. But he has also criticized the anti-abortion movement for going too far in his view. He criticized Ron DeSantis’ six-week ban for going too far. He has said that any restrictions need to have exemptions for rape and incest, which not everyone in the movement agrees with. A lot of people disagree with that in the anti-abortion movement. And so it has been all over the place.
But his campaign is in close contact with a lot of these groups and the groups are confident that he would do what they want. So I think that you have this interesting tension right now where he is saying multiple mixed messages.
Rovner: Which he always does, and which he seems to somehow get away with. And again, just like with the ACA, we know that all of these things that he could do just from the executive branch about reproductive health, because he did them when he was president the first time. Meanwhile, President Biden, in addition to taking a victory lap on the Affordable Care Act enrollment, is doubling down on abortion and contraception, which is pretty hard because, first, as executive, he doesn’t have a ton of power to expand abortion rights the way Trump would actually have a lot of power to contract them.
And, also, because as we know, Biden is personally uncomfortable with this issue. So Alice, how well is this going to work for the Biden administration?
Ollstein: So what was announced is mostly sort of reiterating what is already the law, saying we’re going to do more to educate people about it and crack down on people who are not following it. So this falls into a few different buckets. Part of it is Obamacare’s contraception mandate. There have been lots of investigations showing that a lot of insurers are denying coverage for contraceptives they should be covering or making patients jump through hoops. And so it’s not reaching the people it should be reaching. And so they’re trying to do more on that front.
And then, on the abortion front, this is mostly in this realm of abortions in medical emergencies. They’re trying to educate patients on “you can file this complaint if you are turned away.” Of course, I’m thinking of somebody experiencing a medical emergency and needing abortion and being turned away, and I don’t think “I’m going to file an EMTALA [Emergency Medical Treatment and Active Labor Act] complaint with the federal government and hope that they do something” is maybe the first thing on their mind. But the new executive order also includes education for providers and hospitals on their obligations.
This is also something a Trump administration could completely change. They could come in and say, “Forget that guidance. Here’s our guidance, which is no abortions in these circumstances.” So this is a really sensitive issue, but I think that the Biden campaign has seen how people have been voting over the last two years and feels that this is a really good message for them to do something on.
Rovner: Meanwhile, one issue both Republicans and Democrats are trying to campaign on is bringing down the cost of prescription drugs. Stat News has a story this week suggesting that all the lawsuits against the Medicare drug negotiation program could actually help Biden with voters because it shows he’s going after Big Pharma. Frankly, it could also tell voters that the Biden administration actually did something to challenge Big Pharma. Polls show most people have no idea, but Trump can point to lots of lawsuits over things he tried to do to Big Pharma.
Does one or the other of them have an advantage here, Anna? I mean, I know they’re going in different directions, but when you sort of boil it into campaign-speak, it’s going to sound pretty similar, right?
Edney: I think that that’s true, but one of the differences is, at least currently, what Biden’s done and doing some price negotiation through Medicare so far for 10 drugs under his administration is going forward. And you can name the drugs, name the prices, talk about it a little bit more specifically. What Trump ran up against was the lawsuits not falling in his favor. So he wanted more transparency as far as the drug companies having to say the price of their drugs in TV ads, and that wasn’t able to happen. And also reference pricing, so that the prices would be benchmarked to other countries. And certainly that never went forward either. And Trump really used the going after pharma hard in the last campaign, I would say, in 2016. And it worked in the beginning, and you would see the stock of these companies start going down the second he said pharmaceutical companies are getting away with murder or whatever big comment he was making. But it eventually lost any real effect because there didn’t seem to be plans to do anything drastic.
He talked about potentially doing negotiation, like is happening currently, but then that never came to fruition once he was in office. So I don’t know if that will come across to voters, but certainly the pharma industry doesn’t seem to be as afraid of Trump as what Biden’s doing right now.
Rovner: Jessie, I know Congress is still working on this PBM [pharmacy benefit managers] transparency, big bill. Are we getting any closer to anything? I think members of Congress would also like to run on being able to say they’ve done something about prescription drug prices.
Hellmann: I was just talking to [Sen.] Chuck Grassley [R-Iowa] about this because he is the “OG PBM hater.” And he was like, “Why is nothing happening?” He was just very frustrated. There are several bills that have passed House and Senate committees, and so I think, at this point, it’s just a matter of cobbling them all together, finding ways to pay for things. And since there’s also so many other health care things that people want to get done, it’s a matter of “Do we have enough money to pay for everything? What’s going to save money? What’s going to cost money?”
There’s also these health care transparency measures that Congress is looking at. There’s this site-neutral hospital payments thing that could be a money saver. So I think there’s just a lot going on in trying to figure out how it all fits together. But PBMs, I could definitely see them doing something this year.
Rovner: Sometimes, I mean, often it’s like you can’t get things onto the agenda. In this case, it sounds like there’s lots of things on the agenda, but they’re going to need to pay for all of them and they’re going to fight over the few places where they could presumably get some savings.
Edney: I was going to say, I saw that Grassley and some other senators wrote the Federal Trade Commission because they are due for a report on PBMs they’ve been working on for about a year and a half. And I think that the senators who want to go after PBMs are kind of looking for that sort of backup and that deep dive into the industry to make those statements about cost savings and what this would do for pharmaceutical prices.
Rovner: Well, to ratchet this up one more step, the Biden administration has proposed a framework for when march-in rights might be used. Is this the real deal or a threat to get pharma to back down on complaints about the Medicare price negotiations? Anna, why don’t you explain what march-in rights are?
Edney: March-in rights, which have never been used on a pharmaceutical company, were something that were put into law — I think it was around 1980 with the Bayh-Dole Act — and what it allows the government to do is say we invested a ton of money, either through giving money to university research or in the company itself, to do the very basic science that got us to this breakthrough that then the company took across the finish line to get a drug on the market. But usually, I think the main reason you might use it is because then the company does nothing with it.
Say they bought it up and it could be a competitor to one of their drugs, so they don’t use it. But it seems like it could also be used if the price is prohibitive, that it’s something that’s really needed, but Americans aren’t getting access to it. And so the government would be able to take that patent back and lower the price on the drug. But I haven’t heard a specific drug that they want to use this on. So I don’t know if they’re serious about using the march-in rights.
There is a request for information to find out how people feel about this, how it might affect the industry. The argument being that it could hamper the innovation, but we hear that a lot from the pharmaceutical industry as well. So unclear if that’s a true defense to not using march-in rights.
Rovner: Although march-in rights are a pretty big gun. There’s a reason they’ve never been used. I’ve seen them … lawmakers sometimes trot it out kind of as a cudgel, but I’ve never … the only time I think I saw them come close was after the anthrax scare, right after 9/11, when there was potentially a shortage of the important antibiotic needed for that. There was muttering about this, but then I think the drug company decided on its own to lower the price, which got us over that.
Well, yet another tack is being pursued by Sen. Bernie Sanders, chairman of the Senate Health Committee. He’s going to make the committee vote next week on whether to subpoena the CEOs of Johnson & Johnson and Merck to require them to “provide testimony about why their companies charge substantially higher prices for medicine in the U.S. compared to other countries.” Well, we all know the answer to that. Other countries have price controls and the U.S. does not. So is this a stunt or not? And is he even going to get the rest of the committee to go along with the subpoena?
Edney: This wouldn’t be the first hearing on high drug prices pulling in CEOs. And it’s so opaque that you never get an answer. You never get something … I mean, certainly, they’ll blame PBMs and talk about that, and the finger-pointing will go somewhere else, but you never have some aha insight moment. So when the CEOs are coming in, it does feel a bit more like a show. And Bernie Sanders, the ones he wants to subpoena are from companies that are suing the Biden administration.
So there’s talk about whether that’s sort of a bit of a revenge him for that as well. I don’t know what exactly he would expect to hear from them that would change policy or what legislation they’re trying to work out by having this hearing.
Rovner: For an issue that everybody cares about, high drug prices. It sure has been hard to figure out a way into it for politicians.
Ollstein: We have seen public shaming, even without legislation behind it, can have a difference. I think we’ve seen that on the insulin front. And so I think it’s not completely a fool’s errand here, what Bernie’s trying to do. It will be interesting to see if the rest of the committee goes along with it. There’s been some tensions on the committee. There’s been bipartisan support for some of his efforts, and then others — less on the health front, I think more on the labor front — you’ve had a lot of pushback from the Republican members, and so it’ll be very telling.
Rovner: I was actually in the room when the tobacco industry CEOs came to testify at the House Energy and Commerce Committee, and that was pretty dramatic, but I feel like that was a very different kind of atmosphere than this is. I know everybody’s been trying to repeat that moment for — what is it? — 25, 30 years now. It was in the early 1990s, and I don’t think anybody really successfully has, but they’re going to keep at it.
All right, well, let us turn to abortion. Last Saturday would have been the 51st anniversary of Roe v. Wade, and the day before was the annual March for Life, the giant annual anti-abortion demonstration that used to be a march to the Supreme Court to urge the justices to overrule Roe. Well, that mission has been accomplished. So now what are their priorities, Alice?
Ollstein: Lots of things. And a lot of the effort right now is going towards laying the groundwork, making plans for a potential second Trump administration or a future conservative president. They see not that much hope on the federal level for their efforts currently, with the current president and Congress, but they are trying to do the prep work for the future. They want a future president to roll back everything Biden has done to expand abortion access. That includes the policies for veterans and military service members. That includes wider access to abortion pills through the mail and dispensing at retail pharmacies, all of that.
So they want to scrap all of that, but they also want to go a lot further and are exploring ways to use a lot of different agencies and rules and bureaucratic methods and funding mechanisms to do this, because they’re not confident in passing a bill through Congress. We’ve seen Congress not able to do that even under one-party rule in either direction. And so they’re really looking at the courts, which are a lot more conservative than they were several years ago.
Rovner: Largely thanks to Trump.
Ollstein: Exactly, exactly. So the courts, the executive branch, and then, of course, more efforts at the state level, which I know we’re going to get into.
Rovner: We are. Before that, though, one of the things that keeps coming up in discussions about the anti-abortion agenda is something called the Comstock Act. We have talked about this before, although it’s been a while, but this is an 1873 law, which is still on the books, although largely unenforced, that banned the mailing of anything that could be used to aid in an abortion, among other things. Could an anti-abortion administration really use Comstock to basically outlaw abortion nationwide?
I mean, even things that are used for surgical abortion tend to come through … it’s not just the mail, it’s the mail or FedEx or UPS, common carrier.
Ollstein: Yes. So this is getting a lot more attention now and it is something anti-abortion groups are absolutely calling for, and people should know that this wouldn’t only prohibit the mailing of abortion pills to individual patients’ homes, which is increasingly happening now. This would prevent it from being mailed to clinics and medical facilities. The mail is the mail. And so because abortion medication is used in more than half of all abortions nationwide, it could be a fairly sweeping ban.
And so the Biden administration put out a memo from the Justice Department saying, “Our interpretation of the Comstock Act is that it does not prohibit the mailing of abortion pills.” The Trump administration or whoever could come in and say, “We disagree. Our interpretation is that it does.” Now, how they would actually enforce it is a big question. Are you going to search everyone’s mail in the country? Are you going to choose a couple of people and make an example out of them?
That’s what happened under the original Comstock Act. Back in the day, they went after a few high-profile abortion rights activists and made an example out of them. I think nailing them down on how it would be enforced is key here. And of course there would be tons of legal challenges and battles no matter what.
Rovner: Absolutely. Well, let us turn to the states. It’s January, which is kind of “unveil your bills” time in state legislatures, and they are piling up. In Tennessee, there’s a bill that would create a Class C felony, calling for up to 15 years in prison, for an adult who “recruits, harbors or transports a pregnant minor out of state for an abortion.” There’s a similar bill in Oklahoma, although violators there would only be subject to five years in prison.
Meanwhile, in Iowa, Republican lawmakers who are writing guidelines for how to implement that state’s six-week ban, which is not currently in effect, pending a court ruling, said that the rape exception could only be used if the rape is “prosecutable,” without defining that word. Are these state lawmakers just failing to read the room or do they think they are representing what their voters want?
Edney: I don’t really know. I think clearly there are a lot of right-wing Republicans who are elected to office and feel that they have a higher calling that doesn’t necessarily reflect what their constituents may or may not want, but more is that they know better. And I think that that could be some of this, because certainly the anti-abortion bills or movements have been rejected by voters in places you might not exactly expect it.
Rovner: It feels like we’re getting more and more really “out there” ideas on the anti-abortion side at the same time that we’re getting more and more ballot measures of voters in both parties wanting to protect abortion rights, at least to some extent.
Ollstein: And I think going off what Anna said, I think that anti-abortion leaders, including lawmakers, are being more upfront now, saying that they don’t believe that this should be something that the democratic process has a voice in. The framing they use is that fetuses are an oppressed minority and their rights should not be subject to a majority vote. That’s their framing, and they’re being very upfront saying that these kinds of ballot referendums shouldn’t be allowed, and that states that do allow them should get rid of that. We’ll see if that happens. There are obviously lots of attempts to thwart specific state efforts to put abortion on the ballot. There are lawsuits pending in Nevada and Florida. There are attempts to raise the signature threshold, raise the vote threshold, just make it harder to do overall. But I found it very interesting and a pretty recent development that folks are coming out and saying the quiet part out loud. Saying, “We don’t believe The People should be able to decide this.”
Rovner: Well, obviously not an issue that is going away anytime soon. All right, well that is this week’s news. Now we will play my interview with Sarah Somers, and then we will come back and do our extra credits.
I am pleased to welcome to the podcast Sarah Somers, legal director of the National Health Law Program. She’s going to explain, in English hopefully, what’s at stake in the big case the Supreme Court heard earlier this month about herring fishing. Sarah, welcome to “What the Health?”
Sarah Somers: Thank you for having me, Julie. I’m glad to be here.
Rovner: So this case, and I know it’s actually two cases together, is really about much more than herring fishing, right? It seems to be about government regulation writ large.
Somers: That’s right. The particular issue in the case is about a national marine fisheries regulation that requires herring fishing companies to pay for observers who are on board — not exactly an issue that’s keeping everyone but herring fishermen up at night. And the fishing company challenged the rule, saying that it wasn’t a reasonable interpretation of the statute. But what they also asked the court to do was to overrule a Supreme Court case that requires courts to defer to reasonable agency interpretations of federal statutes. That’s what’s known as “Chevron deference.”
Rovner: And what is Chevron deference and why is it named after an oil company?
Somers: Why aren’t we talking about oil now? Yes, Chevron deference is the rule that says that courts have to defer to a reasonable agency interpretation of a federal statute. So, under Chevron, there’s supposed to be a two-step process when considering whether, say, a regulation is a reasonable interpretation. They say, “Does the statute speak directly to it?” So in this case, did the statute talk about whether you have to pay for observers on herring boats? It didn’t.
So the next question was, if it doesn’t speak directly to it or if it’s ambiguous or unclear, then the court should defer to a reasonable interpretation of that statute. And what’s reasonable depends on what the court determines are sort of the bounds of the statute, whether the agency had evidence before it that supported it, whether it showed the proper deliberation and expertise.
Rovner: One of the reasons that regulations are sometimes 200 pages long, right?
Somers: Exactly. And sometimes courts do say, “You know what? The statute spoke right to this. We don’t have to go any further. We know what Congress wanted.” Other times they take a step further. And the reason it’s called Chevron is it’s named after a case that was decided 40 years ago in 1984 during the Reagan administration, and it was Chevron Inc. USA v. the Natural Resources Defense Council. That case was about a regulation interpreting the Clean Air Act and about regulating air pollution.
Rovner: So, as you point out, you helped write one of the amicus briefs in the case about what overturning Chevron would mean for health care. It’s not just about herring fishing and Clean Air Act. Can you give us the CliffsNotes version of what it would mean for health care?
Somers: One of the purposes of our amicus brief was just to give another angle on this, because we were talking a lot about regulations in the context of air pollution, clean water, and the environment, but it touches so many other things, and this is just one aspect of it. So this brief, which we authored along with the American Cancer Society Action Network, and a Boston law firm called Anderson Kreiger, was signed by other health-oriented groups: the American Lung Association, American Heart Association, Campaign for Tobacco-Free [Kids], and then the American Academy of Pediatrics, American Academy of Public Health.
You get the picture. These are all groups that have a vested interest in programs of the Department and Health and Human Services. The brief talks about regulations promulgated by the Centers for Medicare & Medicaid Services. I’m going to call them CMS for short when we’re talking. And CMS is responsible for regulating the vast and complex Medicare and Medicaid programs. And, as you know, Medicare and Medicaid cover more than half of the population and touch the lives of almost everyone, regulating hospitals, some aspects of insurance, some aspects of practice of medicine.
You can’t escape the consequences of problems with these programs. And so that’s why the agency … Congress specifically gave HHS and CMS the power to regulate all of the issues in its purview. So that already have the power, and so the question is whether they use it wisely. We are arguing in this brief that for 40 years it’s worked just fine. That Congress has set the outer limits and been content to let the agency determine the specifics of these programs to fill in the gaps, as one Supreme Court case said. And this has implications for how hospitals operate, how insurance programs operate, and whether they operate smoothly.
And in our brief, we’re not really arguing for or against a particular interpretation or either for or against what the agency says. It’s just a matter of stability and certainty. The agency has the expertise, has the time, has the resources, and has the duty to figure out what these particular terms and statutes mean and how the programs should work. Just two examples we gave in the brief of the kind of issues that the agency should be determining are: What’s the definition of geographic area in the Medicaid Act for the purpose of setting hospital wages?
If your listeners are still listening, I hope, because that is boring, arcane, hyper-technical, and courts don’t have the expertise, much less the time, to do that. And CMS does. Or another question in a different area, whether feeding activities in a nursing home regulated by Medicaid: Are those nursing or nursing related services? The court’s not going to know. The courts doesn’t have expertise or time. And again, that’s what CMS is for.
So not only is this something that you need these interpretations in these rules to have the programs operate smoothly and consistently, and that’s the first part that’s important. But the second part is that you need consistency across the country. As you know well, there are hospital systems that operate across multi-states. There are Medicaid managed-care plans operating across multi-states. All aspects of health care is nationalized. If you have hundreds of district courts and courts of appeals coming up with different interpretations of these terms, you’re going to have a lot of problems. It’s not going to operate smoothly. So I heard some of the justices arguing, “Well, Congress just needs to do its job.”
Congress has obstacles to doing even the big, mega issues that are before them, these kinds of arcane specific issues. They don’t have the time or again, the expertise. That’s why they said, “CMS, you go do this.”
Rovner: When they were writing the Affordable Care Act, there were so many times in that legislation where it says, “The secretary shall” or “The secretary may.” It’s like, we’re going to punt all this technical stuff to HHS and let them do what they will.
Somers: Exactly. You figure out what the definition of a preventive service is, that’s not something that we are going to do. And there are also questions raised about is this … these unelected agency personnel, well, agencies — they are political appointees, and they also serve at the pleasure of the head of the agency. So they’re accountable to the executive branch and indirectly to the voters. The courts, at this point, once they’re on the court and the federal courts, they’re not accountable to the voters anymore. And so this would be a big shift of power towards the courts, and that is what we argued would be antithetical to the system working well.
Rovner: What would be an example of something that could get hung up in the absence of Chevron?
Somers: I thought that Justice [Ketanji Brown] Jackson, during the argument, gave a really good example. Under the Food and Drug Administration’s power to regulate new drugs and determining what is an adequate and well-controlled investigation. The idea of courts, every single drug that’s challenged in every single forum, having to delve into what that means without deference to the agency would be just a recipe for chaos, really.
Rovner: So some people have argued that Chevron is already basically gone, as far as the Supreme Court is concerned, that it’s been replaced by the major questions doctrine, which is kind of what it sounds like. If a judge thinks a question is major, and they will assume that the Congress has not delegated it to the agency to interpret. So what difference would it make if the court formally overturned Chevron or not here? I guess what you’re getting at is that we’re more worried about the lower courts at this point than the Supreme Court, right?
Somers: That’s right. The Supreme Court has not cited Chevron in something like 15 years. And they talked about that in the argument, but it’s for the lower courts. The lower courts still follow it. It is still very commonly cited and gives them a lot of guidance not to have to decide these issues in the first instance. It’s true that the major questions doctrine — and there are other threats to the power of the administrative agencies, and we should all be concerned about them. But this one is really the grease that keeps the machine going and keeps these systems going. And throwing all that up in the air would make a big difference. If only because the question in all of these Chevron cases, and so many of them was not the ultimate issue — about whether the regulation was a good policy — but the question was, was the statute ambiguous or not? And so that’s the part that would be up in the air and everyone can go back and re-litigate these, including the big interests that have a lot of time and resources to devote to litigation. And that would cause a great deal of uncertainty, a lot of disruption, and a lot of problem for the courts and for all the entities that function under these systems.
Rovner: And that’s a really important point. It’s not just going forward. People who are unhappy with what a regulation said could go back, right?
Somers: Oh yeah. They could go back. They could go to different courts. We’ve seen how litigants can forum-shop. They can find a judge that they think is going to be sympathetic to their argument and make a determination that affects the whole country.
Rovner: Well, we will be watching. Sarah Somers, thanks so much for joining us.
Somers: My pleasure. Thank you for having me.
Rovner: We are back, and it’s time for our extra-credit segment. That’s when we each recommend a story we read this week we think you should read, too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Jessie, you were the first to join in this week. Why don’t you tell us about your extra credit?
Hellmann: Yeah. Mine is from North Carolina Health News. They wrote about how congenital syphilis is killing babies in the state. They had eight cases of deaths last year — compared to a decade ago, they had one. So it’s something that’s been on the rise in North Carolina, but also nationwide, and it’s caused a lot of alarm among public health officials because it’s pretty preventable. It’s something that doesn’t need to happen, but the story is about what the state is doing to improve their outreach to pregnant people. They’re doing media campaigns, they’re trying to make sure that people are doing their prenatal care and just trying to stop this from happening. So I thought that was a good story. It’s definitely kind of an under-reported issue. It’s something that public health officials have been raising an alarm about for a while now, but there’s just not enough funding or attention on the issue.
Rovner: For all the arguing about abortion, there’s not been a lot of discussion about maternal and child health, which obviously appears to be the one place that both sides agree on. Anna.
Edney: Mine’s in The New Yorker by Rachael Bedard. It’s “What Would It Mean for Scientists to Listen to Patients?” And it’s interesting, it’s about two Yale researchers who are doing a long-covid study, but it’s unique in the sense that when the CDC or anyone else does a long-covid study, they typically are trying to say, “Here are the exact symptoms. We’re going to work with 12 of them.” Whereas we know long covid, it’s seemingly a much more expansive symptom list than that, but researchers really like to have kind of metrics to go by.
But what these Yale researchers are doing is letting all of that go and just letting anybody in this and talking to them. They’re holding monthly town halls with people who are in this, whoever wants to show up and come and just talk to them about what’s going on with them and trying to find out, obviously, what could help them. But they’re not giving medical advice during these, but just listening. And it just was so novel, and maybe it shouldn’t be, but I found it fascinating to read about and to get their reactions. And it’s not always easy for them. I mean, the patients get upset and want something to happen faster, but just that somebody is out there doing this research and including anybody who feels like they have long covid. It was really well-written too.
Rovner: It’s a really good story. Alice.
Ollstein: So I’m breaking my streak of extremely depressing, grim stories and sharing kind of a funny one, although it could have some serious implications. This is from Stat, and it’s from an inspector general report about how the White House pharmacy, which is run by basically the military, functioned under President Trump. And it functioned like sort of a frat house. There was no official medical personnel in charge of handing out the medications, and they were sort of handed out to whoever wanted them, including people who shouldn’t have been getting them. People were just rifling through bins of medications and taking what they wanted. These included pills like Ambien and Provigil, sort of uppers and downers in the common parlance. And so I think this kind of scrutiny on something that I didn’t even know existed. The White House pharmacy is pretty fascinating.
Rovner: It was a really, really interesting story. Well, I also have something relatively hopeful. My extra credit this week is a journal article from Health Affairs with the not-so-catchy headline “‘Housing First’ Increased Psychiatric Care Office Visits and Prescriptions While Reducing Emergency Visits,” by Devlin Hanson and Sarah Gillespie. And if they will forgive me, I would rename it, calling it maybe “Prioritizing Permanent Housing for Homeless People Provides Them a Better Quality of Life at Potentially Less Cost to the Public.”
It’s about a “Housing First” experiment in Denver, which found that the group that was given supportive housing was more likely to receive outpatient care and medications and less likely to end up in the emergency room. The results weren’t perfect. There was no difference in mortality between the groups that got supportive housing and the groups that didn’t. But it does add to the body of evidence about the use of so-called social determinants of health, and how medicine alone isn’t the answer to a lot of our social and public health ills.
OK. That is our show. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks as always to our technical guru, Francis Ying, and our editor, Emmarie Huetteman. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X, @jrovner, or @julierovner at Bluesky or @julie.rovner at Threads. Anna, where are you these days?
Edney: Mostly just on Threads, so @anna_edneyreports.
Rovner: Alice?
Ollstein: @AliceOllstein.
Rovner: Jessie.
Hellmann: @jessiehellmann on Twitter.
Rovner: We will be back in your feed next week. Until then, be healthy.
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KFF Health News' 'What the Health?': 2023 Is a Wrap
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Julie Rovner
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Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.
Even without covid dominating the headlines, 2023 was a busy year for health policy. The ever-rising cost of health care remained an issue plaguing patients and policymakers alike, while millions of Americans lost insurance coverage as states redetermined eligibility for their Medicaid programs in the wake of the public health emergency.
Meanwhile, women experiencing pregnancy complications continue to get caught up in the ongoing abortion debate, with both women and their doctors potentially facing prison time in some cases.
This week’s panelists are Julie Rovner of KFF Health News, Rachel Cohrs of Stat, Sandhya Raman of CQ Roll Call, and Joanne Kenen of Johns Hopkins University and Politico Magazine.
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Rachel Cohrs
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Joanne Kenen
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Sandhya Raman
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Among the takeaways from this week’s episode:
- As the next election year fast approaches, the Biden administration is touting how much it has accomplished in health care. Whether the voting public is paying attention is a different story. Affordable Care Act enrollment has reached record levels due in part to expanded financial help available to pay premiums, and the administration is also pointing to its enforcement efforts to rein in high drug prices.
- The federal government is adding staff to go after “corporate greed” in health care, targeting in particular the fast-growing role of private equity. The complicated, opaque, and evolving nature of corporate ownership in the nation’s health system makes legislation and regulation a challenge. But increased interest and oversight could lead to a better understanding of the problems of and, eventually, remedies for a profit-focused system of health care.
- Concluding a year that saw many low-income Americans lose insurance coverage as states reviewed eligibility for everyone in the Medicaid program, there’s no shortage of access issues left to tackle. The Biden administration is urging states to take action to help millions of children regain coverage that was stripped from them.
- Also, many patients are all too familiar with the challenges of obtaining insurance approval for care. There is support in Congress to scrutinize and rein in the use of algorithms to deny care to Medicare Advantage patients based on broad comparisons rather than individual patient circumstances.
- And in abortion news, some conservative states are trying to block efforts to put abortion on the ballot next year — a tactic some used in the past against Medicaid expansion.
- This week in health misinformation is an ad from Florida’s All Family Pharmacy touting the benefits of ivermectin for treating covid-19. (Rigorous scientific studies have found that the antibacterial drug does not work against covid and should not be used for that purpose.)
Also this week, Rovner interviews KFF Health News’ Jordan Rau about his joint KFF Health News-New York Times series “Dying Broke.”
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: Business Insider’s “‘I Feel Conned Into Keeping This Baby,’” by Bethany Dawson, Louise Ridley, and Sarah Posner.
Joanne Kenen: The Trace’s “Chicago Shooting Survivors, in Their Own Words,” by Justin Agrelo.
