FDA approval of blockbuster AbbVie drug Rinvoq makes it the first oral therapy for moderately to severely active Crohn’s disease. The regulatory nod is the seventh for the drug, which belongs to a class of therapies called JAK inhibitors.

The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

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

The formal end May 11 of the national public health emergency for covid-19 will usher in lots of changes in the way Americans get vaccines, treatment, and testing for the coronavirus. It will also change the way some people get their health insurance, with millions likely to lose coverage altogether.

Meanwhile, two FDA advisory committees voted unanimously this week to allow the over-the-counter sale of a specific birth control pill. Advocates of making the pill easier to get say it could remove significant barriers to the use of effective contraception and prevent thousands of unplanned pregnancies every year. The FDA, however, must still formally approve the change, and some of its staff scientists have expressed concerns about whether teenagers and low-literacy adults will be able to follow the directions without the direct involvement of a medical professional.

This week’s panelists are Julie Rovner of KFF Health News, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, Tami Luhby of CNN, and Margot Sanger-Katz of The New York Times.

Panelists

Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico

@JoanneKenen

Read Joanne's stories

Tami Luhby
CNN

@luhby

Read Tami's stories

Margot Sanger-Katz
The New York Times

@sangerkatz

Read Margot's stories

Among the takeaways from this week’s episode:

• The formal public health emergency may be over, but covid definitely is not. More than 1,000 people in the United States died of the virus between April 19 and April 26, according to the Centers for Disease Control and Prevention. While most Americans have put covid in their rearview mirrors, it remains a risk around the country.
• The Senate Finance Committee held a hearing on “ghost networks,” lists of health professionals distributed by insurance companies who are not taking new patients or are not actually in the insurance company’s network. Ghost networks are a particular problem in mental health care, where few providers take health insurance at all.
• Another trend in the business of health care is primary care practices being bought by hospitals, insurance companies, and even Amazon. This strategy was popular in the 1990s, as health systems sought to “vertically integrate.” But now the larger entities may have other reasons for having their own networks of doctors, including using their patients to create revenue streams.
• Court battles continue over the fate of the abortion pill mifepristone, as a federal appeals court in New Orleans prepares to hear arguments about a lower-court judge’s ruling that would effectively cancel the drug’s approval by the FDA. In West Virginia, the maker of the generic version of the drug is challenging the right of the state to ban medication approved by federal officials. At the same time, a group of independent abortion clinics from various states is suing the FDA to drop restrictions on how mifepristone can be prescribed, joining mostly Democratic-led states seeking to ensure access to the drug.

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

Julie Rovner: Slate’s “Not Every Man Will Be as Dumb as Marcus Silva,” by Moira Donegan and Mark Joseph Stern.

Joanne Kenen: The Baltimore Banner’s “Baltimore Isn’t Accessible for People With Disabilities. Fixing It Would Cost Over $650 Million,” by Hallie Miller and Adam Willis.

Tami Luhby: CNN’s “Because of Florida Abortion Laws, She Carried Her Baby to Term Knowing He Would Die,” by Elizabeth Cohen, Carma Hassan, and Amanda Musa.

Margot Sanger-Katz: The New Yorker’s “The Problem With Planned Parenthood,” by Eyal Press.

Also mentioned in this week’s episode:

• CNN’s “Here’s How the End of the Covid-19 Public Health Emergency Affects You,” by Tami Luhby and Alex Leeds Matthews.
• The New York Times’ “Corporate Giants Buy Up Primary Care Practices at Rapid Pace,” by Reed Abelson.
• Vox’s “Independents Back Abortion Rights. They’re Less Sure Democrats Do,” by Rachel M. Cohen.

Click to open the transcript

Transcript: The Crisis Is Officially Ending, but Covid Confusion Lives On

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

Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We are taping this week on Thursday, May 11, at 10:30 a.m. As always, news happens fast and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Tami Luhby, of CNN.

Tami Luhby: Hello.

Rovner: Margot Sanger Katz, The New York Times.

Sanger-Katz: Good morning.

Rovner: And Joanne Kenen, of the Johns Hopkins Bloomberg School of Public Health and Politico.

Joanne Kenen: Hi, everybody.

Rovner: So the news on the debt ceiling standoff, just so you know, is that there is no news. Congressional leaders and White House officials are meeting again on Friday, and we still expect to not see this settled until the last possible minute. But there was plenty of other health news. We will start with the official end of the U.S. public health emergency for covid. We have talked at some length about the Medicaid unwinding that’s now happening and a potential to end some telehealth service reimbursement. But there’s a lot more that’s going away after May 11. Tami, you’ve been working to compile everything that’s about to change. What are the high points here?

Luhby: Well, there are a lot of changes depending on what type of insurance you have and whether we’re talking about testing, treatment, or vaccines. So I can give you a quick rundown. We wrote a visual story on this today. If you go to CNN.com, you’ll find it on the homepage right now.

Rovner: I will link to it in the show notes for the podcast.

Luhby: Basically, many people will be paying more for treatments and for tests. However, vaccines will generally remain free for almost everyone. And basically, if you look at our story, you’ll see the color-coded guide as to how it may impact you. But basically, testing — at-home tests are no longer guaranteed to be free. So if you’ve been going to your CVS or somewhere else to pick up your eight tests a month, your insurer may opt to continue providing it for free, but I don’t think many will. And then for lab tests, again, it really depends. But if you have Medicaid, all tests will be free through 2024. However, if you have private insurance or Medicare, you will probably have to start paying out-of-pocket for tests that are ordered by your provider. Those deductibles, those pesky deductibles, and copays or coinsurance will start kicking in again. And for treatments, it’s a little bit different again. The cost will vary by treatment if you have Medicare or private insurance. However, Paxlovid and treatments that are purchased by the federal government, such as Paxlovid, will be free as long as supplies last. Now, also, if you’re uninsured, there is a whole different situation. It’ll be somewhat more difficult for them. But there are still options. And, you know, the White House has been working to provide free treatments and vaccines for them.

Rovner: So if you get covid, get it soon.

Luhby: Like today. Right, exactly. Yeah, but with vaccines, even though, again, they’re free as long as the federal supplies last — but because of the Affordable Care Act, the CARES Act, and the Inflation Reduction Act, people with private insurance, Medicare, and Medicaid will actually continue to be able to get free vaccines after the federal supplies run out.

Rovner: After May 11.

Luhby: It’s very confusing.

Rovner: It is very confusing. That’s why you did a whole graphic. Joanne, you wanted to add something.

Kenen: And the confusion is the problem. We have lots of problems, but, like, last week, we talked a little bit about this. You know, are we still in an emergency? We’re not in an emergency the way we were in 2020, 2021, but it’s not gone. We all know it’s much, much better, but it’s not gone. And it could get worse again, particularly if people are confused, if people don’t know how to test, if people don’t know that they can still get things. The four of us are professionals, and, like, Tami’s having to read this complicated color-coded chart — you know, you get this until September 2024, but this goes away in 2023. And, you know, if you have purple insurance, you get this. And if you have purple polka-dotted insurance, you get that. And the lack of clarity is dangerous, because if people don’t get what they’re eligible for because they hear “emergency over, everything — nothing’s free anymore” — we’re already having trouble with uptake. We don’t have enough people getting boosters. People don’t know that they can get Paxlovid and that it’s free and that it works. We are still in this very inadequate response. We’re not in the terrifying emergency of three years ago, but it’s not copacetic. You know, it’s not perfect. And this confusion is really part of what really worries me the most. And the people who are most likely to be hurt are the people who are always most likely to be hurt: the people who are poor, the people who are in underserved communities, the people who are less educated, and it’s disproportionately people in minority communities. We’ve seen this show before, and that’s part of what I worry about — that there’s a data issue that we’ll get to whenever Julie decides to get to it, right?

Rovner: Yeah, I mean, and that’s the thing. With so much of the emergency going away, we’re not really going to know as much as we have before.

Sanger-Katz: In some ways, how you feel about this transition really reflects how you feel about the way that our health care system works in general. You know, what happened for covid is —and I’m oversimplifying a little bit — is we sort of set up a single-payer system just for one disease. So everyone had access to all of the vaccines, everyone had access to all of the tests, everyone had access to all of the treatments basically for free. And we also created this huge expansion of Medicaid coverage by no longer allowing the states to kick people out if they no longer seem to be eligible. So we had the kind of system that I think a lot of people on the left would like to see, not just for one disease but for every disease, where you have kind of more universal coverage and where the cost of obtaining important treatments and prevention is zero to very low. And this is definitely going to be a bumpy transition, but it’s basically a transition to the way our health care system works for every other disease. So if you are someone who had some other kind of infectious disease or a chronic disease like cancer, rheumatoid arthritis, whatever, you’ve been sort of dealing with all of this stuff the whole time — that you have to pay for your drugs; that, you know, that testing is expensive; that it’s confusing where you get things; that, you know, there’s a lot of complexity and hoops you have to jump through; that a lot depends on what kind of insurance you have; that what kind of insurance you can get depends on your income and other demographic characteristics. And so I find this transition to be pretty interesting because it seems like it would be weird for the United States to just forever have one system for this disease and another system for every other disease. And of course, we do have this for people who are experiencing kidney disease: They get Medicare, they get the government system, regardless of whether they would otherwise be eligible for Medicare.

Rovner: We should point out that Congress did that in 1972. They haven’t really done it since.

Kenen: And when it was much more rare than it was today.

Rovner: And when people didn’t live very long with it mostly.

Kenen: We didn’t have as much diabetes either.

Sanger-Katz: But anyway, I just think this transition kind of just gives us a moment to reflect on, How does the system work in general? How do we feel about how the system works in general? Are these things good or bad? And I agree with everything that Joanne said, that the confusion around this is going to have public health impacts as relates to covid. But we have lots of other diseases where we just basically have the standard system, and now we’re going to have the standard system for covid, too.

Kenen: You could have gone to the hospital with the bad pneumonia and needed oxygen, needed a ventilator, and when they tested you, if you had covid, it was all free. And if you had, you know, regular old-fashioned pneumonia, you got a bill. I agree with everything Margot said, but it’s even that silly. You could have had the same symptoms in your same lungs and you had two different health care systems and financing systems. None of us have ever thought anything made sense.

Rovner: Yes, well, I actually —

Kenen: That’s why we have a podcast. Otherwise, you know —

Sanger-Katz: And also the way that the drugs and vaccines were developed was also totally different, right? With the government deeply involved in the technology and development, you know, funding the research, purchasing large quantities of these drugs in bulk in advance. I mean, this is just not the way that our system really works for other diseases. It’s been a very interesting sort of experiment, and I do wonder whether it will be replicated in the future.

Luhby: Right. But it was also clear that this is not the beginning of the pushback. I mean, Congress has not wanted to allocate more money, you know, and there’s been a lot of arguments and conflicts over the whole course of this so-called single-payer system, or this more flexible system. So the U.S.’ approach to health care has been pushing its way in for many months.

Rovner: I naively, at the beginning of the pandemic, when we first did this and when the Republicans all voted for it, it’s like, let’s have the federal government pay the hospitals for whatever care they’re providing and make everything free at point of service to the patient — and I thought, Wow, are we going to get used to this and maybe move on? And I think the answer is exactly the opposite. It’s like, let’s get rid of it as fast as we possibly can.

Kenen: There’s money that the government has put in. I believe it is $5 billion into the next generation of vaccines and treatments, because the vaccine we have has certainly saved many lives. But as we all know, it’s not perfect. You know, it’s preventing death, but not infection. It’s not ending circulation of the disease. So we need something better. This debt ceiling fight, if the people in the government could spend all $5 billion today — like we were joking, if you want to get covid, if you’re going to get covid, get it today — I mean, if they could, they would spend all $5 billion of it today, too, because that could be clawed back. I mean, that’s — it’s going to be part of the coming fight.

Luhby: But the question is, even if they develop it, will anyone take it, or will enough people take it? That’s another issue.

Rovner: Well, since we’re sort of on the subject, I’m going to skip ahead to what I was going to bring up towards the end, which I’m calling “This Week in Our Dysfunctional Health System.”

Kenen: We could call it that way every week.

Rovner: Yes, that’s true. But this is particularly about how our health system doesn’t work. First up is “ghost networks.” Those are where insurers provide lists of health care providers who are not, in fact, available to those patients. A quote “secret shopper survey” by the staff of the Senate Finance Committee found that more than 80% of mental health providers found in insurance directories in 12 plans from six states were unreachable, not accepting new patients, or not actually in network. This is not a new problem. We’ve been hearing about it for years and years. Why does it persist? One would think that you could clean up your provider directory. That would be possible, right?

