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Mary Agnes Carey
KFF Health News

@maryagnescarey

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

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

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

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

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

Panelists

Rachel Cohrs
Stat News

@rachelcohrs

Read Rachel's stories

Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico

@JoanneKenen

Read Joanne's stories

Sandhya Raman
CQ Roll Call

@SandhyaWrites

Read Sandhya's stories

Among the takeaways from this week’s episode:

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

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

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

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

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

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

click to open the transcript

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

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

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

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

Joanne Kenen: Hi, everybody.

Carey: Rachel Cohrs of Stat.

Cohrs: Morning, everyone.

Carey: And Sandhya Raman of CQ Roll Call.

Raman: Good morning.

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

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

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

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

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

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

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

Cohrs: I think they can do what they want.

Carey: That’s true.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Carey: Sandhya, what’s your extra credit?

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

Carey: Rachel.

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

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

Cohrs: @rachelcohrs.

Carey: Joanne?

Kenen: @JoanneKenen.

Carey: Sandhya.

Raman: @SandhyaWrites.

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

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

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

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

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

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

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Sarah Karlin-Smith
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Victoria Knight
Axios

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Read Victoria's stories

Shefali Luthra
The 19th

@Shefalil

Read Shefali's stories

Among the takeaways from this week’s episode:

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

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

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

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

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

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

Click to open the transcript

Transcript: The Confusing Fate of the Abortion Pill

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

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

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

Victoria Knight: Good morning.

Rovner: Sarah Karlin-Smith of the Pink Sheet.

Sarah Karlin-Smith: Hi, Julie.

Rovner: And Shefali Luthra of The 19th.

Shefali Luthra: Hello.

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

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

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

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

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

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

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

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

Rovner: I think it was last week.

Karlin-Smith: Time. Time —

Rovner: Time is a very flat circle right now.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Rovner: For Medicaid.

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

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

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

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

Knight: — expelled —

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

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

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

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

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

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

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

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

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

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

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

Knight: @victoriaregisk.

Rovner: Sarah?

Karlin-Smith: @SarahKarlin.

Rovner: Shefali.

Luthra: @shefalil.

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

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