Rachel Cohrs: ProPublica’s “Doctors With Histories of Big Malpractice Settlements Work for Insurers, Deciding if They’ll Pay for Care,” by Patrick Rucker, The Capitol Forum; and David Armstrong and Doris Burke, ProPublica.
Sandhya Raman: Roll Call’s “Mississippi Community Workers Battle Maternal Mortality Crisis,” by Lauren Clason.
Also mentioned in this week’s episode:
- Stat News’ “Humana Used Algorithm in ‘Fraudulent Scheme’ to Deny Care to Medicare Advantage Patients, Lawsuit Alleges,” by Casey Ross and Bob Herman.
- USA Today’s “Cigna Denied a Lung Transplant for a Cancer Patient. Insurer Now Says That Was an Eerror.’ By Ken Alltucker.
- Politico’s “Conservatives Move to Keep Abortion off the 2024 Ballot,” by Alice Miranda Ollstein and Megan Messerly.
- The New York Times’ “Why Democracy Hasn’t Settled the Abortion Question,” by Kate Zernike.
click to open the transcript
Transcript: 2023 Is a Wrap
KFF Health News’ ‘What the Health?’Episode Title: 2023 Is a WrapEpisode Number: 327Published: Dec. 21, 2023
[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.]
Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Dec. 21, at 10 a.m. As always, news happens fast and things might’ve changed by the time you hear this, so here we go.
We are joined today via video conference by Joanne Kenen of the Johns Hopkins University and Politico Magazine.
Joanne Kenen: Hi, everybody.
Rovner: Sandhya Raman of CQ Roll Call.
Sandhya Raman: Good morning.
Rovner: And Rachel Cohrs of Stat News.
Rachel Cohrs: Hi.
Rovner: Later in this episode, we’ll have my interview with KFF Health News’ Jordan Rau, co-author of a super scary series done with The New York Times about long-term care. It’s called “Dying Broke.” But first, this week’s news. I thought we would try something a little bit different this week. It just happened that most of this week’s news also illustrates themes that we’ve been following throughout the year. So we get a this-week update plus a little review of the last 12 months, since this is our last podcast of the year. I want to start with the theme of, “The Biden administration has gotten a ton of things done in health, but nobody seems to have noticed.”
We learned this week that, with a month still to go, Affordable Care Act plan sign-ups are already at historic highs, topping 15 million, thanks, at least in part, to extra premium subsidies that the administration helped get past this Congress and which Congress may or may not extend next year. The administration has also managed to score some wins in the battle against high drug prices, which is something that has eluded even previous Democratic administrations. Its latest effort is the unveiling of 48 prescription drugs officially on the naughty list — that’s my phrase, not theirs — for having raised their prices by more than inflation during the last quarter of this year, and whose manufacturers may now have to pay rebates. This is something in addition to the negotiations for the high-priced drugs, right, Rachel?
Cohrs: Yeah, this was just a routine announcement about the drugs that are expected to be charged rebates and drugmakers don’t have to pay immediately; I think they’re kind of pushing that a little further down the road, as to when they’ll actually invoice those rebates. But the announcement raised a question in my mind of — certainly they want to tout that they’re enforcing the law; that’s been a big theme of this year — but it brought up a question for me as to whether the law is working to deter price hikes if these companies are all doing it anyway, so just a thought.
Rovner: It is the first year.
Cohrs: It is. This started going into effect at the end of last year, so it’s been a little over a year, but this is assessed quarterly, so the list has grown as time has gone on. But just a thought. Certainly there’s time for things to play out differently, but that’s at least what we’ve seen so far.
Rovner: They could say, which they did this week, it’s like, Look, these are drugs because they raised the prices, they’re going to have to give back some of that money. At least in theory, they’re going to have to give back some of that money.
Cohrs: In Medicare.
Rovner: Right. In Medicare. Some of this is still in court though, right?
Cohrs: Yes. So I think at any moment, I think this has been a theme of this year and will be carrying into next year, that there are several lawsuits filed by drugmakers, by trade associations, that just have not been resolved yet, and I think some of the cases are close to being fully briefed. So we may see kind of initial court rulings as to whether the law as a whole is constitutional. It is worth noting that most of those lawsuits are solely challenging the negotiation piece of the law and not the inflation rebates, but this could fall apart at any moment. There could be a stay, and I expect that the first court ruling is not going to be the last. There’s going to be a long appeals process. Who knows how long it’s going to take, how high it will go, but I think there is just a lot of uncertainty around the law as a whole.
Rovner: So the administration gets to stand there and say, “We did something about drug prices,” and the drug companies get to stand there and say, “Not yet you didn’t.”
Cohrs: Exactly. Yes, and they can both be correct.
Rovner: That’s basically where we are.
Cohrs: Yes.
Rovner: That’s right. Well, meanwhile, in other news from this week and from this year, the Federal Trade Commission, the Department of Justice, and the Department of Health and Human Services are all adding staff to go after what Biden officials call “corporate greed” — that is their words — in health care. Apparently these new staffers are going to focus on private equity ownership of health care providers, something we have talked about a lot and so-called roll-ups, which we haven’t talked about as much. Somebody explain what a roll-up is please.
Kenen: Julie, why don’t you?
Rovner: OK. I guess I’m going to explain what a roll-up is. I finally learned what a roll-up is. When companies merge and they make a really big company, then the Federal Trade Commission gets to say, “Mmm, you may be too big, and that’s going to hurt trade.” What a roll-up is is when a big company goes and buys a bunch of little companies, so each one doesn’t make it too big, but together they become this enormous — either a hospital system or a nursing home system or something that, again, is not necessarily going to make free trade and price limits by trade happen. So this is something that we have been seeing all year. Can the government really do anything about this? This also feels like sort of a lot of, in theory, they can do these things and in practice it’s really hard.
Cohrs: I feel like what we’ve seen in this space — I think my colleague Brittany wrote about kind of this move — is that the corporate structures around these entities are so complicated. Is it going to discourage companies from doing anything by hiring a couple people? Probably not. But I think the people power behind understanding how these structures work can lay the groundwork for future steps on understanding the landscape, understanding the tactics, and what we see, at least on the congressional side, is that a lot of times Congress is working 10 years behind some of the tactics that these companies are using to build market power and influence prices. So I think the more people power, the better, in terms of understanding what the most current tactics are, but it doesn’t seem like this will have significant immediate difference on these practices.
Kenen: I think that the gap between where the government is and where the industry is is so enormous. I think the role of PE [private equity] in health care has grown so fast in a relatively short period of time. Was there a presence before? Yes, but it’s just really taken off. So I think that if those who advocate for greater oversight, if they could just get some transparency, that would be their win, at the moment. They cannot go in and stop private equity. They would like to get to the point where they could curb abuse or set parameters or however you want to phrase it, and different people would phrase it in different ways, but right now they don’t even really know what’s going on. So, even among the Democrats, there was a fight this year about whether to include transparency language between [the House committees on] Energy and Commerce and Ways and Means, and I don’t think that was ever resolved.
I think that’s part of the “Let’s do it in January” mess. But I think they just sort of want not only greater insight for the government, but also for the public: What is going on here and what are its implications? People who criticize private equity — the defenders can always find some examples of companies that are doing good things. They exist. We all know who the two or three companies we hear all the time are, but I think it’s a really enormous black box, and not only is it a black box, but it’s a black box that’s both growing and shifting, and getting into areas that we didn’t anticipate a few years ago, like ophthalmology. We’ve seen some of these studies this year about specialties that we didn’t think of as PE targets. So it’s a big catch-up for roll-up.
Rovner: Yeah, and I think it’s also another place that the administration — and I think the Trump administration tried to do this too. Republicans don’t love some of these things either. The public complains about high health care costs. They’re right; we have ridiculously high health care costs in this country, much higher than in other countries, and this is one of the reasons why, is that there are companies going in who are looking to simply do it to make a profit and they can go in and buy these things up and raise prices. That’s a lot of what we’re seeing and a lot of why people are so frustrated. I think at very least it at least shows them: It’s like, “See, this is what’s happening, and this is one of the reasons why you’re paying so much.”
Kenen: It’s also changing how providers and practitioners work, and how much autonomy they have and who they work for. It’s in an era when we have workforce shortages in some sectors and burnout and dissatisfaction. There are pockets at least, and again, we don’t really know how big, because we don’t have our arms around this, but there are pockets; at least we do know where the PE ownership and how they dictate practice is worsening these issues of burnout and dissatisfaction. I’m having dinner tomorrow night with a expert on health care antitrust, so if we were doing this next week, I would be so much smarter.
Rovner: We will be sure to call on you in January. Workforce burnout: This is another theme that we’ve talked about a lot this year.
Kenen: It’s getting into places you just wouldn’t think. I was talking to a physical therapist the other day and her firm has been bought up, and it’s changing the way she practices and her ability to make decisions and how often she’s allowed to see a patient.
Rovner: Yeah. Well, another continuing theme. Well, yet another big issue this year has been the so-called Medicaid unwinding, as states redetermine eligibility for the first time since the pandemic began. All year, we’ve been hearing stories about people who are still eligible being dropped from the rolls, either mistakenly or because they failed to file paperwork they may never have received. Among the more common mistakes that states are making is cutting off children’s coverage because their parents are no longer eligible, even though children are eligible for coverage up to much higher family incomes than their parents. So even if the parents aren’t eligible anymore, the children most likely are.
This week, the federal government reached out to the nine states that have the highest rates of discontinuing children’s coverage, including some pretty big states, like Texas and Florida, urging them to use shortcuts that could get those children’s insurance back. But this has been a push-and-pull effort all year between the states and the federal government, with the feds trying not to push too hard. At one point, they wouldn’t even tell us which states they were sort of chiding for taking too many people off too fast. And it feels like some of the states don’t really want to have all these people on Medicaid and they would just as soon drop them even if they might be eligible. Is that kind of where we are?
Raman: You can kind of look to see the tea leaves at what some of these states are. The states that the health secretary wrote to, that have 60% of the decline in the kids being disenrolled, align pretty well with the states that have not expanded Medicaid. So they’re already going to have much fewer people enrolled than states where the eligibility levels are a lot more generous. So it’s not surprising, and some of these states have been just a little bit more aggressive from the get-go or said that they wanted to do the eligibility redeterminations a lot faster than some of the other states that wanted to take the longer time, reevaluate different ways to see if someone was still eligible, whether they were maybe getting SNAP [Supplemental Nutrition Assistance Program] benefits or other things like that. So it’s not surprising.
Rovner: You mean do it more carefully.
Raman: Yeah, yeah, so I think that the letter is one step, but if those states are really going to take up implementing these other strategies to kind of decrease that drop-off, unclear, just because they have been pretty proactive about doing this in a quick process.
Rovner: I also noticed that the states that the HHS secretary wrote to kind of tracked with the states that didn’t expand Medicaid under the Affordable Care Act, but interestingly, that meant that there would’ve been fewer parents who were eligible in the first place. So there shouldn’t have been as many children cut off, because there weren’t as many parents who ever got onto Medicaid in those states, which is why it made me raise my eyebrows a little bit. Again, I think this is something that we shall continue to follow going into next year.
Kenen: But we should also point out that even the more pro-Medicaid, liberal states have not done a great job with unwinding. It’s been bumpy pretty much across the board. It’s been very problematic. It’s a clumsy process in a normal year, and trying to catch up on three years’ worth — this is a population where people’s income varies a lot. Are you just over the line? Are you just under the line? It’s fluctuating, the eligibility changes. But you try to do three years at once after all the chaos, with political undercurrents such as the nonexpansion states, and it makes it harder and messier.
Rovner: Which was predicted and came true. So yet another theme from this year is what I’m calling the managed care backlash redux. In the late 1990s, when lots of people were herded into managed care for the first time, there were lots of horror stories about patients being denied care, doctors being put through bureaucratic hoops, unqualified people making medical decisions. There’s a bipartisan bill that almost came to fruition in 2001 for what was called a patient’s bill of rights, but it was pushed off the agenda by 9/11. Most of the protections in that bill, however, were eventually included in the Affordable Care Act.
So now it’s 2023, and lo and behold, those same issues are back. A top issue for the American Medical Association this year is reining in prior authorization requirements, which require doctors to actually get permission before their patients can get recommended care. In one particularly painful story recently, a woman who’d been approved for a lung transplant had her surgery canceled by her insurer, literally on the way to the OR [operating room]. Later, and not coincidentally after a public outcry, the insurer, Cigna, called the whole thing, quote, “An error.” So she did finally get her lung transplant. Joanne, you covered the patient’s bill of rights fight with me back in the day. Most things that are being complained about now are now illegal. So why are we seeing so much of it again?
Kenen: Because there’s confusion about — patients don’t know what their rights are. All of us are savvy and all of us have had something in our own insurance that we don’t understand, or maybe we end up navigating it, but it’s not ever easy. Things like prior authorization — they say, “Well, we have to make sure people are getting appropriate care.” There is an element of truth there; there is overuse in American health care. There are people who get things they don’t really need or should try something less intrusive and less expensive first. So you have this genuine issue of overtreatment, back surgery being the classic example. Many people will do just as well with physical therapy and things like that than they will with an $80,000 operation. In fact, they might do better with the PT and not with the $80,000 operation.
So is there any validity to the idea of making sure people get appropriate care? Yes, but they say no to stuff that they should be covering. That’s clear, and that patients don’t always know what the right pathway is, because doctors also have incentives, or just the way they’re trained and the way they look at their — surgeons like to cut. It’s what they’re trained to do. They trained for years. So it’s really complicated, because there’s this collision between overuse and overtreatment and overcharging and all the over, over, over stuff that comes from the provider world and the no, no, no, no, no, no, no, “you can’t have that” stuff that comes from the insurer world, sometimes appropriately, but often not appropriately.
Rovner: Then I guess you load onto that the private equity and now the providers whose overlords are in it to make a profit. Then you have sort of private equity butting heads with insurance, which is one of the reasons I think we are sort of ending up here. But it certainly does feel very reminiscent of things that I’ve been through before. We’re seeing yet a similar story with Medicare Advantage, which is the private Medicare managed care program that now enrolls more than half of the Medicare population and makes lots of money for its private insurance companies that offer them.
Rachel, your colleagues wrote about a Humana algorithm that was being used to deny care after a patient had received it for, quote-unquote, “an average period of time, regardless of the patient’s condition,” meaning that if patient is sicker than average, they were saying, “Too bad, we’re only going to give this to you for 18 days because that’s what the average patient needs. If you need more, sorry about that.” So Congress is now trying to get into the act, trying to ensure that Medicare patients, who tend to vote in disproportionate numbers, get their needed care. The insurance industry is pushing back against the pushback. What’s the outlook for Congress actually getting something done on this issue? I’ve heard a lot of talk. I haven’t seen a whole lot of action.
Cohrs: Yeah, I mean certainly there has been talk — and just to point out that the Humana lawsuit is related to the UnitedHealth Group lawsuit that we saw earlier; it’s the same company making the algorithm. Bob and Casey’s reporting was just more focused on UnitedHealth Group, because they got internal documents showing the correlation between the quote-unquote “recommendation” of this algorithm and care decisions and denials and people being cut off from their rehab services. So I think certainly, I think there has been a lot of outcry. We’re seeing this play out in the legal system beforehand. This is an issue that we’ve discussed as well.
Are we going to regulate through the courts, because everything else is too slow? I think AI is certainly a hot topic on the Hill at the moment, and there is lawmaker interest, but this is just a very complicated space. Lawmakers, though they might try their best, are not the most tech-savvy people. These are very powerful interests that I would imagine would oppose some of these regulations if they were to actually materialize. So, there’s nothing imminent. Certainly if we see these lawsuits keep piling up, if we see discovery, if we see some more examples of this happening where other companies are using the algorithms as well, a groundswell — as you mentioned, Medicare patients are an important constituency — I think we could see some action, but it’s not looking imminent at this time.
Kenen: The other thing is there’s been a number of reports from a number of media outlets, Stat and others, that these algorithms are being used without any people to work with them. Like, OK, here’s this algorithm and it’s doing these batches of like, I’m going to say no to 50,000 people in 20 seconds. I’m exaggerating a little bit there, but yes, is there legitimate questions about what is appropriate treatment? Yes.
Or you hear these stories about people told, “You can’t have this drug; you have to have that drug at first,” but they would try that drug and it didn’t work for them, and there’s just no way of — the reason we have five or six similar drugs is that in some cases, those slight differences, people respond differently, mental health being a huge example of that, right? Where it could be very hard to get people on the right drugs, if person A doesn’t respond the same way as person B, even if they have the same condition. But 50,000, I don’t know if that’s the right number, but I think I remember reading one where it was 50,000 going through an algorithm. That’s not appropriate use; that’s mass production of saying no to some legitimate needs.
Rovner: Sandhya, I see you nodding there. I know that this is something that’s kind of bipartisan, right? Members of Congress get complaints about Medicare, which is something that they do, members of Congress, oversee. It is a government program, even though these are being run by private companies. I’m sort of wondering when this is going to reach a boiling point that’s going to require something to be done.
Raman: I think with some of these issues that we face that are kind of evergreen here, there has been a bipartisan push to find kind of ways to reform the prior authorization process. We’ve had people as different as Sen. Elizabeth Warren (D-Mass.) and Sen. Mike Crapo (R-Idaho) say they want reform, or Sen. James Lankford (R-Okla.) is very different from Rep. Pramila Jayapal (D-Wash.), and they’ve both said that, similar things that …
Rovner: Some of the most conservative and the most liberal members of Congress.
Raman: Yeah, so we’ve got a broad stretch, but I think at the same time, if you look at some of the other things that we have to deal with here — Congress is out for the year, but for next year, we are fairly behind in that we have a long list of things that need to be extended by mid-January. Then we have just funding all of HHS and a number of other government things by early February. So getting something from start to finish next year, which is also an election year, is going to be tough. So I think that there’s interest there, but I don’t know that getting something hashed out is going to be the easiest next year of all years.
Rovner: Yeah, I think it’s fair to say that Congress took an incomplete in most subjects this year. Well, finally this week, the topic that I think has been in every podcast this year, which is abortion. One of the threads that has wound through this year’s coverage is the strong support for abortion rights from voters, even in red and red-ish states. This year, Ohio voters affirmed a right to abortion, twice actually; there was a technical vote back in the summer. And in Virginia, Democrats flipped the legislature by running against Republican promises to impose a compromise 15-week ban, which apparently did not seem to be a compromise to most of the voters. That was after a half a dozen states voted in favor of the abortion rights position in the 2022 midterms. So this week we have a pair of stories, one from Politico and one from The New York Times, about how anti-abortion forces are working to keep future abortion-related questions off of the ballot in states where there’s still that possibility, including Florida, Missouri, Arizona, and Nevada.
One Republican Missouri lawmaker said that the right to life, quote, “should not be taken away because of a vote by a simple majority,” which frankly felt a little breathtaking to me. He has filed a bill that would require ballot measures to pass not just statewide, but with a majority in more than half of the state’s congressional districts. So basically in the really red parts of the states, a majority there would also have to vote for this. These people are getting very creative in their attempts to stop these votes from happening, maybe because they don’t think they can win them if it’s just straight up or down.
Raman: I think one thing to look at is kind of how we see some of these similar tactics in the same way that we saw with Medicaid. When Medicaid expansion started winning on different ballots, there were states that tried to put in measures to kind of tamp that down, saying, “You need a higher threshold,” and maybe that doesn’t pass, but still putting in different tactics to reduce the likelihood of that passing. I think that’s kind of what we’ve been seeing here, whether or not it’s Ohio trying to change its threshold, or we’ve had states say that even if something passed, let’s try to tear that back so that it doesn’t actually get implemented, or ahead of the ones for next year, let us find tactics to reduce the likelihood they’ll get the signatures to be on the ballot or reduce the likelihood of it passing by changing the language or pushing for challenging the language.
So there’s kind of what we saw right after the Dobbs decision, which was just a very “throw spaghetti at the wall, see what sticks,” just kind of ramp up things and see what will work, given that the last — all of the elections that we’ve had post-Dobbs have been in the favor of abortion rights. Even when we’ve tried to pass an anti-abortion measure, it’s not passed at the ballot. In the stories that you mentioned, there was another quote that stuck out to me, where they’d also mentioned that maybe this should not be subject to majority vote, I think in the Politico piece as well. So I think that’s something that is interesting that I haven’t really seen vocalized before, that this should be done in a different manner rather than this is how the majority of people feel one way or the other.
Rovner: Yeah, it felt so ironic because when in the Dobbs decision, Justice [Samuel] Alito wrote, “Well, now we’re turning this back to the states to be decided by their voters.” Well, here are their voters deciding, and it turns out the anti-abortion side don’t like the way the voters are voting, so they’re going to try to not have the voters vote, basically. We will see how this one all plays out. The other continuing story this year is women being prosecuted basically for bad pregnancy outcomes. Last week we talked about the case of Brittany Watts, an Ohio woman who was sent home from a hospital emergency room twice, had a miscarriage, and this week had formal charges filed against her for, quote, “abusing a corpse.” This case hasn’t gotten nearly the attention of the case of Kate Cox, the Texas woman whose fetus was diagnosed with fatal defects and who filed suit to be allowed to have an abortion.
She eventually had to go to another state, and that was even before the permission that had been granted by a lower-court judge was overturned by the Texas Supreme Court. It may be at least in part because Brittany Watts is black, or that she didn’t put herself out in public the way Kate Cox did, but this is a way that prosecutors can punish women even in states where abortion remains legal. Remember Ohio voted twice this year to keep abortion legal, and this wasn’t even an abortion; it was a miscarriage. The medical examiner determined that the fetus was already dead when it passed. What are the prosecutors trying to do here? We talk about chilling effects. This is kind of the ultimate chilling effect, right?
Raman: It really is, because here we have someone that was not, as you said, seeking an abortion. She miscarried, and I think that she was 21 weeks and five days pregnant, and then they had the 21-week cutoff. So it gets sent into really murky waters here because I’m not sure what they’re going for, kind of picking this case to prosecute and go with. We’ve had this happen before where people have self-managed or miscarried, and then they’ve ended up being prosecuted. But at this point, I’m not sure why they’re making a case out of this particular woman, kind of dragging this into the debate.
Rovner: Yeah, there was a famous case in Indiana — 2013, may have been even before that — a pregnant woman who tried to kill herself and failed to kill herself, but did kill her fetus, and she was put in jail for several years. There have been, at least there was sort of the question there, were you trying to self-abort at that point? But there was nothing here. This was a woman with a wanted pregnancy whose pregnancy ended via natural circumstances, which happens, I think we’ve discovered now, a lot more than people realize.
I think people don’t talk about unhappy pregnancy outcomes, so people don’t realize how common they actually are. But I wonder — and I’ve been saying this all year — again, if women are fearing prosecution, even women who want babies, they may fear getting pregnant. I’ve seen some stories about more permanent types of birth control happening because women don’t want to get pregnant, because they don’t want to end up in a place where their health is being risked or they’re trying to get health care they need and their doctor or they could be facing prison time.
Kenen: And in this case, she had gone to the hospital. It’s complicated. She went in and out of the hospital. She went to the ER; they sent her home. I think then once they sent her home another time, she left against medical advice, but she wasn’t trying to get an abortion. She was having pregnancy complications. It’s documented. She was in and out of medical care. Pregnancies can fail, and early, the first trimester, it’s a very high rate. It’s less common later on, but it still happens. There are times when an early miscarriage, you might not even know that it’s a miscarriage. It’s early. You don’t know what’s even going on with your own body, or you’re not certain. So she didn’t know what to do at home when she did miscarry. It seems very punitive. Did she behave in an absolutely ideal, textbook-perfect, the way you wish she might have? But she did what she could do at the time.
Rovner: Yeah, it’s hard to know what to do. Well, we will watch this case, I think, even though it’s not, as I say, it’s not getting quite the attention of some of the other cases. Our final this week in health information of 2023 goes to an ad that came to my email from the All Family Pharmacy in Boca Raton, Florida. The headline is “Miracle Drug Ivermectin for Covid-19 Could Save Lives,” and it claims that, quote, “a growing body of evidence from dozens of studies worldwide demonstrates ivermectin’s unique and highly potent ability to inhibit SARS-CoV-2 replication and aid in the recovery from covid-19.”
That sounded not quite right to me, so I looked up some of the studies that they cited and found that most had been thoroughly debunked, that ivermectin is not really good treatment for covid-19. I even found one study from an open-access journal that had to publish a correction, noting that two of its authors were paid consultants to ivermectin manufacturers, though they had failed to disclose that conflict. Meanwhile, if you don’t want ivermectin or hydroxychloroquine, which the All Family Pharmacy also sells, they will also sell you semaglutide, which is the scientific name of the hard-to-get weight loss drug Ozempic. And they say their price even includes a doctor consult. I will post the links in the show notes. All right, that is this week’s news. Now we will play my interview with Jordan Rau about his long-term care financing series. Then we’ll come back with our extra credits.
I am pleased to welcome to the podcast my KFF Health News colleague Jordan Rau. I asked Jordan to join us to talk about his latest project, “Dying Broke,” done in partnership with The New York Times. It’s about the growing expense of long-term care and the declining ability of Americans to pay for it. Jordan, welcome to “What the Health?”
Jordan Rau: Glad to be here, Julie.
Rovner: So I want you to start with the 30-second elevator pitch about what you found working on this, for two years?
Rau: Just about. The big-picture view is that when you’re elderly, if you need long-term care, by which we’re talking about nonmedical things, like personal aides, if you need help in your daily activities going to the bathroom or eating or such, or if you have a cognitive impairment like dementia, it’s exceedingly expensive, except if you are destitute. The private market solutions, which are long-term care insurance, really don’t work, and most people don’t hold it. The government solution, which is Medicaid, is only available to you once you’ve exhausted just about all of your assets and have very low income. And that’s led the vast majority of people out on their own financially to either rely on themselves or their family or other people to take up the burden. And that burden is significant for the children of older people.
Rovner: So it’s not just nursing home care that costs more than all but the richest can afford; assisted living and home care, which people assume are going to be a lot cheaper and that maybe their retirement savings will cover — they’re also increasingly out of reach. Why has the price of long-term care gone up so much faster than Americans’ retirement savings?
Rau: All of medical inflation has gone up enormously, but I think a lot of it is that there’s so little regulation on prices. There’s frankly no regulation on prices of assisted living, and you don’t have a large payer that can control prices. That’s one of the good things about Medicare, is that they set their own prices and that’s helped keep prices down. That’s why it’s less expensive for Medicare to send someone to a nursing home than for someone to pay out-of-pocket. But there’s none of that. So the prices have just gone where they’ve gone, and now you have a scarcity of workers as well. So that’s driving up wages.
Rovner: People who’ve been socking away money and thinking they’re going to be able to pay for this themselves get kind of a rude awakening when they need, and it’s not — as you say, it’s not even medical long-term care; it’s just help with activities of daily living.
Rau: Yeah, yeah, yeah. I think one of the problems is that people assume they have the best-case scenario when they’re envisioning their retirement. They’re going to be off golfing, they’re going to be playing around with their grandkids, they’re going to be taking trips. The fact is, you’re very likely — if you live well into your 80s and 90s, as many people do — to not be able to live independently anymore, to need help with at least a little bit of things, and in worst-case scenario everything. People just don’t expect that that’s going to happen.
Rovner: So why do so many Americans still not know that Medicare doesn’t pay for long-term care? I feel like I’ve been saying this since 1980-something.
Rau: I wonder how much of it would’ve been different if they had decided to name Medicaid something that isn’t so close to Medicare. Maybe that would’ve helped, but realistically, everyone I think has a sense. Well, first of all, who’s paying attention to this stuff when you’re in your 30s and 40s, right? You’re not thinking about what’s going to happen to you in the 60s. And then I think that people just don’t expect that this is going to happen to them, and Medicare has a well-earned reputation as being pretty comprehensive. It doesn’t cover certain things, and there is a “donut hole” situation, so you’ve got to get supplemental. But people know that for the most part, it’s covered. And people don’t understand that long-term care, the nonmedical side, is — not just here, everywhere — it’s the backwater of health care. It’s not even considered health care in some ways.