Kenen: Didn’t they legislate that, though? Didn’t they say a few years ago you have to clean it up? I mean, there are going to be some mistakes because there’s, you know, many, many providers and people will make changes or leave practices or … [unintelligible] …  jobs or whatever. But I thought that they had supposedly, theoretically, taken care of this a couple years ago in one of the annual regulations for ACA or something.

Rovner: They supposedly, theoretically, took care of the hospitals reporting their prices in a way that consumers can understand, too. So we’ve discovered in our dysfunctional health care system that Congress passing legislation or HHS [the Department of Health and Human Services] putting out rules doesn’t necessarily make things so.

Kenen: Really?

Rovner: Yeah. I just — this was one that I had thought, Oh, boy, I have a whole file on that from like the 1990s.

Sanger-Katz: It’s a huge problem, though. I mean —

Rovner: Oh, it is.

Sanger-Katz: You know, we have a system where, for large groups of Americans, you are expected to shop for a health insurance plan. If you’re purchasing a marketplace plan for yourself, if you are purchasing a Medicare Advantage plan when you become eligible for Medicare, and in many cases, if you have a choice of employer plans, you know, you’re supposed to pick the plan that’s best for you. And we have a system that tells people that having those kinds of choices is good and maximizes the benefits to people, to be able to pick the best plan. But for a lot of people, being able to have the doctors and hospitals that they use or to have a choice of a wide range of doctors for various problems, including mental health services, is a huge selling point of one plan versus another. And again, you have these ghost networks, when you have this lack of transparency and accuracy of this information, it just causes people to be unable to make those good choices and it undermines the whole system of market competition that underpins all of this policy design. I think you can argue that there are not a million gazillion people who are actually shopping on the basis of this. But I do think that knowing whether your medical providers are covered when you’re choosing a new health care plan is actually something that a lot of people do look into when they are choosing a health insurance plan. And discovering that a doctor that you’ve been seeing for a long time and whose relationship you really value and whose care has been important to you is suddenly dishonestly represented as a part of an insurance plan that you’ve selected is just, you know, it’s a huge disappointment. It causes huge disruptions in people’s care. And I think the other thing that this study highlighted is that health insurance coverage for mental health services continues to be a very large problem. There has been quite a lot of legislation and regulation trying to expand coverage for mental health care. But there are these kind of lingering problems where a lot of mental health care providers simply don’t accept insurance or don’t accept very many patients who have insurance. And so I think that this report did a good job of highlighting that place where I think these problems are even worse than they are with the health care system at large. It’s just very hard to find mental health care providers who will take your insurance.

Rovner: And I would say, when you’re in mental health distress or you have a relative who’s in mental health distress, the last thing you need is to have to call 200 different providers to find one who can help you.

Kenen: A lot of the ones that are taking insurance are these online companies, and the good thing is that they’re taking insurance and that there may be convenience factors for people, although there’s also privacy and other factors on the downside. But there have been reports about, your data is not private, and I have no idea how you find out which company is a good actor in that department and which company is just selling identifiable data. I mean, I think it was The Washington Post that had a story about that a couple of weeks ago. You know, you click in on something — straight to the data broker. So, yeah, you get insurance coverage, but at a different price.

Rovner: Well, overlaid over all of this is consolidation, this time at the primary care level of health care. Margot, your colleague Reed Abelson had a big story this week on primary care practices being bought up by various larger players in the health care industry, including hospitals, insurance companies, pharmacy chains, and even Amazon. These larger entities say this can act as a move towards more coordinated, value-based care, which is what we say we all want. But there’s also the very real possibility that these giant, vertical, mega medical organizations can just start to name their own price. I mean, this is something that the FTC [Federal Trade Commission] in theory could go after but has been kind of loath to and that Congress could go after but has also been kind of loath to.

Sanger-Katz: Yeah, in some ways we’ve seen this movie before. There was a big wave of primary care acquisitions that happened, I think, in the 1990s by hospitals. And the hospitals learned pretty quickly that primary care doctors are kind of a money-losing proposition, and they divested a lot. But I think what Reed documented so nicely is that the entities that are buying primary care now are more diverse and they have different business strategies. So it’s not just hospitals who are sort of trying to get more patients referred to their higher-profit specialists, but it’s also Medicare Advantage insurers who benefit from being able to tell the primary care doctors to diagnose their patients with lots of diseases that generate profits for the plan, and it’s other kinds of groups that see primary care as kind of the front door to other services that can be revenue-generating. And it’s very — it will be very interesting to see what the effects of these will be and whether these will turn out to be good business decisions for these new entities and of course also whether it will turn out to be good for patient care.

Rovner: Yeah, I remember in the 1990s when hospitals were buying up doctor practices, the doctors ended up hating it because they were asked to work much harder, see patients for a shorter period of time, and some of them actually — because they were now on salary rather than being paid for each patient — were cutting back on, you know, in general, on the amount of care they were providing. And that was what I think ended up with a lot of these hospitals divesting. It didn’t work out the way the hospitals hoped it would. But as you point out, Margot, this is completely different, so we will — we will see how this moves on. All right. Let’s go back a little bit. We’re going to talk about abortion in a minute. But first, something that could prevent a lot of unintended pregnancies: On Wednesday, an advisory committee for the Food and Drug Administration — actually two advisory committees — unanimously recommended that the agency approve an over-the-counter birth control pill. This has been a long time coming here in the U.S., even though pills like these are available without prescription in much of Europe and have been for years. But while the FDA usually follows the recommendations of its advisory committees, we know that some FDA scientists have expressed concerns about over-the-counter availability. So what’s the problem with giving women easier access to something that so many depend on?

Kenen: There are trade-offs. And there are — some of the scientists at the FDA are more conservative than others about, What if the woman doesn’t understand how to take the pill properly? Things like that. I mean, obviously, if we go the over-the-counter route, as other countries are doing, there have to be very simple, easy-to-understand explanations in multiple languages. Pharmacists should be able to explain it like, you know, “You have to take it every day, and you have to take it at approximately the same time every day,” and things like that. So, you know, obviously not taking it right doesn’t protect you as much as taking it right. But there are a lot of people who will be able to get it. You know, getting a prescription is not always the easiest thing in the world. Or if you’re lucky, you just click on something and somebody calls your doctor and gets you a refill. But that doesn’t always work and not everybody has access to that, and you have to still see your doctor sometimes for renewals. So if you’re a working person who doesn’t have sick leave and you have to take time off from work every three months to get a refill or you have to hire child care or you have to take three buses — you know, it takes a whole day, and then you sit in a waiting room at a clinic. I mean, our health system is not patient-friendly.

Rovner: I was going to say, to go back to what Tami was talking about earlier — if pills are available over the counter, it’s going to depend on, you know, what your insurance is like, whether you would get it covered.

Kenen: The cost.

Rovner: That’s right. And it could end up being —

Kenen: But I don’t think the FDA is concerned about that.

Rovner: No, they’re not. That’s not their job.

Kenen: The pill is pretty safe, and these are lower-dose ones than the pills that were invented, you know, 50 years ago. These are lower-dose, safer drugs with fewer side effects. But I mean, there’s concern about the rare side effect, there’s concern about people not knowing how to take it, all that kind of stuff. But Julie just mentioned the cost of coverage is a separate issue because under the ACA it’s covered. And if it becomes over the counter, the mechanism for getting that covered is, at this point, unclear.

Sanger-Katz: But we do have a system now where, for a lot of women, obtaining birth control pills depends on being able to get a doctor’s appointment on a regular basis. I think, you know, this is not standard practice, but I do think that there are a lot of OB-GYNs who basically won’t write you for a birth control pill unless you come in on a regular basis to receive other kinds of health screenings. And I think many of them do that with good intentions because they want to make sure that people are getting Pap smears and other kinds of preventive health services. But on the other hand, it does mean that there are a lot of women who, if they don’t have time or they can’t afford to come in for regular doctor’s appointments, lose access to birth control. And I think over-the-counter pills is one way of counteracting that particular problem.

Rovner: And I think that’s exactly why so many of the medical groups are urging this. During the more than a decade-long fight over making the morning-after pill over the counter, the big hang-up was what to do about minors. Even President Obama, a major backer of women’s reproductive health rights, seemed unhappy at the idea of his then-barely teenage daughters being able to get birth control so easily and without notifying either parent. It seems unimaginable that we’re not going to have that same fight here. I mean, literally, we spent six years trying to figure out what age teens could be to safely buy morning-after pills, which are high doses of basically these birth control pills. I’m actually surprised that we haven’t really seen the minor fight yet.

Kenen: I think everyone’s waiting for somebody else to do it first. I mean, like Julie, I wasn’t expecting to hear more about age limitations, and that’ll probably come up when the FDA acts, because I think the advisory committee just wanted to — they were pretty strong saying, “Yeah, make this OTC.”

Sanger-Katz: I also think the politics around emergency contraception are a little bit different because I think that, while physicians understand that those pills are basically just high-dose birth control pills and that they work in just the same way as typical contraception, I think there’s a perception among many members of the public that because you can take them after unprotected sex, that they might be something closer to an abortion. Now, that is not true, but because I think that is a common misperception, it does lead to more discomfort around the availability of those pills, whereas birth control pills — while I think there are some people who object to their wide dissemination and certainly some who are concerned about them in the hands of children, I think they are more broadly accepted in our society.

Rovner: We obviously are going to see, and we’ll probably see fairly soon. We’re expecting, I guess, a decision from the FDA this summer, although with the morning-after pill we expected a decision from FDA that lingered on for many months, in some cases many years.

Kenen: And I think it’s at least hypothetically possible that states will not do what the FDA says. Say the FDA says they can be over the counter with no age limitations. I can see that becoming a fight in conservative states. I mean, I don’t know exactly the mechanism for how that would fall, but I could certainly think that somebody is going to dream up a mechanism so that a 12-year-old can’t get this over the counter.

Rovner: I want to move to abortion because first up is the continuing question over the fate of the abortion pill, which we get to say at this point: not the same as the emergency contraceptive pill, which, as Margot said, is just high-dosage regular birth control pills. Needless to say, that’s the one that we’re having the current court action over. And there was even more action this week, although not from that original case, which will be heard by the Court of Appeals later in this month. In West Virginia, a judge declined to throw out a case brought by GenBioPro. They are the maker of the generic version of mifepristone, the abortion pill. That generic, which accounts for more than half the market, would be rendered unapproved even under the compromise position of the Court of Appeals because it was approved after the 2016 cutoff period. Remember, the Court of Appeals said, We don’t want to cancel the approval, but we want to roll it back to the date when FDA started to loosen the restrictions on it. So, in theory, there would be no generic allowed, but that’s actually not even what the West Virginia lawsuit is about; it’s about challenging the state’s total abortion ban as violating the federal supremacy of the FDA over state laws. Joanne, that’s what sort of you were talking about now with contraceptives, too. And this is the big unanswered question: Can states basically overrule the FDA’s approval and the FDA’s approval for even an age limit?

Kenen: Well, I mean, I’m not saying they can, but I am saying that I don’t know where the question will come down. Go back to the regular birth control; I can certainly see conservative states trying to put age limits on it. And I don’t know how that’ll play out legally. But this is a different issue, and this is why the abortion pill lawsuits are not just about the abortion pill. They’re about drug safety and drug regulation in this country. The FDA is the agency we charge with deciding whether drugs are safe and good for human beings, and not the system of politicians and state legislators in 50 different states replacing their judgment. So obviously, it’s more complicated, because it’s abortion, but one of several bottom lines in this case is who gets to decide: the FDA or state legislature.

Rovner: And right: Do states get to overrule what the federal Food and Drug Administration says? Well, I —

Kenen: Remember, some states have had — you know, California’s had stricter regulations on several health things, you know, and that’s been allowed that you could have higher ceilings for various health — you know, carcinogenics and so forth. But they haven’t fundamentally challenged the authority of the FDA.

Rovner: Yet. Well, since confusion is our theme of the week, also this week a group of independent abortion clinics led by Whole Woman’s Health, which operates in several states, filed suit against the FDA, basically trying to add Virginia, Kansas, and Montana to the other 18 states that sued to force FDA to further reduce the agency’s current restrictions on mifepristone. A federal judge in Washington state ruled — the same day that Texas judge did that mifepristone should have its approval removed — judge in Washington said the drug should become even more easily available. In the real world, though, this is just sowing so much confusion that nobody knows what’s allowed and what isn’t, which I think is kind of the point for opponents, right? They just want to make everybody as confused as possible, if they can’t actually ban it.

