The Host

Julie Rovner
KHN

@jrovner

Read Julie's stories.

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

Health care was a recurring theme throughout President Joe Biden’s 2023 State of the Union address on Capitol Hill this week. He took a victory lap on recent accomplishments like capping prescription drug costs for seniors on Medicare. He urged Congress to do more, including making permanent the boosted insurance premium subsidies added to the Affordable Care Act during the pandemic. And he sparred with Republicans in the audience — who jeered and called him a liar — over GOP proposals that would cut Medicare and Social Security.

Meanwhile, abortion rights advocates and opponents are anxiously awaiting a federal court decision out of Texas that could result in a nationwide ban on mifepristone, one of two drugs used in medication abortion.

This week’s panelists are Julie Rovner of KHN, Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat, and Sarah Karlin-Smith of the Pink Sheet.

Panelists

Rachel Cohrs
Stat News

@rachelcohrs

Read Rachel's stories

Sarah Karlin-Smith
Pink Sheet

@SarahKarlin

Read Sarah's stories

Alice Miranda Ollstein
Politico

@AliceOllstein

Read Alice's stories

Among the takeaways from this week’s episode:

• President Joe Biden’s State of the Union address emphasized recent victories against high health care costs, like Medicare coverage caps on insulin and out-of-pocket caps on prescription drug spending. Biden’s lively, informal exchange with lawmakers over potential cuts to Medicare and Social Security seemed to steal the show, though the political fight over cutting costs in those entitlement programs is rooted in a key question: What constitutes a “cut”?
• Biden’s calls for bipartisanship to extend health programs like pandemic-era subsidies for Affordable Care Act health plans are expected to clash with conservative demands to slash federal government spending. And last year’s Senate fights demonstrate that sometimes the opposition comes from within the Democratic Party.
• While some abortion advocates praised Biden for vowing to veto a federal abortion ban, others felt he did not talk enough about the looming challenges to abortion access in the courts. A decision is expected soon in a Texas court case challenging the future use of mifepristone. The Trump-appointed judge’s decision could ban the drug nationwide, meaning it would be barred even in states where abortion continues to be legal.
• The FDA is at the center of the abortion pill case, which challenges its approval of the drug decades ago and could set a precedent for legal challenges to the approval of other drugs. In other FDA news, the agency recently changed policy to allow gay men to donate blood; announced new food safety leadership in response to the baby formula crisis; and kicked back to Congress a question of how to regulate CBD, or cannabidiol, products.
• In drug pricing, the top-selling pharmaceutical, Humira, will soon reach the end of its patent, which will offer a telling look at how competition influences the price of biosimilars — and the problems that remain for lawmakers to resolve.

Also this week, Rovner interviews Kate Baicker of the University of Chicago about a new paper providing a possible middle ground in the effort to establish universal health insurance coverage in the U.S.

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

Julie Rovner: The New York Times’ “Don’t Let Republican ‘Judge Shoppers’ Thwart the Will of Voters,” by Stephen I. Vladeck

Alice Miranda Ollstein: Politico’s “Mpox Is Simmering South of the Border, Threatening a Resurgence,” by Carmen Paun

Sarah Karlin-Smith: KHN’s “Decisions by CVS and Optum Panicked Thousands of Their Sickest Patients,” by Arthur Allen

Rachel Cohrs: ProPublica’s “UnitedHealthcare Tried to Deny Coverage to a Chronically Ill Patient. He Fought Back, Exposing the Insurer’s Inner Workings,” by David Armstrong, Patrick Rucker, and Maya Miller

Also mentioned in this week’s podcast:

• The Associated Press’ “20 Attorneys General Warn Walgreens, CVS Over Abortion Pills,” by Jim Salter
• NPR’s “A Trump-Appointed Texas Judge Could Force a Major Abortion Pill off the Market,” by Sarah McCammon
• Politico’s “Federal Judge Says Constitutional Right to Abortion May Still Exist, Despite Dobbs,” by Kyle Cheney and Josh Gerstein
• The Becker Friedman Institute’s “Achieving Universal Health Insurance Coverage in the United States: Addressing Market Failures or Providing a Social Floor?” by Katherine Baicker, Amitabh Chandra, and Mark Shepard

click to open the transcript

Transcript: A Health-Heavy State of the Union

KHN’s ‘What the Health?’Episode Title: A Health-Heavy State of the UnionEpisode Number: 284Published: Feb. 9, 2023

Julie Rovner: Hello and welcome back to KHN’s “What the Health?” I’m Julie Rovner, chief Washington correspondent at Kaiser Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Feb. 9, at 10 a.m. As always, news happens fast, and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Good morning.

Rovner: Rachel Cohrs of Stat News.

Rachel Cohrs: Hi, everybody.

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

Sarah Karlin-Smith: Hi, Julie.

Rovner: Later in this episode, we’ll play my interview with Kate Baicker of the University of Chicago. She’s one of the authors of a new paper outlining a new proposal for the U.S. to achieve universal health insurance coverage, something every other developing nation already has, but we have not yet been able to achieve. But first, this week’s health news. We’re going to start, of course, with the State of the Union, which was livelier than usual, with way more back and forth than I’ve ever seen at one of these, and also more health-heavy than usual. I’m going to start with entitlements, notably the president threatening Republican proposals to hold the debt ceiling hostage for cuts in Social Security and Medicare. I’m still trying to decide whether this was intended or not, but Biden nevertheless ended up getting Republicans to vow not to demand cuts in Social Security and Medicare in exchange for raising the debt ceiling later this year. Here is the tape.

President Joe Biden: So, folks, as we all apparently agree, Social Security and Medicare is off the books now, right? And they’re not going to strike … [prolonged applause] All right. We got unanimity!

Rovner: So was this very clever or very lucky or both?

Ollstein: Well, it’s a little not quite what it seems. Republicans have been swearing up and down more recently that they never intended to cut Medicare and Social Security. But when they say “We want to reform it, we want to shore it up,” they’re talking about things that could limit benefits for beneficiaries. So it’s a semantics game, in part. I also want to point out that neither Republicans nor Biden have yet said that they consider Medicaid in that same untouchable category. So that really jumped out at me in the speech as well.

Rovner: Yeah, I mean, if you don’t touch Social Security or Medicare — and the Republicans are trying to say that because this has been used as a weapon for so many years — then basically that leaves Medicaid. And as we discovered in 2017, when they were trying to repeal the Affordable Care Act, Medicaid is actually pretty popular, too, because it takes care of a lot of people’s grandparents in nursing homes. I’m wondering when somebody is going to bring that up. Obviously, over the years, many, quote-unquote, “cuts” have been made to both Social Security and Medicare, mainly to slow the growth of the programs so that we can continue to afford them. Many more, quote-unquote, “cuts” will have to be made going forward. Every time you reduce payment to a drugmaker or a hospital or any other health care provider, that’s a cut, but it helps beneficiaries. So, you know, you say “cuts,” [and] beneficiaries say “they’re going to cut our benefits.” Not necessarily. They may just be making the program more affordable, including for the beneficiaries. I mean, this is just the continuous back and forth of each side, weaponizing Medicare in particular, right?

Ollstein: Well, and until we see actual proposals on paper, like you’re indicating, it is a semantics game — what some people consider a cut might not be what other people consider a cut. And there’s going to be all sorts of rhetorical games over the next several months along these lines. So, I’m waiting till we see an actual black-and-white proposal that we can all pick at and analyze together.

Rovner: Well, as we have seen, there’s danger in putting things on paper, as Rick Scott discovered this week. For those who don’t remember, it was his rather infamous proposal — was it last summer, I think? It was before the election — suggesting that all federal programs be sunsetted every five years and then have to be reauthorized, which would include Social Security and Medicare and Medicaid. And that’s not playing well at this point, as I think was predicted at the time, including by us. So moving on, I was also impressed at how the speechwriters managed to combine the, quote, “victory lap” stuff, record Affordable Care [Act] enrollment, Medicare drug price changes, limits on insulin, and surprise bills with the agenda ahead: expanding insulin price caps to the non-Medicare population, Medicaid expansion in the states that haven’t done it, making the Affordable Care Act subsidies expansions permanent. But none of these things — popular, though they may be — are likely to happen in this Congress, are they? … These are the things that fell out of the bill that passed last year.

Cohrs: Right. A lot of those cost money, which is going to cause even more problems this Congress than it did in the last one. And I thought it was pretty informative that the chair of the Energy and Commerce Committee in the House threw cold water on the insulin price-cap idea because it did gain some Republican support in the Senate when it came up for a vote. That was complicated. We won’t go into it. But yeah, it wasn’t a straight up-and-down vote on that policy, really. So I think there was some hope that maybe Republicans could get on board with it. But I think, because it applies to private market insurers, [it was called] a socialist policy, like, they just don’t want government in private plans, even though it’s a wildly popular policy. So, yeah, I think that doesn’t seem like a good signal for that policy in particular and for Medicaid expansion and a lot of these things. Democrats couldn’t even do it when they all agreed or had power in both the House and the Senate. So it’s definitely not a good indication for a lot of these things.

Ollstein: Let’s not forget that [Sen. Joe] Manchin [D-W.Va.] was the one who put the kibosh on the federal Medicaid expansion. He thought it wasn’t fair to states like his that expanded a long time ago and have been paying in a little bit. He thought it wasn’t right that states that were holdouts get a free ride. And the other Democrats argued back that it’s not fair for the residents in those states to be left out in the cold uninsured either. So this will continue. But like Rachel said, not going anywhere soon.

Rovner: So the things that in theory could happen, and these didn’t mostly come up in the speech or didn’t come up very much. But earlier in the day, Biden officials were floating a quote-unquote, “unity agenda” that included a long list of potentially bipartisan health issues, starting with the “cancer moonshot,” mental health and opioid treatment, strengthening the mental health parity rules. Some of these things actually could happen, right?

Cohrs: Yeah, I think especially on the mental health package, I think there was some unfinished business from last Congress, from the Senate Finance Committee. I think that all of these are issues that have been talked about this Congress already. And the leaders have signaled that they might be interested in. But I think there is some daylight here, and we’re still in very much the agenda-setting, throwing ideas out there that are a very vague part of this Congress. And I think actually getting things down on paper and going through hearings and that kind of thing will signal which areas there might actually be some agreement on. But again, spending is going to be a big challenge and there’s just not going to be time to get to everything.