So you just assume — I mean, I would assume, right, if Medicare is going to cover my heart transplant, why would I not think that it’s going to cover someone to come to my house a couple hours a day to help me with stuff or to put me in an assisted living facility if it covers nursing home care? It’s such a complicated, Byzantine system. You and I, we’ve been doing this probably combined, well, I don’t want to say how long, but it’s been a long time, and it’s hard for us to untangle exactly what is covered and what overlaps with what and what are the eligibility rules. So to expect a regular person, who isn’t paid to do this 50 hours a week, to know it is highly unrealistic.
Rovner: Yeah, and I was going to say the fact that Medicare actually has a home care benefit and it has a nursing home benefit; they’re just super limited. I think that sort of adds to the confusion too, doesn’t it?
Rau: Yeah. Well, even Medicare is confused about its home care benefit, right? There’s the whole Jimmo case and a whole debate about what you need to qualify for it.
Rovner: So listeners will know that long-term care and our country’s complete lack of a long-term care policy is a pet issue of mine and has been since I started writing about it in 1986. It isn’t like the government hasn’t tried to do something. There was the ill-fated Medicare Catastrophic Coverage Act in 1988 that ended up getting repealed. There were efforts to subsidize private long-term care insurance in the 1990s that didn’t really go anywhere, and there was the CLASS [Community Living Assistance Services and Supports] Act that was briefly part of the Affordable Care Act when it passed in 2010, only to be abandoned as financially unfeasible. Why has this been such a hard issue to address from a policy point of view?
Rau: The one-word answer obviously is money. It’s incredibly expensive. So to have that type of lift, it would be to expand either Medicaid or Medicare or to create a new program; would be inordinately expensive. But beyond that, I think basically, to do this, you either have to tag on something to one of those existing programs, which is a major expansion, or you have to have a mandatory insurance program. It could be a public one; it can be a private one. I think that it’s hard because it’s not universal. Auto insurance — everybody drives, right? So if you say, OK, you all know you’re going to drive, and people know like, Oh, I may get into an accident. So then you have a functioning insurance market.
Health insurance, sort of the same thing. Everyone knows that they’re going to need health insurance maybe next year. So that’s an easier sell. Even that, right, with the Affordable Care Act — that passed by just one vote. That was a heavy lift. So here you’re saying, here’s something that you may need but you very well may never tap. By the way, we want you to pay for it now or buy into it now, and it’s not relevant for your life until 30 years. I just think that’s a hard sell politically to the population, to the political system. It’s a hard sell.
Rovner: So if there was just one message that you hope people take away after reading this exhaustive series, what do you think it should be?
Rau: Printing the series out and frame it and put it on your wall would be my main message. But I would say that this stuff is so unpredictable that you really have to have some flexibility in your expectations and planning, because you can’t plan to not get early-onset dementia. You can’t plan to need help. So I think that you need to — people obviously need to have as much of a cash cushion as they can, and they need to bone up on this before it’s a crisis, because by the time it’s a crisis — and this is a problem, right, with health insurance too. By the time you’ve got the emotional and health issues, to throw on top of it a bureaucratic sort of financial issue is just so hard for most people to juggle. So there isn’t an easy solution, but it is important for people to realize that this is as much of a risk as smashing your car into a telephone pole and that you cannot have one answer.
Your answer cannot be like, “Oh, well I’m just going to stay in my house, because you may not be able to stay in your house.” Or your answer can’t be, “Well, I’m going to go into a fancy assisted living facility with a great chandelier and great food,” because unless you save an inordinate amount of money, even if you go in there, you may not be able to afford to stay there. So it’s really a recognition that you can’t really concretely plan for this, but you may very well not be able to live independently if you are lucky enough to live into your eighth and ninth decade.
Rovner: Great. Jordan Rau, anything I didn’t ask?
Rau: Never. Never, Julie.
Rovner: Jordan Rau, thank you so much for joining us.
Rau: Great to see you.
Rovner: OK. We are back, and it’s time for our last extra credit segment of the year. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Rachel, why don’t you go first this week?
Cohrs: Sure. The story I chose is in ProPublica. The headline is “Doctors With Histories of Big Malpractice Settlements Work for Insurers, Deciding If They’ll Pay for Care,” by Patrick Rucker at The Capitol Forum and David Armstrong and Doris Burke at ProPublica. I think this article very much fits into the larger theme we were talking about earlier about insurance denials. This was pretty shocking still to me, of these instances of doctors with big malpractice settlements that had been disciplined by medical boards failing up essentially and getting jobs. If they can’t practice anymore, then they’re getting jobs in insurance companies instead, deciding whether a much larger volume of patients get care. So I think it was just a fascinating, really well-done investigation. It sounded like it was really difficult to match up all the records with the lawsuits and the settlements, and there aren’t necessarily databases that exist of what doctors work for insurance companies. So it was just really well done and just a really important space that we’ll continue to talk about.
Kenen: That was a great piece. These doctors are making $300,000 to $400,000 a year, these people who failed up, as Rachel just put it. Yeah.
Rovner: Yeah. That’s the perfect phrase. Sandhya.
Raman: My extra credit this week is called “Mississippi Community Workers Battle Maternal Mortality Crisis,” and it’s from my colleague at Roll Call Lauren Clason. This story also illustrates a combination of themes from this year. It touches on some of the maternal health inequities, the racial inequities, and rural health inequities, and how politics kind of comes into all of that. Mississippi Black women die at a rate four times higher than white women, and the state also leads in infant mortality rates nationwide. At the same time, it’s also a nonexpansion state for Medicaid. So Lauren went to Mississippi to look at some of the community and state-led groups that are trying to reduce these inequities that are caused by the different racial, socioeconomic, and access factors that are happening at the same time that an increasing number of hospitals are closing in the state.
Rovner: Also another really good story. Joanne?
Kenen: The theme of the day is yearlong, or decades-long in some cases, but ongoing health stories that have dominated the year. Another one that we didn’t touch on today but clearly is an ongoing multiyear health crisis is gun violence, which is a public health problem as well as a criminal justice problem. The Trace did a fantastic end-of-year project by Justin Agrelo. It’s called “Chicago Shooting Survivors, in Their Own Words.” They worked with both people who had survived shootings as well as people who had lost family members to shootings, and they worked with them about how to write and tell stories.
These five stories are in these people’s own words, and it was partnered with a bunch of other Chicago-based publications. They’re very powerful. In the introduction, they wrote that the Chicago media has been really good about trying to cover every homicide but that these people end up being defined by their death, not everything else about their life. These essays, they didn’t just talk about grief, which is obviously a huge — grief and trauma — but also the lives, not just the deaths. It’s really, really worth spending some time with.
Rovner: Yeah, and we haven’t talked as much as we probably should have about gun violence, but we will put that on the list for 2024. My extra credit this week is from Business Insider. It’s called “I Feel Conned Into Keeping This Baby.” It’s by Bethany Dawson, Louise Ridley, and Sarah Posner. It’s about an anti-abortion group that promised pregnant women financial support for their babies if they agreed not to get an abortion. But even though the women signed contracts, the group, called Let Them Live, did not provide the aid promised. Apparently they promised more money than they could raise in contributions. Now, I have heard of pregnancy crisis centers promising things like diapers and formula, but this group said it would help with groceries and rent and other significant expenses until it didn’t. Apparently the small print in the contract said the benefits could be reduced or stopped at any time. This was supposed to help answer the criticism that anti-abortion groups don’t actually care about the women, particularly after they give birth, except maybe promising things that you can’t deliver isn’t the best way to do that.
OK. That is our show for this week and for this year. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks, as always, to our technical guru, Francis Ying, and our editor, Emmarie Huetteman. Also as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can still find me at X, @jrovner, or @julierovner at Bluesky and @julie.rovner at Threads. Sandhya, where are you on social media these days?
Raman: I’m @SandhyaWrites on both X and Bluesky.
Rovner: Rachel.
Cohrs: I’m @rachelcohrs on X, @rachelcohrsreporter on Threads.
Rovner: Joanne.
Kenen: @joannekenen1 on Threads. I’m occasionally on X — or, as you all know, I’ve been calling it Y — @JoanneKenen.
Rovner: We will be back in your feed in 2024. Until then, have a great holiday season, and be healthy.
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1 year 10 months ago
Health Care Costs, Medicaid, Medicare, Multimedia, Pharmaceuticals, Public Health, Abortion, Drug Costs, Hospitals, KFF Health News' 'What The Health?', Legislation, Medicare Advantage, Podcasts, Women's Health
A New Test Could Save Arthritis Patients Time, Money, and Pain. But Will It Be Used?
SAN DIEGO — Erinn Maury knew Remicade wasn’t the right drug for Patti Schulte, a rheumatoid arthritis patient the physician saw at her Millersville, Maryland, practice. Schulte’s swollen, painful joints hadn’t responded to Enbrel or Humira, two drugs in the same class.
But the insurer insisted, so Schulte went on Remicade. It didn’t work either.
SAN DIEGO — Erinn Maury knew Remicade wasn’t the right drug for Patti Schulte, a rheumatoid arthritis patient the physician saw at her Millersville, Maryland, practice. Schulte’s swollen, painful joints hadn’t responded to Enbrel or Humira, two drugs in the same class.
But the insurer insisted, so Schulte went on Remicade. It didn’t work either.
What’s more, Schulte suffered a severe allergic reaction to the infusion therapy, requiring a heavy dose of prednisone, a steroid with grave side effects if used at high doses for too long.
After 18 months, her insurer finally approved Maury’s drug of choice, Orencia. By then, Schulte’s vertebrae, weakened by prednisone, had started cracking. She was only 60.
Schulte’s story of pain, drug-hopping, and insurance meddling is all too common among patients with rheumatoid arthritis, who often cycle agonizingly through half a dozen drugs in search of one that provides a measure of relief. It’s also a story of how doctors are steered by pharmacy benefit managers — the middlemen of the drug market — as well as by insurers.
Once people with inflammatory conditions such as rheumatoid arthritis reach a certain stage, the first prescription offered is typically Humira, the best-selling drug in history, and part of a class known as tumor necrosis factor inhibitors, or TNFis, which fail to significantly help about half of the patients who take it.
“We practice rheumatology without any help,” said Vibeke Strand, a rheumatologist and adjunct clinical professor at Stanford. She bemoaned the lack of tools available to choose the right drug while bristling at corporate intervention in the decision. “We are told by the insurer what to prescribe to the patient. After they fail methotrexate, it’s a TNF inhibitor, almost always Humira. And that’s not OK.”
If there’s a shred of hope in this story, it’s that a blood test, PrismRA, may herald an era of improved care for patients with rheumatoid arthritis and other autoimmune conditions. But first, it must be embraced by insurers.
PrismRA employs a predictive model that combines clinical factors, blood tests, and 19 gene patterns to identify the roughly 60% of patients who are very unlikely to respond to a TNFi drug.
Over the past 25 years, drug companies have introduced five new classes of autoimmune drugs. TNFis were the first to market, starting in the late 1990s.
Some 1.3 million Americans have rheumatoid arthritis, a disease in which a person’s immune system attacks their joints, causing crippling pain and, if improperly treated, disfigurement. The newer drugs, mostly so-called biologics, are also used by some of the 25 million or more Americans with other autoimmune diseases, such as lupus, Crohn’s disease, and psoriasis. Typically costing tens of thousands of dollars annually, the drugs are prescribed after a patient fails to respond to older, cheaper drugs like methotrexate.
Until recently, rheumatologists have had few ways to predict which of the new drugs would work best on which patients. Often, “it’s a coin flip whether I prescribe drug A or B,” said Jeffrey Curtis, a rheumatology professor at the University of Alabama-Birmingham.
Yet about 90% of the patients who are given one of these advanced drugs start on a TNFi, although there’s often no reason to think a TNFi will work better than another type.
Under these puzzling circumstances, it’s often the insurer rather than the doctor who chooses the patient’s drug. Insurers lean toward TNFis such as adalimumab, commonly sold as brand-name Humira, in part because they get large rebates from manufacturers for using them. Although the size of such payments is a trade secret, AbbVie is said to be offering rebates to insurers of up to 60% of Humira’s price. That has enabled it to control 98.5% of the U.S. adalimumab market, even though it has eight biosimilar competitors.
PrismRA’s developer, Scipher Medicine, has provided more than 26,000 test results, rarely covered by insurance. But on Oct. 15, the Centers for Medicare & Medicaid began reimbursing for the test, and its use is expected to rise. At least two other companies are developing drug-matching tests for rheumatoid arthritis patients.
Although critics say PrismRA is not always useful, it is likely to be the first in a series of diagnostics anticipated over the next decade that could reduce the time that autoimmune disease patients suffer on the wrong drug.
Academics, small biotechs, and large pharmaceutical companies are investing in methods to distinguish the biological pathways involved in these diseases, and the best way to treat each one. This approach, called precision medicine, has existed for years in cancer medicine, in which it’s routine to test the genetics of patients’ tumors to determine the appropriate drug treatment.
“You wouldn’t give Herceptin to a breast cancer patient without knowing whether her tumor was HER2-positive,” said Costantino Pitzalis, a rheumatology professor at the William Harvey Research Institute in London. He was speaking before a well-attended session at an American College of Rheumatology conference in San Diego in November. “Why do we not use biopsies or seek molecular markers in rheumatoid arthritis?”
It’s not only patients and doctors who have a stake in which drugs work best for a given person.
When Remicade failed and Schulte waited for the insurer to approve Orencia, she insisted on keeping her job as an accountant. But as her prednisone-related spinal problems worsened, Schulte was forced to retire, go on Medicaid, and seek disability, something she had always sworn to avoid.
Now taxpayers, rather than the insurer, are covering Schulte’s medical bills, Maury noted.
Precision medicine hasn’t seemed like a priority for large makers of autoimmune drugs, which presumably have some knowledge of which patients are most likely to benefit from their drugs, since they have tested and sold millions of doses over the years. By offering rebate incentives to insurers, companies like AbbVie, which makes Humira, can guarantee theirs are the drugs of choice with insurers.
“If you were AbbVie,” Curtis said, “why would you ever want to publish data showing who’s not going to do well on your drug, if, in the absence of the test, everyone will start with your drug first?”
What Testing Could Do
Medicare and commercial insurers haven’t yet set a price for PrismRA, but it could save insurers thousands of dollars a year for each patient it helps, according to Krishna Patel, Scipher’s associate director of medical affairs.
“If the test cost $750, I still only need it once, and it costs less than a month of whatever drug is not going to work very well for you,” said Curtis, a co-author of some studies of the test. “The economics of a biomarker that’s anything but worthless is pretty favorable because our biologics and targeted drugs are so expensive.”
Patients are enthusiastic about the test because so many have had to take TNFis that didn’t work. Many insurers require patients to try a second TNFi, and sometimes a third.
Jen Weaver, a patient advocate and mother of three, got little benefit from hydroxychloroquine, sulfasalazine, methotrexate, and Orencia, a non-TNFi biologic therapy, before finding some relief in another, Actemra. But she was taken off that drug when her white blood cells plunged, and the next three drugs she tried — all TNFis — caused allergic reactions, culminating with an outbreak of pus-filled sores. Another drug, Otezla, eventually seemed to help heal the sores, and she’s been stable on it since in combination with methotrexate, Weaver said.
“What is needed is to substantially shorten this trial-and-error period for patients,” said Shilpa Venkatachalam, herself a patient and the director of research operations at the Global Healthy Living Foundation. “There’s a lot of anxiety and frustration, weeks in pain wondering whether a drug is going to work for you and what to do if it doesn’t.” A survey by her group found that 91% of patients worried their medications would stop working. And there is evidence that the longer it takes to resolve arthritis symptoms, the less chance they will ever stop.
How insurers will respond to the availability of tests isn’t clear, partly because the arrival of new biosimilar drugs — essentially generic versions — are making TNFis cheaper for insurance plans. While Humira still dominates, AbbVie has increased rebates to insurers, in effect lowering its cost. Lower prices make the PrismRA test less appealing to insurers, since widespread use of the test could cut TNFi prescriptions by up to a third.
However, rheumatologist John Boone in Louisville, Kentucky, found to his surprise that insurers mostly accepted alternative prescriptions for 41 patients whom the test showed unlikely to respond to TNFis as part of a clinical trial. Boone receives consulting fees from Scipher.
Although the test didn’t guarantee good outcomes, he said, the few patients given TNFis despite the test results almost all did poorly on that regimen.
Scientists from AbbVie, which makes several rheumatology drugs in addition to Humira, presented a study at the San Diego conference examining biomarkers that might show which patients would respond to Rinvoq, a new immune-suppressing drug in a class known as the JAK inhibitors. When asked about its use of precision medicine, AbbVie declined to comment.
Over two decades, Humira has been a blockbuster drug for AbbVie. The company sold more than $3.5 billion worth of Humira in the third quarter of 2023, 36% less than a year ago. Sales of Rinvoq, which AbbVie is marketing as a treatment for patients failed by Humira and its class, jumped 60% to $1.1 billion.
What Patients Want
Shannan O’Hara-Levi, a 38-year-old in Monroe, New York, has been on scores of drugs and supplements since being diagnosed with juvenile arthritis at age 3. She’s been nauseated, fatigued, and short of breath and has suffered allergic reactions, but she says the worst part of it was finding a drug that worked and then losing access because of insurance. This happened shortly after she gave birth to a daughter in 2022, and then endured intense joint pain.
“If I could take a blood test that tells me not to waste months or years of my life — absolutely,” she said. “If I could have started my current drug last fall and saved many months of not being able to engage with my baby on the floor — absolutely.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
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1 year 10 months ago
Health Care Costs, Health Industry, Pharmaceuticals, Autoimmune Diseases, Drug Costs, Prescription Drugs
A New Era of Vaccines Leaves Old Questions About Prices Unanswered
The world is entering a new era of vaccines. Following the success of covid-19 mRNA shots, scientists have a far greater capacity to tailor shots to a virus’s structure, putting a host of new vaccines on the horizon.
The world is entering a new era of vaccines. Following the success of covid-19 mRNA shots, scientists have a far greater capacity to tailor shots to a virus’s structure, putting a host of new vaccines on the horizon.
The most recent arrivals — as anyone on the airwaves or social media knows — are several new immunizations against respiratory syncytial virus, or RSV.
These shots are welcome since RSV can be dangerous, even deadly, in the very old and very young. But the shots are also expensive — about $300 for those directed at adults, and up to $1,000 for one of the shots, a monoclonal antibody rather than a traditional vaccine, intended for babies. Many older vaccines cost pennies.
So their advent is forcing the United States to face anew questions it has long sidestepped: How much should an immunization that will possibly be given — maybe yearly — to millions of Americans cost to be truly valuable? Also, given the U.S. is one of two countries that permit direct advertising to consumers: How can we ensure the shots get into the arms of people who will truly benefit and not be given, at great expense, to those who will not?
Already, ads on televisions and social media show active retirees playing pickleball or going to art galleries whose lives are “cut short by RSV.” This explains the lines for the shot at my local pharmacy.
But indiscriminate use of expensive shots could strain both public and private insurers’ already tight budgets.
Other developed countries have deliberate strategies for deciding which vulnerable groups need a particular vaccine and how much to pay for it. The U.S. does not, and as specialized vaccines proliferate, public programs and private insurers will need to grapple with how to use and finance shots that can be hugely beneficial for some but will waste precious health dollars if taken by all.
A seasonal viral illness, RSV can cause hospitalization or, in rare cases, death in babies and in people age 75 or older, as well as those with serious underlying medical conditions such as heart disease or cancer. For most people who get RSV, it plays out as a cold; you’ve likely had RSV without knowing it.
But RSV puts about 2% of babies under age 1 in the hospital and kills between 100 and 300 of those under 6 months, because their immune systems are immature and their airways too narrow to tolerate the inflammation. Merely having a bad case of RSV in young childhood increases the risk of long-term asthma.
That’s why Barney Graham, the scientist who spent decades at the government’s National Institutes for Health perfecting the basic science that led to the current shots, said: “The most obvious use is in infants,” not adults.
That’s also why European countries trying to figure out how best to use these vaccines without breaking the bank focused first on babies and determining a sensible price. Though more of the very old may die of RSV, the years of life lost are much greater for the very young. (Babies can get the monoclonal antibody shot or gain protection through a traditional vaccine given to the mother near the end of pregnancy, conferring immunity through the womb.)
A consortium of European experts led by Philippe Beutels, a professor in health economics at the University of Antwerp in Belgium, calculated that the shots would only be “worth it” in terms of the lives saved and hospitalizations averted in infants if the price were under about $80, he said in a phone interview. That’s because almost all babies make it through RSV with supportive care.
The calculation will be used by countries such as Belgium, England, Denmark, Finland, and the Netherlands to negotiate a set price for the two infant shots, followed by decisions on which version should be offered, depending partly on which is more affordable.
They have not yet considered how to distribute the vaccines to adults — considered less pressing — because studies show that RSV rarely causes severe disease in adults who live outside of care settings, such as a nursing home.
Why did the United States and Europe approach the problem from opposite directions?
In the U.S., there was a financial incentive: Roughly 3.7 million babies are born each year, while there are about 75 million Americans age 60 and older — the group for whom the two adult vaccines were approved. And about half of children get their vaccines through the Vaccines for Children program, which negotiates discounted prices.
Also, babies can get vaccinated only by their clinicians. Adults can walk into pharmacies for vaccinations, and pharmacies are only too happy to have the business.
But which older adults truly benefit from the shot? The two manufacturers of the adult vaccines, GSK and Pfizer, conducted their studies presented to the FDA for approval in a population of generally healthy people 60 and older, so that’s the group to whom they may be marketed. And marketed they are, even though the studies didn’t show the shots staved off hospitalization or death in people ages 60 to 75.
That led to what some have called a “narrow” endorsement from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices for people 60 to 75: Patients in that age range could get the shot after “shared clinical decision-making” with a health provider.
It is likely that because of this fuzzy recommendation, some Americans 60 and over with commercial insurance are finding that their insurers won’t cover it. Under Obamacare, insurers are generally required to cover at no cost vaccines that are recommended by the ACIP; however, if a provider recommends vaccination, then it must be covered by insurance.
(In late September, the ACIP recommended immunization of all babies with either the antibody or the maternal vaccine. Insurers have a year to commence coverage and many have been dragging their feet because of the high price.)
There are better and more equitable ways to steer the shots into the arms of those who need it, rather than simply administering it to those who have the “right” insurance or, swayed by advertising, can pay. For example, insurers, including Medicare, could be required to cover only those ages 60 to 75 who have a prescription from a doctor, indicating shared decision-making has occurred.
Finally, during the pandemic emergency, the federal government purchased all covid-19 vaccines in bulk at a negotiated price, initially below $20 a shot, and distributed them nationally. If, to protect public health, we want vaccines to get into the arms of all who benefit, that’s a more cohesive strategy than the patchwork one used now.
Vaccines are miraculous, and it’s great news that they now exist to prevent serious illness and death from RSV. But using such novel vaccines wisely — directing them to the people who need them at a price they can afford — will be key. Otherwise, the cost to the health system, and to patients, could undermine this big medical win.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
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2 years 21 hours ago
Aging, Health Care Costs, Health Industry, Pharmaceuticals, Public Health, CDC, Children's Health, Drug Costs, vaccines
KFF Health News' 'What the Health?': Health Funding in Question in a Speaker-Less Congress
The Host
Julie Rovner
KFF Health News
Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.
As House Republicans struggle — again — to decide who will lead them, the clock is ticking on a short-term spending bill that keeps the federal government running only until mid-November. The turn of the fiscal year has also left key health programs in limbo, including the one that provides international aid to combat HIV and AIDS.
Meanwhile, a major investigation by The Washington Post into why U.S. life expectancy is declining found that the reasons, while many and varied, tend to point to a lesser emphasis on public health here than in many peer nations.
This week’s panelists are Julie Rovner of KFF Health News, Sarah Karlin-Smith of the Pink Sheet, Victoria Knight of Axios, and Lauren Weber of The Washington Post.
Panelists
Sarah Karlin-Smith
Pink Sheet
Victoria Knight
Axios
Lauren Weber
The Washington Post
Among the takeaways from this week’s episode:
- House Republicans are choosing a new speaker with government funding still uncertain beyond Nov. 17. But some programs are already experiencing a lapse in their congressional authorizations, notably the global HIV/AIDS program known as PEPFAR — and the problems in renewing it are sending a troubling signal to the world about the United States’ commitment to a program credited with saving millions of lives.
- Drug companies have entered into agreements with federal health officials for new Medicare price negotiations even as many of them challenge the process in court. Early signals from one conservative federal judge indicate the courts may not be sympathetic to the notion that drug companies are being compelled to participate in the negotiations.
- Kaiser Permanente health system employees and pharmacists with major chains are among the American health care workers on strike. What do the labor strikes have in common? The outcry from workers over how staffing shortages are endangering patients, leaving overwhelmed medical personnel to manage seemingly impossible workloads.
- Elsewhere in the nation, new covid-19 vaccines are proving difficult to come by, particularly for young kids. Officials point to this being the first time the vaccines are being distributed and paid for by the private sector, rather than the federal government.
- Reporting shows those getting kicked off Medicaid are struggling to transition to coverage through the Affordable Care Act exchanges, even though many are eligible.
Also this week, Rovner interviews physician-author-novelist Samuel Shem, whose landmark satirical novel, “The House of God,” shook up medical training in the late 1970s. Shem’s new book, “Our Hospital,” paints a grim picture of the state of the American health care workforce in the age of covid.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: The Atlantic’s “Virginia Could Decide the Future of the GOP’s Abortion Policy,” by Ronald Brownstein.
Sarah Karlin-Smith: The Wall Street Journal’s “Children Are Dying in Ill-Prepared Emergency Rooms Across America,” by Liz Essley Whyte and Melanie Evans.
Lauren Weber: ProPublica’s “Philips Kept Complaints About Dangerous Breathing Machines Secret While Company Profits Soared,” by Debbie Cenziper, ProPublica; Michael D. Sallah, Michael Korsh, and Evan Robinson-Johnson, Pittsburgh Post-Gazette; and Monica Sager, Northwestern University.
Victoria Knight: KFF Health News’ “Feds Rein In Use of Predictive Software That Limits Care for Medicare Advantage Patients,” by Susan Jaffe.
Also mentioned in this week’s episode:
- The Washington Post’s “Medicaid Rolls Are Being Cut. Few Are Finding Refuge in ACA Plans,” by Amy Goldstein.
- The Washington Post’s “An Epidemic of Chronic Illness Is Killing Us Too Soon,” by Joel Achenbach, Dan Keating, Laurie McGinley, Akilah Johnson, and Jahi Chikwendiu.
- The Washington Post’s “How Red-State Politics Are Shaving Years Off American Lives,” by Lauren Weber, Dan Diamond, and Dan Keating.
- The Washington Post’s “England Considers Raising Smoking Age Until Cigarettes Are Banned Entirely,” by Andrew Jeong.
click to open the transcript
Transcript: Health Funding in Question in a Speaker-Less Congress
KFF Health News’ ‘What the Health?’Episode Title: Health Funding in Question in a Speaker-Less CongressEpisode Number: 318Published: Oct. 12, 2023
[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.]
Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Oct. 12, at 10 a.m. As always, news happens fast, and things might’ve changed by the time you hear this, so here we go.
We are joined today via video conference by Victoria Knight of Axios.
Victoria Knight: Good morning.
Rovner: Sarah Karlin-Smith of the Pink Sheet.
Sarah Karlin-Smith: Hi, everybody.
Rovner: And Lauren Weber of The Washington Post.
Lauren Weber: Hello, hello.
Rovner: Later in this episode, we’ll have my interview with doctor-author Samuel Shem, who wrote “House of God,” the seminal novel about medical training, back in the 1970s, and who has a new take on what ails our health care system. But first, the news. So, we’ve been off for a week so KFF could have an all-staff retreat in California, which was lovely, by the way. And against all odds, it’s Oct. 12 and the federal government is not shut down, although the continuing resolution that squeaked through Congress at the very last minute on Sept. 30 expires Nov. 17, so we could be going through all of this again next month.