Sanger-Katz: I think they actually want to ban it. I mean, I think that’s their primary goal. I’m sure there are some that will settle for confusion as a secondary outcome. I think just this whole mess of cases really highlights what a weird moment we are, where we’re having individual judges and individual jurisdictions making determinations about whether or not the FDA can or can’t approve the safety and efficacy of drugs. You know, as Joanne said, we’ve just had a system in this country since the foundation of the FDA where they are the scientific experts and they make determinations and those determinations affect drug availability and legal status around the country. And this is a very unusual situation where we’re seeing federal courts in different jurisdictions making their own judgments about what the FDA should do. And I think the Texas judge that struck down the approval of mifepristone, at least temporarily, has come in for a lot of criticism. But what the judge in Washington state did is sort of a flavor of the same thing. It’s telling the FDA, you know, how they should do their business. And it’s a weird thing.

Rovner: It is. Well, one last thing this week, since we’re talking about confusion, and the public is definitely confused, according to two different polls that are out this week — on the one hand, a Washington Post-ABC News poll found that a full two-thirds of respondents say mifepristone, the abortion pill, should stay on the market, and more than half say they disagree with the Supreme Court’s overturn of Roe v. Wade, including 70% of independents and more than a third of Republicans. Yet, in focus groups in April, more than a third of independents couldn’t differentiate Democrats’ position on abortion from Republicans’. As reported by Vox, one participant said, quote, “I really haven’t basically heard anything about which party is leaning toward it and which one isn’t.” When pressed, she said, “If I had to guess, I would say Democrat would probably be against it and Republican would probably be for it.” Another participant said she thought that Joe Biden helped get the Supreme Court judges who overturned Roe. We really do live in a bubble, don’t we? I think that was sort of the most mind-blowing thing I’ve read since — all the months since Roe got overturned, that there are people who care about this issue who have no idea where anybody stands.

Sanger-Katz: I think it’s just a truth about our political system that there are a lot of Americans who are what the political scientists call low-information voters. These are people who are just not following the news very closely and not following politics very closely. And they may have a certain set of opinions about issues of the day, but I think it is a big challenge to get those people aware of where candidates stand on issues of concern to them and to get them activated. And it doesn’t really surprise me that independent voters are the ones who seem to be confused about where the parties are, because they’re probably the least plugged into politics generally. And so, for Democrats, it does seem like this lack of information is potentially an opportunity for them, because it seems like when you ask voters what they want on abortion, they want things that are more aligned with Democratic politicians’ preferences than Republicans’. And so it strikes me that perhaps some of those people in the focus group who didn’t know who stood for what, maybe those are gettable voters for the Democratic Party. But I think — you know, we’re about to go into a very heated campaign season, you know, as we go into the presidential primaries and then the general election in which there are going to be a lot of ads, a lot of news coverage. And, you know, I think abortion is very likely to be a prominent issue during the campaigns. And I think it is almost certainly going to be a major goal of the Biden presidential reelection campaign to try to make sure that these people know where Biden stands relative to abortion, because it is an issue that so many voters agree with him on.

Rovner: And it makes you see, I mean, there’s a lot of Republicans who are trying to sort of finesse this issue now and say, you know, “Oh, well, we’re going to restrict it, but we’re not going to ban it,” or, “We have all these exceptions” that are, of course, in practice, you can’t use. Obviously, these are the kinds of voters who might be attracted to that. So we will obviously see this as it goes on.

Kenen: But Julie, do you remember whether they were actually voters? Because I had the same reaction to you: like, of all the things to not be sure of, that one was pretty surprising. But we also know that in places like Kansas where, you know, where there are not that many Democrats, these referenda won. Voters have supported abortion rights in the 2022 elections and in these state referenda. So independents must be voting with the —

Rovner: I was going to say, I think if you’re doing —

Kenen: Something isn’t totally — something is not totally adding up there.

Rovner: If you’re doing a focus group for politics, one presumes that you get voters. So, I mean, I think that was — that was the point of the focus group. But yeah, it’s —

Kenen: Or people who say they’re voters.

Rovner: Or people who say they’re voters. That is a different issue. All right. Well, something not that confusing: Now it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Tami, why don’t you go first this week?

Luhby: OK. Well, I picked a story from CNN by my colleagues on the health team. It’s titled “Because of Florida Abortion Laws, She Carried Her Baby to Term Knowing He Would Die,” by Elizabeth Cohen, Carma Hassan, and Amanda Musa. And I have to say that when I first read this story, I couldn’t get through it, because it was so upsetting. And then when I selected it as an extra credit, I had to read it in full. But it’s about a family in Florida whose son was born without kidneys. They knew that he was going to die. And it’s about all of the effects from everything from, you know, the mother, Deborah Dorbert, on her physically and emotionally. But it also, you know, talked about the family and, you know, the effect on the marriage and the effect — which was just so upsetting — was on the 4-year-old son, who became very attached. I don’t think they even knew — well, it wasn’t a girl. It was actually a boy. But for some reason, this older son felt that it was a girl and just kept saying, like, “My sister is going to do X, Y, Z.” And, you know, how did the parents break it to him? Because he saw that his mother was, you know, pregnant and getting larger. And, you know, it was just figuring out how to break it to him that no baby was coming home. So the details are heart-wrenching. The quotes in the third paragraph: “‘He gasped for air a couple of times when I held him,’ said Dorbert. ‘I watched my child take his first breath, and I held him as he took his last one.’” So, you know, these are things that, you know — and we just talked about how the states are arguing over what exceptions there should be, if any, you know, and these are the stories that the legislators don’t think about when they pass these laws.

Rovner: I think I said this before because we’ve had a story like this almost every week. This one was particularly wrenching. But I think the one thing that all these stories are doing is helping people understand, particularly men, that there are complications in pregnancy, that they’re not that rare, that, you know, that they sort of throw off and say, “Oh, well, that’s, you know, one in a million,” — It’s not one in a million. It’s like one in a thousand. That’s a lot of people. So I mean, that’s why there are a lot of these stories, because there are a lot of pregnancies that don’t go as expected.

Luhby: Right. And it really shows the chilling effect on doctors because, you know, you would say, “Oh, it’s simple: life of the mother or, you know, life of the fetus” or something like that. That seems pretty straightforward, but it isn’t. And these doctors, in cases where, you know, other cases where it is the life of the mother, which seem, again, very straightforward, the doctors are not willing to do anything because they’re afraid.

Rovner: I know. Joanne.

Kenen: This is a story from The Baltimore Banner that has a very long title. It’s by Hallie Miller and Adam Willis, and it’s called “Baltimore Isn’t Accessible for People With Disabilities. Fixing It Would Cost Over $650 Million.” Baltimore is not that big a city. $650 million is a lot of curbs and barriers. And there’s also a lot of gun violence in Baltimore. If you drive around Baltimore, and I work there a few days a week, you see lots of people on walkers and scooters and wheelchairs because many of them are survivors of gun violence. And you see them struggling. And there were quotes from people saying they, you know, were afraid walking near the harbor that they would fall in because there wasn’t a path for them. It is not invisible, but we treat it like it’s invisible. And it’s been many years since the Americans with Disabilities Act was passed, and we still don’t have it right. It’s a — this one isn’t confusion like everything else we talked about today. I loved Margot’s phrase about confusion as a secondary outcome. I think you should write a novel with that title. But it’s — this isn’t confusion. This is just not doing the right thing for people who are — we’re just not protecting or valuing.

Rovner: And I’d say for whom there are laws that this should be happening. Margot.

Sanger-Katz: I had another story about abortion. This one was in The New Yorker, called “The Problem With Planned Parenthood,” by Eyal Press. The story sort of looked at Planned Parenthood, you know, which is kind of the largest abortion provider in the country. It’s — I mean, it’s really a network of providers. They have all these affiliates. They’re often seen as being more monolithic than perhaps they are. But this story argued that people who were operating independent abortion clinics, who do represent a lot of the abortion providers in the country as well, have felt that Planned Parenthood has been too cautious legally, too afraid of running afoul of state laws, and so that has led them to be very conservative and also too conservative from the perspective of business, and that there is a view that Planned Parenthood is not serving the role that it could be by expanding into areas where abortion is less available. I thought it was just interesting to hear these criticisms and hoped to understand that the community of abortion providers are, you know, they’re diverse and they have different perspectives on how abortion access should work and what kinds of services should be provided in different settings. And they also view each other as business competition in some cases. I mean, a lot of the complaints in this article had to do with Planned Parenthood opening clinics near to independent clinics and kind of taking away the business from them, making it harder for them to survive and operate. Anyway, I thought it was a very interesting window into these debates, and it did mesh with some of my reporting experience, particularly around the legal cautiousness. I did a story before the Dobbs decision came down from the Supreme Court where Planned Parenthood in several states had just stopped offering abortions even before the court had ruled, because they anticipated that the court would rule and they just didn’t want to make any mistake about running afoul of these laws such that, you know, women were denied care that was still legal in the days leading up to the Supreme Court decision.

Rovner: Yeah, it’s a really good story. Well, my story is kind of tangentially about abortion. It’s from Slate, and it’s called “Not Every Man Will Be as Dumb as Marcus Silva,” by Moira Donegan and Mark Joseph Stern. And it’s about a case from Texas, of course, that we talked about a couple of weeks ago, where an ex-husband is suing two friends of his ex-wife for wrongful death, for helping her get an abortion. Well, now the two friends have filed a countersuit claiming that the ex-husband knew his wife was going to have an abortion beforehand because he found the pill in her purse and he put it back so that he could use the threat of a lawsuit to force her to stay with him. It feels like a soap opera, except it is happening in real life. And my first thought when I read this is that it’s going to make some great episode of “Dateline” or “20/20.” That is our show, as always.

Kenen: Or, not “The Bachelor.”

Rovner: Yeah, but not “The Bachelor.” That is our show. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks, as always, to our ever-patient producer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me. I’m still there. I’m at @jrovner. Joanne?

Kenen: @JoanneKenen.

Rovner: Tami.

Luhby: @Luhby.

Rovner: Margot.

Sanger-Katz: @sangerkatz.

Rovner: We will be back in your feed next week, hopefully with a little less confusion. Until then, be healthy.

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La marihuana y otros productos que contienen THC, el principal ingrediente psicoactivo de la planta, se han vuelto más potentes y peligrosos a medida que la legalización los ha vuelto más accesibles.

Décadas atrás, el contenido de THC de la hierba solía ser inferior al 1,5%. Hoy, algunos productos tienen más de un 90%.

La euforia de antaño ha dado paso a algo más alarmante. Cientos de miles de personas llegan a salas de emergencias por crisis relacionadas con la marihuana, y millones sufren trastornos psicológicos vinculados al consumo de cannabis, según investigaciones federales.

Pero los organismos reguladores no están a la altura.

En los estados que permiten la venta y el consumo de la marihuana y sus derivados, la protección al consumidor no es consistente.

“En muchos estados, los productos tienen una etiqueta de advertencia y poco más por parte de las entidades reguladoras”, dijo Cassin Coleman, vicepresidente del comité de asesoramiento científico de la Asociación Nacional de la Industria del Cannabis.

En general, el gobierno federal no ha intervenido. Sigue prohibiendo la marihuana como sustancia catalogada en la Lista 1 —como droga sin uso médico aceptado y con un alto riesgo de abuso— en virtud de la Ley de Sustancias Controladas (CSA). Pero en lo que respecta a la venta de cannabis, que muchos estados han legalizado, no regula características como la pureza o la potencia.

La Administración de Drogas y Alimentos (FDA) “básicamente se ha cruzado de brazos y no ha cumplido con su deber de proteger la salud pública”, afirmó Eric Lindblom, de la Facultad de Derecho de la Universidad de Georgetown que anteriormente trabajó en el Centro para Productos del Tabaco de la FDA.

La marihuana se ha transformado profundamente desde que generaciones de estadounidenses la usaron por primera vez.

El cannabis se cultiva para suministrar dosis mucho más altas de THC. En 1980, el contenido de THC de la marihuana confiscada era inferior al 1,5%. Hoy en día, muchas variedades de flores de cannabis —la materia vegetal que se puede fumar en un porro— tienen más de un 30% de THC.

Recientemente, en un dispensario de California el menú incluía una variedad con un 41% de THC.

La legalización también ha abierto la puerta a productos que se extraen de la marihuana pero que no siquiera parecidos: concentrados de THC aceitosos, cerosos o cristalinos que se calientan e inhalan mediante el vapeo o el dab, utilizando dispositivos parecidos a un soplete.

Los concentrados actuales pueden tener más de un 90% de THC. Algunos se anuncian como THC casi puro.

Pocos personifican la expansión de la marihuana de forma tan clara como John Boehner, ex presidente de la Cámara de Representantes de Estados Unidos. El republicano de Ohio se opuso durante mucho tiempo a la marihuana y, en 2011, se declaró “inalterablemente contrario” a su legalización.

Ahora forma parte del consejo directivo de Acreage Holdings, un productor de derivados de la marihuana.