Rovner: I think one of my frustrations is that normally the State of the Union comes right before the president’s budget comes out, usually within a week or two. And this year, the president’s budget isn’t coming out until March 9. So we have this, you know, talk about agenda-setting. We’re going to have a lot of time for people to just yap at each other without any specifics. But speaking of things that didn’t and aren’t likely to happen, the president didn’t talk very much about abortion. And what he did say — like threatening to veto any abortion ban Congress might pass, which won’t happen either with Democrats in charge of the Senate — that disappointed abortion rights supporters. They’re not happy, right, Alice?

Ollstein: Some were not. To be fair, some praised the speech, praised the president for saying the word “abortion.” This was a big thing over much of his career, including the beginning of his presidency. He would talk around it and not actually say the word “abortion,” which the groups felt contributed to stigma around it. And so the big mainstream groups, Planned Parenthood, NARAL, put out statements praising the speech, praising him for saying he would veto a ban, although, again, like you said, that’s a hypothetical. It’s not going to happen. But some other groups were critical that, one, he didn’t talk about some of the very looming direct threats to abortion access in the courts that we’re probably going to get to later.

Rovner: In a minute.

Ollstein: Just in a minute! But they were frustrated that he didn’t lay out more specifics that his administration will actually do to respond to the current loss of access in a lot of the country. They felt that we’re in a crisis moment and he spent less of the speech on abortion than he did on resort fees. That was a sore point for some advocates who I talked to.

Rovner: There was a lot of emphasis on junk fees. And I get why: These are the things that drive people crazy, and, particularly, in times of high inflation. But yes, abortion came very late in the speech — almost after a lot of people had tuned out and stopped paying attention, which I think also made some people unhappy. Well, speaking of abortion, here we are waiting for another make-or-break court decision out of Texas. Alice, this time it’s the future of the “abortion pill,” not just in Texas, but around the nation that’s at stake. How did we get here? And could we really see the abortion pill banned nationwide?

Ollstein: We really could. People have really been sleeping on this case, including some elected officials who were slow to realize the impact it could have. And mainly what people don’t understand is a bunch of states already ban all methods of abortion, including the pill, and then some additional states besides that have restrictions just on the pill. So this will mainly hit blue states and states where abortion access still exists. And so it could really have a huge impact because those states are now serving more than just their own populations. And in a lot of places, losing access to medication abortion means losing access to all abortion because there aren’t clinical services available. And so my colleague and I did some reporting on how the Biden administration is preparing or not for this ruling. They rebuffed calls from activists to declare a public health emergency for abortion. They said they don’t think that would help. While they do plan to appeal the ruling should the FDA lose, the upheaval that could happen in the meantime can’t really be overstated. And not to mention that an appeal would go to the 5th Circuit, which is very conservative, and then to the Supreme Court, which just overturned Roe v. Wade. And so while most experts we’ve talked to don’t think the legal arguments are that sound, you just can’t really …

Rovner: And remind us, this is the lawsuit that’s challenging the 22-year-old approval of the drug in the first place.

Ollstein: Exactly. And so health care legal experts also say that besides the absolute upheaval in the abortion space that this could cause, this would just completely destroy any certainty around drug approvals for the FDA. If anybody could come back decades later and challenge the approval of a drug, how can drugmakers feel comfortable developing and submitting things for approval and making their plans around that? It’s very chaotic.

Rovner: Sarah, is the FDA worried about this case? Has it not been on their radar either?

Karlin-Smith: I mean, they’re involved in the defense.

Rovner: They’re being sued.

Karlin-Smith: Right. I think it is a concern if this is used, right? If the folks who want this drug pulled would win, does it become precedent-setting in a way that you can get other products pulled? Perhaps. Again, the sentiments would not be there for a lot of other products in the way to use it. But it is a bit concerning when you think about judges having this power to overrule the scientific decisions we’ve left to civil servants, not politicians or judges, because they have expertise in science and medicine and clinical trial design and all these things we just would not expect judges to be able to rule on.

Rovner: Well, speaking of more politics, this week — actually, last week — a group of 20 state attorneys general from states with abortion restrictions wrote to CVS and Walgreens, which had already announced that they would apply to become providers of the abortion pill, warning them not to rely on the Justice Department’s interpretation of a 19th-century law that banned the use of the U.S. mail to send abortifacients. The letter doesn’t outright threaten the companies. It merely says that, quote, “We offer you these thoughts on the current legal landscape.” Has anybody sued over this yet? And what do we expect to happen here? I mean, are CVS and Walgreens going to back off their plans to become providers?

Ollstein: Well, the anti-abortion elected officials and advocacy groups are hoping that’s the case. But I think this could play out in so many ways. I mean, one, we have this national ruling that could come down, but we also have a few state rulings that could flip things the other way and force states that have put restrictions on the abortion pill to lift those restrictions and allow it. So now we have cases pending in North Carolina and West Virginia. One of them is by the manufacturer of the abortion pill, saying that states don’t have the right to put the FDA’s hat on their own heads and make those decisions. And the other is by an abortion provider, a doctor who says that these state restrictions hurt her ability to practice and hurt her patients. And so it’s just wild that we can swing anywhere from a national ban to forcing states with bans to lift those bans. I mean, it’s just all up in the air right now. I wanted to quickly point out two other things. A lot of activist groups say they are not counting on the Biden administration to adequately respond to this crisis. And so they’re doing a couple things. One, they’re encouraging people to do something known as “advance provision,” which is order abortion pills before they’re pregnant, before you need them, and just have them on hand just in case. And so they’re advising people do that in advance of the ruling. Interestingly, the FDA does not support that practice, but activist groups are encouraging it anyways. And then the other thing is the abortion pill regimen is actually two pills. And the big FDA lawsuit only goes after the first one. And so people are saying, you know, you can terminate a pregnancy just by taking a few of the second pill, even though that has a higher rate of not working and needing a follow-up procedure. And so …

Rovner: Although it’s still like, 95%, right?

Ollstein: It’s still very effective, but not quite as effective as using the two pills together.

Rovner: And I think it used to be when people would go to Mexico, that’s what they would get. They would get misoprostol, not mifepristone, which is what we think of as “the abortion pill” — and also methotrexate, which we talked about in the context of people with diseases for which methotrexate is indicated not being able to get it because it can cause abortions. But that’s another option there, right? And … it would be hard for FDA to pull those drugs because those drugs do have a lot of uses for other diseases.

Karlin-Smith: Or FDA could, I guess, be forced to take off the formal indication for use for abortion, but the drug would be out there and then could be subject to off-label prescribing, which then could potentially, I guess, impact insurance coverage if you’re using it for abortion. Pivot to if you had to go back to this one-drug regimen while, yes, it would still exist and be possible, I think a lot of providers are worried about the added burden that would create on folks that help people obtain abortion. And this system is just not set up to have enough workers to deal with that more complicated regimen. And it seems like it could end up leading to more need for surgical abortions, depending on how well it works and so forth. So I think logistically it creates a lot more challenges.

Rovner: Yeah, it’s a mess. Well, meanwhile, last issue here, we have a curious story out of a lawsuit in federal district court here in Washington, D.C., in which a judge proffered the notion that while the Supreme Court may have found no right to abortion in the 14th Amendment, that doesn’t mean there isn’t a federal right under the 13th Amendment. That’s the one barring slavery, specifically the restriction on the pregnant person’s personal liberty. As the judge correctly pointed out, the majority in last year’s Dobbs [v. Jackson Women’s Health Organization] ruling may well believe there’s no right to abortion anywhere in the Constitution. But that’s not the question that they litigated. Is this potentially an avenue that abortion rights advocates are going to explore?

Ollstein: I am not hearing a lot of hope being placed on this. If it goes anywhere, it would go back to the same Supreme Court that just ruled last year. And so abortion rights advocates are not optimistic about this strategy, but I think it’s a good indication of really both sides right now just trying to get as creative as possible and explore every legal avenue in the U.S. Constitution, in state constitutions, things where it never says the word abortion, but you could interpret it a certain way. I think that’s what we’re seeing right now. And so it’s really interesting to see where it goes.

Rovner: We are literally at the point where everybody is throwing whatever they can against the wall and seeing what sticks. All right. Well, let us turn to the federal research establishment. Late last month, a panel of advisers recommended a set of policies to strengthen oversight of so-called gain-of-function research that could inadvertently cause new pandemics. This was also one of the subjects of the first House hearing that called leading federal public health officials up on the carpet. What do we learn from the hearing? And has the federal government actually been funding gain-of-function research, or do we even know for sure?

Cohrs: So there has been a moratorium on this sort of research. And the interim director of the NIH [National Institutes of Health] quibbled over the term “gain-of-function research.” And he said we’re talking about a very select part of all of the research that could technically fall under that umbrella term. But he did say that there is a moratorium on funding that right now; there’s not current funding because they are reviewing their practices. And an advisory board did pass proposals and he laid out the process forward for that. So once those are finalized, he’ll write a memo to [Department of Health and Human Services] HHS Secretary Xavier Becerra, then it will get to the White House. So there is this bureaucratic progression that these new guidelines are going to go under, and it’s been pretty transparent and public so far. But we’ll see how things ultimately turn out. But I think they are very sensitive to this politically and they are trying to create guidelines that offer some lessons learned from some of the criticism they’ve gotten recently.

Rovner: And I think, I mean, this has become one of the major lines of argument about Republicans trying to figure out where covid came from. Perhaps it came from U.S.-funded gain-of-function research in China, which we don’t know, I don’t think. But there’s been a lot of “Yes, you did”-“No, you didn’t” going on. I mean, Sarah, does this go back to the, you know, politicians playing scientists?

Karlin-Smith: A little bit. And I think at the hearing, a lot of the Republicans who are pressuring NIH in particular on this are not super interested in listening to the subtleties and nuance of the argument. They just really want to make the point and bring up in people’s minds the possibility of, you know, covid being a lab leak, which I think … which hasn’t 100% been ruled out, but it’s kind of on the 98%, probably 99% ruled out by a lot of scientists. And so it was very hard for NIH and those lawmakers to have a reasonable discussion about the nuances and where this research might possibly benefit us in future pandemic prep. What type of precautions do need to be put in place? And I think NIH was trying to strive to communicate that actually a lot of what was recommended in this oversight report is things they’ve been working on and have put in place. But the hearing was designed by Republicans more to land those political punches and sound bites and not really delve into “Are there policy improvements that could be made here?”