Meanwhile, conservative Republicans, who were angry that House Speaker Kevin McCarthy agreed to keep the government open, ousted him from his job, the first time ever a speaker has been kicked out mid-Congress, and things are, to put it mildly, in disarray. But I want to go back to that six-week continuing resolution. It does just continue appropriations, but it also had some important, if temporary, authorizing provisions, like for community health centers, right, Victoria?
Knight: Yeah, that’s right. There were a few provisions that just kind of kept it going as it was, funded at the same level. That was community health centers, and there were a few for the Pandemic and All-Hazards Preparedness Act. Then there were also some things that were not renewed in PAHPA, and then also the PEPFAR program [the U.S. President’s Emergency Plan for AIDS Relief], which I figured we might talk about a little bit, which is the program that funds programs in other countries to help with HIV/AIDS treatment and research, and it’s been a long-standing bipartisan program, and it has come up against some obstacles this Congress.
Rovner: Just to remind people who don’t follow this as closely as we do, the appropriations are what actually keep the lights on. Those are the spending bills that Congress has to pass, either in permanent or temporary fashion, at the beginning of the fiscal year, Oct. 1, or things shut down. Things like PEPFAR and community health centers continue to get funded, but their official authorizations expired at the end of the fiscal year. While the community health centers were kept going, PEPFAR has not. Of course, the House, which is, as we speak, still leaderless, can’t really do anything. Are there, at least, negotiations going on? I know PEPFAR really is a bipartisan program, as you say, and there is some effort to keep it going, because some people frankly say it’s embarrassing for the United States to look like it is reneging on this, even though it’s technically not.
Knight: Well, I know it was originally started under a Republican president, George W. Bush, and has always been reauthorized for five-year intervals. That’s never not happened. I’ve talked to members of Congress about this. In the House, they only want to reauthorize it for one year, and they’ve been very open about that’s because they want a new Republican president to come in and further restrict where funding is going, to really, in their mind, ensure it’s not going to abortion funding, even though there’s really no evidence that funding from PEPFAR goes to NGOs [nongovernmental organizations] that fund abortions or anything like that.
Then, in the Senate, it’s a different story. Another little factor is that Sen. Bob Menendez was the lead on this, and then he had to step —
Rovner: Oops.
Knight: He had to step down from his chair of the Senate Foreign Relations Committee, and that’s just a matter of Senate rules, since he’s under indictment.
Rovner: Again.
Knight: Again, yes, and so Sen. Ben Cardin just took that chairmanship. I’m not sure how much PEPFAR is on his radar. I tried to ask him about it recently, and he was like, “I’ve got to go to a meeting.” I know for Menendez, it was a really big thing that he cared about and was like, “I want to reauthorize it for five years.” So, as far as I can tell, it’s kind of a standstill between the House and the Senate and, to be determined, but maybe at the end of the year, if we get a big bill, something will be put in there. Maybe they’ll negotiate it to three years. I’ve heard something about that, but again, this will be the first time it hasn’t been reauthorized for five years, and that would send a signal to other countries that maybe the U.S. is not as devoted to treating HIV/AIDS and helping programs in other countries.
Rovner: Yeah, obviously, with everything else going on in the world, it’s not the biggest deal, but there are still a lot of people who are very concerned about it. The other at least somewhat surprising thing that happened on Oct. 1, the beginning of the fiscal year, is that all of the drugmakers responsible for the 10 drugs that Medicare has selected for the first round of price negotiation have agreed to negotiate, at least for now. That’s likely because the first round of the first of several lawsuits in federal court seeking to block the program found in favor of the government. In other words, the program did not get blocked by the courts. But Sarah, this fight is a long way from over, right?
Karlin-Smith: Yeah, there’s a number of lawsuits. I think we might be up to eight now, but don’t hold me to that exact figure.
Rovner: Excel spreadsheets.
Karlin-Smith: Yeah. Even this lawsuit, the initial blow I think was pretty big for the drug industry here, because we have a Trump-appointed judge who made a pretty clear preliminary decision that he doesn’t think the drug industry can make its constitutionality challenges that this law is not constitutional, which I think is a pretty big deal, because most of the initial lawsuits revolved around constitutional challenges. Then, there are other issues, in the first particular case, around whether even the people who are suing have standing or it’s ripe for a lawsuit now, whether because anybody’s actually been harmed at this point. Yet, everybody, all the companies, have entered into agreements with Medicare to negotiate now. A lot of them have said, “Well, we’re doing this, but basically because we have no other choice. We have to. We’re doing it in protest. We’re still continuing our lawsuits.”
So, you can expect two parallel tracks to be going on right now, mostly behind the scenes. This is pretty much going to take a whole year for Medicare and the companies to get to the place where we’ll then see a public negotiated price next fall, next September. And these lawsuits to proceed, again, just I think the constitutionality issue got a really big blow. There are some other lawsuits that I think could be more interesting that are arguing more about decisions Medicare made, so more about APA, Procedures Act, cases, which are a little bit different and I think might have a little bit more chance of getting the drug industry some wins.
Rovner: The APA is the Administrative Procedures Act —
Karlin-Smith: Procedures Act, thank you.
Rovner: — and basically saying that Medicare didn’t follow all of the appropriate rules in how it devised and rolled out the program.
Karlin-Smith: Right, and I think —
Rovner: As opposed to the big lawsuits that said, “You can’t force us to do this,” which, not a lawyer, but every other health provider goes under the if you want to play in Medicare, you have to take our price, so it’s hard to see where the drug companies are going to have something completely different, but that’s just me. You never know.
Karlin-Smith: Right, and this Trump-appointed judge — I keep emphasizing that because they picked the 5th Circuit, they looked for a friendly judge, and they couldn’t get the win there. He said, “Medicare is a voluntary program. The government has stopped forcing you to participate in Medicare. If you don’t like this, you can leave.” I think this is a pretty symbolic loss for the industry and some of these arguments they’re going to make.
That said, these APA cases, you can maybe see them getting more tweaks around the edges to shift the program in ways that favor it, but we know the way litigation works in this country; it’s going to be this long slog to figure out how that shakes out as the program is potentially, again, on the other side, getting worked out and maybe implemented.
Rovner: We will see. All right. Well, elsewhere in disarray, if this was the summer of strikes in Hollywood, it’s shaping up as the autumn of strikes by health workers. Last week, 75,000 workers at Kaiser Permanente — no relation, just for my listeners — in several states walked out for three days. Workers at several other hospitals in and around Los Angeles walked out, and we’re seeing pharmacists taking work actions at both of the big chains, CVS and Walgreens. All of these walkouts have basically the same thing in common. Striking workers say that the shortage of personnel is endangering patients, as those who are left at work face impossible workloads.
These employers are not in a great situation to fix this. Covid accelerated the departure of a lot of healthcare workers, and there simply aren’t the bodies to fill all of these vacant positions. Is there any settlement in sight? Any way to fix any of this that anybody’s proposed?
Weber: I think if any of us sitting at this table have family, friends that work as nurses or pharmacists, they’ve been hearing about these problems for years. I mean, all it takes is talking to somebody that works in this industry to realize that they have been short-staffed and underfunded for a very long time. A lot of them really worry about the actual errors that can result from that. I mean, I think what’s really important to consider is to get to a strike, you have to have a lot of bad things going on. I mean, I think some of the reports say that some of these hospitals have filed countless complaints with the local county health in California that had not gotten listened to about their staffing shortages.
When you have short staffing for nurses, that means that you feel like patients are not getting seen. Something could be happening. They feel like they’re putting these people in jeopardy. I don’t really think there’s going to be a lot of end to this in sight. I think, once you kick off these strikes like this, it’s a bit of a chain effect. I mean, we saw CVS pharmacy employees had a strike, and then Walgreens employees have started doing that.
Frankly, the CVS one was pretty successful. The CVS CEO went out there and said, “Look, we hear your conditions. We’ll work on cutting down hours, and we’ll try and accommodate you.” I think we’re going to be in for a lot more of these in the months to come.
Rovner: Yeah, I mean, it’s one thing if workers — there aren’t enough checkers at the grocery store and you have to stand in line for longer, but it’s quite another thing when you have a nurse in an intensive care unit trying to keep track of six patients instead of three or a pharmacist trying to keep track of basically everything that’s going on with no help. That’s what we’re seeing around the country with these shortages of trained health care workers.
In California, there’s another complication, because they actually have laws about patient-nurse ratios in hospitals, and some of them are not being actually obeyed, so I imagine that this is going to go on. We hear a lot about health care worker shortages. I think this is the worst one that I’ve seen in my career, where there just really aren’t the bodies to meet the demand here.
Well, speaking of things that also aren’t going swimmingly — that seems to be our theme this week — there’s a lot of early demand for the new covid vaccine that was approved in September, and apparently not a lot of supply. Also, as we just discussed, a lot of the responsibility for the vaccine is being pushed to pharmacies, whose already overstretched staff simply don’t have the bandwidth to deliver vaccines in addition to all the drugs that they’re asked to be counting out and prescribing. Sarah, shouldn’t the system have been more ready for this? It’s not like we didn’t know pretty much exactly when this vaccine was going to become available. They’ve been saying mid-September for the last five months.
Karlin-Smith: Right, yeah. I mean, there’s definitely been a lot of criticism, particularly on the health insurance side with the codes and things not being set up to put it in. It’s less clear exactly what has gone wrong in the supply chain issue, where there are reports of wholesalers not being able to get supply to the pharmacies. Do you even have enough shots? Lots of people are reporting they have appointments. They get there. They show up. The pharmacist is out.
One thing I’ve been wondering is just there’s been low uptake of boosters in the U.S., and so if it’s been harder for them to predict how much supply they want to have, it’s a bit different when the government is no longer funding those shots. Pharmacies, doctor’s offices have been concerned. What if they buy more than they end up using? Are they out money? I know, in some cases, some of the companies have made some concessions and said, “We will take back unused product,” and so forth, because there’s just different financial considerations that I think are impacting how much supply is on hand at different times right now.
Rovner: And, of course, it’s even worse for kids, right? Because kids can’t go, generally, to the pharmacies to get their vaccines.
Karlin-Smith: Right. Most of the country, to get a vaccine by a pharmacist, you have to be at least 3. It varies a little bit by state and so forth. A lot of pediatricians’ offices don’t have these shots. One of the reasons it seems to be is that, again, these wholesalers who ship the supply around the country have prioritized adult vaccinations. I know, personally, my pediatrician’s office still does not have a shot, as well.
Rovner: And you have two little ones, right?
Karlin-Smith: Right. Again, I have one under 3, and I looked into vaccines.gov the other day to see what would they tell me if I put in for an under-3-year-old. There was one pharmacy in all of D.C. that claimed they would vaccinate someone under 3 for covid, which, I haven’t done the legwork yet to see if that’s actually correct, but, you know, you’re hearing these reports of people traveling really far to get pediatric shots. Again, just to emphasize that there are babies being born all the time who, when they turn 6 months, they are getting their first covid shot, right? They have not, hopefully they haven’t, had covid. You want them protected before they get exposed, so that’s a really crucial gap in the health system that I think people don’t appreciate, because a lot of people are just thinking now, well, oh everybody’s had covid or had two or three shots, and this is a particularly vulnerable population that’s having trouble finding vaccines right now.
Rovner: Yet, I mean, considering it’s very early in the respiratory disease season, there seems to be a lot of covid going around right now, which I suspect is why there’s such a demand, at least among the people who are most concerned about getting the vaccine, for getting the vaccine. It feels like it did at the beginning, when it’s like suddenly there’s this big rush of people at the beginning who want it. Eventually, there’ll probably be more vaccine than is needed, but for right now, I mean, I’m seeing lots and lots and lots of stories and anecdotes and everything about people, as you say, making appointments, showing up, and having the pharmacy saying, “Oops, we didn’t get our supply.”
Karlin-Smith: I mean, there’s been this sort of hope and narrative that covid, is it going to become seasonal in the way we think of flu, where there’s generally a more clear, defined season? You can kind of make a good guess that the best time to get your flu shot is in October and know you’ll be protected all flu season. As much as we hope that’s the case with covid and eventually becomes the case, that’s really not true now. We’ve still had — again, they’re relative maybe compared to some other surges, but we’ve had surges pretty much every summer, so it’s been really difficult. A lot of parents, I think, wanted to get their kids vaccinated before they went back into school and classrooms. If you have little kids, you just know, it becomes a big germ bath, and everybody gets sick.
Rovner: And parents wanted to get themselves vaccinated before their kids went back to school and brought home those germs.
Karlin-Smith: Right, so the timing of it, again, hasn’t been great, for that regard, but I think it is just this difficulty with covid, in that we haven’t had that same predictability of when you might get it during the year, so it is a lot harder to protect yourself.
Rovner: We’ll see how that sorts itself out. Well, keeping with our continuing theme of things that are not going great, let’s talk about the Medicaid unwinding. Our podcast colleague, Amy Goldstein, has a troubling story in The Washington Post about how people whose Medicaid coverage is being canceled but who are eligible for subsidized plans under the Affordable Care Act are in fact having trouble making that transition. Sometimes people are falling through the cracks because states don’t have enough information to know what they’re eligible for or they don’t have the staff to process the transitions.
Sometimes in states like California, people fail to follow up, even when they are given all the information they need. Is this just the inevitable fallout of trying to redetermine the complicated eligibility rules for more than 90 million Americans in a single year, or could something more have been done? I mean, how many times did I hear them say, “It’s OK if you get dropped from Medicaid. We’re going to get you onto your Affordable Care Act plan that’s fully subsidized.” That doesn’t seem to be happening in every state.
Karlin-Smith: I mean, it seemed like, from Amy’s reporting, that there are some states that have connected their Medicaid systems and their exchange sign-ups really closely, and those are going better, but —
Rovner: California, yeah.
Karlin-Smith: Right. Yeah, she mentioned the Medi-Cal system, but then even these states that she calls out as the success stories still have fairly low transition rates. It’s just one of the many examples of our country of having such separate systems and very different bureaucratic processes for sign-up that really hurt people. As we’ve seen with this Medicaid process, a lot of it is just about these paperwork, if you will, call them burdens, that really get people to lose their health insurance and not be covered, so that’s really —
Rovner: I taped a podcast earlier this week aimed at young adults, teaching them how to quote-unquote “adult,” talking about health insurance and open enrollment and how to get signed up. After the Affordable Care Act, there are so many more protections than there were before, and yet it is still unbelievably complicated to try to explain to somebody who’s facing this for the first time. There are just so many possibilities and so many ways. There’s lots of ways to get health insurance, and there’s even more ways to fall through the cracks and not get health insurance. It seems that the more we try to put band-aids on the system, the more confusing it gets to everybody. Maybe I’ve been doing this for too long.
All right, well, finally this week, also in not great news, The Washington Post has published a giant project on declining life expectancy in the United States. It turns out the problem is a lot more complicated than just covid and drug overdoses. Those are the things we’ve been hearing about for a while, although those are indeed a piece of it. Lauren, you were part of the team that put this project together. Tell us the real reasons why Americans aren’t living as long as they used to and aren’t living as long as people in other countries.
Weber: Our team found that income had a big, big part to do with that. The poorest counties in the U.S., compared to the richest counties of the U.S., are doing 6 times worse than they were 40-some years ago, when it comes to life expectancy. The income gap has increased, obviously, but not nearly as much as the life expectancy gap has increased. I think that says something about the U.S.
In general, I mean, as you mentioned, a lot of people consider opioids, deaths of despair, to be what’s killing Americans across the country, but they’re really overlooking chronic illness. Our reporting, my reporting with Dan Diamond and Dan Keating and I, we looked at how the politics also play into life expectancy. What we found is that public health initiatives and public health laws, like tobacco laws for tobacco taxes, seat belt laws, and investing in public health, does have a direct correlation to longevity of life.
State politics and state policies and lawmaker decisions can shave years off of Americans’ lives. What we found in our reporting and in our analysis is that that was happening in red states, particularly those in the South and the Midwest. What we did is we compared three counties that ring Lake Erie: Ashtabula, Ohio; Erie County, Pennsylvania; and Chautauqua, New York. These three counties, they’re all pretty down on their luck. Industrially, the jobs have gone. None of these counties is a success story in health, but they’re all across state lines. It’s just very vivid to see how the different tobacco taxes, seat belt laws have resulted in totally different outcomes when it comes to life expectancy. And you could see, even reflected in these counties, the covid death rates tracked the state investments in public health and the state infrastructure in public health.
So, you know, something that our series looks to do is explain why a state like Ohio has the same life expectancy as Slovakia. One in 5 Ohioans won’t make it to 65. That’s a pretty wild stat. I think a lot of people in this country don’t realize that life expectancy, some of these preventable diseases are preventable.
Rovner: Yeah, I mean, I was really taken by the comparison of tobacco taxes. Where the tobacco taxes were the lowest, which I guess was Ohio, the rate of smoking and, surprise, smoking-related diseases was much higher, and therefore life expectancy was much lower. I noticed The Washington Post had yet another story this week, not quite the same, but how Great Britain and some other countries in Europe are trying to effectively ban smoking, not by banning it outright, which will just make it a black market, but by doing it year by year so that the current cohort of people who smoke will be able to continue but as younger people get older, it will become illegal, until eventually, when everybody dies off, smoking will be basically banned in Great Britain. Somehow, I can’t see that ever happening here, but it’s certainly a public health initiative that’s pretty bold.
Weber: It’s pretty bold. It would not happen here. I mean, look, one of the legislators that we talked to in Ohio, who had stopped a lot of the tobacco taxes — Bill Seitz, House floor majority leader for Ohio — he smoked for 50 years before he quit this summer, actually, because he got kidney cancer and lost a kidney, so he stopped smoking. But what he said to us, when we asked him how he felt about having blocked all these tobacco taxes and if he planned to keep doing that, he said, “Well, just because I quit smoking doesn’t mean I’m going to become a smoke Nazi now. People have the liberty and the right to smoke.”
I mean, a lot of what our reporting came down to is this concept of personal freedom and liberty versus public health, looking at the community as a whole. It was really fascinating to dig into some of the interesting dynamics in Ohio, especially because Gov. DeWine, who is a Republican, has been more bold on public health and has tried to push the legislature to consider more of these initiatives, in part because he has a personal story. His daughter died over 30 years ago in a car accident, and so he’s been very aggressive in especially car safety, but really in a lot of public health initiatives because, as he told us, that kind of death clarifies things for you when it comes to tipping the scales for people’s loved ones. We’ll see that dynamic play out across the U.S., but it is fascinating to examine how tobacco is very much with us. I mean, 20% of Ohioans smoke. I mean, this is not — I think a lot of people consider opioids and these things to still be the new thing to focus on, but tobacco cessation is still very much a fight happening across the country.
Rovner: It’s interesting to me that it’s not just — I mean, the shorthand is red versus blue, but it’s not really just red versus blue because, as you point out, Gov. DeWine’s a Republican, fairly conservative Republican. Before him, Gov. Kasich, also fairly conservative, or used to be considered a fairly conservative Republican. I mean, it’s really about being pro-public health or anti-public health. It gets us back to PEPFAR, right? Victoria, in the early 2000s, Republicans were very pro-public health. Newt Gingrich led the charge to double the funding at the National Institutes of Health. And these days, what you have are very conservative Republicans who apparently don’t believe in public health or in science.
Knight: I was going to say, I think what this series does so well is it emphasizes that so much of our challenges in the U.S. with health is not about the medical system of health; it is the things that we sometimes don’t even think about as health care, not even just public health, but the economic practices, our labor practices, our housing, our food system, that actually these are some of the main things that end up impacting who is living longer and healthier, and so forth. I actually did an interview with an outgoing pharma lobbyist this week, and she was saying — she mentioned chronic diseases, which was a big part of Lauren’s story, and saying, “We actually have more problems with chronic disease now than we did when I started, even though now we have all these cheap, generic medicines for, you know, we have statins and blood thinners and a lot of diabetes medicines that are generic and all these things.” Yes, we have problems with people accessing this medical system and affording it in the U.S., and that’s a big thing, but a lot of this is starting way before you get to the hospital and the doctor’s office, and the U.S. has all these amazing technologies, but we’re failing on these much more basic solutions to keeping people healthy and alive.
Rovner: It’s also not just physical access to health care. I mean, Ohio’s the home of the Cleveland Clinic, for heaven’s sakes, one of the major health care providers in the country. Many parts of Ohio are pretty rural, but it’s not like people have to drive hundreds of miles to get health care. I mean, this whole public health issue is not simply a matter of people can’t get to the doctor, the way we have concerns about that in places like Texas and the Far West. I mean, it really is just these everyday things, whether you wear your seat belt, whether you start smoking. I think it kind of shined a light on actual public health and the importance of public health to life expectancy.
Knight: I think, also, just going back to the politics of it for one second, I mean, I think the result of some of this is just the increased polarization between the two parties, and Republicans also, I think, were really mad about some decisions made during covid, and so we’re also seeing that where they’re, at the state and local level, wanting to strip money from public health departments, as Lauren has reported on at KFF Health News and the Post, and then that’s also, you’re seeing that in Congress as well, now, where they’re not wanting — they’re angry at some of these decisions made, and they want to strip funding from the CDC. They want to strip it from the NIH. We don’t know how the appropriations bills are going to end up, but it’s definitely something that they’re talking about in the House, at least, which is in Republican control.
Karlin-Smith: Everybody I talk to about anti-vaccine sentiment, they say once these sort of sentiments become aligned with your political identity, it makes it so much harder to shift course, so again, this idea that there’s political alignment around how we think about public health is just seen as so problematic because of how people see their identities. It becomes much harder to change people’s opinions when it’s tied into your politics like that.
Weber: Yeah, and I just wanted to highlight, so one of the folks I met in Ashtabula, Ohio, was Mike Czup, who was a funeral home owner, who was 52 years old. What he told me is that a quarter of the people he buries are younger than him. I mean, that’s just a wild statistic; a quarter of the people he buries are younger than him. Honestly, he wasn’t even surprised. I mean, that was just the norm. That was the way of life. I think that’s what this series shines a light on is that people across the U.S. just assume that lung cancer, heart attack, stroke — that’s just what happens. But that’s not the case across the world. It doesn’t have to be the case, and in certain states it’s not the case. California has much better life expectancy than Ohio does, despite them both being on a very similar trajectory in the ’90s. It’s pretty stark findings.
Rovner: Yeah, it’s a really, really, really good series. We will link to it on the podcast page. All right, well, that is this week’s news. Now we will play my interview with Sam Shem, physician, author, and playwright, and then we will come back and do our extra credits for this week.
I am honored to welcome to the podcast Samuel Shem — not his real name, by the way. Dr. Shem shook up the world of medical training back in 1978, when he wrote a groundbreaking novel about his first year as a medical resident, called “House of God.” It was funny and sad and painted an altogether not very pretty picture of medical training in Boston at some of the nation’s most esteemed hospitals and medical schools.
He has spent most of the past five decades crusading, if I can use that verb, to “put the human back in health care.” Fun fact: My mom interviewed him for The Washington Post in 1985. Now Shem has a new novel called “Our Hospital.” It paints a funny and sad picture of the state of medical practice and the state of the American patient in the era of covid. It’s actually the fourth and final volume of his irreverent evaluation of the U.S. health care system. I spoke to Dr. Shem from his home office in upstate New York and started by asking him why he wanted to write a novel about covid.
Samuel Shem: I don’t know how much longer I’m going to be able to write. Nobody does, really. What I did is I said, “Someone has to write about what’s going on in a hospital, and we have to now talk about nurses.” I haven’t put them at the forefront until now, because they have done so incredibly much. I’m taking all the other books, the “House of God” books and others, and I’m bringing them all together like a family. I don’t have a big family, so I’m absolutely doing this with care and vehemence and also a lot of skill in shifting gears, so go read it.
Rovner: I sort of approached this with trepidation, because who wants to read a novel about covid? But, in the end, it’s a pretty optimistic book about what the future of medicine can be, which, forgive me, feels odd for a novel about covid and the possible end of democracy. Are you really that optimistic about America’s ability to cure what ails our health care system, or did you just get tired of writing depressing literature about the health care system?
Shem: Well, I am a crazy optimist, because I grew up in a time, like your mother, when things changed. They changed because we got out there and we were in the streets, and it changed. I was partly in the USA and partly on a Rhodes in Oxford. I think we just have to get together and try to stay together. What this book does: The doctors and the nurses come together, and that is an immense force. We can do this. That’s what I think. The best person in the book, that I have ever written, in some ways, were the women nurses.
Rovner: The heroes of this book are all women, doctors and nurses. You’ve obviously been roundly criticized for your portrayal of women in the original “House of God.” Is it just that you wanted to make it up, or do you really think that women are the future of fixing health care?
Shem: The future of anything. My wife, Janet Surrey, and I, we worked a lot a long time ago on male-female relationships. Women are a beacon of what men could do in medicine. You’ve got to have some kind of group that can get what we need.
Rovner: You’ve watched the evolution of medical practice in America for half a century now, the amazing advances and depressing depersonalization and corporatization. Which one is winning, at this point?
Shem: Well, both. The money — it’s hard to take money from people with so much money. It’s crazy. It’s insane. There are other models, in Australia and all that stuff. What’s happening, unfortunately, is that doctors are running. They’re saying, “I don’t want to do this anymore.” Sooner or later, with some giant people talking about it — doctors and nurses — it can’t go on. It really can’t go on.
Some of the things that I’m hearing: Doctors, they’re saying, “Well, in two years, I’m gone. I can’t do this anymore.” But we can’t do it alone. I can’t say it so more and more. I mean, I know a lot about this in various different jobs I’ve had. It’s got to be with doctors and nurses.
Rovner: What ties a lot of your writing together is the notion of burnout for medical professionals, which may be, as you mentioned, one of the biggest problems right now in U.S. health care. If you could wave a magic wand, what’s one thing that you could do that could help medical professionals, both doctors and nurses and everybody else who works in medicine, love their work again?
Shem: It’s terrible. Young doctors, they don’t know what to do, you know?
Rovner: I mean, do you worry that people won’t want to go into medicine because it’s now viewed as doctors particularly don’t have the community esteem that they used to? Health workers are in danger sometimes in their own workplaces. It’s not a great situation.
Shem: Yes, I think we became horrified when we went on our first medical school times that we were in the hospital. Right when the kids go into the hospital, it’s obvious. It’s really obvious. They’re seeing the house staff spending 80% in front of a computer to bill, so they can’t help but do it.
The problem is you’ve spent so much money and so much time. What the hell should I do? But there are people who are really paying attention to this. I don’t really do it in person too much, but in everything I say these kinds of things, so I think it might help.
Rovner: You’ve now influenced several generations of medical practitioners. Is there a single lesson that you hope you have imparted on all of them?
Shem: Yes. This is what I start my addresses with. I call it staying human in medicine, the danger of isolation and the healing power of good connection. It’s not I-you; it’s the connection that goes after each of them. What’s good connection? Mutual connection. If it’s not mutual, it’s not that good. If you let me, maybe I could read the very end. Is that all right?
Rovner: Yes, please.
Shem: “I’m with you totally. Almost everyone in medicine is hurting, doctors, nurses, and all the others, working in the money-driven hell realms of American care. We’re all suffering terribly. Covid has lit it all up for all to see. The resists to our bodies, minds, and spirits are profound, killing ourselves, acting normal, the poor and people of color dying in droves.”
He paused, scanning the trees for the fat man. Nothing. He went on, “We do miracles every day, we doctors, but we haven’t been able to get a place to work in body and spirit. One in 5 health care workers have quit. Many of us died. At the start of covid, we did the most important thing for us and our patients. We stuck together.” We did. It’s a model, right? But not lasting into the daytime. Hatred and money killed it. I have confidence. We’re no dopes, we docs.
I just think people like you, and people who pay attention, it’s inevitable. I do think it’s inevitable that we’re going to get better stuff. It really will.
Rovner: And get some of the greed out of medicine?