Y Acreage Holdings ilustra la evolución del sector. Su marca Superflux comercializa un producto para vapear —”resina pura en un formato cómodo e instantáneo”— y concentrados como “budder”, “sugar”, “shatter” y “wax”. La empresa anuncia su concentrado de “THCa cristalino” como “lo último en potencia”.

Según el Instituto Nacional sobre el Abuso de Drogas, las concentraciones más elevadas entrañan mayores riesgos. “Los riesgos de dependencia física y adicción aumentan con la exposición a altas concentraciones de THC, y las dosis más altas de THC tienen más probabilidades de producir ansiedad, agitación, paranoia y psicosis”, se explica en su sitio web.

En 2021, 16,3 millones de personas en Estados Unidos —el 5,8% de las personas de 12 años en adelante— habían sufrido un trastorno por consumo de marihuana en el último año, según una encuesta publicada en enero por el Departamento de Salud y Servicios Humanos (HHS).

Esta cifra es muy superior a la suma de los trastornos por consumo de cocaína, heroína, metanfetamina, estimulantes de venta bajo receta, como Adderall, o analgésicos recetados, como fentanilo y OxyContin.

Otras drogas son más peligrosas que la marihuana, y la mayoría de las personas afectadas por su consumo padecieron un caso leve. Pero aproximadamente 1 de cada 7 —más de 2,6 millones de personas— padecieron un caso grave, según la encuesta federal.

La mayoría de los médicos equiparan el término “trastorno grave por consumo de sustancias” con la adicción, señaló Wilson Compton, subdirector del Instituto Nacional sobre el Abuso de Drogas.

El trastorno por consumo de cannabis “puede ser devastador”, afirmó Smita Das, psiquiatra de Stanford y presidenta de un consejo sobre adicciones de la Asociación Americana de Psiquiatría.

Das dijo que ha visto vidas destrozadas por el cannabis: personas de éxito que han perdido familias y trabajos. “Se encuentran en una situación en la que no saben cómo han llegado, porque sólo era un porro, sólo era cannabis, y no se suponía que el cannabis les creara adicción”, explicó Das.

Entre los diagnósticos médicos atribuidos a la marihuana figuran la “dependencia del cannabis con trastorno psicótico con delirios” y el síndrome de hiperémesis cannabinoide, una forma de vómito persistente.

Se estima que unas 800,000 personas realizaron visitas a emergencias relacionadas con la marihuana en 2021, según un estudio del gobierno publicado en diciembre de 2022.

Derecho a desintoxicación.

Un padre de Colorado pensó que era cuestión de tiempo para que el cannabis matara a su hijo.

En la primavera de 2021, el adolescente pasó un semáforo en rojo, chocó contra otro auto —resultando heridos él y el otro conductor— y huyó del lugar, según recordó el padre en una entrevista.

En los restos del accidente, el padre encontró porros, envases vacíos de un concentrado de THC de alta potencia conocido como “wax” y un vaporizador de THC.

En el teléfono móvil de su hijo descubrió mensajes de texto y decenas de referencias al “dabbing” y a la hierba. El adolescente dijo que había estado fumando antes del accidente y que intentó suicidarse.

Semanas después, la policía ordenó su ingreso involuntario en un hospital para una evaluación psiquiátrica. Según un informe policial, creía que lo perseguían francotiradores de un cártel de drogas.

El médico que evaluó al adolescente le diagnosticó “abuso de cannabis”.

“Deja de consumir dabs o wax, ya que pueden volverte extremadamente paranoico”, escribió el médico. “Vete directamente al programa de desintoxicación que elijas”.

Según el relato del padre, en los dos últimos años el adolescente sufrió varias retenciones involuntarias, docenas de encuentros con la policía, repetidos encarcelamientos y una serie de estadías en centros de tratamiento hospitalario.

A veces parecía fuera de la realidad, y enviaba mensajes de texto diciendo que Dios le hablaba y le daba superpoderes.

Los daños también fueron económicos. Los reclamos al seguro médico por su tratamiento ascendieron a casi $600,000 y los gastos de la familia llegaron a casi $40,000 hasta febrero.

En las entrevistas para este artículo, el padre habló bajo condición de anonimato para no perjudicar la recuperación de su hijo.

Está convencido de que la enfermedad mental de su hijo fue el resultado del consumo de drogas. Dijo que los síntomas remitían cuando su hijo dejaba de consumir THC y volvían cuando usaba de nuevo.

Su hijo tiene ahora 20 años, ha dejado la marihuana y le va bien, dijo el padre, y añadió: "No me cabe la menor duda de que el consumo de cannabis fue lo que le causó la psicosis, los delirios y la paranoia".

Regulación estatal desigual

Ahora, el uso médico de la marihuana es legal en 40 estados y el Distrito de Columbia, y el uso recreativo o para adultos es legal en 22 estados más el Distrito de Columbia, según MJBizDaily, una publicación especializada.

Al principio de la pandemia de covid-19, mientras gran parte de Estados Unidos cerró sus negocios, los dispensarios de marihuana siguieron abiertos. Muchos estados los declararon negocios esenciales.

Pero sólo dos estados que permiten el uso para adultos, Vermont y Connecticut, han puesto límites al contenido de THC —30% para la flor de cannabis y 60% para los concentrados de THC— y eximen de los límites a los cartuchos precargados, dijo Gillian Schauer de la Asociación de Reguladores de Cannabis, un grupo de reguladores estatales.

Algunos estados limitan el número de onzas o gramos que los consumidores pueden comprar. Sin embargo, incluso un poco de marihuana puede equivaler a mucho THC, apuntó Rosalie Liccardo Pacula, profesora de políticas de salud, economía y derecho en la Universidad del Sur de California.

Algunos estados sólo permiten el uso médico de productos con bajo contenido de THC; por ejemplo, en Texas, las sustancias que no contienen más de un 0,5% de THC en peso. Y algunos estados exigen etiquetas de advertencia. En Nueva Jersey, los productos de cannabis con más de un 40% de THC deben declarar: "Este es un producto de alta potencia y puede aumentar el riesgo de psicosis".

La normativa sobre marihuana de Colorado tiene más de 500 páginas. Sin embargo, se enfatizan los límites de las protecciones al consumidor: "Este producto se ha producido sin supervisión reglamentaria en materia de salud, seguridad o eficacia".

Determinar las normas adecuadas puede no ser sencillo. Por ejemplo, las etiquetas de advertencia podrían proteger a la industria de la marihuana de su responsabilidad, al igual que hicieron con las empresas tabacaleras durante años. Poner un tope a la potencia podría limitar las opciones de las personas que toman dosis elevadas para aliviar problemas médicos.

En general, en el ámbito estatal, la industria del cannabis ha frenado los esfuerzos reguladores argumentando que unas normas onerosas dificultarían la competencia entre las empresas legítimas y las ilícitas, explicó Pacula.

Pacula y otros investigadores han pedido al gobierno federal que intervenga.

Meses después de terminar su mandato como comisionado de la FDA, Scott Gottlieb hizo un llamamiento similar.

Al quejarse de que los estados habían llegado "muy lejos mientras el gobierno federal permanecía al margen", Gottlieb pidió "un esquema nacional uniforme para el THC que proteja a los consumidores."

Eso fue en 2019 y poco ha cambiado desde entonces.

¿Dónde está la FDA?

La FDA supervisa los alimentos, los medicamentos recetados, los de venta libre y los dispositivos médicos. Regula el tabaco, la nicotina y los vapes de nicotina. Supervisa las etiquetas de advertencia del tabaco. En interés de la salud y la seguridad públicas, también regula los productos botánicos, productos médicos que pueden incluir material vegetal.

Sin embargo, cuando se trata de la marihuana para fumar, los concentrados de THC derivados del cannabis que se vapean o dabean y los comestibles infundidos con THC, la FDA parece estar muy al margen.

La marihuana medicinal que se vende en los dispensarios no está aprobada por la FDA. La agencia no ha avalado su seguridad o eficacia ni ha determinado la dosis adecuada. No inspecciona las instalaciones donde se producen los productos ni evalúa el control de calidad.

La agencia sí invita a los fabricantes a someter los productos del cannabis a ensayos clínicos y a su proceso de aprobación de medicamentos.

El sitio web de la FDA señala que el THC es el ingrediente activo de dos medicamentos aprobados por la FDA para el tratamiento del cáncer. Aparentemente, sólo por eso la sustancia está bajo la jurisdicción de la FDA.

La FDA tiene "todo el poder que necesita para regular de forma mucho más eficaz los productos de cannabis legalizados por los estados", afirmó Lindblom, ex funcionario de la agencia.

Al menos públicamente, la FDA no le ha prestado atención a los concentrados de THC derivados del cannabis o la hierba fumada en porros, sino más bien en otras sustancias: una variante del THC derivada del cáñamo, que el gobierno federal ha legalizado, y un derivado diferente del cannabis llamado cannabidiol o CBD, que se ha comercializado como terapéutico.

"La FDA se ha comprometido a vigilar el mercado, identificar los productos de cannabis que plantean riesgos y actuar, dentro de nuestras competencias, para proteger al público", declaró Courtney Rhodes, vocera de la FDA.

"Muchos, la mayoría de los productos con THC se ajustan a la definición de marihuana, que es una sustancia controlada. La Drug Enforcement Administration (DEA) regula la marihuana en virtud de la Ley de Sustancias Controladas (CSA). Le remitimos a la DEA para preguntas sobre la regulación y aplicación de las disposiciones de la CSA", escribió Rhodes en un correo electrónico.

La DEA, dependiente del Departamento de Justicia, no respondió a las preguntas formuladas para este artículo.

En cuanto al Congreso, quizá su medida más importante haya sido limitar la aplicación de la prohibición federal.

"Hasta ahora, la respuesta federal a las acciones estatales para legalizar la marihuana ha consistido, sobre todo, en permitir que los estados apliquen sus propias leyes sobre la droga", señaló un informe de 2022 del Servicio de Investigación del Congreso.

En octubre, el presidente Joe Biden ordenó al secretario de Salud y Servicios Humanos y al fiscal general que revisaran la postura del gobierno federal respecto a la marihuana: si debería seguir clasificada entre las sustancias más peligrosas y estrictamente controladas.

En diciembre, Biden firmó un proyecto de ley que ampliaba la investigación sobre la marihuana y obligaba a las agencias federales a estudiar sus efectos. La ley dice que las agencias tienen un año para publicar sus conclusiones.

Algunos defensores de la marihuana dicen que el gobierno federal podría desempeñar un papel más constructivo.

"La NORML no opina que el cannabis sea inocuo, sino que la mejor forma de mitigar sus riesgos potenciales es mediante la legalización, la regulación y la educación pública", afirmó Paul Armentano, subdirector del grupo antes conocido como Organización Nacional para la Reforma de las Leyes sobre la Marihuana (NORML).

"Los productos tienen que someterse a pruebas de pureza y potencia", añadió, y "el gobierno federal podría ejercer cierta supervisión en la concesión de licencias a los laboratorios que prueban esos productos".

Mientras tanto, según Coleman, asesor de la Asociación Nacional de la Industria del Cannabis, los estados se quedan "teniendo que actuar como si fueran USDA + FDA + DEA, todo al mismo tiempo".

¿Y dónde deja eso a los consumidores? Algunos, como Wendy E., jubilada en sus 60 años, luchan contra los efectos de la marihuana.

Wendy, que habló con la condición de que no se revelara su nombre, empezó a fumar marihuana en la secundaria en los años 70 y la convirtió en su estilo de vida durante décadas.

Luego, cuando su estado la legalizó, la compró en dispensarios "y enseguida me di cuenta de que la potencia era mucho mayor que la que yo había consumido tradicionalmente", contó. "Parecía haber aumentado de manera exponencial".

En 2020, explicó, la marihuana legal —mucho más fuerte que la hierba ilícita de su juventud— la llevó a obsesionarse con el suicidio.

Antes, la mujer que se define como "hippie de la madre tierra" encontraba camaradería pasando un porro con sus amigos. Ahora asiste a reuniones de Marihuana Anónimos, con otras personas que se recuperan de esta adicción.

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

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

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

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

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

Panelists

Sarah Karlin-Smith
Pink Sheet

@SarahKarlin

Read Sarah's stories

Victoria Knight
Axios

@victoriaregisk

Read Victoria's stories

Shefali Luthra
The 19th

@Shefalil

Read Shefali's stories

Among the takeaways from this week’s episode:

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

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

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

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

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

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

Click to open the transcript

Transcript: The Confusing Fate of the Abortion Pill

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

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

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

Victoria Knight: Good morning.

Rovner: Sarah Karlin-Smith of the Pink Sheet.

Sarah Karlin-Smith: Hi, Julie.

Rovner: And Shefali Luthra of The 19th.