Rovner: Well, speaking of civil servants trying to do their science policy jobs, the FDA’s been busy the last couple of weeks, including lifting a ban on men who have sex with other men donating blood. That’s a ban that’s been in effect in one way or another since the 1980s, when AIDS was first discovered. And in the wake of baby formula shortages, there’s now going to be a new deputy commissioner for food. And finally, the agency is asking Congress for new authority to regulate CBD [cannabidiol] products, particularly as more states legalize marijuana in all forms for recreational use. Sarah, this is an awful lot of stuff at once. Big policy changes where they try to hide some of them, or did they just all show up at once because that’s when they got finished?

Karlin-Smith: The food changes were sort of driven by events not quite within their control, and the blood policy, the CBD stuff were things in the works for some number of years now. So FDA is busy, and these are different divisions operating under it. I think the CBD stuff is drawing a lot of frustration because FDA had been working on considering how to regulate this aspect of hemp for a while now. And instead of coming up with a policy and taking action, they’ve rewound the circle; we’re back to square one and putting it on Congress’ issues. So that’s like one area where there’s a lot of frustration versus, I think, people are generally happier that the blood donation process was finally gone through and changed.

Rovner: Yes, the wheels of the federal regulatory process move slowly, as we know. All right. Finally this week, drug prices. Humira — which is a biological that treats rheumatoid arthritis and many other serious ailments, and for which you have undoubtedly seen TV commercials if you have ever turned on your television, because it’s the top-selling pharmaceutical in the world — is reaching the end of its patent life. That will soon provide the first real test of where the Affordable Care Act’s pathway to allow biosimilar competitors — effectively biologics version of generic drugs — whether that will actually bring down prices. Because there’s a chance here that there’s going to be a bunch of competitors to Humira and the price isn’t going to come down, right?

Karlin-Smith: Yeah, I mean, that’s a major concern for a number of reasons that get us back to the broader U.S. drug pricing debate and — including the role of pharmacy benefit managers in figuring out how people get coverage of their drugs. So Humira is one of the first biologics to lose patent protection, where patients actually fill the prescriptions themselves and give themselves the medicine, which is a very different payment system than if you’re getting a biologic medicine at a doctor’s office or a hospital. And so the way that most of the insurers are covering the drug for this year, they’re actually going to charge patients the same out-of-pocket cost in most instances, as if you’ve got the brand drug or the biosimilar. And because, unlike traditional generic medicines, a lot of these, at least initially, they’re not what is called auto-substitutable. So if your doctor writes you Humira, the pharmacist doesn’t automatically give you that generic. So you’d actually have to request a new prescription from your doctor, and they’d have to write it. And if you’re not going to pay less, why are you motivated to do that?

Rovner: When you’re not even positive how much whether the drug works the same way, whether the biosimilar works the same way.

Karlin-Smith: Right. And they think people are a little bit more hesitant. They don’t understand how biosimilars work compared to generic drugs, where it took — again, when the generic drug industry first started, it took people a while to get comfortable. So there are those issues. So, basically, what has happened is AbbVie has given insurance plans and payers’ discounts on their brand drug to keep it in a good place on their formularies. So there will be savings to the broader health system, for sure. The problem is if that doesn’t get passed on to the patients, and AbbVie can continue their market monopoly, my worry is, down the line, what happens to this biosimilar industry overall? Humira is not the only top-selling, big-selling biologic medicine where we want to bring down the cost. So if these biosimilar competitors don’t eventually gain market share and make money off of doing this, why are they going to go back and develop a biosimilar and try and lower the cost of the next big drug? And that’s what people are watching. I think there’s cautious optimism that, as more biosimilars for Humira launch, there will be some pressure for insurance companies to cut deals and lower prices and not just rely on making money off high rebates. But we don’t really know how it’s going to play out. And AbbVie was pretty creative over the years. In some ways that helped patients and others questionable — how much of … like, you know, there’s high concentration of the drug, low concentration. There is citrate-free, non-citrate-free. And that means that not all the competitors are going to be exactly the same in a way that creates as much competition as it seems at first. So yeah, it’s going to be messy.

Rovner: This is the famous evergreening that we saw with drugs. I mean, where they would change something small and get a whole new patent life.

Karlin-Smith: Right. So usually with generic research, you need three direct competitors to help bring the price down a lot. But in the case of Humira, while there’s going to be, probably at least six competitors this summer, maybe more, they’re not all direct competitors for the same version of Humira. So it sort of bifurcates the space a bit more and makes it harder to, you know, figure out the economics of all of that.

Rovner: Well, if you thought that drug pricing was confusing, now we’re adding a whole new level to it. So, I’m sure we will be talking about this more as we go forward. OK. That’s the news for this week. Now, we will play my interview with Kate Baicker of the University of Chicago. Then we will come back and do our extra credits.

I am excited to welcome to the podcast Katherine Baicker, currently the dean of the University of Chicago Harris School of Public Policy and soon to be provost of the university. Congratulations.

Katherine Baicker: Thank you so much.

Rovner: So, Kate is a health economist who is well known to health policy students for a lot of things, but most notably as the co-lead author of the Oregon Medicaid health experiment, which was able to follow a randomized population of people who got Medicaid coverage and a population that didn’t to help determine the actual impact of having Medicaid health insurance. Today, she’s here as lead author of a paper with a new way to possibly provide health coverage to all Americans. Kate, thank you so much for joining us.

Baicker: It’s a pleasure.

Rovner: So your new paper is called “Achieving Universal Health Insurance Coverage in the United States: Addressing Market Failures or Providing a Social Safety Net.” And in that single sentence, you’ve pretty much summed up the entire health insurance debate for, like, the last half-century. For those who don’t know, why is it that the U.S. doesn’t have universal insurance when literally all of our economic competitors do?

Baicker: Well, like so many things about our health care system, it goes back to the history of how it evolved, as well as some things that are different about the U.S. from other countries. If you look at how big the U.S. is geographically, how diverse our country is, how heterogeneous the health needs are. A lot of the solutions you see in other countries might not work so well in the U.S.

Rovner: So … and we’ve basically just not ever gotten over the hump here.

Baicker: Well, I also think we haven’t been asking the right questions necessarily. There is a real debate about whether health care is a “right” or not. And, of course, your listeners can’t see my “air quotes,” but I put that in air quotes because I think that’s the wrong question. Health care is not just one thing. Health care is a continuum of things. And if we just boil it down to should people have access to care or not, that doesn’t let us engage with the hard question of how much care we want to provide to everyone and how we’re going to pay for it.

Rovner: So I know a lot of people assume that the Affordable Care Act would — I’ll use my air quotes — “fix” the U.S. health insurance problem. And it has gone a long way to cover a lot of previously uninsured people. But who are the rest of the uninsured and why don’t they have coverage? It’s not necessarily who you think, right?

Baicker: That’s right. And, you know, the ACA, or Obamacare, actually made a lot of headway in covering big swaths of the uninsured population. There was a lot of discussion about health insurance exchanges, but actually more people were covered by Medicaid expansions than by health insurance exchanges. But both of those, as well as letting young people up to age 26 get on their parents’ policies. All of this chipped away at the ranks of the uninsured, but it left, for example, undocumented immigrants uninsured and also the vast majority of the uninsured people in the U.S. are already eligible for either a public program or heavily subsidized private insurance. And we have a problem of takeup and availability, not just affordability.

Rovner: So let’s get to your proposal. It’s not really that different from things that either we’ve tried in some parts of our health insurance ecosystem or what other countries do. What would it actually look like if we were to do it?

Baicker: Well, if you go back to what I think is the right question of how much health care do we want to make sure that everyone has access to and how are we going to get them enrolled in those programs? I think one key feature is having that coverage be as low-hassle as possible, automatic if possible, because we know that nonfinancial barriers to insurance are responsible for a lot of the uninsured population we still see today.

Rovner: We’ve seen that with pension plans, right? That automatically enrolling people get more people to actually put money away?

Baicker: That’s right. That’s one of the takeaways from behavioral economics is that defaults matter. Meaning what the baseline is and letting you opt in and out makes a big difference because people tend to stick with where they are. There’s a lot of inertia in saving for retirement, in enrolling in health insurance, in lots of different things. And being sophisticated in how we design the mechanics of those programs is important, as well as making sure that they’re financially affordable to people. So one step is making sure that whatever is available to people is as easy as possible for them to take advantage of. But the other is having a much harder discussion about what we want that basic package to be. And when you say “I want everybody to have all of the care that might possibly be available, no matter what price and no matter how much it impacts their health,” that’s more than 100% of GDP. We just can’t do that and still have any money for anything like food and housing and education and roads and all of the things that we also care about. So if we had that tough discussion as a nation, as a body politic, to say, here is the care that we think is really high-value that we think is a right for everyone and that we want to make sure is available to everyone, then people could be automatically enrolled in that default package and have the option to get more care that is more expensive and maybe a little less effective, but still worth it to them that they purchase on their own. And that opens up a whole host of other questions and ethical dilemmas that I’m sure you’re going to want to ask about.

Rovner: But it also — as a lot of people are concerned, that something like “Medicare for All” would eliminate the incentive to innovate new kinds of care. I mean, obviously, there’s this race to figure out, you know, a drug to treat Alzheimer’s and that if the federal government were to basically set prices for everything, that there would be no more innovation incentive. You actually address that here, right?