Shem: Yes, because it’s going to crash. You can’t go on like this. Nobody can go on like this. I think so. I really do. You know what? It doesn’t take much. How did we get rid of the presidents in the ’60s? Basically, people who are into power are scared about losing the power, you know, all of the people who protect them and all that stuff.
Rovner: Well, thank you very much, Dr. Samuel Shem. Thank you for joining us.
Shem: OK.
Rovner: We are back, and it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read, too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Victoria, why don’t you go first this week?
Knight: Sure thing. My extra credit is from KFF Health News, and it is called “Feds Rein In Use of Predictive Software That Limits Care for Medicare Advantage Patients,” by Susan Jaffe. This basically was looking at how Medicare Advantage plans, which are plans that private health insurers run for people that are of Medicare age — they’re basically running their health insurance programs — it’s talking about how these MA plans are using predictive software systems to make coverage decisions for patients, and so they’re looking at other patients that may have similar illnesses and what their treatments were and how long it took to treat them and then, based on that, deciding when they should cut off coverage for patients.
Rovner: That doesn’t always work very well, does it?
Knight: No, it does not. This story chronicles how this has happened to several patients, who were not ready to finish having whatever their treatment, illness — the person profiled in the story still couldn’t walk well. She had a colostomy bag, and they were going to cut off her coverage, and so she had to keep paying for it, almost $10,000, just because this software said, “Oh, you should be done by now, based on other people’s cases.”
But there is some good news, in that there is a Biden administration regulation that will be put into effect in January, and that’s going to do a better job of making sure these plans take the individual patient’s circumstances into account when making these coverage decisions, but we’ll see how that actually plays out. It takes effect in January.
Rovner: Really good story.
Knight: Yes, it’s a very good story, yes.
Rovner: Sarah.
Karlin-Smith: I looked at a Wall Street Journal story, “Children Are Dying in Ill-Prepared Emergency Rooms Across America,” by Liz Essley Whyte and Melanie Evans. It’s a piece that talks about how so many hospitals are not properly equipped to treat pediatric patients when they go to the ER. It’s a failure of regulations, standards, and so forth. They really document how this has been a long-known problem, going back 20-plus years, and things have not changed. This may mean that you might not — even if you have a hospital near you — you might not have a hospital that really can successfully save your child’s life. That is because children are not little adults. There’s different — you really have to be trained to know how to deal with them in emergencies and also even just have the equipment, the specialized sized equipment and so forth, to deal with them in emergencies.
It’s a really sad story. It gets into some of the economic reasons why these hospitals are not prepared. But again, it gives you a sense of a connection to Lauren’s piece, and the Post’s big piece, which is that we have a lot of tools and technology we’ve developed in this country, but if it’s not available to the people when and where they need it, lives don’t get saved.
Rovner: This piece really shook me, because I assume that — I mean, kids are the ones who seem to end up in the emergency room most often. They’re the ones who have accidents and fall off their bikes and get sick in the middle of the night and all those other things, and yet so many emergency rooms are not prepared for them. Anyway, Lauren.
Weber: I picked a piece that is particularly alarming if you know anyone that has a CPAP [continuous positive airway pressure] machine, but it’s titled “Philips Kept Complaints About Dangerous Breathing Machines Secret While Company Profits Soared.” It’s a collaboration between ProPublica, the Pittsburgh Post-Gazette, and Northwestern, and I believe a Netherlands paper, as well. It’s a very disturbing investigation about how Philips knew, had been getting a ton of complaints, that when they rejiggered some of their breathing machines, the foam was disintegrating and chunks of the black material was then getting into people who were using the breathing machine’s lungs and, from the court cases, it appears, causing them potential cancers and adverse health effects.
The FDA, I guess, from reading the piece, requires that companies report complaints, but according to this, Philips did not tell the FDA about all these complaints. It’s a really alarming story, because you’re like, how many other companies are not telling anyone about the complaints they’re receiving? Just really well-done investigation. It appears to be based on court documents, so hats off to them, but very disturbing, again, if you have anyone that has a CPAP or breathing machine they need to sleep, which is vital for everyone. If you have an understanding about how those work, you are hooked up to it, so you are forced to breathe through it, so it really disturbed me that that could be causing you adverse health effects down the road.
Rovner: Yeah, I mean, this is obviously not the first story we’ve seen on this, but it’s certainly one of the most detailed stories that we have seen about this. Well, my story this week is from The Atlantic, by Ron Brownstein. It’s called “Virginia Could Determine the Future of the GOP’s Abortion Policy.” I think he’s right. Virginia votes in odd-numbered years, remember. While Republican Gov. Glenn Youngkin isn’t on the ballot next month, the entire state legislature, which has teetered between Republican and Democratic control over the past several elections, is facing the voters.
Democrats in Virginia, as elsewhere, are charging that if Republicans take back the majority in the State House and Senate, they will restrict abortion, which is likely true, but Republicans say they won’t, quote, “ban abortion,” per se, but would rather set a limit of 15 weeks, with exceptions for rape, incest, and the life of the pregnant person. If voters in a purple state like Virginia see that as a compromise position, rather than a ban, it could set the stage for Republicans elsewhere to fight the current Democratic advantage on the abortion issue. We will see, in about a month, how that all shakes out.
OK, that is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review. That helps other people find us, too. Special thanks, as always, to our amazing engineer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X @jrovner or @julierovner at Bluesky and Threads. Sarah?
Karlin-Smith: I’m @SarahKarlin or @sarahkarlin-smith.
Rovner: Lauren.
Weber: I’m @LaurenWeberHP, for health policy.
Rovner: Victoria.
Knight: I’m @victoriaregisk [on X and Threads].
Rovner: We will be back in your feed next week. Until then, be healthy.
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An Arm and a Leg: John Green vs. Johnson & Johnson (Part 1)
Why is treating drug-resistant tuberculosis so expensive?
Pharmaceutical giant Johnson & Johnson’s patents on a drug called bedaquiline have a lot to do with it.
Why is treating drug-resistant tuberculosis so expensive?
Pharmaceutical giant Johnson & Johnson’s patents on a drug called bedaquiline have a lot to do with it.
In this episode of “An Arm and a Leg,” host Dan Weissmann speaks with writer and YouTube star John Green about how he mobilized his massive online community of “nerdfighters” to change the company’s policy and help make the drug more accessible.
But not every lifesaving drug has a champion with a platform as big as Green’s. Drug companies’ patents limit access to affordable treatments as well.
Weissmann also speaks with drug-patent expert Tahir Amin about how companies keep their drugs under patent for so long and the legal challenges that have been made to these policies around the world.
Dan Weissmann
Host and producer of "An Arm and a Leg." Previously, Dan was a staff reporter for Marketplace and Chicago's WBEZ. His work also appears on All Things Considered, Marketplace, the BBC, 99 Percent Invisible, and Reveal, from the Center for Investigative Reporting.
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Transcript: John Green vs. Johnson & Johnson (Part 1)
Note: “An Arm and a Leg” uses speech-recognition software to generate transcripts, which may contain errors. Please use the transcript as a tool but check the corresponding audio before quoting the podcast.
Dan: Hey there — A little while ago, I got to talk with this widely-beloved dude.
John Green: My name is John Green, and I’m a writer and YouTuber.
Dan: John Green, writer, may be the most likely to ring a bell. His best-known book, “The Fault in Our Stars,” sold millions of copies and became a movie.
But before he was such a big deal as a writer, he and his brother Hank were a big deal on YouTube. And they still are. We’ll get into the details a little bit later.
But for now the thing to know is: Pretty recently, John Green got on the main YouTube channel he and his brother share, and started talking to hundreds of thousands of people about how the drug-maker Johnson & Johnson was using legalistic drug patent games to deny access to life saving tuberculosis medicine to millions of people in poor countries. And John Green wanted anybody listening to stand up and do something about it.
John Green: Tell your friends about this injustice, tell your family, tell the internet, because the only reason Johnson Johnson executives think they can get away with this is that they think we aren’t paying attention in the part of the world where they sell most of their products, their Band Aids, their Tylenol, their Listerine.
Dan: And a lot of the people who watch John Green’s videos– the community calls themselves “nerdfighters” — made a fair amount of noise.
And a few days later, Johnson & Johnson seemed to blink. The company issued a statement saying it would allow a cheaper generic version of that TB drug to be more widely distributed. Here’s John’s brother Hank from their next YouTube video.
Hank Green: And this happened in a week, John, you made a video on Tuesday, “it’s Friday right now! I’m really proud to be a part of this community I’m really proud to be your brother…”
Dan: I mean, that’s a super-fun story that we’re gonna get into: How a self-proclaimed nerd raised an internet posse to influence a global pharma giant to do something pretty decent-sounding.
We are definitely going to tell that story.
… But that story is just a first impression, because the whole thing is bigger and way more complicated.
As John Green would tell you –as he told me – he was adding his bit to a global movement — to advocates and lawyers in places like India, for instance, that have been doing the heavy, heavy lifting, for years.
And, of course, to understand any of this, we are going to have to get into how pharma companies use drug patents. And what it means.
And that is part of where this story comes home.
As John Green mentioned in his video, the story of this tuberculosis drug wouldn’t normally draw a lot of attention in the U.S. TB isn’t one of our top health issues.
But … the mechanisms at play with this tuberculosis drug – the patent games – are some of the same mechanisms that make so many drugs here so expensive: Drugs like Humira, and insulin, and pretty much everything else.
And here’s what’s actually the most interesting part:
Behind the first impression version of this story – nerds in the U.S. and their online posse for people in what’s called the Global South –
There’s a story about people and ideas from the Global South coming here to save the U.S. from our own messed-up drug patent system.
Because they’ve figured out that unless we save ourselves, they’re screwed too. That’s a LOT! And it’s gonna take us two episodes to connect all the dots.
You ready? Here we go…
This is An Arm and a Leg. A show about why health care costs so freaking much, and what we can maybe do about it. I’m Dan Weissmann. I’m a reporter, and I like a challenge. So our job on this show is to take one of the most enraging, terrifying, depressing parts of American life, and to bring you something entertaining, empowering, and useful.
And so, let’s start with John Green — YouTuber.
John and his brother Hank were among the people who invented the idea of being a professional quote-unquote “creator” on the internet – maybe kind of by accident, at first. But they were hugely successful at it.
In 2007, they started posting video messages to each other on this still-kinda-new website called YouTube. They thought a few hundred people might be interested, if they kept it up for a year.
Then Hank posted a song about waiting for the last Harry Potter book to come out.
Hank Green: [Singing] … I’m getting kind of petrified. What would Ron do if Hermione died or if Voldemort killed Hedwig, Just for yucks? …
Dan: It got a million views– which, early YouTube? That was huge. And they were off. Today, that original YouTube channel has more than three and a half million subscribers. Hank now manages more than a hundred full-time employees and a whole bunch of contractors.
And, you know, it’s impossible to sum up the thousands of videos they’ve shared.
Hank Green: Good morning, John. Today we’re gonna be making cinnamon toast two different ways.
John Green: Good morning, Hank, it’s Tuesday. So I need your help with the thing I’m working on. I need to learn some jokes, but not just any jokes.
Dan: But it’s fair to say digressive, ranty arguments are kind of a staple.
John Green: Good morning Hank, it’s Tuesday. I kind of hate Batman.
Hank Green: Good morning, John, you pretty much got Batman entirely wrong.
John Green: Batman is just a rich guy with an affinity for bats who’s playing out his insane fantasy of single-handedly ridding Gotham of crime. How is that heroic?
Hank Green: Of course, I know that Your video on Tuesday wasn’t really about Batman, it was just using Batman as a tool to say something.
Dan: The arguing may have something to do with why they call their community nerd-fighters.
But the idea is more that this is a community of nerds fighting for something. As they put it: fighting to ‘reduce the amount of suck in the world.’
Partly by producing things that can be amusing and sweet and thoughtful – but also by giving money to worthy causes and encouraging others to do the same.
Every year, since the beginning, they have hosted a kind of online telethon called the Project for Awesome.
John Green: Good morning, Hank. It’s Thursday, December 17th, 2009. Time for the Project for Awesome! Hooray! Oh! [crashing sound] Ow! Whoa! I got too excited about the awesome.
Dan: It is SUPER-interactive: People upload videos pitching their favorite charities, they vote, they give. They’ve raised more than 30 million dollars. And a lot of it has gone to an organization called Partners in Health, which provides incredibly effective health services in places like Haiti and Sierra Leone.
And just to indulge my own tendency to nerdy digression here: A book about Partners in Health and its founder, Paul Farmer, is one of my favorite books of all time.
It’s called Mountains Beyond Mountains, and when we finally do start a book club – and I haven’t forgotten making that suggestion here – I want to nominate it as one of our first picks.
Anyway, the Green brothers are huge supporters of Partners in Health. And then, three years ago, John started one of his weekly videos this way.
John Green: Good morning, Hank, it’s Tuesday. So over the next five years, our families are donating six and a half million dollars to Partners in Health Sierra Leone. Also we need your help…
Dan: And here’s where we get to tuberculosis. In the run up to that commitment, John Green visited Sierra Leone with his wife Sarah, and met some of the folks there from Partners in Health.
Here’s how he told the story to me. I’m not gonna interrupt:
John Green: On the last day, two of the physicians from Partners in Health, who we were visiting with said, “Hey, if it’s not a big deal to you, we’d really like to stop by this TB hospital on the way back to the capitol because we have a case we’re really concerned about.” And I said, “Yeah, of course, I’m not going to get in the way of actual doctoring.” So … But I, you know, I didn’t think much of it at the time.
So we get to this TB hospital. And immediately upon arriving, the doctors go off to do doctor stuff. And Sarah and I are just sort of sitting there in this little nine year old boy who tells me his name is Henry, which is my son’s name, at the time, my son was nine, kind of grabs me by the shirt and starts walking me around. And he takes me to the lab, shows me how to look into the microscope to see if a specimen has tuberculosis, introduces me to the lab technician, he takes me to the patient wards, he takes me to the kitchen where they make the food, he takes me all over the hospital, and then eventually I end up in the room with where the doctors are, and, uh, and the, and the kid has departed and I said, you know, “I just spent 30 minutes with an extraordinary child named Henry and he gave me a tour of the whole facility and I have no idea who he is. Is he somebody’s kid? Is he a doctor’s kid?” And one of the doctors said, “you know, that’s what I thought when I first got here, uh, about Henry because he does seem like that. And actually he’s the case that we’re so concerned about that we, um, needed to come here.” And he wasn’t nine. He was 16. He was just really stunted and emaciated by tuberculosis.
And, um, even though he was feeling pretty good at the time, the doctors knew that his treatment for multidrug resistant TB was failing, and that he needed access to a new cocktail that included bedaquiline, this drug that’s been around in the U.S. since 2013, but was, was at the time totally unavailable in Sierra Leone. And so, that was my introduction to TB and we were on our way to the airport and I said, “what’s gonna, what’s gonna happen to that kid?” And they were like, “it’s going to be a difficult path for him um, if we can’t get, if we can’t get the new treatment cocktail to him, he has a very low chance of survival.”
So that’s the beginning of the story for me, is meeting Henry.
Dan: I’m going to skip to the end of this part of the story: Henry’s OK. He’s alive, because he did get the drug cocktail that included Bedaquiline.
But, after that visit, John Green did not know that, and he started obsessing a bit about tuberculosis. Reading about it, thinking about it. And over the last year or so, he started occasionally sharing, making videos about TB. Some of them were fun, short, nerdy explainers.
John Green: What if I told you that tuberculosis gave us the cowboy hat?
John Green: How did TB reinvigorate women’s shoe fashions?
John Green: How did tuberculosis help New Mexico become a state? I’m so glad you asked.
Dan: But he also dug into the deeper reason he’d become obsessed with TB. Because it’s a surprisingly big deal, still.
John Green: It’s almost certain that in the last 2, 000 years, more people died just from tuberculosis than died from all wars combined.
And before you think like, oh, but that’s ancient history. No, more people died last year from tuberculosis than died in war, and every year going back to World War II
Dan: We fact checked that. He’s actually understating things. By a lot.
TB is a growing problem. In the middle of the 20th Century, new medicines took TB off the list of diseases that most people in the rich parts of the world had to worry about. But it never got wiped out.
And in less-rich parts of the world, where access to the best treatments was spottier, drug-resistant strains of TB developed and developed. But no new drugs came out– no drugs for drug-resistant TB.
Until bedaquiline, produced by Johnson & Johnson. The drug that did eventually help save Henry, the kid that John Green met in Sierra Leone.
But bedaquiline is expensive. So people in less-rich parts of the world often can’t get it. One study estimated that eight out of nine people who needed treatment with a drug like bedaquiline weren’t getting it.
And of course medicines stay expensive when they’re under patent protection: Once the patent on a drug expires, anybody can make and sell a generic version of the drug. Which, you know, competition, usually allows prices to fall.
And in one way, as John Green started making tuberculosis videos in 2022, it might have seemed like there was hope coming up:
Bedaquiline was patented in 2003. Patents last twenty years. By 2023, that patent would expire.
Except, not really. Because it turns out, patents on drugs have ways of living for way more than twenty years.
That’s next.
MIDROLL: This episode of An Arm and a Leg is produced in partnership with KFF Health News. That’s a nonprofit newsroom that covers health care in America. KFF Health News are amazing journalists – their work wins all kinds of awards every year – and I’m honored to work with them. We’ll have a little more information about KFF at the end of this episode.
Dan: So, let’s talk about drug patents and how they work– and why they don’t just last 20 years. And this is something my colleague Emily Pisacreta has been interested in for a long time.
Emily: It’s true. As I’ve said before on the show, I’m an insulin-dependent diabetic. If I can’t get insulin, I’m literally dead. And, insulin is super expensive. And insulins have became so expensive in part because of the kinds of patents on them – even though those patents are way more than twenty years old! ..
Dan: Right, so you’ve got a big interest in this question: How can a patent last more than twenty years?
Emily: And Dan, my answer to that question is a riddle: When is a patent not a patent?
Dan: OK, I give up. When is a patent not a patent.
Emily: When it’s 74 patents.
Dan: Yeah, this riddle is going to need some explaining.
Emily: Right. So, for a while I used an insulin called Lantus.It’s a once-a-day, long acting insulin made by the French company Sanofi. Sanofi first patented Lantus in 1994. So, that should mean it’s out of patent protection by 2014, right?
Dan: Uh-huh
Emily: Except, according to a report from a few years back, Sanofi actually filed for 74 patents on Lantus. And a lot of those patents were filed WAY after 1994. So, ONE patent from 1994 would’ve lasted till 2014. 74 patents could’ve lasted until 2031.
Dan: Ah, hence the very-specific answer for your riddle. I mean, I knew the principle – these insulin products have multiple patents on them, but 74 is … more than I’d imagined. What are 74 things you even COULD patent?
Emily: I mean, for Lantus, there are patents on formulations to improve stability. Like, all right … But there are also patents on the pen cartridge that Lantus comes in. And inside of that, a whole bunch of patents on the drive mechanisms, like the little plastic piston that lets you pick the right dose. These kinds of things.
Dan: OK. Now, I notice you said, those 74 patents COULD’ve lasted until 2031?
Emily: That’s right. As it turns out, in the case of Lantus, another drug maker actually did fight some of Sanofi’s later patents and won. But more often – and I mean a lot more often — simply filing for a patent is enough to keep generic makers away.
Dan: Sure. Who wants to spend money fighting a patent lawsuit when you could just y’know, manufacture some other drug?
Emily: Right. And of course this is not just insulin.
Tahir Amin: Oh, this is the standard practice. This happens with every drug.
Emily: That’s Tahir Amin – one of the big global experts on drug patents. Tahir the CEO and cofounder of a non-profit called I-MAK, which stands for …
Tahir Amin: The Initiative for Medicines Access and Knowledge. We work on building a more just and equitable access to medicine system.
Emily: The report that documented 74 patents on Lantus, that one insulinI used to use? Tahir’s group wrote it. And Tahir says this is business as usual, because it means big money.
Tahir Amin: Particularly when you’re talking about some of the drugs that you see in the US market, like for rheumatoid arthritis, these are worth billions of dollars.
Emily: Tahir’s group did a study on the 12 best-selling drugs in the U.S. They had an average of 131 patents each. If all the patents stick, that’s an average of 38 years of patent protection.
Dan: So maybe we can update your riddle:
When is a patent not a patent?
When it’s 131 patents.
Emily: Yeah, activists and experts call this kind of thing “patent thicketing” or “evergreening.”
Dan: I’ve been reading up on this too. Drug companies have their own name for this practice. They call it “life-cycle management.”
Emily: What a term of art. And actually bedaquiline, the TB drug,is a great example. In 2014, Tahir did what they call a “patent landscape” on bedaquiline, mapping all the different patents J&J filed around the world.
Tahir Amin: We all knew that with the advent of multiple drug resistance TB, we needed to know how we’re gonna get these drugs to the communities and the countries that need them most.
Emily: He identified a long list of patents J&J filed. And the most important being the original formula for the drug, set to expire in 2023, and the second most important patent was on something called the salt formulation for the drug.
Dan: Salt formulation.
Emily: Yep, and it’s kind of worth getting into the weeds here just for a second. Because this sort of thing is at the absolute heart of these drug patent games. When you develop a drug, the first step is finding a molecule that works in a test tube, that does the thing you want, like kills the germ. That gonna be the first patent, that molecule. But the molecule isn’t medicine.
Tahir Amin: You have to develop it, formulate it so that it’s actually more bioavailable, that it can get into the bloodstream and, and do whatever biological activity that it does. And this is classic organic chemistry stuff that is routine.
Emily: It’s routine. SO what he’s saying here, and other experts agree, by the way, identifying a salt formulation that can work as medicine isn’t where the innovation is. And most importantly, it doesn’t have to take a long time. But J&J didn’t apply for their secondary patent on it until a full four years after their initial patent.
Dan: I’ve started reading about “lifecycle management,” you know, what the pharma industry calls all this. And this is literally the playbook. One lawyer has advice about when to file this kind of secondary patent, here’s what he says, quote:
“You want to do this as late as possible, but before clinical trials. If Company X can hold off filing for two or three years during the drug discovery phase, it will buy more time on the back end of the patent’s term.”
Emily: Yep, and J & J waited four years. A little extra.
Dan: And we asked Johnson & Johnson: Hey, did you put off filing this secondary patent on the salt formulation to stretch out your patent rights? We haven’t heard back.
So: TB advocates kind of had their eye on July 2023. Because in July 2023 the original patent that Johnson & Johnson had on bedaquiline was set to expire. And the secondary patent, this sort of basic add on, was to become the next big obstacle.
So, back to John Green. He’s learning all this stuff about TB – including about how the secondary patent on bedaquiline is gonna keep clamping down access.
And he’s making all these TB videos, but it’s not like he has some kind of big plan:
John Green: But the, for me, You know, this is all I was thinking about. It was the first thing I thought about in the morning and the last thing I thought about before I went to sleep, is how did we end up in a world where the world’s deadliest infectious disease is largely ignored in the richest parts of the world?
Dan: And he was getting kind of discouraged.
John Green: I felt powerless before it. And this is one of the real lessons for me is that I felt like, well, what … what are we going to do? It’s not like Johnson & Johnson is going to abandon the idea of secondary patents, right?
Dan: He knew: secondary patents can be worth billions of dollars.
John Green: And so they’re not going to abandon these attempts to make their patents last longer than they should because they’re a for profit company. And I felt really … Yeah, I just felt powerless.
Dan: And then, earlier this year, something changed. It was not something that John Green, or an army of nerds could have done, or could’ve done anything about.
It was done by India’s patent office – responding to a legal challenge brought by two young women who had survived tuberculosis – one from India and one from South Africa.
It was based on legal work that our new pal Tahir Amin and others did in India almost twenty years ago.
And gave John Green an idea of how an army of nerdfighters could join this battle.
That’s next time, on An Arm and a Leg. Till then, take care of yourself.
This episode of An Arm and a Leg was produced by me, Dan Weissmann, and Emily Pisacreta – with help from Bella Cjazkowski, and edited by Ellen Weiss.
Daisy Rosario is our consulting managing producer.
Adam Raymonda is our audio wizard.
Our music is by Dave Winer and Blue Dot Sessions.
Gabrielle Healy is our managing editor for audience. She edits the First Aid Kit Newsletter.
Bea Bosco is our consulting director of operations.
Sarah Ballema is our operations manager.
An Arm and a Leg is produced in partnership with KFF Health News–formerly known as Kaiser Health News. That’s a national newsroom producing in-depth journalism about health care in America, and a core program at KFF — an independent source of health policy research, polling, and journalism.
And yes, you did hear the name Kaiser in there, and no: KFF isn’t affiliated with the health care giant Kaiser Permanente. You can learn more about KFF Health News at armandalegshow.com/KFF.
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KFF Health News' 'What the Health?': Countdown to Shutdown
The Host
Julie Rovner
KFF Health News
Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.
Health and other federal programs are at risk of shutting down, at least temporarily, as Congress races toward the Oct. 1 start of the fiscal year without having passed any of its 12 annual appropriations bills. A small band of conservative House Republicans are refusing to approve spending bills unless domestic spending is cut beyond levels agreed to in May.
Meanwhile, former President Donald Trump roils the GOP presidential primary field by vowing to please both sides in the divisive abortion debate.
This week’s panelists are Julie Rovner of KFF Health News, Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat News, and Tami Luhby of CNN.
Panelists
Alice Miranda Ollstein
Politico
Rachel Cohrs
Stat News
Tami Luhby
CNN
Among the takeaways from this week’s episode:
- The odds of a government shutdown over spending levels are rising. While entitlement programs like Medicare would be largely spared, past shutdowns have shown that closing the federal government hobbles things Americans rely on, like food safety inspections and air travel.
- In Congress, the discord isn’t limited to spending bills. A House bill to increase price transparency in health care melted down before a vote this week, demonstrating again how hard it is to take on the hospital industry. Legislation on how pharmacy benefit managers operate is also in disarray, though its projected government savings means it could resurface as part of a spending deal before the end of the year.
- On the Senate side, legislation intended to strengthen primary care is teetering under Bernie Sanders’ stewardship — in large part over questions about how to pay for it. Also, this week Democrats broke Alabama Republican Sen. Tommy Tuberville’s abortion-related blockade of military promotions (kind of), going around him procedurally to confirm the new chair of the Joint Chiefs of Staff.
- And some Republicans are breaking with abortion opponents and mobilizing in support of legislation to renew the United States President’s Emergency Plan for AIDS Relief — including the former president who spearheaded the program, George W. Bush. Meanwhile, polling shows President Joe Biden is struggling to claim credit for the new Medicare drug negotiation program.
- And speaking of past presidents, former President Donald Trump gave NBC an interview over the weekend in which he offered a muddled stance on abortion. Vowing to settle the long, inflamed debate over the procedure — among other things — Trump’s comments were strikingly general election-focused for someone who has yet to win his party’s nomination.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: The Washington Post’s “Inside the Gold Rush to Sell Cheaper Imitations of Ozempic,” by Daniel Gilbert.
Alice Miranda Ollstein: Politico’s “The Anti-Vaccine Movement Is on the Rise. The White House Is at a Loss Over What to Do About It,” by Adam Cancryn.
Rachel Cohrs: KFF Health News’ “Save Billions or Stick With Humira? Drug Brokers Steer Americans to the Costly Choice,” by Arthur Allen.
Tami Luhby: CNN’s “Supply and Insurance Issues Snarl Fall Covid-19 Vaccine Campaign for Some,” by Brenda Goodman.
Also mentioned in this week’s episode:
- The AP’s “Biden’s Medicare Price Negotiation Is Broadly Popular. But He’s Not Getting Much Credit,” by Seung Min Kim and Linley Sanders.
- Roll Call’s “Sanders, Marshall Reach Deal on Health Programs, but Challenges Remain,” by Jessie Hellmann and Lauren Clason.
CLICK TO EXPAND THE TRANSCRIPT
Transcript: Countdown to Shutdown
[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.]
Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Sept. 21, at 9 a.m. because, well, lots of news this week. And as always, news happens fast, and things might well have changed by the time you hear this. So here we go. We are joined today via video conference by Tami Luhby of CNN.
Tami Luhby: Good morning.
Rovner: Rachel Cohrs of Stat News.
Rachel Cohrs: Hi, everybody.
Rovner: And Alice Miranda Ollstein of Politico.
Alice Miranda Ollstein: Hello.
Rovner: Let’s get to some of that news. We will begin on Capitol Hill, where I might make a T-shirt from this tweet from Wednesday from longtime congressional reporter Jake Sherman: “I feel like this is not the orderly appropriations process that was promised after the debt ceiling deal passed.” For those of you who might’ve forgotten, many moons ago, actually it was May, Congress managed to avoid defaulting on the national debt, and as part of that debt ceiling deal agreed to a small reduction in annual domestic spending for the fiscal year that starts Oct. 1 (as in nine days from now). But some of the more conservative Republicans in the House want those cuts to go deeper, much deeper, in fact. And now they’re refusing to either vote for spending bills approved by the Republican-led appropriations committee or even for a short-term spending bill that would keep the government open after this year’s funding runs out. So how likely is a shutdown at this point? I would hazard a guess to say pretty likely. And anybody disagree with that?
Ollstein: It’s more likely than it was a week or two ago, for sure. The fact that we’re at the point where the House passing something that they know is dead on arrival in the Senate would be considered a victory for them. And so, if that’s the case, you really have to wonder what the end game is.
Rovner: Yeah, I mean it was notable, I think, that the House couldn’t even pass the rule for the Defense Appropriations Bill, which is the most Republican-backed spending bill, and the House couldn’t get that done. So I mean it does not bode well for the fate of some of these domestic programs that Republicans would, as I say, like to cut a lot deeper. Right?
Cohrs: Democrats are happy, I think, to watch Republicans flail for a while. I think we saw this during the speaker votes. Obviously, a CR [continuing resolution] could pass with wide bipartisan support, but I think there’s a political interest for Democrats going into an election year next year to lean into the idea of the House Republican chaos and blaming them for a shutdown. So I wouldn’t be too optimistic about Democrats billing them out anytime soon.
Rovner: But, bottom line, of course, is that a shutdown is not great for Democrats who support things that the government does. I mean, Tami, you’re watching, what does happen if there’s a shutdown? Not everything shuts down and not all the money stops flowing.
Luhby: No, and the important thing, unlike in the debt ceiling, potentially, was that Social Security will continue, Medicare will continue, but it’ll be very bothersome to a lot of people. There’ll be important things that … potentially chaos at airlines and food safety inspectors. I mean some of them are sometimes considered essential workers, but there’s still issues there. So people will be mad because they can’t go to their national parks potentially. I mean it’s different every time, so it’s a little hard to say exactly what the effects will be and we’ll see also whether this will be a full government shutdown, which will be much more serious than a partial government shutdown, although at this point it doesn’t look like they’re going to get any of the appropriation bills through.
Rovner: I was going to say, yeah, sometimes when they get some of the spending bills done, there’s a partial shutdown because they’ve gotten some of the spending bills done, but I’m pretty sure they’ve gotten zero done now. I think there’s one that managed to pass both the House and the Senate, but basically this would be a full shutdown of everything that’s funded through the appropriations process. Which as Tami points out, the big things are the Smithsonian and the National Zoo close, and national parks close, but also you can’t get an awful lot of government services. Meanwhile, the ill will among House Republicans is apparently rubbing off on other legislation. The House earlier this week was supposed to vote on a relatively noncontroversial package of bills aimed at making hospital insurance and drug prices more transparent, among other things. But even that couldn’t get through. Rachel, what happened to the transparency bill that everybody thought was going to be a slam-dunk?
Cohrs: Well, I don’t think everybody thought it was going to be a slam-dunk given the chaos that we saw, especially in the Democratic Caucus last week, where one out of three chairmen who work on health care in the House endorsed the package, but the other two would not. And they ran into a situation where, with the special rule that they were using to consider the House transparency package, they needed two-thirds vote to pass and they couldn’t get enough Democrats on board to pass it. And I think there were some process concerns from both sides that there was a compromise that came out right after August recess and it hadn’t been socialized properly and they didn’t have their ducks in a row in the Democratic side. But ultimately, I mean, the big picture for me I think was how hard it really is to take on the hospital industry. Because this was the first real effort I think from the House and it melted down before its first vote. That doesn’t mean it’s dead yet, but it was an embarrassment, I think, to everyone who worked on this that they couldn’t get this pretty noncontroversial package through. And when I tried to talk to people about what they actually oppose, it was these tiny little details about a privacy provision or one transparency provision and not with the big idea. It wasn’t ideological necessarily. So I think it was just a reflection on Congress has taken on pharma, they’re working on PBMs this year, but if they really do want to tackle hospital costs, which are a very big part of Medicare spending, it’s going to be a tough road ahead for them.
Rovner: As we like to point out, every single member of Congress has a hospital in their district, and they are quick to let their members of Congress know what they want and how they want them to vote on things. Before we move on, where are we on the PBM legislation? I know there was a whole raft of hearings this week on doing something about PBMs. And my inbox is full of people from both sides. “The PBMs are making drug prices higher.” “No, the PBMs are helping keep drug prices in check.” Where are we with the congressional effort to try and at least figure out what the PBMs do?
Cohrs: Yeah, I think there is still some disarray at this point. I would watch for action in December or whenever we actually have a conversation about government funding because some of these PBM bills do save money, which is the golden ticket in health care because there are a lot of programs that need to be paid for this year. So Congress will continue to debate those over the next couple of weeks, but I think everyone that I talk to is expecting potential passage in a larger package at the end of the year.
Rovner: So speaking of things that need to be paid for, the saga of Sen. Bernie Sanders and the reauthorization of some key primary care programs, including the popular community health center program, continues. When we left off last July, Sen. Sanders, who chairs the Senate Health, Education, Labor & Pensions Committee [HELP], tried to advance a bill to extend and greatly expand primary care programs without negotiating with his ranking Republican on the committee, Louisiana Sen. Bill Cassidy, who had his own bill to renew the programs. Cassidy protested and blocked the bill’s movement and the whole enterprise came to a screeching halt. Last week, Sanders announced he’d negotiated a bipartisan bill, but not with Cassidy, rather with Kansas Republican Roger Marshall, who chairs the relevant subcommittee. Cassidy, however, is still not pleased. Rachel, you’re following this. Sanders has scheduled a markup of the bill for later today. Is it really going to happen?
Cohrs: Well, I think things are on track and the thing to remember about a markup is it passes on a majority. So as long as Sen. Sanders can keep his Democratic members in line and gets Sen. Marshall, then it can pass committee. But I think there are some concerns that other Republicans will share with Sen. Cassidy about how the bill is paid for. There are a lot of ambitious programs to expand workforce training, have debt forgiveness, and address the primary care workforce crisis in a more meaningful way. But the list of pay-fors is a little undisciplined from what I’ve seen, I would say.
Rovner: That’s a good word.
Cohrs: Sen. Sanders is pulling some pay-fors from other committees, which he can’t necessarily do by himself, and they don’t actually have estimates from the Congressional Budget Office for some of the pay-fors that they’re planning to use. They’re just using internal committee math, which I don’t think is going to pass muster with Republicans in the full Senate, even if it gets through committee today. So I think we’ll see some of those concerns flare up. It could get ugly today compared with HELP markups of the past of community health center bills. And there are certainly some concerns about the application of the Hyde Amendment too, and how it would apply to some of this funding as it moves through the appropriations process.
Rovner: That’s the amendment that bans direct government funding of abortion, and there’s always a fight about the Hyde Amendment, which are reauthorizing these health programs. But I mean, we should point out, I mean this is one of the most bipartisanly popular programs, both the community health center program and these programs that basically give federal money to train more primary care doctors, which the country desperately needs. I mean, it’s something that pretty much everybody, or most of Congress, supports, but Cassidy has what, 60 amendments to this bill. I guess he’s really not happy. Cassidy who supports this in general just is unhappy with this process, right?
Cohrs: I think his concern is more that the legislation is half-baked, not that he’s against the idea of it. And Sen. Cassidy did sign on to a more limited House proposal as well, just saying, we need to fund the community health centers, we need to do something. This isn’t ready for prime time. We could see further negotiations, but the time is ticking for this funding to expire.
Rovner: Well, another program whose authorization expires at the end of the month is PEPFAR, the international AIDS/HIV program. It’s being blocked by anti-abortion activists among others, even though it doesn’t have anything to do with the abortion. And this is not just a bipartisan program, it’s a Republican-led program. Former President George W. Bush who signed it into law in 2003, had an op-ed this week pushing for the program in The Washington Post. Alice, you’ve been following this one. Is there any progress on PEPFAR?
Ollstein: Yes and no. There’s not a vote scheduled, there’s not a “Kumbaya” moment, but we are seeing some movement. I call it “Establishment Republican Strike Back.” You have some both on- and off-the-Hill Republicans really mobilizing to say, “Look, we need to reauthorize this program. This is ridiculous.” And they’re going against the anti-abortion groups and their allies on Capitol Hill who say, “No, let’s just extend this program just year by year through appropriations, not a reauthorization.” Which they say would rubber-stamp the Biden administration redirecting money towards abortion, which the Biden administration and everybody else denies is happening. And so we confirmed that Chairman Mike McCaul in the House and Lindsey Graham in the Senate are working with Democrats on some sort of reauthorization bill. It might not be the full five years, it might be three years, we don’t really know yet. But they think that at least a multiyear reauthorization will give the program some stability rather than the one-year funding patch that other House Republicans are mulling. So we’re going to see where this goes; obviously, it’s an interesting test for the influence of these anti-abortion groups on Capitol Hill. And my colleague and I also scooped that former President Bush, who oversaw the creation of this program, is quietly lobbying certain members, having meetings, and so we will see what kind of pull he still has in the party.
Rovner: Well, this was one of his signature achievements, literally. So it’s something that I know that … and we should point out, unlike the spending bills, the appropriation bills, if this doesn’t happen by Oct. 1, nothing stops, it’s just it becomes theoretically unauthorized, like many programs are, and it’s considered not a good sign for the program.
Luhby: One thing I also wanted to just bring up quickly, tangentially related to health care, but also showing how bipartisan programs are not getting the support that they did, is the WIC program, which is food assistance for women, infants and children, needs more money. Actually participation is up, but even before that, the House Republicans wanted to cut the funding for it, and that was going to be a big divide between them and the Senate. And now because participation is up, the Biden administration is actually asking for another $1.4 billion for the program. This is a program that, again, has always had support and has been fully funded, not had to turn people away. And now it’s looking that many women and small children may not be able to get the assistance if Congress isn’t able to actually fund the program fully.
Rovner: Yes, they’re definitely tied in knots. Well, Oct. 1 turns out to be a key date for a lot of health care issues. It’s also the day drugmakers are supposed to notify Medicare whether they will participate in negotiations for the 10 high-cost drugs Medicare has chosen for the first phase of the program that Congress approved last year. But that might all get blocked if a federal judge rules in favor of a suit brought by the U.S. Chamber of Commerce, among others. Rachel, there was a hearing on this last week, where does this lawsuit stand and when do we expect to hear something from the judge?
Cohrs: So the judge didn’t ask any questions of the attorneys, so they were essentially presenting arguments that we’ve already seen previewed in some of the briefing materials. We are expecting some action by Oct. 1, which is when the Chamber had requested a ruling on whether there’s going to be a preliminary injunction, just because drugmakers are supposed to sign paperwork and submit data to CMS by that Oct. 1 date. So I think we are just waiting to see what the ruling might be. Some of the key issues or whether the Chamber actually has standing to file this lawsuit, given it’s not an actual drug manufacturer. And there was some quibbling about what members they listed in the lawsuit. And then I think they only addressed the argument that the negotiation program violated drugmakers’ due process rights, which isn’t the full scope of the lawsuit. It’s not an indicator of success really anywhere else, but it is important because it is the very first test. And if a preliminary injunction is issued, then it brings everything to a halt. So I think it would be very impactful for other drugmakers as well.
Rovner: Nobody told me when I became a health reporter that I was going to have to learn every step of the civil judicial process, and yet here we are. Well, while we are still on the subject of drug prices, a new poll from the AP and the NORC finds that while the public, Republicans and Democrats, still strongly support Medicare being able to negotiate the price of prescription drugs, President [Joe] Biden is getting barely any credit for having accomplished something that Democrats have been pushing for for more than 20 years. Most respondents in the survey either don’t think the plan goes far enough, because, as we point out, it’s only the first 10 drugs, or they don’t realize that he’s the one that helped push it over the finish line. This should have been a huge win and it’s turning out to be a nothing. Is that going to change?
Ollstein: It’s kind of a “Groundhog Day” of the Obamacare experience in which they pass this big, huge reform that people had been fighting for so long, but they’re trying to campaign on it when people aren’t really feeling the effects of it yet. And so when people aren’t really feeling the benefit and they’re hearing, “Oh, we’re lowering your drug prices.” But they’re going to the pharmacy and they’re paying the same very high amount, it’s hard to get a political win from that. The long implementation timeline is against them there. So there are some provisions that kick in more quickly, so we’ll have to see if that makes any kind of difference. I think that’s why you hear them talk a lot about the insulin price cap because that is already in effect, but that hits fewer people than the bigger negotiation will theoretically hit eventually. So it’s tough, and I think it leaves a vacuum where the drug industry and conservatives can fearmonger or raise concerns and say, “This will make drugs inaccessible and they won’t submit new cures for approval.” And all this stuff. And because people aren’t feeling the benefits, but they’re hearing those downsides, yeah, that makes the landscape even tougher for Democrats.
Luhby: This is very much the pattern that the Biden administration has had with a lot of its achievements or successes because it’s also not getting any credit for anything in the economy. The job market is relatively strong still, the economy is relatively strong. Yes, we have high inflation and high prices, even though that’s moderated, prices are still high, and that’s what people are seeing. Gas prices are now up again, which is not good for the administration. But they’re touting their Bidenomics, which also includes lowering drug prices. But generally polling shows, including our CNN polling shows, that people do not think the economy is doing well and they’re not giving Biden any credit for anything.
Cohrs: I think part of the problem is that … it’s different from the Affordable Care Act where it was health care, health care, health care for a very long time. This is lumped into a bill called the Inflation Reduction Act. I think it got lumped in with climate, got looped in with tax. And the media, we did our best, but it was hard to explain everything that was in the bill. And Medicare negotiation is complicated, it’s wonky, and I don’t know that people fully understood everything that was in the Inflation Reduction Act when it passed and they capitulated to Sen. [Joe] Manchin for what he wanted to name it. And so I think some of that got muddled when it first passed and they’re kind of trying to do catch-up work to explain, again, like Alice said, something that hasn’t gone into effect, which is a really tough uphill climb.
Rovner: This has been a continuing frustration for Democrats, which is that actually getting legislation done in Washington always involves some kind of compromise, and it’s always going to be incremental. And the public doesn’t really respond to things that are incremental. It’s like, “Why isn’t it bigger? Why didn’t they do what they promised?” And so the Republicans get more credit for stopping things than the Democrats get for actually passing things. Right. Well, let us turn to abortion. The breaking news today is that the Senate is finally acting to bust the blockade Alabama Republican Sen. Tommy Tuberville has had on military promotion since February to protest a Defense Department policy allowing service people leave to travel to other states for abortions. And Tuberville himself is part of this breakage, right, Alice? And it’s not a full breakage.
Ollstein: Right. And there have also been some interesting interviews that maybe raise questions on how much Tuberville understands the mechanics of what he’s doing because he said in an interview, “Oh, well, the people who were in these jobs before, they’ll just stay in it and it’s fine.” And they had to explain, “Well, statutorily, they can’t after a certain date.” And he seemed surprised by that. And now you’re seeing these attempts to go around his own blockade, and Democrats to go around his blockade. In part, for a while, Democrats were really not wanting to do that, schedule these votes, until he fully relented because they thought that would increase the pressure.
Rovner: They didn’t want to do it nomination by nomination for the big-picture ones because they were afraid that would leave behind the smaller ones.
Ollstein: Exactly. But this is dragging on so long that I think you’re seeing some frustration and desire to do something, even if it’s not fully resolving the standoff.
Rovner: And I’m seeing frustration from other Republicans. Again, the idea of a Republican holding up military promotions for six months is something that was not on my Republican Bingo card five years ago or even two years ago. I’m sure he’s not making a lot of his colleagues very happy with this. So on the Republican presidential campaign trail, abortion continues to be a subject all the candidates are struggling with — all of them, it seems, except former President Donald Trump, who said in an interview with NBC on Sunday that he alone can solve this. Francis, you have the tape.
Donald Trump: We are going to agree to a number of weeks or months or however you want to define it, and both sides are going to come together, and both sides, and this is a big statement, both sides will come together and for the first time in 52 years, you’ll have an issue that we can put behind us.
Rovner: OK. Well, Trump — who actually seemed all over the place about where he is on the issue in a fairly bald attempt to both placate anti-abortion hardliners in the party’s base and those who support abortion rights, whose votes he might need if he wants to win another election — criticized his fellow Republicans, who he called, “inarticulate on the subject.” I imagine that’s not going over very well among all of the other Republican candidates, right?
Ollstein: We have a piece up on this this morning. One, Trump is clearly acting like he has already won the primary, so he is trying to speak to a general audience, as you noted, and go after those votes in the middle that he may need and so he’s pitching this compromise. And we have a piece that the anti-abortion groups are furious about this, but they don’t really know what to do about it because he probably is going to be the nominee and they’re probably going to spend tens of millions to help elect him if he is, even though they’re furious with these comments he’s making. And so it’s a really interesting moment for their influence. Of course, Trump is trying to have it both ways, he also is calling himself the most pro-life president of all time. He is continually taking credit for appointing the justices to the Supreme Court who overturned Roe v. Wade.
Rovner: Which he did.
Ollstein: Exactly.
Rovner: Which is true.
Ollstein: Which he definitely did. But he is not toeing the line anymore that these groups want. These groups want him to endorse some sort of federal ban on abortion and they want him to praise states like Florida that have passed even stricter bans. He is not doing that. And so there’s an interesting dynamic there. And now his primary opponents see this as an opening, they’re trailing him in the polls, and so they’re trying to capitalize on this. [Gov. Ron] DeSantis and a bunch of others came out blasting him for these abortion remarks. But again, he’s acting like he’s already won the primary, he’s brushing it off and ignoring them.
Rovner: I love how confident he is though, that there’s a way to settle this — really, that there is a compromise, it’s just nobody’s been smart enough to get to it.
Ollstein: Well, he also, in the same interview, he said he’ll solve the Ukraine-Russia war in a day. So I mean, I think we should consider it in that context. It was interesting when I talked to all these different anti-abortion groups, they all said the idea of cutting some sort of deal is ludicrous. There is no magic deal that everybody would be happy about. If anything …
Rovner: And those on the other side will say the same thing.
Ollstein: Exactly. How could you watch what’s happened over the past year or 30 years and think that’s remotely possible? However, they did acknowledge that him saying that does appeal to a certain kind of voter, who is like, “Yeah, let’s just compromise. Let’s just get past this. I’m sick of all the fighting.” So it’s another interesting tension.
Rovner: Yeah. And I love how Trump always says the quiet part out loud, which is that this is not a great issue for Republicans and they’re not talking about it right. It’s like Republicans know this is a not-great issue for Republicans, but they don’t usually say that in an interview on national television. That is Trump, and this will continue. Well, finally this week I wanted to talk about what I am calling the dark underbelly of the new weight loss drugs. This is my extra credit this week. It’s a Washington Post story by Daniel Gilbert called “Inside the Gold Rush to Sell Cheaper Imitations of Ozempic.” It’s about the huge swell of sometimes not-so-legitimate websites and wellness spas selling unapproved formulations of semaglutide and tirzepatide — better known by their brand names Ozempic, Wegovy, and Mounjaro — to unsuspecting consumers because the demand for these diabetes drugs is so high for people who want to lose weight. The FDA has declared semaglutide at least to be in shortage for the people it was originally approved for, those with Type 2 diabetes. But that designation legally allows compounding pharmacies to manufacture their own versions, at least in some cases, except to quote the piece, “Since then, a parallel marketplace with no modern precedent has sprung up attracting both licensed medical professionals and entrepreneurs with histories ranging from regulatory violations to armed robbery.” Meanwhile, and this is coming from a separate story, both Eli Lilly and Novo Nordisk, the manufacturers of the approved versions of the drugs, are suing companies they say are selling unapproved versions of their drug, including, in some cases, drugs that actually pretend to be the brand name drug that aren’t. This is becoming really a big messy buyer-beware market, right? Rachel, you guys have written about this.
Cohrs: It has. Yeah, my colleagues have done great coverage, including I think the lawsuit by manufacturers of these drugs who are seeing their profits slipping through their fingers as patients are turning to these alternatives that aren’t necessarily approved by the FDA. And I think there are also risks because we have seen some side effects from these medications; they range from some very serious GI symptoms to strange dreams. There’s just a whole lot going on there. And I think it is concerning that some patients are getting ahold of these medications, which are expensive if you’re buying them the traditional way. And again, for weight loss, I think some of these medications are still off-label, they’re not FDA-approved. So if they’re getting these without any supervision from a medical provider or somebody who they can ask when they have questions that come up and are monitoring for some of these other side effects, then I think it is a very dangerous game for these patients. And I think it’s just a symptom of this outpouring of interest and the regulators’, I think, failure to keep up with it. And there’s also some supply concerns. So I think it’s just this perfect storm of desperation from patients and the bureaucracy struggling to keep up.
Rovner: Yeah. One of the reasons I chose the story is I really feel like this is unprecedented. I mean, I suppose it could have been predicted because these drugs do seem to be very good at what they do and they are very expensive and very hard to get, so not such a surprise that not-so-honest people might spring up to try and fill the void. But it’s still a little bit scary to see people selling heaven only knows what to people who are very anxious to take things.
Luhby: And in related news, there are more doctors who are interested in obesity medicine now, so everyone is trying to cash in.
Rovner: Yeah, I mean, eventually I imagine this will sort itself out. It’s just that at the beginning when it’s so popular, although I will still … I keep thinking this, is the solution to really throw this much money at it or to try to figure out how to make these drugs cheaper? If it’s going to be such a societal good, maybe we should do something about the price. Anyway, that is my extra credit in this week’s news. Now we will take a quick break and then we’ll come back with the rest of our extra credits.
Hey, “What the Health?” listeners, you already know that few things in health care are ever simple. So, if you like our show, I recommend you also listen to “Tradeoffs,” a podcast that goes even deeper into our costly, complicated, and often counterintuitive health care system. Hosted by longtime health care journalist and friend Dan Gorenstein, “Tradeoffs” digs into the evidence and research data behind health care policies and tells the stories of real people impacted by decisions made in C-suites, doctors’ offices, and even Congress. Subscribe wherever you listen to your podcasts.
OK, we are back and it’s time for our extra-credit segment. That’s when we each recommend a story we read this week we think you should read, too. As always, don’t worry if you miss it; we will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Tami, why don’t you go first this week?
Luhby: Sure. Well, this week I chose a good story by one of my colleagues, Brenda Goodman. It’s titled “Supply and Insurance Issues Snarl Fall Covid-19 Vaccine Campaign for Some.” And we’ve all been hearing this, I heard this from a friend of mine who’s a doctor, we know Cynthia Cox at KFF tweeted about this. And that even though the new vaccines are ready and the Biden administration has been pushing people to go get them, and many people are eager to get them, they’re not so easy to get. Either because drugstores are running out, that’s what happened to my friend. She went in and said there just wasn’t any supply available. Or for some other people, they’re supposed to be free for most Americans, but the insurance companies haven’t caught up with that yet. So they go in and either they’re denied or the pharmacy tells them that they have to pay potentially $200 for the vaccines. So the problem here is that there’s already an issue with getting vaccines and people getting vaccinated in this country and then putting up extra hurdles for them will only cause more problems and cause fewer people to get vaccinated because some people may not come back.
Rovner: Talk about something that should have been predictable. The distributors knew it was going to be available and pretty much when, and the insurance companies knew it was going to be available and pretty much when, and yet somehow they seem to have not gotten their act together when the predictable surge of people wanting to get the vaccine early came about. Alice, you wanted to add something?
Ollstein: Just anecdotally, the supply and the demand are completely out of whack. My partner is back home in Alabama right now and he was at a pharmacy where they were just wandering around asking random people, “Will you take the shot? Will you take the shot?” And a bunch of people were saying, “No.” And meanwhile, here in D.C., myself and everyone I know is just calling around wanting to get it and not able to. And so you think we’d have figured this out better after so many years of this.
Rovner: Well, I have an appointment for tomorrow. We’ll see if it happens. Rachel, why don’t you go next?
Cohrs: Sure. I chose a KFF Health News story by Arthur Allen, and the headline is “Save Billions or Stick With Humira? Drug Brokers Steer Americans to the Costly Choice.” And I just love a story where it’s off the news cycle a little bit and we see this big splashy announcement. And I think Arthur did a great job of following up here and seeing what actually was happening with formulary placement for Humira and the new biosimilars that just came on the market.
Rovner: Yep. Remind us what Humira is?
Cohrs: Oh, yeah. So it’s one of the most profitable drugs ever. The company that makes it, AbbVie, had created this big patent thicket to try to prevent it from competition for a very long time, but this year saw competition that had been on the market in Europe finally come online in the U.S. So again, a big change for AbbVie, for the market. But I think there was concern about whether people would actually switch to these new medications that have lower prices. But again, as it gets caught up and spit out of our drug supply chain, there are a whole lot of incentives that don’t necessarily result in the cheaper medication being prescribed. And Arthur found that Express Scripts and Optum, which are two of the three biggest pharmacy benefit managers, have the biosimilar versions of Humira at the same price as Humira. So that doesn’t really create a lot of incentive for people to switch. So I think it was just great follow-up reporting and we don’t really have a lot of visibility into these formularies sometimes. So I think it was a illuminating piece.
Rovner: Yeah. And the mess that is drug pricing. Alice.
Ollstein: So I also chose a great piece by my colleague Adam Cancryn and it’s called “The Anti-Vaccine Movement Is on the Rise. The White House Is at a Loss Over What to Do About It.” It’s part of a series we’re doing on anti-vax sentiment and its impacts. And this is just going into how the Biden administration really doesn’t have a plan for combating this, even as it’s posing a bigger and bigger public health threat. And some of their attempts to go after misinformation online were stymied in court and they also are struggling with not wanting to elevate it by debunking it — that that age-old tension of, is it better to just ignore it or is it better to combat it directly? A lot of this is also tying into RFK Jr.’s presidential bid and how much to acknowledge that or not. But the impact is that they’re not really taking this on, even as it’s getting worse and worse in the country.
Rovner: And I got a bunch of emails this week about the anti-vax movement spreading to pets — that people are now resisting getting their dogs and cats vaccinated. Seriously. I mean, it is a serious problem. Obviously, if people stop getting rabies vaccines, that could be a big deal. So something else to watch. All right. Well, I already did my extra credit. So that is it for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks as always to our indefatigable engineer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me; I’m still @jrovner on X and on Bluesky. Tami?
Luhby: You can tweet me at @Luhby. I sometimes check it still.
Rovner: Rachel.
Cohrs: I’m on X @rachelcohrs.
Rovner: Alice.
Ollstein: I’m @AliceOllstein.
Rovner: We will be back in your feed next week. Until then, be healthy.
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2 years 1 month ago
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Save Billions or Stick With Humira? Drug Brokers Steer Americans to the Costly Choice
Tennessee last year spent $48 million on a single drug, Humira — about $62,000 for each of the 775 patients who were covered by its employee health insurance program and receiving the treatment. So when nine Humira knockoffs, known as biosimilars, hit the market for as little as $995 a month, the opportunity for savings appeared ample and immediate.