Shefali Luthra: Hello.

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

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

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

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

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

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

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

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

Rovner: I think it was last week.

Karlin-Smith: Time. Time —

Rovner: Time is a very flat circle right now.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Rovner: For Medicaid.

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

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

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

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

Knight: — expelled —

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

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

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

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

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

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

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

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

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

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

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

Knight: @victoriaregisk.

Rovner: Sarah?

Karlin-Smith: @SarahKarlin.

Rovner: Shefali.

Luthra: @shefalil.

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

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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.

Opponents of the Affordable Care Act may have stopped trying to overturn the entire law in court, but they have not stopped challenging pieces of it — and they have found an ally in Fort Worth, Texas: U.S. District Judge Reed O’Connor. In 2018, O’Connor held that the entire ACA was unconstitutional — a ruling eventually overturned by the Supreme Court. Now the judge has found that part of the law’s requirement for insurers to cover preventive care without copays violates a federal religious freedom law.

In a boost for the health law, though, North Carolina has become the 40th state to expand the Medicaid program to lower-income people who were previously ineligible. Even though the federal government will pay 90% of the cost of expansion, a broad swath of states — mostly in the South — have resisted widening eligibility for the program.

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

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Sandhya Raman
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Among the takeaways from this week’s episode:

• Thursday’s decision out of Texas affects health plans nationwide and is expected to disrupt the health insurance market, which for years has provided preventive care without cost sharing under the ACA. Even if the decision survives a likely appeal, insurers could continue offering the popular, generally not-so-costly benefits, but they would no longer be required to do so.
• The decision, which found that the U.S. Preventive Services Task Force cannot mandate coverage requirements, hinges on religious freedom objections to plans covering PrEP, the HIV medication, alongside other preventive care.
• Speaking of the ACA, this week North Carolina became the latest state to expand Medicaid coverage under the health law, which will render an estimated 600,000 residents newly eligible for the program. The development comes amid reports about hospitals struggling to cover uncompensated care, particularly in the 10 states that have resisted expanding Medicaid.
• Pushback against Medicaid expansion has contributed over the years to a yawning coverage divide between politically “blue” and “red” states, with liberal-leaning states pushing to cover more services and people, while conservative-leaning states home in on policies that limit coverage, like work requirements.
• On the abortion front, state attorneys general are challenging the FDA’s authority on the abortion pill — not only in Texas, but also in Washington state, where Democratic state officials are fighting the FDA’s existing restrictions on prescribing and dispensing the drug. The Biden administration has adopted a similar argument as it has in the Texas case challenging the agency’s original approval of the abortion pill: Let the FDA do its job and impose restrictions it deems appropriate, the administration says.
• The FDA is poised to make a long-awaited decision on an over-the-counter birth control pill, an option already available in other countries. One key unknown, though, is whether the agency would impose age restrictions on access to it.
• And as of this week, 160 Defense Department promotions have stalled over one Republican senator’s objections to a Pentagon policy regarding federal payments to service members traveling to obtain abortions.

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

Julie Rovner: New York Magazine/The Cut’s “Abortion Wins Elections: The Fight to Make Reproductive Rights the Centerpiece of the Democratic Party’s 2024 Agenda,” by Rebecca Traister.

Alice Miranda Ollstein: Stat’s “How the Drug Industry Uses Fear of Fentanyl to Extract More Profit From Naloxone,” by Lev Facher.

Rachel Cohrs: The Washington Post’s “These Women Survived Combat. Then They Had to Fight for Health Care,” by Hope Hodge Seck.

Sandhya Raman: Capital B’s “What the Covid-19 Pandemic and Mpox Outbreak Taught Us About Reducing Health Disparities,” by Margo Snipe and Kenya Hunter.

Also mentioned in this week’s podcast:

• The New York Times’ “‘We’re Going Away’: A State’s Choice to Forgo Medicaid Funds Is Killing Hospitals,” by Sharon LaFraniere.
• KHN’s “Fresh Produce Is an Increasingly Popular Prescription for Chronically Ill Patients,” by Carly Graf.
• California Healthline’s “Prescription for Housing? California Wants Medicaid to Cover 6 Months of Rent,” by Angela Hart.

click to open the transcript

Transcript: A Judicial Body Blow to the ACA

KHN’s ‘What the Health?’Episode Title: A Judicial Body Blow to the ACAEpisode Number: 291Published: March 30, 2023

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

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, March 30, at 11 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: Sandhya Raman of CQ Roll Call.

Sandhya Raman: Good morning.

Rovner: And happy birthday to you.

Raman: Thank you.

Rovner: And Rachel Cohrs of Stat News.

Rachel Cohrs: Hi, everybody.

Rovner: We’ve got breaking news, so we will get right to it. In Texas, we’ve got a major decision from a federal judge with national implications. No, not the abortion pill case — that is still out there. This time, Judge Reed O’Connor has ruled that the Affordable Care Act can’t require coverage of preventive services recommended by the [U.S.] Preventive Services Task Force because the PSTF, as an independent advisory board, can’t legally mandate anything. This case was specifically — although it was about a lot of things — but it was mostly about employers who didn’t want to cover preexposure prophylaxis [PrEP] for people at high risk of HIV because it violated their religious beliefs. And if the name Reed O’Connor sounds familiar, that’s because he’s the same judge who ruled in 2018 that the entire Affordable Care Act was unconstitutional, a finding that wasn’t formally overturned until it got to the Supreme Court. Alice, you’ve been following this case. What happens now?

Ollstein: I’m expecting the Biden administration to appeal at lightning speed, although that appeal will go to the 5th Circuit, which is very right-leaning. It’s ruled to chip away at the Affordable Care Act in the past. So who really knows what will happen there? But yeah, this is really huge. This is saying that this board that has decided what services insurance companies have to cover for free, with no cost sharing, going all the way back to 2010 is not constitutional, and thus what they say can’t be enforced. And so this throws the insurance market into a bit of chaos.

Rovner: Yeah, although one would think that it wouldn’t affect this year’s policies — I mean, for people who are going to be worried that all of a sudden, you know, oh my God, I scheduled my mammogram and now my insurer might not pay for it. It’s not going to be that immediate, right?

Ollstein: We’re not expecting that. I mean, we’re expecting the Biden administration to ask for courts to stay the impact of the ruling until further arguments and appeals can be made. But we really don’t know at this point. And I will say, you know, I’ve seen some misinformation out there about how the ruling deals with contraception. They do not block the contraception mandate. That is related to this case, but the court did not accept that part of the challengers’ claims.

Rovner: Yeah, we should say there are a bunch of different claims and the judge only accepted a couple of them. It could have been even broader. But, you know, unlike the previous Affordable Care Act cases, this one doesn’t threaten the entire law, but it does threaten one of the law’s most popular pieces, those requirements that plans cover preventive care that’s been shown to be cost-effective. This could be an uncomfortable case for the Supreme Court, assuming it gets there, couldn’t it?

Cohrs: It could be an uncomfortable case for the Supreme Court, but it’s also uncomfortable for insurers, too, who’ve promised this. People have come to expect it. And if it is cost-effective, I mean, certainly there may be plans that, you know, make choices to restrict coverage or impose some cost sharing. If this stands, if this is applied nationwide — again, very big ifs at this point — but if these really are cost-effective, then it’s kind of an open question what insurers will choose to do, because obviously they want people to enroll in their plans as well.

Rovner: Yeah, I was going to say, I could see insurers sort of deciding as a group that we’re going to keep providing this stuff, as you say, Rachel, because they want, you know, they want to attract customers, because for the most part it’s not that expensive. I mean, obviously, you know, things like colonoscopies can run into the thousands of dollars, but a lot of these things are, if not de minimis, then just not very expensive. And, as I mentioned, they’re very popular. So it’s possible that, even though they may strike down the mandate, there won’t be as much of an impact from this as some people are saying. But, as Alice points out, we don’t really know anything at this point.

Ollstein: And I think some of the concern is the kind of risk-pool sorting we used to see, you know. So the challengers said that their right to purchase insurance that doesn’t cover certain things was being infringed upon. And so if insurers start to create separate plans, some of which cover all kinds of preventive care, including sexual health care, and separate ones that don’t, and people who don’t think they need a lot of stuff, you know, sort themselves into some plans and not others, you can see that reflected in premiums that could lead to some of the major pre-ACA problems we used to see.

Rovner: If the idea that somebody doesn’t like something and therefore can’t buy something without it, you can see that leading to all kinds of problems down the line about people saying, well, “I don’t like that drugstores sell condoms, so therefore I should be able to go to a drugstore that doesn’t sell condoms,” although that’s not a mandate. But you can see that this could stretch very far with people’s religious beliefs. And indeed, the basis of this claim is that this violated the Religious Freedom Restoration Act. That’s one of the things that Judge O’Connor found, and that could be taken to quite the extreme, I imagine.

Ollstein: Right. I mean, they weren’t required to actually purchase PrEP. They weren’t required to use it. They weren’t required to prescribe it. Just the insurance company was required to cover it along with everything else they cover. And the folks said even purchasing insurance that had that as one of the things it could conceivably cover violated their religious rights.

Rovner: Yes. And this goes back to the contraceptive cases, where the religious organization said that, you know, by having birth control in their plans, it made them complicit in something that they thought was a sin. And that’s exactly what’s being stressed here, even among the individual plaintiffs: that having to buy insurance that has these benefits, even if they don’t use them, makes them complicit in, basically, sex outside of marriage. I mean, that’s what’s in the decision. It’s quite a reach. I’ll be interested to see, as this goes up, what people think of it. So, before we got Judge O’Connor’s opinion, what I thought would be the biggest news of the week comes from North Carolina, which on Monday became the 40th state to expand Medicaid under the Affordable Care Act, to cover people with incomes up to 138% of poverty. That’s about $20,000 in 2023. Well, it’s almost there. The newly eligible 600,000 people won’t be able to sign up until the legislature approves a budget, which is likely later this spring. North Carolina expanding the program leaves only a swath of states across the South, including Florida, Georgia, and Texas, and a couple in the Great Plains as still holding out on a 90% federal match. Is anyone else on the horizon or is this going to be it for a while?

Raman: I think one thing to note about how this is happening is that North Carolina was able to do this finally through the legislature after like a yearslong process. And it has been increasingly rare for this to happen through the legislature. The last time was Virginia, in 2018, but every other state that has done it in recent years has all been through ballot initiative and going that route. And the 10 holdouts that we have, you know, we have Republican-controlled legislatures who’ve been pretty against doing this. So I think if any of those states were to be able to do that at this point that haven’t been tempted by, you know, any of the incentives … [unintelligible] … get a higher match rate or anything like that, it would have to be through the ballot, which is already a difficult process, can take years. There have been various roadblocks to push back and even some of the states in the past that have been able to get it through ballot initiative — some of the legislatures afterwards have tried to like push back on it — when we saw with Utah a few years ago, where even if the voters had voted that they wanted to expand, they wanted to kind of pull it back.

Rovner: We thought in Maine, where the governor blocked it until basically he was out of office.

Raman: Yeah.

Ollstein: And in Missouri, where they just refused to fund it.

Raman: Yeah, so I think that’ll be definitely something to watch with how the budget goes in the next few months. But I guess, at least with North Carolina, this was something that was bipartisan. It was spearheaded in the legislature by Republicans, so I think they might not have the same issues there than Missouri, but it’s a tough haul to get the remaining 10 at this point after this many years.

Rovner: Yeah, I feel like North Carolina is much more like Virginia, which is that, finally, after a lot of wearing down, the Republican legislature and the Democratic governor were able to come to some kind of agreement. That’s what happened in Virginia. And that seems to be what’s happened here in North Carolina. Meanwhile, in those 10 states, hospitals which end up providing free care to people who can’t pay aren’t doing so well. In Florida, the state’s hospital association has been all but begging the state government to expand Medicaid pretty much since it was available to them, which is now going on 13 years. According to the American Hospital Association, 74% of rural hospital closures around the country took place in states that have not expanded Medicaid or where expansion had been in place for less than a year. And the New York Times has a story this week about the toll that that lack of insurance is taking — I’m sorry — and the New York Times has a story this week about the toll that lack of insurance for the working poor is taking there, not just on the state’s hospitals, but on the health of the state’s population. Lawmakers in these states are very happy to take federal money for all manner of things. What is it about this Medicaid expansion that’s making them say, “No, no, no”?