Baicker: Yes. And I’m so glad you raised that concern, because there are many challenges to having a monolithic one-size-fits-all Medicare for All type plan. One of them is, you know, affordability for the system and accessibility. But another is the dulled incentive for innovation and the dulled drive towards having new medicines and new treatments available. Medicare is very slow to innovate. It took 40-plus years for Medicare to include prescription drugs at all. And that was because when Medicare was formed in the Sixties, prescription medicine wasn’t a very important part of health care. It wasn’t a very expensive part of health care, there just weren’t that many drugs to treat people. Well, now those medicines are crucial to health and well-being. And Medicare finally added a prescription drug benefit in 2005. But that was a long lag, and that’s just one example. So I think having some fundamental access to care that we know is of high value for everyone could be coupled with having the option to purchase more generous insurance that covers more things. And that private insurance layered on top would really provide the financial incentives for continued innovation. It acknowledges the reality that in a world of scarce resources, higher-income people are going to have more health care than lower-income people. And that is an ugly reality and one that we ought to grapple with ethically, and as a matter of public policy priorities. I would argue we’re already rationing care. It is not possible for public programs to pay for all care for all people, no matter what the price, no matter what the health benefit, and being intentional about defining what it is we’re going to cover with public dollars and then letting people buy more care with private dollars is a way perhaps to make a financially sustainable system that also promotes innovation.

Rovner: And this isn’t really new. I mean, lots of other countries do this. I was in Switzerland a decade ago, and I remember that they … their extra-benefit package includes things like single rooms in hospitals and homeopathic medicine and things that I’m not sure we would end up putting into our top-up plans, but it’s something that’s important to them.

Baicker: Yes. And when people point to our European counterparts and say, look, they all have single-payer. In fact, a lot of them have a hybrid system like the one that we’re describing. And it’s important to differentiate: We’re talking about a basic plan that’s available for everyone. That doesn’t mean that it only covers cheap things. It should only cover high-value things. But some cheap things are incredibly ineffective and low-value, and some expensive things are really important for health and very high-value. So it’s about the value of the dollar spent in terms of producing health, not whether it’s expensive or cheap. And so when you think about having a top-up plan, it shouldn’t be about billing cost sharing that, you know, lower-income people are exposed to in the basic plan. It should be about adding services that are of less health importance but still valuable to the people purchasing them.

Rovner: Obviously, the biggest issue here is going to be who’s going to make that determination? I’m old enough to remember fights over the ACA, death panels, and the independent Medicare advisory board that never happened. In fact, there were a lot of these, you know, we’re going to appoint experts. And it never happened because none of the experts ever wanted to be on these panels. How do you overcome that hurdle of actually grappling with the decision of what should be covered?

Baicker: Yes, the devil is always in the details for these things, and you put your finger on a really important one where we haven’t provided a robust answer, and our analysis is meant to highlight the importance of making these hard decisions and the value of this framework. But we don’t have a magic bullet for this. I would argue that having Congress make this decision every year is a recipe for lobbying and decision-making that doesn’t actually line up with value. There’s an opportunity perhaps to have a panel of experts who, as you note, is just a hop, skip and a jump from being called a “death panel.” But I think we can rely on some clinical guidelines as guardrails on this. And we do have some examples of experimentation in this direction in the U.S. In fact, more than experimentation — if you look at Medicare Advantage, this used to be a small part of the Medicare program. These are private plans for Medicare beneficiaries that are now, I think, pretty soon going to be the majority of plans that people have. And it’s a mechanism for people to choose among plans that have some things that have to be covered, but can then add additional benefits for enrollees, and it can be a little more tailored to what people value in their plans. So I don’t think that’s the answer either. But it’s a proof of concept that we can do something like this in the U.S.

Rovner: So in some ways this would bridge the gap between Republican marketplace ideas and Democratic Medicare for All ideas. But it feels like, since the fight over the Affordable Care Act, Republicans have moved more to the right on health care and Democrats have moved more to the left on health care. You are no stranger to partisan politics nor the ways of Washington, D.C. How could everybody be brought back to what I daresay looks like a political compromise?

Baicker: Well, I’m an economist, as you noted, and that’s notoriously bad at understanding actual human beings. I don’t have any idea for the path forward through the political thicket that we’re in. In some ways, it is a little disheartening to see how difficult it is to do some basic commonsense things. In any complicated system like the U.S. health care system, there are always small technical fixes that need to be made that are just commonsense, that ought not to be political. And it’s hard to do those.

Rovner: We’re lacking in common sense right now in Washington.

Baicker: Yeah. So I can’t say that I’m hugely optimistic about a big change happening right away. On the other hand, I think covid really highlighted to people across the political spectrum how important it is to have continuity of coverage, how disparate our current system is in terms of access to care, how problematic it is to have your main avenue of health insurance be through your employer when a pandemic is coupled with a recession. So I think the challenges and the vast inequities of our health care system were laid bare during covid. So it is perhaps salient enough that people might be willing to consider alternative structures. But I can’t say I’m holding my breath.

Rovner: Well, Kate Baicker, thank you very much for, if anything, a great thought experiment. It’s really wonderful to look your way through … it’s like, oh, we could get there, maybe in another half a century.

Baicker: I hope sooner than that.

Rovner: I do, too. Thank you so much.

Baicker: My pleasure.

Rovner: OK, we’re 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 khn.org and in our show notes on your phone or other mobile device. Rachel, why don’t you go first this week?

Cohrs: My extra credit is headlined “UnitedHealthcare Tried to Deny Coverage to a Chronically Ill Patient. He Fought Back, Exposing the Insurer’s Inner Workings,” in ProPublica by David Armstrong, Patrick Rucker, and Maya Miller. And I thought this story was just such a good illustration of the jargon that we use in D.C., of, like, utilization management and prior authorization. And sometimes these terms just feel so impersonal. But I feel like this story did such a good job walking through one patient’s struggle to find something that worked and then just the arbitrary choices that insurers were making, looking at their bottom line to try to prevent him from getting a very expensive treatment that actually did increase his quality of life significantly. So I would definitely recommend, as we’re thinking about insurers’ role in this whole health care cost debate as well.

Rovner: Yeah, it does bring home how the patient is always in the middle of this. Alice.

Ollstein: I chose a piece by my colleague Carmen Paun called “Mpox Is Simmering South of the Border, Threatening a Resurgence,” and it’s about how the U.S. was extremely successful in vaccinating high-risk people against mpox, which for folks who still remember the artist formerly known as monkeypox, the name was changed to reduce stigma and be more accurate. The U.S. vaccination campaign and messaging campaign to the most high-risk populations was really successful and did the trick. But as we learned from covid and every other infectious disease, if you don’t take care of other parts of the world, it could eventually come back. We’re not an island, and even islands aren’t safe. But, you know, this is about a bunch of countries, including Mexico, that really have made no mass vaccination effort at all. You know, some civil society groups are trying on their own, but they just don’t have official government backing. And that’s really dangerous. And it meant that cases are surging in parts of Latin America and parts of Africa. And as we saw from covid, that leads to the development of new variants and things traveling back to the U.S. and other places around the world. So, certainly, something to pay attention to.

Rovner: Public health is important. World public health is important. Sarah.

Karlin-Smith: I looked at a piece called “Decisions by CVS and Optum Panicked Thousands of Their Sickest Patients,” by Arthur Allen for Kaiser Health News. It’s a deep dive into CVS and Optum moving out of, to some degree, business places where they provide home infusion services of perinatal nutrition to people that essentially cannot eat or drink in most cases. And they basically decided that it’s not a great business opportunity for them in many cases. But these are people that really depend on these services to live and survive, and they’re very complex medicines and essential nutrition to get and deliver. And at the same time, I think what really fascinated me about this story is it talks about this dynamic of while companies are getting out of the space where you’re providing this service to people that need these IV treatments to survive and live, there also has been development of these medical spas, as they’re called, where people that actually do not need IV hydration or IV nutrition are essentially being given it for nonmedical purposes. And there’s a lot of money being made there. And it just shows you how some of the profit incentives in our system don’t necessarily align with treating the people that actually need the health care first.

Rovner: Yeah, it’s like the people with diabetes not being able to get their drugs because people in Hollywood want to lose 10 pounds fast. But this obviously is, you know, another life-or-death issue. Well, I chose an op-ed this week in The New York Times by the University of Texas law professor Steven I. Vladeck called “Don’t Let Republican ‘Judge Shoppers’ Thwart the Will of Voters.” And it answered a lot of questions for me. First, how is it that so many suits end up in front of the same judges who the plaintiffs know are likely to rule in their favor, and all in Texas? So it turns out that Texas has distributed its federal judges in a way that in nine districts there is only one judge. And in 10 more, there are only two judges. Obviously, there’s no random draw in those districts where there’s only one judge. That’s what you’re going to get. So we keep seeing some of the same Texas judges, first Judge Reed O’Connor in Fort Worth, and now Matthew Kacsmaryk, a former advocate for a conservative think tank and the only federal judge in Amarillo. Judge O’Connor had the big ACA case, now has a big preventive care case. Judge Kacsmaryk has the abortion pill case that we’ve been talking about. It’s a really interesting piece about how that could really twist justice. But it also includes several ways to fix it. We’ll have to see if any of them actually get taken up.

OK. That is our show for this week. 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 — all one word — @kff.org. Or you can tweet me as long as Twitter is still up. I’m @jrovner. Alice?

Ollstein: @AliceOllstein

Rovner: Rachel

Cohrs: @rachelcohrs

Rovner: Sarah.

Karlin-Smith: @SarahKarlin

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

Credits

Francis Ying
Audio producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

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

USE OUR CONTENT

This story can be republished for free (details).

Word spread to Facebook groups, and patients started calling Coram CVS, a major U.S. supplier of the compounded IV nutrients on which they rely for survival. To their dismay, CVS Health confirmed the rumors on June 1: It was closing 36 of the 71 branches of its Coram home infusion business and laying off about 2,000 nurses, dietitians, pharmacists, and other employees.

Many of the patients left in the lurch have life-threatening digestive disorders that render them unable to eat or drink. They depend on parenteral nutrition, or PN — in which amino acids, sugars, fats, vitamins, and electrolytes are pumped, in most cases, through a specialized catheter directly into a large vein near the heart.

The day after CVS’ move, another big supplier, Optum Rx, announced its own consolidation. Suddenly, thousands would be without their highly complex, shortage-plagued, essential drugs and nutrients.

“With this kind of disruption, patients can’t get through on the phones. They panic,” said Cynthia Reddick, a senior nutritionist who was let go in the CVS restructuring.