But it isn’t here yet. Makers of biosimilars must still work within a health care system in which basic economics rarely seems to hold sway.
For real competition to take hold, the big pharmacy benefit managers, or PBMs, the companies that negotiate prices and set the prescription drug menu for 80% of insured patients in the United States, would have to position the new drugs favorably in health plans.
They haven’t, though the logic for doing so seems plain.
Humira has enjoyed high-priced U.S. exclusivity for 20 years. Its challengers could save the health care system $9 billion and herald savings from the whole class of drugs called biosimilars — a windfall akin to the hundreds of billions saved each year through the purchase of generic drugs.
The biosimilars work the same way as Humira, an injectable treatment for rheumatoid arthritis and other autoimmune diseases. And countries such as the United Kingdom, Denmark, and Poland have moved more than 90% of their Humira patients to the rival drugs since they launched in Europe in 2018. Kaiser Permanente, which oversees medical care for 12 million people in eight U.S. states, switched most of its patients to a biosimilar in February and expects to save $300 million this year alone.
Biologics — both the brand-name drugs and their imitators, or biosimilars — are made with living cells, such as yeast or bacteria. With dozens of biologics nearing the end of their patent protection in the next two decades, biosimilars could generate much higher savings than generics, said Paul Holmes, a partner at Williams Barber Morel who works with self-insured health plans. That’s because biologics are much more expensive than pills and other formulations made through simpler chemical processes.
For example, after the first generics for the blockbuster anti-reflux drug Nexium hit the market in 2015, they cost around $10 a month, compared with Nexium’s $100 price tag. Coherus BioSciences launched its Humira biosimilar, Yusimry, in July at $995 per two-syringe carton, compared with Humira’s $6,600 list price for a nearly identical product.
“The percentage savings might be similar, but the total dollar savings are much bigger,” Holmes said, “as long as the plan sponsors, the employers, realize the opportunity.”
That’s a big if.
While a manufacturer may need to spend a few million dollars to get a generic pill ready to market, makers of biosimilars say their development can require up to eight years and $200 million. The business won’t work unless they gain significant market share, they say.
The biggest hitch seems to be the PBMs. Express Scripts and Optum Rx, two of the three giant PBMs, have put biosimilars on their formularies, but at the same price as Humira. That gives doctors and patients little incentive to switch. So Humira remains dominant for now.
“We’re not seeing a lot of takeup of the biosimilar,” said Keith Athow, pharmacy director for Tennessee’s group insurance program, which covers 292,000 state and local employees and their dependents.
The ongoing saga of Humira — its peculiar appeal to drug middlemen and insurers, the patients who’ve benefited, the patients who’ve suffered as its list price jumped sixfold since 2003 — exemplifies the convoluted U.S. health care system, whose prescription drug coverage can be spotty and expenditures far more unequal than in other advanced economies.
Biologics like Humira occupy a growing share of U.S. health care spending, with their costs increasing 12.5% annually over the past five years. The drugs are increasingly important in treating cancers and autoimmune diseases, such as rheumatoid arthritis and inflammatory bowel disease, that afflict about 1 in 10 Americans.
Humira’s $200 billion in global sales make it the best-selling drug in history. Its manufacturer, AbbVie, has aggressively defended the drug, filing more than 240 patents and deploying legal threats and tweaks to the product to keep patent protections and competitors at bay.
The company’s fight for Humira didn’t stop when the biosimilars finally appeared. The drugmaker has told investors it doesn’t expect to lose much market share through 2024. “We are competing very effectively with the various biosimilar offerings,” AbbVie CEO Richard Gonzalez said during an earnings call.
How AbbVie Maintains Market Share
One of AbbVie’s strategies was to warn health plans that if they recommended biosimilars over Humira they would lose rebates on purchases of Skyrizi and Rinvoq, two drugs with no generic imitators that are each listed at about $120,000 a year, according to PBM officials. In other words, dropping one AbbVie drug would lead to higher costs for others.
Industry sources also say the PBMs persuaded AbbVie to increase its Humira rebates — the end-of-the-year payments, based on total use of the drug, which are mostly passed along by the PBMs to the health plan sponsors. Although rebate numbers are kept secret and vary widely, some reportedly jumped this year by 40% to 60% of the drug’s list price.
The leading PBMs — Express Scripts, Optum, and CVS Caremark — are powerful players, each part of a giant health conglomerate that includes a leading insurer, specialty pharmacies, doctors’ offices, and other businesses, some of them based overseas for tax advantages.
Yet challenges to PBM practices are mounting. The Federal Trade Commission began a major probe of the companies last year. Kroger canceled its pharmacy contract with Express Scripts last fall, saying it had no bargaining power in the arrangement, and, on Aug. 17, the insurer Blue Shield of California announced it was severing most of its business with CVS Caremark for similar reasons.
Critics of the top PBMs see the Humira biosimilars as a potential turning point for the secretive business processes that have contributed to stunningly high drug prices.
Although list prices for Humira are many times higher than those of the new biosimilars, discounts and rebates offered by AbbVie make its drug more competitive. But even if health plans were paying only, say, half of the net amount they pay for Humira now — and if several biosimilar makers charged as little as a sixth of the gross price — the costs could fall by around $30,000 a year per patient, said Greg Baker, CEO of AffirmedRx, a smaller PBM that is challenging the big companies.
Multiplied by the 313,000 patients currently prescribed Humira, that comes to about $9 billion in annual savings — a not inconsequential 1.4% of total national spending on pharmaceuticals in 2022.
The launch of the biosimilar Yusimry, which is being sold through Mark Cuban’s Cost Plus Drugs pharmacy and elsewhere, “should send off alarms to the employers,” said Juliana Reed, executive director of the Biosimilars Forum, an industry group. “They are going to ask, ‘Time out, why are you charging me 85% more, Mr. PBM, than what Mark Cuban is offering? What is going on in this system?’”
Cheaper drugs could make it easier for patients to pay for their drugs and presumably make them healthier. A KFF survey in 2022 found that nearly a fifth of adults reported not filling a prescription because of the cost. Reports of Humira patients quitting the drug for its cost are rife.
Convenience, Inertia, and Fear
When Sue Lee of suburban Louisville, Kentucky, retired as an insurance claims reviewer and went on Medicare in 2017, she learned that her monthly copay for Humira, which she took to treat painful plaque psoriasis, was rising from $60 to $8,000 a year.
It was a particularly bitter experience for Lee, now 81, because AbbVie had paid her for the previous three years to proselytize for the drug by chatting up dermatology nurses at fancy AbbVie-sponsored dinners. Casting about for a way to stay on the drug, Lee asked the company for help, but her income at the time was too high to qualify her for its assistance program.
“They were done with me,” she said. Lee went off the drug, and within a few weeks the psoriasis came back with a vengeance. Sores covered her calves, torso, and even the tips of her ears. Months later she got relief by entering a clinical trial for another drug.
Health plans are motivated to keep Humira as a preferred choice out of convenience, inertia, and fear. While such data is secret, one Midwestern firm with 2,500 employees told KFF Health News that AbbVie had effectively lowered Humira’s net cost to the company by 40% after July 1, the day most of the biosimilars launched.
One of the top three PBMs, CVS Caremark, announced in August that it was creating a partnership with drugmaker Sandoz to market its own cut-rate version of Humira, called Hyrimoz, in 2024. But Caremark didn’t appear to be fully embracing even its own biosimilar. Officials from the PBM notified customers that Hyrimoz will be on the same tier as Humira to “maximize rebates” from AbbVie, Tennessee’s Athow said.
Most of the rebates are passed along to health plans, the PBMs say. But if the state of Tennessee received a check for, say, $20 million at the end of last year, it was merely getting back some of the $48 million it already spent.
“It’s a devil’s bargain,” said Michael Thompson, president and CEO of the National Alliance of Healthcare Purchaser Coalitions. “The happiest day of a benefit executive’s year is walking into the CFO’s office with a several-million-dollar check and saying, ‘Look what I got you!’”
Executives from the leading PBMs have said their clients prefer high-priced, high-rebate drugs, but that’s not the whole story. Some of the fees and other payments that PBMs, distributors, consultants, and wholesalers earn are calculated based on a drug’s price, which gives them equally misplaced incentives, said Antonio Ciaccia, CEO of 46Brooklyn, a nonprofit that researches the drug supply chain.
“The large intermediaries are wedded to inflated sticker prices,” said Ciaccia.
AbbVie has warned some PBMs that if Humira isn’t offered on the same tier as biosimilars it will stop paying rebates for the drug, according to Alex Jung, a forensic accountant who consults with the Midwest Business Group on Health.
AbbVie did not respond to requests for comment.
One of the low-cost Humira biosimilars, Organon’s Hadlima, has made it onto several formularies, the ranked lists of drugs that health plans offer patients, since launching in February, but “access alone does not guarantee success” and doesn’t mean patients will get the product, Kevin Ali, Organon’s CEO, said in an earnings call in August.
If the biosimilars are priced no lower than Humira on health plan formularies, rheumatologists will lack an incentive to prescribe them. When PBMs put drugs on the same “tier” on a formulary, the patient’s copay is generally the same.
In an emailed statement, Optum Rx said that by adding several biosimilars to its formularies at the same price as Humira, “we are fostering competition while ensuring the broadest possible choice and access for those we serve.”
Switching a patient involves administrative costs for the patient, health plan, pharmacy, and doctor, said Marcus Snow, chair of the American College of Rheumatology’s Committee on Rheumatologic Care.
Doctors’ Inertia Is Powerful
Doctors seem reluctant to move patients off Humira. After years of struggling with insurance, the biggest concern of the patient and the rheumatologist, Snow said, is “forced switching by the insurer. If the patient is doing well, any change is concerning to them.” Still, the American College of Rheumatology recently distributed a video informing patients of the availability of biosimilars, and “the data is there that there’s virtually no difference,” Snow said. “We know the cost of health care is exploding. But at the same time, my job is to make my patient better. That trumps everything.”
“All things being equal, I like to keep the patient on the same drug,” said Madelaine Feldman, a New Orleans rheumatologist.
Gastrointestinal specialists, who often prescribe Humira for inflammatory bowel disease, seem similarly conflicted. American Gastroenterological Association spokesperson Rachel Shubert said the group’s policy guidance “opposes nonmedical switching” by an insurer, unless the decision is shared by provider and patient. But Siddharth Singh, chair of the group’s clinical guidelines committee, said he would not hesitate to switch a new patient to a biosimilar, although “these decisions are largely insurance-driven.”
HealthTrust, a company that procures drugs for about 2 million people, has had only five patients switch from Humira this year, said Cora Opsahl, director of the Service Employees International Union’s 32BJ Health Fund, a New York state plan that procures drugs through HealthTrust.
But the biosimilar companies hope to slowly gain market footholds. Companies like Coherus will have a niche and “they might be on the front end of a wave,” said Ciaccia, given employers’ growing demands for change in the system.
The $2,000 out-of-pocket cap on Medicare drug spending that goes into effect in 2025 under the Inflation Reduction Act could spur more interest in biosimilars. With insurers on the hook for more of a drug’s cost, they should be looking for cheaper options.
For Kaiser Permanente, the move to biosimilars was obvious once the company determined they were safe and effective, said Mary Beth Lang, KP’s chief pharmacy officer. The first Humira biosimilar, Amjevita, was 55% cheaper than the original drug, and she indicated that KP was paying even less since more drastically discounted biosimilars launched. Switched patients pay less for their medication than before, she said, and very few have tried to get back on Humira.
Prescryptive, a small PBM that promises transparent policies, switched 100% of its patients after most of the other biosimilars entered the market July 1 “with absolutely no interruption of therapy, no complaints, and no changes,” said Rich Lieblich, the company’s vice president for clinical services and industry relations.
AbbVie declined to respond to him with a competitive price, he said.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
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2 years 1 month ago
Health Care Costs, Health Industry, Pharmaceuticals, Drug Costs, Kentucky, New York, Prescription Drugs, Tennessee
KFF Health News' 'What the Health?': Welcome Back, Congress. Now Get to Work.
The Host
Julie Rovner
KFF Health News
Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.
Congress returns from its August recess with a long list of things to do and not a lot of time to do them. The fiscal year ends Sept. 30, and it’s possible that lawmakers will fail to finish work not only on the annual appropriations bills, but also on any short-term spending bill to keep the government open.
Meanwhile, Medicare has announced the first 10 drugs whose prices will be negotiated under the Inflation Reduction Act of 2022. Exactly how the program will work remains a question, however. Even how the process will begin is uncertain, as drugmakers and other groups have filed lawsuits to stop it.
This week’s panelists are Julie Rovner of KFF Health News, Rachel Cohrs of Stat, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, and Alice Miranda Ollstein of Politico.
Panelists
Rachel Cohrs
Stat News
Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico
Alice Miranda Ollstein
Politico
Among the takeaways from this week’s episode:
- Hard-line Republicans are refusing to back even a temporary government spending bill, suggesting a government shutdown looms — with repercussions for health programs. While the Senate and House have come to intra-chamber agreements on subjects like community health center funding or even have passed spending bills, Congress as a whole has been unable to broker an overarching deal.
- A coalition of House Republicans is falsely claiming that global HIV/AIDS funding through PEPFAR promotes abortion and is battling efforts to extend the program’s funding. PEPFAR is a bipartisan effort spearheaded by then-President George W. Bush and credited with saving millions of lives.
- The PEPFAR fight underscores the dysfunction of the current Congress, which is struggling to fund even a highly regarded, lifesaving program. Another example is the months-long blockade of military promotions by a freshman Republican senator, Alabama’s Tommy Tuberville, a member of the Senate Armed Services Committee. His objections over an abortion-related Pentagon policy have placed him at odds with top military leaders, who recently warned that his heavy-handed approach is weakening military readiness.
- The Biden administration recently announced new staffing requirements for nursing homes, as a way to get more nurses into such facilities. But how long will compliance take, considering ongoing nursing shortages? And the drug industry is reacting to the news of which 10 drugs will be up first for Medicare negotiation, with much left to be sorted out.
- In abortion news, a Texas effort to block patients seeking abortions from using the state’s roads is spreading town to town — and, despite being dubiously enforceable, it could still have a chilling effect.
Also this week, Rovner interviews Meena Seshamani, who leads the federal Medicare program, about the plan to start negotiating drug prices.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: JAMA Health Forum’s “Health Systems and Social Services — A Bridge Too Far?” by Sherry Glied and Thomas D’Aunno.
Alice Miranda Ollstein: The Washington Post’s “Heat’s Hidden Risk,” by Shannon Osaka, Erin Patrick O’Connor, and John Muyskens.
Rachel Cohrs: The Wall Street Journal’s “How Novartis’s CEO Learned From His Mistakes and Got Help From an Unlikely Quarter,” by Jared S. Hopkins.
Joanne Kenen: Politico’s “How to Wage War on Conspiracy Theories,” by Joanne Kenen, and “Court Revives Doctors’ Lawsuit Saying FDA Overstepped Its Authority With Anti-Ivermectin Campaign,” by Kevin McGill.
Also mentioned in this week’s episode:
- The Washington Post’s “Highways Are the Next Antiabortion Target. One Texas Town Is Resisting,” by Caroline Kitchener.
- KFF Health News’ “Biden Administration Proposes New Standards to Boost Nursing Home Staffing,” by Jordan Rau.
- Stat’s “The Curious Case of J&J’s Stelara, The Unluckiest Drug on Medicare’s List,” by Rachel Cohrs.
Click to open the transcript
Transcript: Welcome Back, Congress. Now Get to Work.
[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]
Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Sept. 7, at 10 a.m. As always, news happens fast, and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Rachel Cohrs of Stat News.
Rachel Cohrs: Good morning.
Rovner: Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico.
Joanne Kenen: Hi, everybody.
Rovner: And Alice Miranda Ollstein of Politico.
Alice Miranda Ollstein: Hello.
Rovner: Later in this episode, we’ll have an interview with Meena Seshamani, who runs the Medicare program for the federal government, with an update on the Medicare drug negotiation debate as, we’ll discuss, the first 10 drugs that will be subject to negotiation were announced last week. But first, this week’s news. So Labor Day is behind us, and Congress is back — sort of. The Senate is back. The House returns next week. And there are lots of questions to be answered this fall, starting with whether or not Congress can finish the annual spending bills before the start of fiscal 2024 on Oct. 1. Spoiler: They cannot. But there’s also a real question whether Congress can even pass a short-term bill to keep the government running while lawmakers continue to work on the rest of the appropriations. As of now, what do you guys think are the odds that we’re going to end up with some kind of government shutdown at the end of the month?
Ollstein: Well, it’s whether it happens at the end of the month or at the end of the year, really. Folks seem pretty convinced that it will happen at some point. It could be short-lived. But, yeah, like you said, you have some hard-line House Republicans who say they won’t support even a temporary stopgap bill without spending cuts, policy changes, without sort of extracting some of their demands from leadership. And you could work around that in the House by cobbling together a coalition of Republicans and Democrats. But that also puts [House Speaker Kevin] McCarthy’s leadership in jeopardy. And so, we’re having sort of the same dynamic play out that we saw earlier this year, trying to navigate between the hard-line House Republicans and, you know, the more vulnerable swing districts’ members. So it’s … tough.
Rovner: Yeah, it’s the Republicans from districts that [President Joe] Biden won … basically.
Ollstein: Yeah. And so you have this weird game of chicken right now where both the House and Senate are trying to pass whatever they can to give themselves more leverage in the ultimate House-Senate negotiations. They think, OK, if we pass five bills and they only pass one, you know, then we have the upper hand. So we’ll see where that goes.
Rovner: It’s funny, because the Senate has been a well-oiled machine this year on the spending bills, which is unusual. I was about to say I will point out that there are two women: the chairman and ranking member. But that’s actually also true in the House. We do have women running the appropriations process this year. But I was amused that Kevin McCarthy, sometime during August, a couple of weeks ago, said, you know, very confidently, well, we’ll pass a short-term spending bill. You know, we won’t let the government shut down. And by the next day, the hard-line Republicans, the right wing, were saying, yeah, no you won’t. You’re going to have to deal with us first. And, obviously, there’s lots of health stuff that’s going to get caught up in that. The end of the fiscal year also marks the end of funding authority for a number of prominent programs. This is not the same as the appropriations programs whose authorizations lapse can continue, although things can get complicated. PEPFAR, the two-decade-old bipartisan program that provides AIDS and HIV prevention and treatment around the world, is one of those programs that, at least as of now, looks pretty stuck. Alice, is there any movement on this? We’ve talked about it before.
Ollstein: Not yet. So the latest we know, and we got this last night, is that [Foreign Relations Committee] Chairman [Bob] Menendez in the Senate is floating a new compromise. Basically, supporters of PEPFAR have been pushing for the full five-year standard reauthorization. And a coalition of House Republicans who are claiming that PEPFAR money is going to abortion say they want no reauthorization at all. They just want the program to sort of limp along through appropriations. So between five years and zero, Menendez is now suggesting a three-year extension. There is a huge desire not to just have the one-year funding patch because that would kick all of this into the heat of the 2024 season. And if you think the debate is ugly now over abortion and federal spending, just wait until 2024.
Kenen: I mean, this … [unintelligible] money … it’s saved tens of millions of lives — and with bipartisan support in the past.
Rovner: It was a Republican initiative.
Kenen: Right. It was President Bush, George the second.
Rovner: George W. Bush. Yeah.
Kenen: And they’re not saying they’re actually going out and using the AIDS dollars to conduct, to actually do abortions. They’re saying that there’s, you know, they’re in the world of abortion and they’re promoting abortion, etc., etc. So the conversation gets really, really, really, really muddled. Under U.S. law, they cannot use U.S. dollars for abortion under the Hyde Amendment, you know, all sorts of other foreign policy rules. So it’s hard to overstate how important this program has been, particularly in Africa. It has saved millions and millions of lives. And I think Alice might have broken the story originally, but it got caught up in abortion politics, and it caught people by surprise. This is not something … everything in Washington gets caught up in politics, except this! So I think it’s been quite shocking to people. And it’s, I mean — life-and-death sounds like a, you know, it’s a Washington cliché — this is life-and-death.
Ollstein: Yeah, absolutely. And, you know, even though the program won’t shut down if they don’t manage to get a reauthorization through, you know, I talked to people who run PEPFAR services in other countries, and they said that, you know, having this year-to-year funding and instability and uncertainty — you know, they won’t be able to hire, they won’t be able to do long-term planning. They said this will really undermine the goal to eliminate HIV transmission by 2030.
Cohrs: Oh, I actually did just want to jump in about another Sept. 30 deadline, because there was a big development this week. I know we were just talking about long-term planning. There is funding for community health centers that’s expiring at the end of September as well. DSH cuts could go into effect for hospitals. We do this routine every so often, but the House is actually more in step than the Senate on this issue; they released — at least Republicans released — a draft legislation, where all three committees of jurisdiction are in agreement about how to proceed. There are some transparency measures in there.
Rovner: The three committees in the House.
Cohrs: In the House. Yes, yes, we’re talking about the House. Yeah. So, they have reconciled their differences here and are hoping to go to the floor this month. So, I think they are out of the gate first, certainly with some sort of longer-term solution here. Again, could get punted. But I think it is a pretty big development when we’re talking about these extenders that the industry cares about very much.
Kenen: Congress is so polarized that it can’t even do the things that it agrees on. And we have seen this before where CHIP [Children’s Health Insurance Program] got caught up a few years ago. Community health clinics have gotten caught right in that same bill, right? But, you know, we really have this situation where it’s so dysfunctional they can’t even move fully on things that everybody likes. And community health centers date back to the early ’60s. However, they got a really big expansion, again, under second President Bush. And they’re popular, and they serve a need, and everybody likes them.
Rovner: They got a bigger expansion under the Affordable Care Act.
Kenen: Right, but they, you know — but I think that the Bush years was like the biggest in many years. And then they got more. So again, I mean, are they going to shut their doors? No. Is it going to be a mess? It is already a mess. They can’t — they don’t know what’s coming next. That’s no way to run a railroad or a health clinic.
Rovner: All right, well, one more while we’re on the subject of abortion-related delays: Alabama Sen. Tommy Tuberville is still blocking Senate approval of routine military promotions to protest the Biden administration’s policy of allowing funding for servicewomen and military dependents to travel for abortions if they’re posted to states where it’s banned. Now, the secretaries of the Army, Navy, and Air Force are joining together to warn that Tuberville’s hold is threatening military readiness. Tuberville apparently went on Fox News last night and said he’s got more people who are coming to support him. Is there any end to this standoff in sight? I mean, people seem to be getting kind of upset about it. It’s been going on since, what, February?
Ollstein: Yeah, there is not yet an end in sight. So far, all of the attempts to pressure Tuberville to back down have only hardened his resolve, it seems, you know, and he’s gone beyond sort of his original statement of, you know, all of this is just to get rid of this policy that doesn’t pay for abortions; it just allows people to travel out of state if they’re stationed — they don’t get to choose where they’re stationed — if they’re stationed somewhere where abortion is not legal or accessible. And so now he’s making claims about other things in the military he considers too woke. He’s criticized some of these individual nominees themselves that he’s blocking, which was not sort of part of the original stand he took. And so, it’s tough, and there isn’t enough floor time to move all of these and go around him. And so this pressure campaign doesn’t seem to be really making any headway. So I don’t really see how this gets resolved at this point.
Kenen: Except that other Republicans are getting a little bit more public. I mean, they were sort of letting him run out for a while. And there’s more Republicans who are clearly getting enough of this. But I mean, unless McConnell can really get him to move — and we don’t know what’s gone on behind closed doors, but we’re certainly not seeing any sign of movement. In fact, as Alice said, he’s digging in more. I mean, like, Marines and woke are not the two words you usually hear in one sentence, but in his worldview, they are. So, I think it’s unprecedented. I mean, I don’t think anyone’s ever done this. It’s not like one or two people. It’s like the entire U.S. military command can’t move ahead.
Rovner: I’ve been doing this a very long time, and I don’t remember anything quite like this. Well, the one thing that we do expect to happen this fall is legislation on — and Rachel, you were referring to this already — sort of health care price transparency and PBMs, the pharmacy benefit managers. Where are we with that? They were supposed to work on it over the August break. Did they?
Cohrs: They were supposed to work on it. The House was clearly working on it and reconciling some of their differences. They’re planning to introduce legislative text on Friday. So, I think Democrats aren’t on board yet, so things could change from the draft they had been circulating early this week. But again, Republicans don’t really need Democrats to move forward, at least in the House. The Senate has been pretty quiet so far. Not to say that no work has gone on, but they certainly weren’t ready for the rollout in the same way that the House was. You know, I think there are still some big questions about, you know, what they’re planning to accomplish with insulin policy, how they’re planning to fit together this jigsaw puzzle of PBM transparency and reforms that have come out of different committees. And I think it’ll come down to [Senate Majority Leader] Sen. Schumer making some tough choices. And from my understanding, that hasn’t quite happened yet. But if the actual showdown happens November, December, they still have some time.
Rovner: Yeah. Now they’re not going out early. They’re clearly going to be fighting over the appropriation. So, the legislative committees have plenty of time to work on these other things. All right. Well, let’s turn to Medicaid for a moment. The quote-unquote “unwinding” continues as states move to redetermine who remains eligible for the program and who doesn’t following the pandemic pause. As predicted, it’s been a bit of a bumpy road. And now it seems a bunch of states have been incorrectly dropping children from Medicaid coverage because their parents are no longer eligible. That’s a problem because nationwide, income limits for children’s eligibility is higher than parents’. In some states, it is much higher. I remember after Hurricane Katrina, in Louisiana, parents were only eligible if they earned 15% of poverty. Somebody said 50, and the Medicaid director said, “No, 15, one-five.” Whereas kids are eligible to, I believe it’s 200% of poverty. And I think that’s a national level.
Kenen: Now, in some states it’s higher.
Rovner: Yes. But I say this is happening in a bunch of states because federal government won’t tell us how many or which ones. We do know it’s more than a dozen, but this is the second time the administration has admonished states for wrongly canceling Medicaid coverage. And they wouldn’t say which states were involved at that time either. Is this an effort to keep this as apolitical as possible, given that the states most likely to be doing this are red states who are trying to remove ineligible people from Medicaid as fast as they can, that they’re trying to sort of keep this from becoming a Republican versus Democrat thing.
Ollstein: It seems like, from what we’re hearing, that the administration is really wary of publicly picking a fight with these states. They want the states to work with them. And so, even if the states are going about this in a way they think is totally wrong, they don’t want to just put them publicly on blast, because they think that’ll make them, again, double down and refuse to work with the government at all. And so, they’re trying to maintain some veneer of cooperation. But at the same time, you’re having, you know, millions of people, including children, falling through the cracks. And so, you know, we have sort of this sternly-worded-letter approach and we’ll see if that accomplishes anything, and if not, you know, what measures can be taken. You know, the administration also created a way for states to hit pause on the process and take a little more time and do a little more verification of people’s eligibility. And some — a couple states — have taken advantage of that, and it’s been successful in, you know, having fewer people dropped for paperwork reasons, but it’s not really happening in the states where it sort of most needs to happen, according to experts.
Rovner: The administration has had fingers pointed at it, too, because apparently it approved some of these plans from the states that were going to look at total family income without realizing that, oh, that meant that kids who are still eligible could end up losing coverage because their parents are no longer eligible.
Kenen: Right. And I also read something yesterday that in some cases it’s sort of a technical issue rather than a “how much outreach and what your intentions are,” that it’s a programing issue, which is related to what Julie just said about the plan. So, it’s not that these states set about to drop these kids, and there may be some kind of goodwill to fix it, in which case you don’t want to get in — and I don’t know that it’s 100% red states either. So —
Rovner: No, that’s clear. We assume, because they’re the ones going fastest, but we do not know.