Raman: This was something that came up this week in the House. Appropriations’ Labor, HHS, Education Subcommittee had a hearing this week specifically on rural communities and some of the issues they face. And Medicaid expansion obviously did come up with some of the witnesses and some of the lawmakers as something that would be helpful given the number of hospital closures they’ve seen, and there might only be one health care facility for miles or in a county, and just how it would be helping them to kind of relieve paying for the uncompensated care that they’re already dealing with, you know, highlighted a number of the issues there. So it’s something that comes up, but I think one of the pushbacks that we saw was, you know, again, that it is a) tied to the Affordable Care Act, which has been such a partisan back-and-forth since its inception, and then b) just the messaging has always been about the cost. I mean, even if the general consensus is that it does save money over time for taking care of that care, something that came up was why states get more of a reimbursement for expansion than they do for traditional Medicaid. That was brought up a couple times, things like that. And so I think it’s hard to get some of those folks on board just because of how partisan it has become.

Rovner: Yeah, I remember I watched the hearing in Wyoming on this last year. They didn’t want to do it, it seemed, more for ideology. I mean, a lot of states that are doing this, you know, you can levy a tax on hospitals and nursing homes, who are happy to pay the tax because they’re now getting paid for these patients who couldn’t pay. And the state’s really not out-of-pocket, as it were, at all. But and yet, as we point out, these last 10 states, including some of the really big ones, have yet to actually succumb to this. Well, while we are talking about Medicaid, there have been a couple of interesting stories from my KHN colleagues in the past few weeks about so-called social determinants of health, those not strictly medical interventions that have a big impact on how sick or healthy people are. In California, Democratic Gov. Gavin Newsom wants to use Medicaid to pay for six months of rent or temporary housing for homeless people. And in Montana, health professionals can now prescribe vouchers for fruit and vegetables for patients with little access to fresh food. Is this the wave of the future, or will those who want to shrink rather than expand the welfare state and government in general roll programs like these back?

Cohrs: I think there certainly is a trend, a lot of momentum behind the idea of food as medicine and, you know, moving away and exploring some of these non-medication treatments or some of these underlying reasons why people do have health issues. I think certainly support for the Medicaid program is going to be a hot-button issue in D.C. over the next few months, but there is a lot that states can do on their own as well. And I know states have, you know, programs to kind of cover people that fall between the cracks of traditional insurance programs. California has a robust program for that, the local levels as well. So I think there may be ways to get around that, even if we do see some more restrictions. And again, the administration is Democratic at this point, so I think they may be friendlier to some of these innovations than prior ones, and that could change at any time. But this certainly isn’t something that’s going to go away.

Rovner: I wonder if we’re going to end up with blue states having all of these more robust pro — I mean, we already have blue states with more robust programs, but blue states having these more inclusive programs and red states not. Alice, you’re nodding.

Ollstein: Absolutely. And that’s been the trend for a while, but it could even accelerate now, I think, and you’re seeing that on both sides, with blue states looking to cover more and more things; also looking to cover more and more people, including undocumented people. That’s another trend in Medicaid. At the same time, you have red states that have long explored how to cover fewer and fewer, you know, trying to change the income eligibility threshold for expanded Medicaid, trying to do work requirements, trying to do, like, other restrictions. And so I think the patchwork and the divide is only going to continue.

Rovner: Well, moving on to abortion this week, we are still waiting, as I said, for that other decision out of Texas that could impact the future of the abortion pill mifepristone. But Alice, there’s another case at the other end of the country that could have something to say about the Texas case. What’s going on in Washington state?

Ollstein: This one has really flown under the radar. So this is an interesting situation where the same — a lot of the same Democratic attorneys general who were siding with the Biden administration in the Texas case are challenging the Biden administration in a different case in Washington state, basically saying that the remaining federal restrictions on abortion pills — mainly that providers have to get certified in order to prescribe the drugs or dispense them — saying that that should be tossed out, that it’s not supported by medicine and science. And so it’s interesting because you have the Biden administration fighting back against an effort to make the pills more accessible, which is not what a lot of people expect. It goes sort of against their rhetoric in recent months; they’ve talked about wanting to make the pills more accessible and they’re opposing an effort that would do that. But it is somewhat consistent with their position in the Texas case, which is, they’re saying, “Look, this is the FDA’s job. Let the FDA do its job. The FDA has a process, came up with these rules, got rid of some, kept others, and you outside folks don’t have the right to challenge and overturn it.”

Rovner: So what happens if the judges in both of these cases find for the plaintiffs, which would be kind of, but not completely, conflicting?

Ollstein: Yeah, so the Washington state case could just apply to the dozen states that are part of the challenge. And so you could have, again, more of a patchwork in which the abortion pills become even more accessible in those blue states and even less accessible in other states. You could also have these competing rulings that ultimately trigger Supreme Court review.

Rovner: Yeah, it’s not exactly a circuit split because it wouldn’t be opposite decisions on the same case; they’re different cases here. But as you point out, it’s really a case challenging the authority of the FDA to do what the FDA does. So it’s going to be really interesting to watch how this all plays out. While the future of mifepristone remains in doubt, the FDA is going to consider making at least one birth control pill over the counter. We know that morning-after pills, which are high doses of regular birth control pills, are already available without a prescription. So why hasn’t there been an over-the-counter birth control pill until now?

Ollstein: Everything concerning birth control, emergency contraception, abortion, it just — these fights drag on for years and years and years. So finally, we seem to be on the cusp of having a decision on this. It’s expected, from most people I’ve talked to, that they will approve this over-the-counter birth control. There’s a lot of data from around the world. A lot of other countries already have this. And one key unknown is whether the FDA will maintain an age restriction on it. A lot of progressive advocates do not want an age restriction because they think that this is important to help teens prevent unwanted pregnancies. And I think that’s going to be a big piece of the fight that I’m watching.

Rovner: And oh, my goodness, it was that age restriction that held up the over-the-counter morning-after pill for years. That was like a 13-year process to get that over the counter. It went on and on and on, and I covered it. All right. Well, there is abortion-related action on Capitol Hill too this week. We’ve got a potential abortion standoff brewing in the Senate over reproductive health policy at the Department of Defense. Who wants to talk about that one?

Raman: This one has been, I think, really interesting, since we’re all health reporters. And it’s been really something that I think my defense colleagues have been following so closely. But we have Senator Tuberville, who’s been holding up military nominations because the Pentagon has a policy that allows, you know, service members leave for reproductive care and it covers travel to seek an abortion. And so —

Rovner: Although it still doesn’t pay for the abortion.

Raman: It does not pay for the abortions. It’s for the travel. And so I know that my colleagues have looked at this and how this point, like, both sides have been getting a little frustrated, you know, with even some senators saying, “Hey, I agree that I don’t like this policy, but you need to find another way,” because as of earlier this week 160 promotions have been stalled. And so it’s just been kind of ramping up and holding up a lot of folks for kind of an unusual method.

Rovner: Yeah, and the defense secretary saying, I mean, this threatens national security because these are promotions — are important promotions. Flag officers, these are not, you know, just sort of — they’re routine, but they’re, you know, but if they don’t happen, if they get stalled, it’s a problem. In all of my years of seeing anti-abortion senators hold up things, this is not one I have seen before. It’s at least — it’s sort of new and imaginative, and I guess we will see how that plays out. Back in the states, though, it seems that the efforts to restrict reproductive rights are getting very extreme, very fast. Yes, the Oklahoma Supreme Court ruled earlier this month that a pregnant woman does have a right to an abortion when continuing the pregnancy threatens her life. But four of the nine justices there didn’t even want to go that far, suggesting that the legislature has the right to basically require saving the fetus even at the cost of the pregnant person’s life. In Texas, a lawsuit in which the ex-husband is suing the friend of his ex-wife for the wrongful death of his child for helping her get abortion medication is setting the stage for the so-called personhood debate: the idea that a new person with full legal right is created upon fertilization of an egg by sperm. Over the past few decades, several states have rejected personhood ballot measures as a bridge too far. But it feels like all bets are off now. I mean, it’s sort of like a race to see who can be the most extreme state.

Ollstein: I think the trends are revealing some interesting things. I mean, one, anti-abortion folks are well aware that people are still getting abortions, mainly in one of two ways: either traveling out of state or ordering pills online and taking them at home, both of which are very difficult to enforce and stop. And so there’s just a lot of, like, throwing spaghetti against the wall and seeing what sticks, in terms of, can we actually criminalize either of those things? If so, how is it enforced, or does it even need to be enforced? Or is just the fear and the chilling effect enough? I mean, we definitely see that. We definitely see medical providers holding off on doing even perfectly legal things because of fear and the chilling effect. And so there’s just a lot of experimentation at the state level right now.

Rovner: Yeah, I forgot to mention Idaho, where the legislature introduced a bill that would make it a crime — that creates abortion trafficking as a crime — for someone to take a minor, it’s not really across state lines, because the state can’t do that, so it’s like taking the minor to the border in an effort to cross state lines to get an abortion. There was, for many years in the late 1990s and early 2000s, something called the Child Custody Protection Act in Congress, because they needed that for the interstate part of it, that would make it a crime to take a minor across state lines in violation of the home state’s parental involvement laws. It passed both the House and the Senate at various times. It never became law. It’s been introduced recently, but nobody’s tried to take it up recently. I wouldn’t be surprised to see that come back up, too. But it really does seem that every day there’s another bill in another state legislature that says — after all the claims of the anti-abortion movement for decades, that we don’t want to punish the women, we only want to punish the providers — that’s gone out the window, right?

Raman: I guess I would add that, you know, we’re seeing a lot of this activity now. But something that I keep in mind is that a) it’s gotten a lot harder to know what’s going to, you know, using the spaghetti metaphor that Alice did, like what will stick. So there’s just a lot more flurry of action. And then I feel like I see increasingly, you know, people, since they don’t know that, just like fixating a lot on various things, just because you don’t know. I think, you know, even a few years ago, there were a lot of things that would have one sponsor or two sponsors and have no chance of going anywhere, as most bills introduced anywhere do. But now, a) a lot of these things are moving very, very quickly in the legislature, and b) since we don’t know, it’s hard to know where to kind of focus, even to some of the experts that I’ve talked to, where it’s just, “We’re not sure.” So just be aware of all of these things in various places because of kind of that uncertainty.

Rovner: Yeah, I know I’m generally loath to talk about bills that got introduced either in Congress or in state legislatures, because I think it unnecessarily creates expectations that for the most part don’t happen. But as both of you say, some of these things are happening so fast that, if you mention them one week, they’re law by the next week. So we will see as this continues to move quickly. All right. That’s the news for this week. Now it is 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: All right. So my story is from the Washington Post, and the headline is “These Women Survived Combat. Then They Had to Fight for Health Care,” by Hope Hodge Seck. And I thought it was just a really great feature on this very niche issue. And I think veterans’ kind of health care overall just doesn’t get as much coverage as it should, and —

Rovner: Particularly women’s veteran’s health care.

Cohrs: Exactly. Yes. And so these women were essentially going into combat situations to help relations with women in very conservative cultures, and they were exposed to the grenade blasts and a lot of these combat situations. But then their health care coverage upon returning wasn’t covered. And there is kind of a new bill with some momentum behind it that is trying to plug that loophole. So, yeah, I thought it was a very great feature on an issue that’s undercovered.

Rovner: Yeah, this was something I knew nothing about until I read this story. Alice?

Ollstein: I chose a piece by Rachel’s colleague at Stat, Lev Facher, called “How the Drug Industry Uses Fear of Fentanyl to Extract More Profit From Naloxone.” And this is really timely, with the approval this week of over-the-counter opioid-overdose-reverse medication. And basically it’s about how these drug companies are coming up with new forms of the drug, really huge doses, new delivery forms, injectables, and nasal sprays, and stuff that are not really justified by science and are sort of just an opportunity for more profit because the basic form of the drug that works extremely well and is very affordable, they are basically hyping the fear of fentanyl to try to push these stronger products they’re coming up with. And the fear is that municipal governments that have limited resources are going to spend their money on those not really justified new forms and get fewer medication for everyone than just using the basic stuff that we know works.

Rovner: Indeed. Sandhya?

Raman: My extra credit is from Margo Snipe and Kenya Hunter at Capital B, and it’s called “What the Covid-19 Pandemic and Mpox Outbreak Taught Us About Reducing Health Disparities.” And I thought this was an interesting look that they did, highlighting how, you know, there’s been a lot more talk about the various health inequities among, you know, racial and ethnic and sexual minority communities after these two pandemics have started. And they look at how some of the targeted efforts have narrowed some of the gaps in things like vaccines, but just how some of these lessons can be used to address other health disparities, you know, things like community outreach and expanding types of screenings and how many languages public health information is translated into and things like that. So, it’s a good read.

Rovner: Well, my extra credit this week is a long read, a very long read, by Rebecca Traister in New York Magazine, called “Abortion Wins Elections: The Fight to Make Reproductive Rights the Centerpiece of the Democratic Party’s 2024 Agenda.” And while I’m not sure I’m buying everything that she’s selling here, this is an incredibly thorough and interesting look at the past, present, and possibly future of the abortion rights movement at the national, state, and local levels. If you are truly interested in this subject, it’s well worth the half hour or so of your time that it takes to get through the entire thing. It’s a really, really good piece. 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@kff.org. Or you can tweet me still. I’m @jrovner. Alice?