“It was very difficult. Many emails, many phone calls, acting as a liaison between my doctor and the company,” said Elizabeth Fisher Smith, a 32-year-old public health instructor in New York City, whose Coram branch closed. A rare medical disorder has forced her to rely on PN for survival since 2017. “In the end, I got my supplies, but it added to my mental burden. And I’m someone who has worked in health care nearly my entire adult life.”

CVS had abandoned most of its less lucrative market in home parenteral nutrition, or HPN, and “acute care” drugs like IV antibiotics. Instead, it would focus on high-dollar, specialty intravenous medications like Remicade, which is used for arthritis and other autoimmune conditions.

Home and outpatient infusions are a growing business in the United States, as new drugs for chronic illness enable patients, health care providers, and insurers to bypass in-person treatment. Even the wellness industry is cashing in, with spa storefronts and home hydration services.

But while reimbursement for expensive new drugs has drawn the interest of big corporations and private equity, the industry is strained by a lack of nurses and pharmacists. And the less profitable parts of the business — as well as the vulnerable patients they serve — are at serious risk.

This includes the 30,000-plus Americans who rely for survival on parenteral nutrition, which has 72 ingredients. Among those patients are premature infants and post-surgery patients with digestive problems, and people with short or damaged bowels, often the result of genetic defects.

While some specialty infusion drugs are billed through pharmacy benefit managers that typically pay suppliers in a few weeks, medical plans that cover HPN, IV antibiotics, and some other infusion drugs can take 90 days to pay, said Dan Manchise, president of Mann Medical Consultants, a home care consulting company.

In the 2010s, CVS bought Coram, and Optum bought up smaller home infusion companies, both with the hope that consolidation and scale would offer more negotiating power with insurers and manufacturers, leading to a more stable market. But the level of patient care required was too high for them to make money, industry officials said.

“With the margins seen in the industry,” Manchise said, “if you’ve taken on expensive patients and you don’t get paid, you’re dead.”

In September, CVS announced its purchase of Signify Health, a high-tech company that sends out home health workers to evaluate billing rates for “high-priority” Medicare Advantage patients, according to an analyst’s report. In other words, as CVS shed one group of patients whose care yields low margins, it was spending $8 billion to seek more profitable ones.

CVS “pivots when necessary,” spokesperson Mike DeAngelis told KHN. “We decided to focus more resources on patients who receive infusion services for specialty medications” that “continue to see sustained growth.” Optum declined to discuss its move, but a spokesperson said the company was “steadfastly committed to serving the needs” of more than 2,000 HPN patients.

DeAngelis said CVS worked with its HPN patients to “seamlessly transition their care” to new companies.

However, several Coram patients interviewed about the transition indicated it was hardly smooth. Other HPN businesses were strained by the new demand for services, and frightening disruptions occurred.

Smith had to convince her new supplier that she still needed two IV pumps — one for HPN, the other for hydration. Without two, she’d rely partly on “gravity” infusion, in which the IV bag hangs from a pole that must move with the patient, making it impossible for her to keep her job.

“They just blatantly told her they weren’t giving her a pump because it was more expensive, she didn’t need it, and that’s why Coram went out of business,” Smith said.

Many patients who were hospitalized at the time of the switch — several inpatient stays a year are not unusual for HPN patients — had to remain in the hospital until they could find new suppliers. Such hospitalizations typically cost at least $3,000 a day.

“The biggest problem was getting people out of the hospital until other companies had ramped up,” said Dr. David Seres, a professor of medicine at the Institute of Human Nutrition at Columbia University Medical Center. Even over a few days, he said, “there was a lot of emotional hardship and fear over losing long-term relationships.”

To address HPN patients’ nutritional needs, a team of physicians, nurses, and dietitians must work with their supplier, Seres said. The companies conduct weekly bloodwork and adjust the contents of the HPN bags, all under sterile conditions because these patients are at risk of blood infections, which can be grave.

As for Coram, “it’s pretty obvious they had to trim down business that was not making money,” Reddick said, adding that it was noteworthy both Coram and Optum Rx “pivoted the same way to focus on higher-dollar, higher-reimbursement, high-margin populations.”

“I get it, from the business perspective,” Smith said. “At the same time, they left a lot of patients in a not great situation.”

***

Smith shares a postage-stamp Queens apartment with her husband, Matt; his enormous flight simulator (he’s an amateur pilot); cabinets and fridges full of medical supplies; and two large, friendly dogs, Caspian and Gretl. On a recent morning, she went about her routine: detaching the bag of milky IV fluid that had pumped all night through a central line implanted in her chest, flushing the line with saline, injecting medications into another saline bag, and then hooking it through a paperback-sized pump into her central line.

Smith has a connective tissue disorder called Ehlers-Danlos syndrome, which can cause many health problems. As a child, Smith had frequent issues such as a torn Achilles tendon and shoulder dislocations. In her 20s, while working as an EMT, she developed severe gut blockages and became progressively less able to digest food. In 2017, she went on HPN and takes nothing by mouth except for an occasional sip of liquid or bite of soft food, in hopes of preventing the total atrophy of her intestines. HPN enabled her to commute to George Washington University in Washington, D.C., where in 2020 she completed a master’s in public health.

On days when she teaches at LaGuardia Community College — she had 35 students this semester — Smith is up at 6 a.m. to tend to her medical care, leaves the house at 9:15 for class, comes home in the afternoon for a bag of IV hydration, then returns for a late afternoon or evening class. In the evening she gets more hydration, then hooks up the HPN bag for the night. On rare occasions she skips the HPN, “but then I regret it,” she said. The next day she’ll have headaches and feel dizzy, sometimes losing her train of thought in class.

Smith describes a “love-hate relationship” with HPN. She hates being dependent on it, the sour smell of the stuff when it spills, and the mountains of unrecyclable garbage from the 120 pounds of supplies couriered to her apartment weekly. She worries about blood clots and infections. She finds the smell of food disconcerting; Matt tries not to cook when she’s home. Other HPN patients speak of sudden cravings for pasta or Frosted Mini-Wheats.

Yet HPN “has given me my life back,” Smith said.

She is a zealous self-caretaker, but some dangers are beyond her control. IV feeding over time is associated with liver damage. The assemblage of HPN bags by compounding pharmacists is risky. If the ingredients aren’t mixed in the right order, they can crystallize and kill a patient, said Seres, Smith’s doctor.

He and other doctors would like to transition patients to food, but this isn’t always possible. Some eventually seek drastic treatments such as bowel lengthening or even transplants of the entire digestive tract.

“When they run out of options, they could die,” said Dr. Ryan Hurt, a Mayo Clinic physician and president of the American Society for Parenteral and Enteral Nutrition.

***

And then there are the shortages.

In 2017, Hurricane Maria crippled dozens of labs and factories making IV components in Puerto Rico; next came the covid-19 emergency, which shifted vital supplies to gravely ill hospital patients.

Prices for vital HPN ingredients can fluctuate unpredictably as companies making them come and go. For example, in recent years the cost of the sodium acetate used as an electrolyte in a bag of HPN ballooned from $2 to $25, then briefly to $300, said Michael Rigas, a co-founder of the home infusion pharmacy KabaFusion.

“There may be 50 different companies involved in producing everything in an HPN bag,” Rigas said. “They’re all doing their own thing — expanding, contracting, looking for ways to make money.” This leaves patients struggling to deal with various shortages from saline and IV bags to special tubing and vitamins.

“In the last five years I’ve seen more things out of stock or on shortage than the previous 35 years combined,” said Rigas.

The sudden retrenchment of CVS and Optum Rx made things worse. Another, infuriating source of worry: the steady rise of IV spas and concierge services, staffed by moonlighting or burned-out hospital nurses, offering IV vitamins and hydration to well-off people who enjoy the rush of infusions to relieve symptoms of a cold, morning sickness, a hangover, or just a case of the blahs.

In January, infusion professionals urged FDA Commissioner Robert Califf to examine spa and concierge services’ use of IV products as an “emerging contributing factor” to shortages.

The FDA, however, has little authority over IV spas. The Federal Trade Commission has cracked down on some spa operations — for unsubstantiated health claims rather than resource misuse.

Bracha Banayan’s concierge service, called IVDRIPS, started in 2017 in New York City and now employs 90 people, including 60 registered nurses, in four states, she said. They visit about 5,000 patrons each year, providing IV hydration and vitamins in sessions of an hour or two for up to $600 a visit. The goal is “to hydrate and be healthy” with a “boost that makes us feel better,” Banayan said.

Although experts don’t recommend IV hydration outside of medical settings, the market has exploded, Banayan said: “Every med spa is like, ‘We want to bring in IV services.’ Every single paramedic I know is opening an IV center.”

Matt Smith, Elizabeth’s husband, isn’t surprised. Educated as a lawyer, he is a paramedic who trains others at Columbia University Irving Medical Center. “You give someone a choice of go up to some rich person’s apartment and start an IV on them, or carry a 500-pound person living in squalor down from their apartment,” he said. “There’s one that’s going to be very hard on your body and one very easy on your body.”

The very existence of IV spa companies can feel like an insult.

“These people are using resources that are literally a matter of life or death to us,” Elizabeth Smith said.

Shortages in HPN supplies have caused serious health problems including organ failure, severe blisters, rashes, and brain damage.

For five months last year, Rylee Cornwell, 18 and living in Spokane, Washington, could rarely procure lipids for her HPN treatment. She grew dizzy or fainted when she tried to stand, so she mostly slept. Eventually she moved to Phoenix, where the Mayo Clinic has many Ehlers-Danlos patients and supplies are easier to access.

Mike Sherels was a University of Minnesota Gophers football coach when an allergic reaction caused him to lose most of his intestines. At times he’s had to rely on an ethanol solution that damages the ports on his central line, a potentially deadly problem “since you can only have so many central access sites put into your body during your life,” he said.

When Faith Johnson, a 22-year-old Las Vegas student, was unable to get IV multivitamins, she tried crushing vitamin pills and swallowing the powder, but couldn’t keep the substance down and became malnourished. She has been hospitalized five times this past year.

Dread stalks Matt Smith, who daily fears that Elizabeth will call to say she has a headache, which could mean a minor allergic or viral issue — or a bloodstream infection that will land her in the hospital.