Kenen: Right, so that there seems to be some kind of — the way it was set up, technically, that can be remedied. And if it’s a technical fix as opposed to an ideological fight, you don’t really want to — you want to figure out how to reprogram the computer or whatever it is they have to do and then go back and catch the people that were lost. So, they’ve been pretty low-key about politicizing rewinding in general. But on the kids, I think they’re going to be even more — CHIP passed, another thing with bipartisan support that’s a mess. I mean, it seems to be the theme of the day. But, you know, CHIP was created on a bipartisan basis, and it’s always been sustained on a bipartisan basis. So, I think that the issue, I don’t know how technically easy it is to fix, but there’s a big difference in how the administration goes after someone that’s intentionally doing something versus someone who wrote their computer programmer set something up wrong.
Rovner: Well, we will definitely keep on this one.
Kenen: But it’s a big mess. It’s a lot of kids.
Rovner: It is a big mess. And let’s turn to the thing that is not bipartisan in Congress, and that is —
Kenen: That’ll be a bigger mess.
Rovner: — Medicare drug negotiations. Yes. While we were away, the federal government released its much-anticipated list of the 10 brand-name drugs that will be the first tranche up for potential price negotiation. I say potential, because the companies have the option of negotiating or not — sort of — and because there are now, I think, nine lawsuits challenging the entire program. My interview with Medicare administrator Meena Seshamani will get into the nuts and bolts of how the negotiation program is supposed to work. But Rachel, tell us a little bit about the drugs on the list and how their makers are trying to cancel this entire enterprise before it even begins.
Cohrs: Sure. So, a lot of these drugs that we’re seeing on the list are blood thinners. Some are diabetes medications. There are drugs for heart failure, rheumatoid arthritis, Crohn’s disease, and there’s also a cancer treatment, too. But I think overall, the drugs were chosen because they have high cost to Medicare. And it was —
Rovner: So that either could mean a lot of people use an inexpensive drug —
Cohrs: Yes.
Rovner: — or a few people use a very expensive drug.
Cohrs: Correct. And it was Wall Street’s favorite parlor game to try to guess what drugs were going to be on this list of 10 drugs that are going to be the guinea pigs to go through this program for the very first time. But it was interesting, because there were a few surprises. Medicare officials were using newer data than Wall Street analysts had access to. So, there were a couple drugs, especially further down on the list, that people used more in the period CMS [Centers for Medicare & Medicaid Services] was studying than had been used previously. So, we saw a couple very interesting instances of a drug being chosen for the list, even though it just kind of fell through the cracks. It was J&J’s [Johnson & Johnson’s] Stelara. It’s a Crohn’s disease treatment, and it does have competition coming in the market soon, but just because of a fluke of kind of when it was approved by the FDA, it just missed cutoffs for some of these exemptions and is now subject to some pretty significant discounts through the program.
Rovner: We’ll link to your very sad story about Stelara.
Cohrs: Sad for the company, but not sad for the patients who will hopefully be paying less for this medication. And there’s also the case of Astellas [Pharma Inc.], which makes a prostate cancer drug that’s very expensive. A lot of people expected that to be selected, but actually wasn’t. And Astellas had sued the Biden administration already before the list came out and then had to withdraw their lawsuit yesterday because their argument that they were going to be harmed by this legislation was made much weaker by the fact that they weren’t selected for this first year of the program. So, who knows? They could dust off their arguments a year from now or two years from now. But it was interesting to see kind of some of these surprises on the list. Again, there are still several, like you mentioned, outstanding lawsuits in several different jurisdictions. I think the main one that we’re watching is by the [U.S.] Chamber of Commerce, which requested a preliminary injunction by the end of this month. So, we’ll see if that comes through. But it is a very long road to 2026. There might be a new administration by then. So, I think there are still a lot of questions about whether this reaches the finish line. But I think it’s a very important step for CMS to get this list out there in the world.
Rovner: So, I spent some time digging in my notes from earlier years, and I dug up notes from an interview I did on Aug. 26 with a spokesperson from the drug industry about how the Medicare drug benefit, quote, “impact the ability of companies to research new medicines. And if that happens, the elderly would be the ones hurt the most.” That quote, by the way, was from Aug. 26 of 1987. Some things truly never change. But is this maybe, possibly, the beginning of the end of drugmakers being able to charge whatever they want in the United States? Because it’s the only country where they can.
Cohrs: Oh, they can still charge whatever they want. This law doesn’t change that. It just changes the fact that Medicare won’t be paying whatever drugmakers happen to charge for an unlimited amount of time. Like, they can still charge whatever they want to Medicare for as long as they can get on the market before they’re selected for this negotiation program. But certainly there could be significant cost — significant savings to Medicare, even if those prices are high. And it’s just kind of a measure that forces price reductions, even if the generic or biosimilar market isn’t functioning to lower those prices through competition.
Kenen: Right. And it’s only Medicare. So, people who are not on Medicare — insurance companies also negotiate prices, but they’re not the government. It’s different. But I mean, these drugs are not going to start being, you know, three bucks.
Rovner: But they may stop being 300,000.
Kenen: Well, we don’t know, because there are some people who think that if Medicare is paying less, they’re going to charge everybody else more. We just don’t know. We don’t know what their behavior is going to be. But no, this does not solve the question of affordability of medication in the United States.
Rovner: The drug companies certainly think it’s the camel’s nose under the tent.
Kenen: They have some medicine for camels’ noses that they can charge a lot of money for, I’m sure.
Rovner: I bet they do. While we are on the subject of things that I have covered since the 1980s, last week the Biden administration finally put out its regulation requiring that nursing homes be staffed 24/7/365 by, you know, an actual nurse. One of the first big reconciliation bills I covered was in 1987 — that was a big year for health policy — and it completely overhauled federal regulation of nursing homes, except for mandating staffing standards, because the nursing homes said they couldn’t afford it. Basically, that same fight has been going on ever since. Except now the industry also says there aren’t enough nurses to hire, even if they could afford it. Yet patient advocates say these admittedly low staffing ratios that the Biden administration has put out are still not enough. So, what happens now? Is this going to be like the prescription drug industry, where they’re going to try to sue their way out of it? Or is it going to be more like the hospital transparency, where they’re just not going to do it and say, “Come and get us”?
Kenen: My suspicion is litigation, but it’s too soon to know. I assume that either one of the nursing home chains — because there are some very big corporations that own a lot of nursing homes — there are several nursing home trade industry groups, for-profit, nonprofit. Does one owner — is in an area where there is a workforce shortage, because that does exist. I mean, I’d be surprised if we don’t see some litigation, because when don’t we see that? I mean, it’s rare. That’s the norm in health care, is somebody sues. Some of the workforce issues are real, but also this proposal doesn’t go into effect tomorrow. It’s not like — but I mean, there are issues of the nursing workforce. There are issues about not just the number of nurses, but do we have them in the right places doing the right jobs? It’s not just RNs [registered nurses]; there are also shortages of other direct care workers. I did a story a few months ago on this, and there are actually nursing homes that have closed entire wings because they don’t have enough staff, and those are some of the nonprofits. There are nursing issues.
Rovner: And a lot of nursing home staff got sick at the beginning of the covid pandemic, and many of them died before there were good treatments. I mean, it’s always been a very hard and not very well-paid job to care for people in nursing homes. And then it became a not very pleasant, not very well-paid, and very deadly job. So I don’t think that’s probably helping the recruitment of people to work in nursing.
Kenen: Right, but the issue — I think a lot of people, when you have your first family experience with a nursing home or, you know, or those of us reporters who hadn’t been familiar with them until we went and did some stories on them, I think people are surprised at how little nursing there actually is. It’s nurses’ aides; it’s, you know, what they used to call licensed practical nurses or nursing assistants; and CNAs, certified nursing assistants. They’re various; different states have different names. But these are not four-year RNs. The amount of actual nursing — forget doctors. I mean, there’s just not a lot of RNs in nursing homes. There’s not a lot of doctors who spend time in nursing homes. A lot of the care is done through people with less training. So, this is trying to get more nurses in nursing homes. And there’s been a lot of stories about inadequate care. KFF Health News — I think it was Jordan Rau who did them. There have been some good stories about particularly nights and weekends, just really nobody there. These are fragile people. And they wouldn’t be in a nursing home if they weren’t fragile people. There are a lot of horror stories. At the same time, there are some legitimate — How fast can you do this? And how well can you do it? And can you do it across the country? I mean, it’s going to take some working out, but I don’t think anybody thinks that nursing home care in this country is, you know, a paragon of what we want our elders to experience.
Rovner: And the nursing home industry points out, truthfully, that most nursing home payments now come from Medicaid, because even people who start out being able to afford it themselves often run out of money and then they end up — then they qualify for Medicaid. And Medicaid in many states doesn’t pay very much, doesn’t pay nursing homes very much. So it’s hard for these companies. We’re not even talking about the private equity companies. A lot of nursing homes operate on the financial edge. I mean, there are —our long-term care policy in this country is, you know, just: What happens, happens, and we’ll worry about it later. And this has been going on for 50 years. And now we have baby boomers retiring and getting older and needing nursing home care. And at some point, this is all going to come to a head. All right. Well, let us turn to abortion. This week marks the second anniversary of the Texas abortion ban, the so-called heartbeat bill, that bans most abortion and lets individuals sue other individuals for helping anyone getting an abortion, which the Supreme Court, if you’ll recall, allowed to take effect months before it formally overturned Roe v. Wade. And, I guess not surprisingly, Texas is still in the news about abortion. This time. The same people who brought us Texas SB 8, which is the heartbeat bill, are going town by town and trying to pass ordinances that make it illegal to use roads within that town’s borders to help anyone obtain an abortion. They’re calling it abortion “trafficking.” Now, it’s not only not clear to me whether a local ordinance can even impact a state or an interstate highway, which is what these laws are mostly aimed at; but how on earth would you enforce something like this, even if you want to?
Ollstein: So, my impression is that they do not want to. These are not meant to be practical. They are not meant to be enforced, because how would you do it other than implementing a very totalitarian checkpoint system? This is meant to —
Rovner: Yes, have you been drinking and are you on your way to get an abortion?
Ollstein: Right. Right, right, right. So, it seems like the main purpose is to have a chilling effect, which it very well could have, even if it doesn’t stand up in court. You know, you also have this situation that we’ve had play out in other ways, where people are challenging laws in courts for having a chilling effect, and courts are saying, look, you have to wait till you actually get prosecuted and challenge it, you know, do an as-applied challenge. If you can’t challenge unless there’s a prosecution but there’s no prosecutions, then you sort of just have it hanging over your head like a cloud.
Kenen: Like Alice said, there’s no way you could do this. Like, what do you do, stop every car and give every person a pregnancy test? Are you going to, like, have, you know, ultrasounds on the E-ZPass monitors? Like, you go through it, it checks your uterus. So, I mean, it’s just not — you can’t do this. But I think one of the things that was really interesting in one of the stories I read about it, I think it was in The Washington Post, was that when they interviewed people about it, they thought it was trafficking, like really trafficking, that there were pregnant woman being kidnapped and forced to have an abortion. So even if you’re pro-choice, you might say, “Oh, I’m against abortion trafficking. I mean, I don’t want anyone to be forced to have an abortion.” You know, so, it’s — the wording and the whole design of it is, they know what they’re doing. I mean, they want to create this confusion. They want to create a disincentive. There’s no way — you know, radar guns? I mean, it’s just, there’s no way of doing this. But it is part of the effort to clamp down even further on a state that has already really, really, really clamped down.
Rovner: Although, I mean, if one could sue and if one could then know about something that’s happening and then you could presumably take the person to court and say, I know you were pregnant and now you’re not, and somebody took you in a car to New Mexico or whatever …
Kenen: You can’t even prove — how do you prove that it wasn’t a miscarriage?
Rovner: That’s —
Kenen: Right? I mean …
Rovner: I’m not saying — I’m not talking about the burden of proof. I’m just saying in theory, somebody could try to have a case here. I mean, but we certainly know that Texas has done a very good job creating a chilling effect, because we still have this lawsuit from the women who were not seeking abortions, who had pregnancy complications and were unable to get health-saving and, in some cases, lifesaving care promptly. And that’s still being litigated. But meanwhile, we have, you know, just today a study out from the Guttmacher Institute that showed that despite how well these states that are banning abortion have done in banning abortion, there were presumably more abortions in the first half of 2023 than there were before these bans took effect, because women from ban states were going to states where it is not banned. And there has been, ironically, better access in those states where it is not banned. I can’t imagine that this is going to please the anti-abortion community. One would think it would make them double down, wouldn’t it?
Ollstein: We know that people are leaving their states to obtain an abortion. We also know that that’s not an option for a lot of people, and not just because a lot of people can’t afford it or they can’t take time off work, they can’t get child care — tons of reasons why somebody might not be able to travel out of state. They have a disability, they’re undocumented. We also have — it’s become easier and easier and easier to obtain abortion pills online through, you know, a variety of ways: individual doctors in more progressive states, big online pharmacies are engaged in this, overseas activist groups are engaged in this. And so, you know, that’s also become an option for a lot of people. And anti-abortion groups know that those are the two main methods. People are still continuing to have abortions. And so, they’re continuing to just throw out different ways to try to either, you know, deter people or actually block them from either of those paths.
Rovner: This fight will also continue on. So, that is this week’s news. Now we will play my interview with Meena Seshamani, and then we will come back and do our extra credits.
Hey, “What the Health?” listeners, you already know that few things in health care are ever simple. So, if you like our show, I recommend you also listen to “Tradeoffs,” a podcast that goes even deeper into our costly, complicated, and often counterintuitive health care system. Hosted by longtime health care journalist and friend Dan Gorenstein, “Tradeoffs” digs into the evidence and research data behind health care policies and tells the stories of real people impacted by decisions made in C-suites, doctors’ offices, and even Congress. Subscribe wherever you listen to your podcasts.
I am pleased to welcome back to the podcast Dr. Meena Seshamani, deputy administrator and director of the Center for Medicare at the Centers for Medicare & Medicaid Services. Meena was with us to talk generally about Medicare’s new prescription drug negotiation program earlier this summer. But now that the first 10 drugs subject to negotiation have been announced, we’re pleased to have her back. Welcome.
Meena Seshamani: Thank you for having me.
Rovner: So, remind our listeners, why hasn’t Medicare been able to negotiate drug prices until now — they negotiate prices of everything else — and what changed to make that happen?
Seshamani: That’s right. It was because of the Medicare law that Medicare did not have the ability to negotiate drugs. And thanks to the new drug law, the Inflation Reduction Act, now Medicare has the ability to negotiate the prices of the highest-cost drugs that don’t have competition. And that is part of the announcement that we had on what the first 10 drugs are that have been selected.
Rovner: So, as you say, last week, for the first time and in time for the Sept. 1 deadline, Medicare announced the list of the first 10 drugs that will be part of the first round of price negotiations. Why these 10 specifically? I imagine it’s not a coincidence that the list includes some of the drugs whose ads we see the most often on TV: drugs like Eliquis, Xarelto, and Jardiance, which I of course know how to pronounce because I see the ads all the time.
Seshamani: Well, the process of selection really was laid out in the drug law and also through the guidance that we put out that we had incorporated everybody’s comment for. So, what we did is we started with the, you know, over 7,500 drugs that are covered in the Part D Medicare prescription drug program. From there, we picked those drugs that had been on the market for seven years for a drug product or 11 years for a larger molecule or biologic product that did not have competition. And then from there, there are various exemptions and exclusions that, again, are laid out in the law: for example, drugs that have low Medicare spend, of less than $200 million; drugs that are plasma-derived products; certain orphan drugs. An orphan drug is a drug that is indicated for a rarer disease. So that, again, those specific criteria are laid out in the law and in our guidance. And then there were opportunities for manufacturers to apply, for example, for a small biotech exemption; if their drug was, you know, 80% of their, you know, Medicare Part D revenue, they could say, “Hey, I’m a small biotech.” Again, a lot of these criteria were laid out in the law. Or for a manufacturer of a biosimilar, which is kind of like a generic drug for one of these biologic drugs, they could say, “Hey, we have a biosimilar that’s going to be coming on the market, has a high likelihood of coming on the market, so you should delay negotiating” the brand, if you will, drug. So, again, all of these steps were laid out in the drug law, and those are the steps and criteria that we followed that came to that list of 10 drugs that we published.
Rovner: I did see the makers of one drug — and forgive me, I can’t remember which one it was — saying, “But our drug isn’t that expensive.” On the other hand, their drug is used by a lot of people on Medicare. So, it’s not just the list price of the drug, right? It’s how much it costs Medicare overall.
Seshamani: That’s right. The list is made up of those drugs that have the highest gross total cost to the program — so, price per unit times units of volume that is used.
Rovner: So, how does this negotiation process work? What happens now? Now we have this list of 10 drugs.
Seshamani: Yeah, a lot of this is also laid out in the law, and then we fleshed out further in our guidance. So, from the list of 10 drugs, on Oct. 1, manufacturers now have to decide if they want to participate in the negotiation program. It is a voluntary program. It is our hope that they will come to the table and want to negotiate, because I think we all have shared goals of improving access and affordability and really driving innovation for the cures and therapies that people need. So, Oct. 1, they sign agreements for the negotiation program if they decide to participate. And Oct. 2 is the deadline for gathering data. We put out what’s called an information collection request to say, this is the kind of data we’re thinking about collecting. We got lots of comments and incorporated that. So, that provides the framework for the data that we’re requesting both from the manufacturer of the selected drug, but also, there are aspects open to the public on, you know, how the drug benefits populations, for example. So that’s Oct. 2. Then we’re going to have patient-focused listening sessions, a session for each drug, for patients, their caregivers, you know, other advocates, to be able to share what they see as the benefits of the drugs that are selected. And, we will have meetings with each of the manufacturers. All of that information will come together in an initial offer that CMS will make Feb. 1, 2024, and that is a date that is stipulated in the law. The manufacturer then has about 30 days to evaluate that. If they like that offer, they can agree. If they want, they can make a counteroffer. From that counteroffer, CMS has the ability to agree or to say, “You know, we don’t agree, so let’s now have a series of negotiation meetings.” There can be up to three negotiation meetings that provides that back-and-forth, ultimately leading to an agreed-upon what’s called maximum fair price in the law. And those maximum fair prices are published by Sept. 1, 2024. Again, that Sept. 1 is stipulated in the law. And also as part of this process, CMS will publish a narrative about that negotiation process — you know, the data that was received, you know, the back-and-forth, and also we’ll publish ultimately the maximum fair prices that are agreed to.
Rovner: And does that maximum fair price just apply to Medicare?
Seshamani: The maximum fair price just applies to Medicare. The information will be available. I mean, we don’t have any authority. You know, the commercial sector, they do their own negotiations, and they will continue to do so. But part of this is an opportunity to really further the conversation about how drugs impact the lives of people. We have an opportunity now with some drugs that have been on the market for quite a while, right? Minimum of seven years or 11 years, to see how these drugs work in the real world, in people’s communities, so that we can incorporate that into what it is that we need and want for people to be healthy, to stay out of the hospital, to live meaningful lives. So it’s really an opportunity to further that conversation. And a lot of that data, a lot of those listening sessions, that will all go into our negotiation process and will be part of the narrative that we publish.
Rovner: And what happens if the drug company says either we don’t want to negotiate or we don’t like our final offer? If they say they don’t want to play, what happens?
Seshamani: Julie, I will say again, to start with, we are hopeful that the drug companies will come forward and will want to negotiate because, again, through many conversations that we have had, we do have shared goals of access and affordability and really driving innovation and procures and therapies that people need. And it is a choice for drug companies if they want to participate or not, as stipulated in the law. If a drug company decides not to sign, you know, the negotiation agreement, not to participate in negotiation, then we would refer them to the Department of Treasury for an excise tax. That excise tax is also described in the law. If a drug company has this excise tax applied, they can get out of paying the excise tax. If, No. 1, they decide to come to the table and negotiate, or No. 2, if they exit the Medicare and Medicaid market. So those are kind of their off-ramps, if you will, for that excise tax.
Rovner: So they don’t have to participate in the negotiation, but they also don’t have to participate in Medicare and Medicaid.
Seshamani: Correct.
Rovner: So I saw a lot of complaining last week with the first group of drugs that this is really only going to benefit the people on Medicare who take those drugs. But, in fact, if there really is a lot of money saved, the benefits could go well beyond this, right?
Seshamani: Yeah, I think two points. So, yes, this negotiation is for, you know, some of the highest-cost drugs to the Medicare program that don’t have competition. And the negotiated drug prices apply to the Medicare program. However, as we talked about, this really drives a conversation around drugs and really grounding this negotiation process in the clinical benefit that a drug provides. Considering things like if a drug is easier for someone to take and it’s easier for a caregiver, that can have tangible improvements to the health of the person they’re caring for, right? And I think we have that opportunity to really drive the conversation. And as we know in many aspects of health care, people look to Medicare to see what Medicare is doing. And also, the transparency around providing that narrative of the negotiation, publishing the maximum fair prices that are agreed to. That’s all data that anybody can use as they would like. And I think the second piece that’s important to remember is that negotiation is one very important piece of a very big change to Medicare prescription drug coverage. You know, alongside the $2,000 out-of-pocket tab that’s going to go into effect in 2025, the no-cost vaccines, $35 copay cap for insulin that have already gone into effect. So, really, it is part of a larger sea change in Medicare drug coverage that will help millions of people and their families. You know, I did a roundtable with seniors as we were rolling out the insulin copay cap. And one woman was telling me that she was providing money to her brother every month so that he could pay for his insulin on Medicare. So, really, I mean, this has tremendous impact not just for people on Medicare, but their families, their communities, and really furthers the conversation for the entire system.
Rovner: I was actually thinking of more nitty-gritty money, which is if you save money for Medicare, premiums will be lower for people who are getting drug coverage, and taxpayers will save money, too, right? I mean, this is not just for these people and their families.
Seshamani: Our priority is being able to reach agreement on a fair price for the people who rely on these medications for their lives and the American taxpayer in the Medicare program.
Rovner: I know you can’t comment on lawsuits, and there are many lawsuits already challenging this. But the drug companies, one of their major arguments is that if you limit what they can charge for their drugs, particularly in the United States, the last country where they can charge whatever they want for their drugs, they will not be able to afford to keep the pipeline going to discover more new, important drugs. This is an argument they’ve been making since, I told somebody earlier, since I covered this in the late 1980s. What is your response just to that argument?
Seshamani: Well, I think there were several articles, many articles were written about this on the day that the 10 selected drugs were published. They were published before the stock market opened. And there really was no impact on the stocks of the companies. There were many financial pieces written about this. So I think that is one indication of the fact that the pharmaceutical industry is strong, it is thriving, and it is designed to innovate. And what we’re hoping to do through this negotiation program is really reward the kinds of innovations that we all need, the cures and therapies that people need. Recently, the venture fund that backed Moderna invested in a new startup for small molecules. Bayer has recently invested a billion dollars in the U.S. So you see, the industry very much is thriving. That is what the stock market response also shows. And it’s also the way that we are approaching negotiation to make sure that we’re rewarding the kinds of innovations that people need.
Rovner: Well, Meena Seshamani, thank you so much. I hope we can come back to you as this negotiation process for the first time proceeds.
Seshamani: Absolutely. Thanks again, Julie.
Rovner: OK. We are back, and it’s time for our extra-credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Alice, why don’t you go first this week?
Ollstein: Yeah, I picked a very sad story from The Washington Post about how people who have schizophrenia are a lot more vulnerable to extreme heat. And it’s rare to find one of these health care stories where you’re just astonished. You know, I had no idea about this. You know, it really walks through not only are people more vulnerable for mental health reasons, you know, it profiles this terrible story of a guy in Phoenix who wandered off into the desert and died because he was experiencing paranoid delusions. But also, just physically, people with schizophrenia have difficulty regulating their body temperature. A lot of medications people take make people more dehydrated, less able to cope. And just an astonishingly high percentage of people hospitalized and killed by extreme heat have these mental illnesses. Of course, they’re also more likely to have housing instability or be out on the street. So just a fascinating piece, and I hope it spurs cities to think of ways to address it. One other small thing I want to compliment is it just, technically, on this article online, they have a little widget where you can convert all of the temperatures cited in the lengthy story from Fahrenheit to Celsius. And I just really appreciated that for allowing, you know, no matter where you live, you sort of get what these high temperatures mean.
Rovner: Yeah, graphics can be really helpful sometimes. Rachel.
Cohrs: Yeah. So I chose a story in The Wall Street Journal and the headline is “How Novartis’s CEO Learned From His Mistakes and Got Help From an Unlikely Quarter,” by Jared S. Hopkins. And I think it was a really interesting and rare look inside one of these pharmaceutical companies. And Novartis hired a Wall Street analyst, Ronny Gal, to help advise them. And I think I had read his analysis before he crossed over to Novartis. So I think it was interesting to just hear how that has integrated into Novartis’ strategy and just how they’re changing their business. But I think as we’re, you know, having these conversations about drug pricing and how strategies are changing due to some of these policies, it is helpful to look at who these executives are listening to and what they’re prioritizing, whose voices in this decision-making process that really has impacts for so many people who are waiting for treatments. And I think there are tough choices that are made all the time. So I just thought it was very illuminating and helpful as we’re talking about how medicines get made in D.C.
Rovner: Yeah, maybe there will be a little more transparency to actually how the drug industry works. We will see. Joanne.
Kenen: With Julie’s permission, I have two that are both short and related. I wrote a piece for Politico Nightly called “How to Wage War on Conspiracy Theories,” and I liked it because it really linked political trends and disinformation and attempts to debunk, with very parallel things going on in the world of health care and efforts to the motivations and efforts to sow trust and what we do and do not know about how to debunk, which we’re not very good at yet. And then the classic example, of course, is the related AP story, which has a very long headline, so bear with me. It’s by Kevin McGill: “Court Revives Doctors’ Lawsuit Saying FDA Overstepped Its Authority With Anti-Ivermectin Campaign.” And, basically, it’s that the 5th Circuit, a conservative court that we’ve talked about before, is saying that the FDA is allowed to inform doctors, but it can’t advise doctors. And I’m not really sure what the difference is there, because if the FDA is informing doctors that ivermectin, we now know, does not work against covid, and it can in fact harm people, there’s ample data, that the FDA is not allowed to tell doctors not to use it. So the ivermectin campaign is a form of disinformation, or misinformation, whatever you want to call it, that at the very beginning, people had, you know, there were some test-tube experiments. We had nothing else. You can sort of see why people wanted … might have wanted to try it. But we have lots and lots and lots of good solid clinical research and human beings and, no, it does not cure covid. It does not improve covid. And it can be damaging. It’s for parasites, not viruses.
Rovner: It can cure worms. Well, I’m going to channel my inner Margot Sanger-Katz this week and choose a story from a medical journal, in this case the Journal of the American Medical Association. Its lead author is Sherry Glied, who’s dean of the NYU Robert F. Wagner Graduate School of Public Service and former assistant HHS [Department of Health and Human Services] secretary for planning and evaluation during the Obama administration — and I daresay one of the most respected health policy analysts anywhere. The piece is called “Health Systems and Social Services — A Bridge Too Far?” And it’s the first article I’ve seen that really does question whether what’s become dogma in health policy over the past decade that — tending to what are called social determinants of health, things like housing, education, and nutrition — can improve health as much as medical care can. Rather, argues Glied, quote, “There are fundamental mismatches between the priorities and capabilities of hospitals and health systems and the task of addressing social determinants of health,” and that, basically, medical providers should leave social services to those who are professional social service providers. That is obviously a gross oversimplification of the argument of the piece, however, but I found it really thought-provoking and really, for the first time, someone saying, maybe we shouldn’t be spending all of this health care money on social determinants of health. Maybe we should let social service money go to the social service determinants of health. Anyway, we will see if this is the start of a trend or just sort of one outlier voice. OK, that is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks, as always, to our amazing engineer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me, or X me, or whatever. I’m still there @jrovner, also on Bluesky and Threads. Rachel?
Cohrs: I’m @rachelcohrs on X.
Rovner: Alice.
Ollstein: @AliceOllstein.
Rovner: Joanne.
Kenen: @JoanneKenen on Twitter, @joannekenen1 on Threads.
Rovner: We will be back in your feed next week. Until then, be healthy.
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