Ollstein: @AliceOllstein.

Rovner: Rachel?

Cohrs: @rachelcohrs.

Rovner: Sandhya?

Raman: @SandhyaWrites.

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

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

With Medicare and Social Security apparently off the table for federal budget cuts, the focus has turned to Medicaid, the federal-state health program for those with low incomes. President Joe Biden has made it clear he wants to protect the program, along with the Affordable Care Act, but Republicans will likely propose cuts to both when they present a proposed budget in the next several weeks.

Meanwhile, confusion over abortion restrictions continues, particularly at the FDA. One lawsuit in Texas calls for a federal judge to temporarily halt distribution of the abortion pill mifepristone. A separate suit, though, asks a different federal judge to temporarily make the drug easier to get, by removing some of the FDA’s safety restrictions.

This week’s panelists are Julie Rovner of Kaiser Health News, Alice Miranda Ollstein of Politico, Rachel Cohrs of STAT News, and Lauren Weber of The Washington Post.

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Rachel Cohrs
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Alice Miranda Ollstein
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Read Alice's stories

Lauren Weber
The Washington Post

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Read Lauren's stories

Among the takeaways from this week’s episode:

• States are working to review Medicaid eligibility for millions of people as pandemic-era coverage rules lapse at the end of March, amid fears that many Americans kicked off Medicaid who are eligible for free or near-free coverage under the ACA won’t know their options and will go uninsured.
• Biden promised this week to stop Republicans from “gutting” Medicaid and the ACA. But not all Republicans are on board with cuts to Medicaid. Between the party’s narrow majority in the House and the fact that Medicaid pays for nursing homes for many seniors, cutting the program is a politically dicey move.
• A national group that pushed the use of ivermectin to treat covid-19 is now hyping the drug as a treatment for flu and RSV — despite a lack of clinical evidence to support their claims that it is effective against any of those illnesses. Nonetheless, there is a movement of people, many of them doctors, who believe ivermectin works.
• In reproductive health news, a federal judge recently ruled that a Texas law cannot be used to prosecute groups that help women travel out of state to obtain abortions. And the abortion issue has highlighted the role of attorneys general around the country — politicizing a formerly nonpartisan state post. –And Eli Lilly announced plans to cut the price of some insulin products and cap out-of-pocket costs, though their reasons may not be completely altruistic: An expert pointed out that a change to Medicaid rebates next year means drugmakers soon will have to pay the government every time a patient fills a prescription for insulin, meaning Eli Lilly’s plan could save the company money.

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

Julie Rovner: The New York Times’ “A Drug Company Exploited a Safety Requirement to Make Money,” by Rebecca Robbins.

Alice Miranda Ollstein: The New York Times’ “Alone and Exploited, Migrant Children Work Brutal Jobs Across the U.S.,” by Hannah Dreier.

Rachel Cohrs: STAT News’ “Nonprofit Hospitals Are Failing Americans. Their Boards May Be a Reason Why,” by Sanjay Kishore and Suhas Gondi.

Lauren Weber: KHN and CBS News’ “This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth,” by Brett Kelman and Anna Werner.

Also mentioned in this week’s podcast:

• Politico’s “Why One State’s Plan to Unwind a Covid-Era Medicaid Rule Is Raising Red Flags,” by Megan Messerly.
• The Washington Post’s “Doctors Who Touted Ivermectin as Covid Fix Now Pushing It for Flu, RSV,” by Lauren Weber.
• NPR’s “To Safeguard Healthy Twins in Utero, She Had to ‘Escape’ Texas for Abortion Procedure,” by Selena Simmons-Duffin.
• The Daily Beast’s “Tennessee Abortion Ban a ‘Nightmare’ for Woman With Doomed Pregnancy,” by Michael Daly.

click to open the transcript

Transcript: March Medicaid Madness

KHN’s ‘What the Health?’Episode Title: Medicaid March MadnessEpisode Number: 287Published: March 2, 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 are taping this week on Thursday, March 2, at 10 a.m. As always, news happens fast, and things might have changed by the time you hear this. So, here we go. We are joined today via video conference by Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Good morning.

Rovner: Rachel Cohrs of Stat News.

Rachel Cohrs: Hi, everybody.

Rovner: And we officially welcome to the podcast panel this week Lauren Weber, ex of KHN and now at The Washington Post covering a cool new beat on health and science disinformation. Lauren, welcome back to the podcast.

Lauren Weber: Thanks for having me.

Rovner: So we’re going to get right to this week’s news. We’ve talked a lot about the political fight swirling around Medicare the past couple of weeks. So this week, I want to talk more about Medicaid. Our regular listeners will know, or should know, that states are beginning to re-determine eligibility for people who got on Medicaid during the covid pandemic and were allowed to stay on until now. In fact, Arkansas is vowing to re-determine eligibility for half a million people over the next six months. Alice, the last time Arkansas tried to do something bureaucratically complicated with Medicaid, it didn’t turn out so well, did it?

Ollstein: No. It was so much of a cautionary tale that no other state until now has gone down that path, although now at least a couple are attempting to. So Arkansas was the only state to actually move forward under the Trump administration with implementing Medicaid work requirements. And we covered it at the time, and just thousands and thousands of people lost coverage who should have qualified. They were working. They just couldn’t navigate the reporting system. Part of the problem was that you had to report your working hours online and a lot of people who are poor don’t have access to the internet. And, you know, the system was buggy and clunky and it was just a huge mess. But that is not stopping the state from trying again on several fronts. One, they want to do Medicaid work requirements again. The governor, Sarah Huckabee Sanders, has said that they plan to do that and also they plan to do their redeterminations for the end of the public health emergency in half the time the federal government would like states to take to do it. The federal government has incentives for states to go slow and take a full year to make sure people know how to prove whether or not they qualify for Medicaid and to learn what other insurance coverage options might be available to them. For instance, you know, Obamacare plans that are free or almost free.

Rovner: Yeah. Presumably most of the people who are no longer eligible for Medicaid but are still low-income will be eligible for Obamacare with hefty subsidies.

Ollstein: That’s right. So the fear is that history will repeat itself. A lot of people who should be covered will be dropped from coverage and won’t even know it because the state didn’t take the time to contact people and seek them out.

Rovner: This is something that we will certainly follow as it plays out over the next year. More broadly, though, there have been whispers — well, more than whispers, whines — over the past couple of weeks that President [Joe] Biden’s challenge to Republicans not to cut Social Security and Medicare, and Republicans’ apparent acceptance of that challenge, specifically leaves out Medicaid. Now, I never thought that was true, at least for the Democrats. But earlier this week, President Biden extended his promises to Medicaid and the Affordable Care Act. How much of a threat is there really to Medicaid in the coming budget battles? Rachel, you wrote about that today.

Cohrs: There is a lot of anxiety swirling around this on the Hill. I know there’s a former Trump White House official who’s circulated some documents that are making people a little bit nervous about Republicans’ position. But it is useful to look at existing documents out there. It is not reflective necessarily of the consensus Republican position. And it’s a very diverse party right now in the House. They have an incredibly narrow majority and Kevin McCarthy is really going to have to walk a tightrope here. And I think it is important to remember that when Medicaid has come up on steep ballot initiatives in red states, so many times it has passed overwhelmingly. So I think there is an argument to be made that Medicaid enjoys more political support among the GOP voting populace than maybe it does among members of Congress. So I think I am viewing it with caution. You know, obviously, it’s something that we’re going to have to be tracking and watching as these negotiations develop. But Democrats still hold the Senate and they still hold the presidency. So Republicans have more leverage than they did last Congress, but they’re still … Democrats still have a lot of sway here.

Rovner: Although I’ll just point out, as I think I pointed out before, that in 2017, when the Republicans tried to repeal the Affordable Care Act, one of the things they discovered is that Medicaid is actually kind of popular. I think … much to their surprise, they discovered that Medicaid is also kind of popular, maybe not as much as Medicare, but more than I think they thought. So I guess the budget wars really get started next week: We get President Biden’s budget, right?

Ollstein: And House Republicans are allegedly working on something. We don’t know when it will come or how much detail it will have, but it will be some sort of counter to Biden’s budget. But, you know, the real work will come later, in hashing it out in negotiations. And, really, a small number of people will be involved in that. And so just like Rachel said, you know, you’re going to see a lot of proposals thrown out over the next several months. Not all of them should necessarily be taken seriously or taken as determinative. Just one last interesting thing: This has been a really interesting education time, both for lawmakers and the public on just who is covered under these programs. I mean, the idea is that Medicare is so untouchable, is this third rail, because it is primarily seniors, and seniors vote. And seniors are more politically important to conservatives and Republicans. But people forget a lot of seniors are also on Medicaid. They get their nursing home coverage through there. And so I’ve heard a lot of Democratic lawmakers really hammering that argument lately and saying, look, you know, the stereotype for Medicaid is that it’s just poor adults, but …

Rovner: Yeah, moms and kids. That was how it started out.

Ollstein: Exactly.

Rovner: It was poor moms and kids.

Ollstein: Exactly. But it’s a lot more than that now. And it is more politically dicey to go after it than maybe people think.

Rovner: Yeah, I think Nancy Pelosi … in 2017 when, you know, if the threat with Medicare is throwing Granny off the cliff in her wheelchair, the threat of Medicaid is throwing Granny out of her nursing home, both of which have their political perils. All right. Well, we’ll definitely see this one play out for a while. I want to move to the public health beat. Lauren, you had a really cool story on the front page of The Washington Post this week about how the promise of ivermectin to treat infectious diseases in humans. And for those who forget, ivermectin is an anti-wormer drug that I give to my horse and both of my dogs. But the idea of using it for various infectious diseases just won’t die. What is the latest ivermectin craze?

Weber: Yes, and to be clear, there is an ivermectin that is a pill that can be given to humans, which is what these folks are talking about. But there’s this group called the Front Line COVID-19 Critical Care Alliance that really pushed ivermectin in the height of covid. As we all know on this podcast, scientific study after scientific study after clinical trial has disproved that there is any efficacy for that. But this group has continued to push it. And I discovered, looking at their website back this winter, that they’re now pushing it for the flu and RSV. And as I asked the CDC [Centers for Disease Control and Prevention] and medical experts, there’s no clinical data to support pushing that for the flu or RSV. And, you know, as one scientist said to me, they had data that … had antiviral properties in a test tube. But as one scientist said to me, well, if you put Coca-Cola in a test tube, it would show it had antiviral properties as well. So there’s a lot of pushback to these folks. But, that said, they told me that they have had their protocols downloaded over a million times. You know, they’re … absolutely have some prominence and have, you know, converted a share of the American population to the belief that this is a useful medical treatment for them. And one of the doctors that has left their group over their support of ivermectin said to me, “Look, I’m not surprised that they’re continuing to push this for something else. This is what they do now. They push this for other things.” And so it’s quite interesting to see this continue to play out as we continue into covid, to see them kind of expand, as these folks said to me, into other diseases.

Rovner: I know I mean, usually when we see these kinds of things, it’s because the people who are pushing them are also selling them and making money off of them. And I know that’s the case in some of this, but a lot of these are just doctors who are writing prescriptions for ivermectin. Right? I mean, this is an actual belief that they have.

Weber: Yeah, some of them do make money off of telehealth appointments. They can charge up to a couple hundred dollars for telehealth appointments. And one of the couple of co-founders had a lucrative Substack and book deal that talks about ivermectin and do get paid by this alliance. One of them made almost a quarter of a million dollars in salary from the alliance. But yeah, I mean, the average doctor that’s prescribing ivermectin, I mean — there were over 400,000 ivermectin prescriptions in, I think, it was August of 2021. So that’s a lot of prescriptions.

Rovner: They’re not all making money off of it.

Weber: They’re not all making money. And I mean, what’s wild to me is Merck has come out and said, which, in a very rare statement for a pharmaceutical company, you know, don’t prescribe our drug for this. And when I asked them about RSV and the flu, they said, yeah, our statement would still stand on that. So it’s a movement, to some extent. And the folks I talked to about it, they really believe …

Rovner: And I will say, for a while in 2021, you couldn’t get horse wormer, which is a very nasty-tasting paste, even the horses don’t really like it. Because it was hard to get ivermectin at all. So we’ll see where this goes next. Here’s one of those “in case you missed It” stories. The Tulsa World this week has an interview with former Republican Sen. James Inhofe, who said, in his blunt Inhofe way, that he retired last year not only because he’s 88, but because he’s still suffering the effects of long covid. And he’s not the only one — quote, “five or six others have [long covid], but I’m the only one who admits it,” he told the paper, referring to other members of the Senate, presumably other Republican members of the Senate. Now, mind you, the very conservative Inhofe voted against just about every covid funding bill. And my impression from not going to the Hill regularly in 2021 and 2022 is that while covid seemed to be floating around in the air, lots of people were getting it, very few people seemed to be getting very sick. But now we’re thinking that’s not really the case, right?