Even more worrying, he said: “What happens if all these companies stop doing it? What is the alternative? I don’t know what the economics of HPN are. All I know is the stuff either comes or it doesn’t.”

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

USE OUR CONTENT

This story can be republished for free (details).

So to give it a nudge in a useful direction, we are firing up the coffee kettle to brew another cup of stimulation. Our choice today is maple bourbon. As always, you are invited to join us. Meanwhile, here is the latest menu of tidbits to help you start your journey. We hope your day is productive and meaningful. And of course, do keep in touch. We are searching for new pen pals …

Now that its blockbuster immune-disease therapy Humira is facing lower-priced competition, AbbVie is turning to a pair of next-generation successors to replenish the billions of dollars in sales that will be lost, The Wall Street Journal writes. The company is also betting on four drug approvals by the end of next year. In addition, AbbVie is lifting a self-imposed $2 billion limit on the size of deals it would do to add more products. AbbVie is counting most on persuading doctors that two newer immune drugs, Skyrizi and Rinvoq, are more effective than Humira and can pass peak Humira sales in four years.

Continue to STAT+ to read the full story…

Underscoring the opaque and confusing nature of pharmaceutical pricing, Amgen announced long-awaited discounts for its biosimilar version of Humira — the world’s best-selling medicine — and the numbers suggest the biggest winners may be health insurers and others in the supply chain, but not patients.

Here’s why: The drug company will offer its medication, called Amjevita, at two different discounts — 5% and 55% — off the roughly $80,000 wholesale, or list, price. The maneuver reflects the behind-the-scenes negotiations that occur between pharmaceutical companies and the pharmacy benefit managers, or PBMs, that create formularies, or lists of medicines for which insurance coverage is provided.

Continue to STAT+ to read the full story…

The Host

Julie Rovner
KHN

@jrovner

Read Julie's stories.

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

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

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

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

Panelists

Alice Miranda Ollstein
Politico

@AliceOllstein

Read Alice's stories

Sandhya Raman
CQ Roll Call

@SandhyaWrites

Read Sandhya's stories

Sarah Varney
KHN

@sarahvarney4

Read Sarah's stories

Among the takeaways from this week’s episode:

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

And for extra credit, the panelists recommend their most memorable reproductive health stories from the last year:

Julie Rovner: NPR’s “Because of Texas’ Abortion Law, Her Wanted Pregnancy Became a Medical Nightmare,” by Carrie Feibel

Alice Miranda Ollstein: The New York Times Magazine’s “She Wasn’t Ready for Children. A Judge Wouldn’t Let Her Have an Abortion,” by Lizzie Presser

Sandhya Raman: ProPublica’s “’We Need to Defend This Law’: Inside an Anti-Abortion Meeting with Tennessee’s GOP Lawmakers,” by Kavitha Surana

Sarah Varney: Science Friday’s and KHN’s “Why Contraceptive Failure Rates Matter in a Post-Roe America,” by Sarah Varney

Also mentioned in this week’s podcast:

• NPR’s “Doctors Who Want to Defy Abortion Laws Say It’s Too Risky,” by Selena Simmons-Duffin
• The Columbus Dispatch’s “Suspect Indicted in Rape of 10-Year-Old Columbus Girl Who Got Indiana Abortion,” by Bethany Bruner
• Reveal’s “The Long Campaign to Turn Birth Control Into the New Abortion”
• Reuters’ “Alabama Case Over Mistaken Pregnancy Highlights Risks in a Post-Roe World,” by Hassan Kanu
• Politico’s “The Next Abortion Fight Could Be Over Wastewater Regulation,” by Alice Miranda Ollstein
• The Washington Post’s “Abortion Bans Complicate Access to Drugs for Cancer, Arthritis, Even Ulcers,” by Katie Shepherd and Frances Stead Sellers
• The Washington Post’s “A Triumphant Antiabortion Movement Begins to Deal With Its Divisions,” by Rachel Roubein and Brittany Shammas
• NBC News’ “Abortion Rights Groups Look to Build on Their Victories With New Ballot Measures,” by Adam Edelman

Click to open the transcript

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

KHN’s ‘What the Health?’Episode Title: Part II: The State of the Abortion Debate 50 Years After ‘Roe’Episode Number: 282Published: Jan. 26, 2023

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

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

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

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

Julie Rovner: Hi, it’s Julie Rovner from KHN’s “What the Health?” What follows is Part II of a great panel discussion on the state of the abortion debate 50 years after Roe v. Wade, featuring Alice Miranda Ollstein of Politico, Sandhya Raman of CQ Roll Call, and Sarah Varney of KHN. If you missed Part I, you might want to go back and listen to that first. So, without further ado, here we go.

We already talked a little bit about the difficult legal situation that abortion providers or just OB-GYNs have been put into, worried about whether what they consider just medical care will be seen as an abortion and they’ll be dragged into court. But in Tennessee, doctors would actually have to prove in court that an abortion was medically necessary, which seems a bit backwards. So, basically, it’s do it, see if you get arrested, and then you’ll have to present an affirmative defense in court. But the other thing that we’re starting to see is doctors leaving states, women’s health clinics closing, medical students and residents choosing to train elsewhere. This could really lead to a doctor drain in significant parts of the country, right?

Sandhya Raman: Yeah, I was looking at before where some of the states that have some of the highest rates of maternal mortality, maternal morbidity, and just lower maternal health outcomes overall are some of the same ones that don’t have Medicaid expansion and also do not have access to abortion right now. And it’s one of the things where, looking ahead, there have been people sounding the alarm at how this is going to get amplified. And as folks that might be interested in this discipline that are in medical school, school or readying for residency, or another type of provider that works in this space, if they choose to not train in these states — and a lot of folks that train in states often end up staying in those states — even if there are changes in some of these laws in the near term, it could have a huge effect in the future in terms of who’s training and who’s staying there and who’s able to provide not just abortions, but other terms of pregnancy care and maternal care.

Sarah Varney: And the workaround has become much more difficult because it used to be that if you’re in a state where abortion was very difficult to access or even, say, Texas during S.B. 8, these medical students could go to other states for the training. But now that you have these huge swaths of the South and the Plains and the Midwest where they are not allowed to do abortions, there’s just not enough places for OB-GYN residents and medical students to go to train. I did a story about this last year as well and looked at these students who were in medical school, who were coming up to Match Day and at the end, at the very end before the deadline, actually changed their match altogether or changed their list of priorities altogether because they didn’t want to be in Texas. So instead of doing an OB-GYN residency in Texas, this one young woman changed to a family medicine practice in Maryland. And I think the thing that’s important for people to remember is that these are the future OB-GYNs that will help many of us with our pregnancies and births for many decades to come. And as we have seen, pregnancy is very complicated and it oftentimes doesn’t end well. You know, about 10% of all confirmed pregnancies end in miscarriage; a far higher number end in miscarriage that are not confirmed pregnancies. And these will be the doctors that are supposed to actually know how to do these procedures. So if you’re in a state like Texas and you have a daughter who’s 15 and you anticipate in 15 years she may want to have a baby, you have to think about what kind of medical care she can have access to then.

Rovner: I’ve talked to a lot of people, a lot of women, who want to get pregnant, who want to get pregnant and have kids, but they are worried about getting pregnant because if something goes wrong, they’re afraid they won’t be able to get appropriate medical care. They would like to get pregnant, but they would actually not like to risk their own lives in trying to have a baby. And that’s actually what we’re looking at in a number of these states. I guess this is the appropriate place to bring up the idea of “personhood,” the declaration, not medically based, that a separate person with separate rights is created at the moment of conception. That could have really sweeping ramifications, couldn’t it? They’re talking about that, I know, in several states.

Varney: Yes. You don’t have to probe far to find out that the pro-life movement is 100% behind a federal fetal rights … the Supreme Court last year didn’t take up a case about fetal rights yet, but many of the members of the court have expressed in previous writings, and even in the Dobbs [v. Jackson Women’s Health Organization] decision, you saw [Justice Samuel] Alito using the language of the state of Mississippi that essentially granted to the fetus all of the … even, like, personality of a full human being. So I think this is going to get really tricky because Kristan Hawkins and many of the leaders of the movement, Jeanne Mancini, they do believe that there is no distinction between a zygote and a fetus and a full human being. So now this is really a religious belief. And it was interesting. I really struggled last year. I had to … I was basically assigned to write a story about, you know, when does life begin? And I think it’s an interesting question we have to ask ourselves as journalists: Why should we do that story? Is that, in a sense, propaganda for the pro-life movement? When really what the question should be is, you have a full human being, the woman, at what point should her rights be impeded upon? Right? And that’s essentially what the Roe decision tried to do, was to strike that balance. But now we’re in a whole new world where fetal rights are really the … they almost have supremacy over women’s rights.

Rovner: Yeah, I did two stories on When Does Life Begin? And it turned into one of them is … really the question is when does pregnancy begin? One of the doctors I talked to said, rather, that pregnancy begins when we can detect it, which is in many ways true. A doctor can’t say that you’re pregnant unless they can detect it at that point. But that’s a really important distinction medically between, you know, when does life begin philosophically and when does a pregnancy actually begin. But, obviously, in places that are going to declare personhood, this is going to get really complicated really fast because it would mean that you mostly couldn’t do IVF, that you can’t create embryos and then not implant them. And of course, the way IVF works for most people who are infertile and would like to have children is that you take out the eggs, you fertilize them, you grow them to a certain cell size, and then you implant them back into the woman. But you don’t generally use all of the embryos. And that would be illegal if every one of those embryos was an actual person. Could you take tax deductions for children if the child hasn’t been born yet, but you’re pregnant? I think you can already do that in Georgia, right?

Varney: Correct. Yeah. The Department of Revenue did that there.

Rovner: Yeah. This could be really, really far-reaching.

Varney: I mean, that’s what’s been going on in Alabama for years. … When the Alabama state Supreme Court years ago agreed with this argument that a law that was put in place to try and go after parents who were bringing their children to meth labs, that the notion of the environment was no longer just the meth lab, but the womb itself. And a child also then meant a fetus in the womb. Now you’re in that territory already. So Alabama’s a very good way to look into the future, in a sense.

Rovner: So basically, if you’re pregnant and go into a bar, you could be threatening the fetus.

Varney: I mean, there’s kind of no limit, right? Like, did you drive recklessly? Did you slip or did you fall on purpose? I mean, that’s what I was saying earlier about it’s really going to be up to these local prosecutors to figure out how far they want to take this.

Rovner: And that’s not hypothetical. We’ve seen cases about a woman who fell down the stairs and had a miscarriage and was prosecuted for throwing herself down the stairs.

Varney: Or a woman who was pregnant and got into an altercation in a parking lot of a big-box store and got shot and the fetus died. And then she was arrested. I mean, eventually they dropped the charges, but. yeah.

Rovner: Well, moving on. So with narrow majorities in both houses of Congress for the party in charge, changing federal law in either direction seems pretty unlikely for the next two years, which leaves the Biden administration to try to reassure people who support abortion rights. But the Biden administration doesn’t have a long list of things that can be done by executive action either, beyond what they’ve done with the abortion pill, which we mentioned already — the FDA has loosened some of those restrictions. How has the Biden administration managed to protect abortion rights?

Alice Miranda Ollstein: First, along the lines of the FDA, the FDA has been called on by the pro-abortion rights side to drop the remaining restrictions on the abortion pill. So they’ve dropped some, but they still require a special certification for the doctors who prescribe it, a special certification for the pharmacies that are just newly allowed to dispense it. Patients have to sign something saying they understand the risks. These are called REMS. These are on drugs that are considered dangerous. And a lot of medical groups and advocates argue that there isn’t evidence that this is necessary, that the safety profile of these drugs is better than a lot of drugs that don’t have these kinds of restrictions. And so they said that it would improve access to drop these remaining rules around the pills. Some have even called for them to be available over the counter, although I don’t see that happening anytime soon. Along the lines of preventing unwanted pregnancies in the first place, the FDA also is sitting on a decision of whether or not to make just regular hormonal birth control available over the counter. So that’s one to watch as well. But the Biden administration have more things they could do. They have looked at providing abortions through the VA [ Department of Veterans Affairs]. That was a big one. Earlier this year, the president signed a memo just over the weekend directing the health secretary and others in the Cabinet to look at what they can do to improve access. We’ve seen similar statements and memos before. It’s not really clear what they’ll mean in practice. But I also want to go back to you saying that nothing is likely to happen in Congress. I agree on the legislative side, but I am watching closely on the appropriations side, because I think that’s where you could see some attempts to pull things in one direction or another in terms of where federal spending goes. And going back to the group’s wastewater strategy, one piece of that they want to do, the anti-abortion groups, is pressure Republican members of Congress to hold the FDA’s funding hostage until they do certain environmental studies on the impacts of the pills. That’s where I would watch.

Rovner: Yeah, and spending bills over the years have been the primary place to do legislating on abortion restrictions or take them off. It’s not just the Hyde Amendment that banned most federal spending for abortion. There are amendments tucked into lots of different spending bills restricting abortion and other types of reproductive health care. And when Democrats are in charge, they try to take them out. And when Republicans are in charge, they try to put them back in. So I agree with Alice. I think we’re going to see those fights, although it’s hard to imagine anything happening beyond the status quo. I don’t think either side has the ability to change it, but I suspect that they’re going to try. The administration has gone after some states on the federal EMTALA law, right? The Emergency Medical Treatment and Active Labor Act, which basically says that hospitals have to stabilize and take in women in active labor. And basically, if that conflicts with an abortion ban again, like with the FDA and drugs, federal law should supersede the state law. But we haven’t really seen any place where that’s come to a head, right?

Raman: Idaho has been the main one to watch with the lawsuit there. And the Justice Department did a briefing this week before their reproductive rights council met. And they had said that that was one of the cases they’re still doing — the Idaho, in addition to the lawsuit on the VA rule that Alice mentioned, and then also an FDA rule that we talked about earlier. But they’re monitoring different things going forward. But I think one of the interesting things is that they haven’t cast a very huge net in terms of the different things that they’ve been involved with in states. It’s mainly been these three situations. And even Idaho, they’ve already in that legislature introduced a bill that would amend their law as it is now, to deal with some of the nuances so that they would adhere to EMTALA. I don’t know how far that could go through or any of the logistics with that, but I mean, that sort of thing, the Idaho situation could be solved more quickly if they’re able to get that done. And DOJ [the Department of Justice] thinks that that aligns. But it is interesting that they haven’t dug into a lot of the other state efforts yet, but that they have that on their radar.

Varney: We have seen a sort of political battle being waged, of course. So on the anniversary of Roe v. Wade, Vice President Kamala Harris was in Florida, in Tallahassee, making the 50th-anniversary-of-Roe speech. Clearly, she wants [Gov. Ron] DeSantis to be on notice that should he become a candidate in the presidential election, that Florida is very much in play. And Florida is interesting because they still have a 15-week ban. So it would not have been allowed under Roe, but it’s not as draconian as what these other states have, which is essentially nothing.

Rovner: Most of the surrounding states, too.

Varney: Correct. Yeah, exactly. So Florida has really become a receiving state for abortions, particularly in the last six months. I’m going to be interested to see if somebody like a DeSantis can even run for president from a state with a 15-week ban. I mean, he’s going to be under a lot of pressure, not simply just to do a six-week ban, but to do an outright ban altogether. So I think if he tries to thread that needle and try and get anti-abortion groups on board to support him, he’s going to have to show them more.

Rovner: That’s just about what we’re going to get to. But before we leave, what the Biden administration has done, I need to mention, because it’s my own personal hobbyhorse — that the FDA has finally come out and changed the label on the “morning-after pill” to point out that it is not an abortion pill, that it does not cause abortion, that the way it works is by preventing ovulation. So there is no fertilized egg and that at least we can maybe put that aside, finally. That label change happened in Europe 10 years ago, and for some reason it took the FDA until now to make that clarification.

Varney: But as you said, Julie, it doesn’t matter because it’s just what you believe about the drug. You know, and just to remind listeners that that drug I did — I mean, we’ve all done stories on Plan B over the years — but the one I did recently was how Plan B is actually owned by a private equity company, actually two private equity companies. And they would not go to the mat to the FDA to get this thing changed. They could have done it years ago. So now that the FDA has made this … it’s just like anything, any kind of misinformation, that people who don’t support it can just simply say, well, the FDA is biased or that’s not actually how it works.

Rovner: True.

Varney: But I don’t think it will put it to bed.

Rovner: Well, quickly, let us turn to 2023 and what we might see for the rest of this year. We’ll start with the anti-abortion side. Obviously, overturning Roe was not the culmination of their efforts. They have some pretty ambitious goals for the coming year, right? Things like travel bans and limiting exceptions in some of these states. Sandhya, I see you nodding.

Raman: There are so many things, I think, on my radar that I’m hoping to watch this year just because we are in this whole new era where it might have been three years ago a lot easier for us to predict which things might be caught up in litigation, which things might be struck down. But I think now, after the Dobbs decision, even after the Texas S.B. 8 law that we mentioned earlier, it’s a lot more difficult to see what sort of things will go in effect that might not have been able to go into effect before. And one thing I think has been interesting is that the anti-abortion movement had been in unison before this on some of their traditional Hyde exceptions — that abortions to save the life of the mother, in cases of rape and incest were something that was broadly on board, that those would be allowed. And I think we’ve seen a lot increasingly in different states, things that have been brought up by different state lawmakers that would chip away at that, that vary by state, whether or not what defines is medically necessary to save a life. And even when we were talking about Idaho earlier with the EMTALA requirements or … there was a great piece in The New Yorker last year about the anti-abortion activist who really wants to lobby against rape exceptions because she was born as a product of rape and is using her own experience in that. And so I think that will be a very interesting thing to watch because there is not a uniform agreement on that. Whereas some of the things that have been taken out, there’s a lot more strong backing for across the board.

Rovner: Yeah, that’s actually my next question, which is we’re starting to see not only a split within the anti-abortion community about what to pursue, but a little bit of distance between the Republicans and the anti-abortion forces. And I think there’s a lot of Republicans who are uncomfortable with going further or who are uncomfortable even in some of the states that don’t have exceptions. I mean, are we looking at a potential breakup of this Republican anti-abortion team that’s been so valuable to both sides over the last few decades?

Ollstein: I wouldn’t call it a breakup, but the tension is absolutely there. I mean, I wouldn’t call it a breakup just because, where else are they going to go? I mean, the Democratic Party is much more supportive of abortion rights as a whole than even just a few years ago. And so, really, they know Republicans are their best bet for getting these restrictions passed. But there is this interesting tension right now. I think a lot of it is competing interpretations of what happened in this most recent election. You have anti-abortion groups who insist that the takeaway should be candidates didn’t run hard enough on banning and restricting abortion and were too wishy-washy, and that’s why they lost. And then you have a lot of other Republicans and party officials, party leaders who feel that they were too aggressive on promoting abortion restrictions and that’s why they lost. Also, you know, I will say this isn’t purely, purely cynical politics. A lot of Republican state lawmakers have told us they’re genuinely concerned now that they’re actually seeing the laws they drafted and voted for take effect and have consequences that they maybe didn’t intend. And they’re hearing from these state medical groups who are pleading for changes to be made. And so some of them say, OK, we want to get this right. We want to go back and make fixes. And the anti-abortion groups are telling them, no, don’t create loopholes. Don’t water down these laws. And so you do have this really interesting tug of war playing out at the state level right now. And because of what you said about the federal level, the state level is really where it’s at.

Varney: And I was going to make two points. One is that the split is also really developing between the national groups and the state and local groups. So while the national groups may say, yes, we support a 15-week ban in Florida as a step to get to something else, the local groups are gung-ho. I mean, they’re in extremely gerrymandered districts. You look at Florida and Texas, they elected the most anti-abortion state legislature in history so far. And, you know, these are people coming from extremely safe seats. And then you’ll see that the city level — the city sanctuary of the unborn, I believe it’s called — that movement, they really see them going down to even the local-local level to try and get that in effect.

Rovner: Well, I think in a lot of places, states that are very affirmatively supportive of abortion rights or have it in their constitution, are trying to move that down to the local level, to the city level, to see if they can actually have success in limiting abortion locality by locality. All right. Well, meanwhile, what’s the other side doing? What’s the agenda for the abortion rights side? It’s going to be, as we pointed out, it’s gonna be kind of hard for them to advance very much.

Ollstein: Yes. I think that there is a lot of excitement around the results last year using state-level ballot initiatives in red and purple states, putting the question of abortion rights to the general public, because on all six ballots last year, the abortion rights side prevailed. Some of those were more offensive, some of those were more defensive. But in all six, they swept. And so they are really excited about trying to replicate that this year. Of course, it’s not possible in every state to put a constitutional amendment on the ballot for a popular vote. But in states where it is possible and where it could make a difference, including some states where abortion is already banned and they could try to unban it through the popular vote process, that’s really something they’re looking at. And then, of course, even though our federal judiciary has become a lot more conservative over time with the appointments, courts have still been convinced to block a lot of these state abortion restrictions. And so there are efforts to bring lots of different, interesting legal theories. You know, one that caught my attention is trying to make religious freedom arguments against abortion bans, saying these abortion bans infringe on the rights of religious people who believe in the right to abortion, which is sort of flipping that narrative there.

Rovner: There have been a bunch of Jewish groups who have filed cases saying that.

Ollstein: Exactly. Judaism, Islam, certain Christian denominations, all support abortion rights. And so there’s an interesting tactic there. Also pointing to language in state constitutions about privacy rights and arguing that should extend to abortion. And so a lot of interesting stuff there.

Raman: I would add to that, in terms of another tactic that’s kind of flipping what the other side has been doing, a long-term strategy of the anti-abortion movement has been prioritizing judicial elections and a long-term thing of … just in the Senate, we saw, you know, wanting to get a lot of judges confirmed that had pro-life beliefs. And you can even look to where the women’s march over the weekend, that the state … one that they were prioritizing was in Wisconsin, which was held there, to jump-start the fact that they have a state Supreme Court race coming up. They were 4-3 conservative majority right now. And the judge that is retiring is conservative. So getting a new judge that supports abortion rights could really open a path to overturn the ban there. Even though judicial elections are considered nonpartisan, there are often ways to tell clues about where someone might rule in the future. And so, I think, looking at things like that in different states as a way to dial back some of the things that the other side has been doing will be an interesting thing to watch, too.

Rovner: All right. Well, I think that’s it for our discussion. Thank you, for those of you who have hung with us this long. I hope we’ve given a good overview of the landscape. Now it’s time for our extra-credit segment. Usually that’s when we each recommend a story we read this week we think you should read, too. But this week I’ve asked each of the panelists to choose their favorite or most meaningful story about reproductive health from the last year. 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. Alice, why don’t you go first this week?

Ollstein: Yes, I think I’ve promoted this story before, but I just can’t say enough good things about it. It’s really stuck with me. It’s from the New York Times Magazine by Lizzie Presser, and it’s called “She Wasn’t Ready for Children. A Judge Wouldn’t Let Her Have an Abortion.” And it really digs into what happens to teenagers who need to get their parent’s consent and can’t in order to have an abortion. They have this judicial bypass process where their lives, the fate of their lives are in the hands of an individual judge, who, in many cases, as this article demonstrates, come with their own biases and preconceptions about abortion. And then it just follows this one teenager who was denied an abortion, ended up having twins, and just completely struggled financially, her mental health. And she in the end said, you know, I knew what was right for me. I knew I needed an abortion. And it’s a very moving, painful story that shines a light on a piece of the story that I think is overlooked.

Rovner: Yeah. Sandhya.

Raman: For my extra credit, I picked a story that also has stuck in my head for a long time, kind of like Alice. So it’s “‘We Need to Defend This Law’: Inside an Anti-Abortion Meeting with Tennessee’s GOP Lawmakers,” from Kavitha Surana from ProPublica. I really thought this was one of the most interesting pieces on this topic that I read last year. The author got audio from a webinar in Tennessee hosted by the Tennessee Right to Life on strategy on the movement going ahead in their state. They talk a lot about the Tennessee ban and how it has narrow life exceptions as a model for other states and how the burden of proof would be on the doctor. And then they have some quotes from a Tennessee lawmaker who suggests things that I think the other side has sounded the alarm about: mining data to investigate doctors, how to push back against rape and incest exceptions. And I think one of the things that really struck me was when they brought up IVF, some of the advocates during the meeting that they had said that two years from now, next year, or three years from now, IVF and contraception can be regulated on the table. But that’s like next steps.

Rovner: Absolutely. That was a great scoop, that story. Sarah.

Varney: So I actually picked a radio segment. It’s about a 12-minute-long radio segment that I did with Science Friday. On “Why Contraceptive Failure Rates Matter in a Post-Roe America.” So one of the things I kept hearing was, well, women are just going to have to really double up on contraception or make sure that they’re being responsible about taking their contraception. So it turns out that there’s a textbook on contraceptive technology and in that is a whole page on contraceptive failure rates, which show you what contraceptive failure rates should be in a laboratory and what they are actually out in the real world. So, for instance, the typical-use failure rate for birth control pills is 7%. So that means that seven out of 100 women on pills could experience pregnancy in the first year of use. So then I went and found the data that shows us the number of women ages 15 to 49 who are on specific methods of birth control, everything from the Depo-Provera to the contraceptive ring and patch to male condoms, to IUDs, to birth control pills. And you’ll see on both the Science Friday and the KHN website, we have these wonderful graphics where you can see that in one year of people using male condoms, because of their failure rate is about 13% in the real world, that could lead to up to 513,000 wanted pregnancies. Birth control pills, based on the number of women using birth control pills, up to 460,000 pregnancies a year in people who are actually using contraception to not get pregnant. So I think these data visualization is really important. And you can hear interviews that I did with the researcher and the physician who actually is the author of this textbook, as well as one of the world’s leading reproductive endocrinologists who talks about what’s next in contraceptive efficacy.

Rovner: Yes, I loved that story. Well, my story is also a radio story. It’s from NPR by Carrie Feibel. And it’s called “Because of Texas’ Abortion Law, Her Wanted Pregnancy Became a Medical Nightmare.” And it’s from July. And the events that it chronicles happened before the overturn of Roe v. Wade, because, as we’ve said, Texas’ abortion ban was already in effect. By now, we’ve heard this story many times. A woman with desired pregnancies, water breaks prematurely, which would normally result in a quote-unquote “medical termination.” Except the doctors and hospitals aren’t sure how sick the mom needs to be before the pregnancy actually threatens her life. And any other abortion is illegal, and they could get in legal trouble. So they put her through days of hell and sickness before she starts to show signs of sepsis and just before she and her husband were actually going to fly out of the state to get the pregnancy terminated. But this was the first of these stories that I read. And it hit me very hard. And I have such respect for the couple here who were willing to come forward and publicize all that the women called these gray areas of abortion, which lawmakers often think of as black-and-white. It was just one of those stories that sticks with you.

All right. That is our show for this week. 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 — all one word — @kff.org. Or you can tweet me. I’m @jrovner. Sandhya?

Raman: @SandhyaWrites

Rovner: Alice?

Ollstein: @AliceOllstein

Rovner: Sarah.

Varney: And @SarahVarney4

Rovner: Will be back in your feed with our regular news rundown next week. Until then, be healthy.

Credits

Francis Ying
Audio Producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

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

USE OUR CONTENT

This story can be republished for free (details).

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

Continue to STAT+ to read the full story…

The Host

Julie Rovner
KHN

@jrovner

Read Julie's stories.

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

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

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

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

Panelists

Alice Miranda Ollstein
Politico

@AliceOllstein

Read Alice's stories

Sandhya Raman
CQ Roll Call

@SandhyaWrites

Read Sandhya's stories

Sarah Varney
KHN

@sarahvarney4

Read Sarah's stories

Among the takeaways from this week’s episode:

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

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

Click to open the transcript

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

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

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

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

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

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

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

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

Alice Miranda Ollstein: Good morning.

Rovner: Sandhya Raman of CQ Roll Call.

Sandhya Raman: Good morning.

Rovner: And my KHN colleague Sarah Varney.

Sarah Varney: Hey.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Rovner: We will definitely have you back.

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

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

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

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

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

Rovner: And yet … 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Raman: Yes, yes.

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

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

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

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

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

Varney: Can I just add something? 

Rovner: Yes.

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

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

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

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

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

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

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

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

Credits

Francis Ying
Audio Producer

Emmarie Huetteman
Editor

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

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

USE OUR CONTENT

This story can be republished for free (details).

The Host

Julie Rovner
KHN

@jrovner

Read Julie's stories.

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

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

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

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

Panelists

Sarah Karlin-Smith
Pink Sheet

@SarahKarlin

Read Sarah's stories

Alice Miranda Ollstein
Politico

@AliceOllstein

Read Alice's stories

Margot Sanger-Katz
The New York Times

@sangerkatz

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

Among the takeaways from this week’s episode:

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

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

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

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

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

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

Also mentioned in this week’s podcast:

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

TRANSCRIPT

Click here for a transcript of the episode.

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

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

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

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

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

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

Alice Miranda Ollstein: Good morning.

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

Margot Sanger-Katz: Hello.

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

Sarah Karlin-Smith: Hi, everybody.

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

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

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

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

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

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

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

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

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

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

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

Karlin-Smith: Right.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Rovner: Yeah, in the year 2000.

Karlin-Smith: Right. Which is actually …

Rovner: Right at the end of the Clinton administration.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Sanger-Katz: It sure looks that way.

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

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

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

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

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

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

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

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

Rovner: Like candy stripers.

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

Rovner: Hospitals are very clever. Margot.

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

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

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

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

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

Karlin-Smith: I’m @SarahKarlin

Rovner: Margot?

Sanger-Katz: @sangerkatz

Rovner: Alice.

Ollstein: @AliceOllstein

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

Credits

Francis Ying
Audio Producer

Stephanie Stapleton
Editor

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts, or wherever you listen to podcasts.

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

USE OUR CONTENT

This story can be republished for free (details).

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

Continue to STAT+ to read the full story…

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

‘The Writing to Me Was on the Wall’

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

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

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

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

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

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

Opportunity in Long Covid

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

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

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

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

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

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

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

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

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

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

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

USE OUR CONTENT

This story can be republished for free (details).