Ollstein: When I saw this, I immediately went back to a story I wrote about a year ago on Tim Kaine’s long covid diagnosis and his attempts to convince his colleagues to put more research funding or treatment funding, more basic covid prevention funding … you know, fewer people will get long covid if fewer people get covid in the first place. And there was just zero appetite on the Republican side for that. And that’s why a lot of it didn’t end up passing. Inhofe was one of the Republicans I talked to, and I said, you know, do you think you should do more about long covid? What do you think about this? And this is what he told me: “I have other priorities. We’re handling all we can right now.” And then he added that long covid is not that well defined. And he argued there’s no way to determine how many people are affected. Well.

Rovner: OK.

Ollstein: So that … in “Quotes That Aged Poorly Hall of Fame.”

Rovner: You know, obviously Tim Kaine came forward and talked about it. But now I’m wondering if there are people who are slowing down or looking like they’re not well, maybe they have long covid and don’t want to say.

Ollstein: Well, I mean, something that Tim Kaine’s case shows is that there’s no one thing it can look like and somebody can look completely healthy and normal on the outside and be suffering symptoms. And Tim Kaine has also said that members of Congress have quietly disclosed to him and thanked him for speaking up, but said they weren’t willing to do it themselves. And he, Tim Kaine, told me that he felt more comfortable speaking up because the kind of symptoms he had were less stigmatized. They weren’t anything in terms of impeding his mental capacity and function. And there’s just a lot of stigma and fear of people coming forward and admitting they’re having a problem.

Rovner: I find it kind of ironic that last week we talked about how, you know, members of Congress and politicians with mental health, you know, normally stigmatizing problems are more willing to talk about it. And yet here are people with long covid not willing to talk about it. So maybe we’ll see a little bit more after this or maybe not. I want to talk a little bit about artificial intelligence and health care. I’ve been wanting to talk about this for a while, but this week seems to be everyone is talking about AI. There have been a spate of stories about how different types of artificial intelligence are aiding in medical care, but also some cautionary tales, particularly about chat engines. They get all their information from the internet, good or bad. Now, we already have robots that do intricate surgeries and lots and lots of treatment algorithms. On the other hand, the little bit of AI that I already have that’s medical-oriented, my Fitbit, that sometimes accurately tracks my exercise and sometimes doesn’t, and the chat bot from my favorite chain drugstore that honestly cannot keep my medication straight. None of that makes me terribly optimistic about launching into health AI. Is this, like most tech, going to roll out a little before it’s ready and then we’ll work the bugs out? Or maybe are we going to be a little bit more careful with some of this stuff?

Cohrs: I think we’ve already seen some examples of things rolling out before they’re exactly ready. And I just thought of my colleague Casey Ross’ reporting on Epic’s algorithm that was supposed to help …

Rovner: Epic, the electronic medical records company.

Cohrs: Yes, yes. They had this algorithm that was supposed to help doctors treat sepsis patients, and it didn’t work. The problem with using AI in health care is that there are life-and-death consequences for some of these things. If you’re misdiagnosing someone, if you’re giving them medicine they don’t need, there are, like, those big consequences. But there are also the smaller ones too. And my colleague Brittany Trang wrote about how with doctor’s notes or transcripts of conversations between a physician and a patient sometimes AI has difficulty differentiating between an “mm-hm” or an “uh-huh” and telling whether that’s a yes or a no. And so I think that there’s just all of these really fascinating issues that we’re going to have to work through. And I think there is enormous potential, certainly, and I think there’s getting more experimentation. But like you said, I think in health care it’s just a very different beast when you’re rolling things out and making sure that they work.

Weber: Yeah, I wanted to add, I mean, one of the things that I found really interesting is that doctors’ offices are using some of it to reduce some of the administrative burden. As we all know, prior authorizations suck up a lot of time for doctors’ offices. And it seems like this has actually been really helpful for them. That said, I mean, that comes with the caveat of — my colleagues and I and much reporting has shown that — sometimes these things just make up references for studies. They just make it up. That level of “Is this just a made-up study that supports what I’m saying?” I think is really jarring. This isn’t quite like using Google. It cannot be trusted to the level … and I think people do have caution with it and they will have to continue to have caution with it. But I think we’re really only at the forefront of figuring out how this all plays out.

Rovner: I was talking before we started taping about how I got a text from my favorite chain drugstore saying that I was out of refills and that they would call my doctor, which is fine. And then they said, “Text ‘Yes’ if you would like us to call” … some other doctor. I’m like, “Who the heck is this other doctor?” And then I realize he’s the doctor I saw at urgent care last September when I burned myself. I’m like, “Why on earth would you even have him in your system?” So, you know, that’s the sort of thing … it’s like, we’re going to be really helpful and do something really stupid. I worry that Congress, in trying to regulate tech, and failing so far — I mean, we’ve seen how much they do and don’t know about, you know, Facebook and Instagram and the hand-wringing over TikTok because it’s owned by the Chinese — I can’t imagine any kind of serious, thoughtful regulation on this. We’re going to have to basically rely on the medical industry to decide how to roll this out, right? Or might somebody step in?

Ollstein: I mean, there could be agency, you know, rulemaking, potentially. But, yes, it’s the classic conundrum of technology evolving way faster than government can act to regulate it. I mean, we see that on so many fronts. I mean, look how long has gone without any kind of update. And, you know, the kinds of ways health information is shared are completely different from when that law was written, so …

Rovner: Indeed.

Weber: And as Rachel said, I mean, this is life-or-death consequences in some places. So the slowness with which the government regulates things could really have a problem here, because this is not something that is just little …

Rovner: Of the things that keep me awake at night, this is one of the things that keeps me awake at night. All right. Well, one of these weeks, we will not have a ton of reproductive health news. But this week isn’t it. As of this taping, we still have not gotten a decision in that Texas case challenging the FDA approval of the abortion pill, mifepristone, back in the year 2000. But there’s plenty of other abortion news happening in the Lone Star State. First, a federal judge in Texas who was not handpicked by the anti-abortion groups ruled that Texas officials cannot enforce the state’s abortion ban against groups who help women get abortion out of state, including abortion funds that help women get the money to go out of state to get an abortion. The judge also questioned whether the state’s pre-Roe ban is even in effect or has actually been repealed, although there are overlapping bans in the state that … so that wouldn’t make abortion legal. But still, this is a win for the abortion rights side, right, Alice?

Ollstein: Yeah, I think the right knows that there are two main ways that people are still getting abortions who live in ban states. They’re traveling out of state or they are ordering pills in the mail. And so they are moving to try to cut off both of those avenues. And, you know, running into some difficulty in doing so, both in the courts and just practically in terms of enforcing. This is part of that bigger battle to try to cut off, you know, people’s remaining avenues to access the procedure.

Rovner: Well, speaking exactly of that, Texas being Texas, this week, we saw a bill introduced in the state legislature that would ban the websites that include information about how to get abortion pills and would punish internet providers that fail to block those sites. It would also overturn the court ruling we just talked about by allowing criminal prosecution of anyone who helps someone get an abortion. Even a year ago, I would have said this is an obvious legislative overreach, but this is Texas. So now maybe not so much.

Ollstein: I mean, I think lots of states are just throwing things at the wall to see what sticks and to see what gets through the courts. You had states test the waters on banning certain kinds of out-of-state travel, and that hasn’t gone anywhere yet. But even things that don’t end up passing and being implemented can have a chilling effect. You have a lot of confusion right now. You have a lot of people not sure what’s legal, what’s not. And if you create this atmosphere of fear where people might be afraid to go out of state, might be afraid to ask for funding to go out of state, afraid to Google around and see what their options are that serves the intended impacts of these proposals, in terms of preventing people from exploring their options and seeing what they can do to terminate a pregnancy.

Rovner: Yeah. Well, meanwhile, a dozen states that are not named Texas are suing the FDA, trying to get it to roll back some of the prescribing requirements around the abortion pill. The states are arguing that not only are the risk-mitigation rules unnecessary, given the proven safety of mifepristone, but that some of the certification requirements could invade the privacy of patients and prescribers and subject them to harassment or worse. They’re asking the judge to halt enforcement of the restrictions while the case is being litigated. That could run right into [U.S. District] Judge [Matthew] Kacsmaryk’s possible injunction in Texas banning mifepristone nationwide. Then what happens? If you’ve got one judge saying, “OK, you can’t sell this nationwide,” and another judge saying … “Of course you can sell it, and you can’t use these safety restrictions that the FDA has put around it.” Then the FDA has two conflicting decisions in front of it.

Weber: Yeah, and I find the battles of the AGs and the abortion wars are really fascinating because, I mean, this is a lawsuit brought by states, which is attorneys general, Democratic attorneys general. And you’re seeing that play out. I mean, you see that in Texas, too, with [Ken] Paxton. You see it in Michigan with [Dana] Nessel. I mean, I would argue one of the things that attorney generals have been the most prominent on in the last several decades of American history and have actually had immediate effects on due to the fall of Roe v. Wade. So we’ll see what happens. But it is fascinating to see in real time this proxy battle, so to speak, between the two sides play out across the states and across the country.

Rovner: No, it’s funny. State AGs did do the tobacco settlement.

Weber: Yes.

Rovner: I mean, that would not have happened. But what was interesting about that is that it was very bipartisan.

Weber: Well, they were on the same side.

Rovner: And this is not.

Weber: Yeah, I mean, yeah, they were on the same side. This is a different deal. And I think to some extent, and I did some reporting on this last year, it speaks to the politicization of that office and what that office has become and how it’s become, frankly, a huge launching pad for people’s political careers. And the rhetoric there often is really notched up to the highest levels on both sides. So, you know, as we continue to see that play out, I think a lot of these folks will end up being folks you see on the national stage for quite some time.

Ollstein: I’ve been really interested in the states where the attorney general has clashed with other parts of their own state government. And so in North Carolina, for example, right now you have the current Democratic attorney general who is planning to run for governor. And he said, I’m not going to defend our state restrictions on abortion pills in court because I agree with the people challenging them. And then you have the Republican state legislatures saying, well, if he’s not going to defend these laws, we will. So that kind of clash has happened in Kentucky and other states where the attorney general is not always on the same side with other state officials.

Rovner: If that’s not confusing enough, we have a story out of Mississippi this week, one of the few states where voters technically have the ability to put a question on the ballot, except that process has been blocked for the moment by a technicality. Now, Republican legislators are proposing to restart the ballot initiative process. They would fix the technicality, but not for abortion questions. Reading from the AP story here, quote, “If the proposed new initiative process is adopted, state legislators would be the only people in Mississippi with the power to change abortion laws.” Really? I mean, it’s hard to conceive that they could say you can have a ballot question, but not on this.

Ollstein: This is, again, part of a national trend. There are several Republican-controlled states that are moving right now to attempt to limit the ability of people to put a measure on the ballot. And this, you know, comes as a direct result of last year. Six states had abortion-related referendums on their ballot. And in all six, the pro-abortion rights side won. Each one was a little different. We don’t need to get into it, but that’s the important thing. And so people voted pretty overwhelmingly, even in really red states like Kentucky and Montana. And so other states that fear that could happen there are now moving to make that process harder in different ways. You have Mississippi trying to do, like, a carve-out where nothing on abortion can make it through. Other states are just trying to raise, like, the signature threshold or the vote threshold people need to get these passed. There are a lot of different ways they’re going about it.

Rovner: I covered the Mississippi “personhood” amendment back in 2011. It was the first statewide vote on, you know, granting personhood to fetuses. And everybody assumed it was going to win, and it didn’t, even in Mississippi. So I think there’s reason for the legislators who are trying to re-stand up this ballot initiative process to worry about what might come up and how the voters might vote on it. Well, because I continue to hear people say that women trying to have babies are not being affected by state abortion bans and restrictions, this week we have not one but two stories of pregnant women who were very much impacted by abortion bans. One from NPR is the story of a Texas woman pregnant with twins — except one twin had genetic defects not only incompatible with life, but that threatened the life of both the other twin and the pregnant woman. She not only had to leave the state for a procedure to preserve her own life and that of the surviving twin, but doctors in Texas couldn’t even tell her explicitly what was going on for fear of being brought up on charges of violating the state’s ban. I think, Alice, you were the one talking about how, you know, women are afraid to Google. Doctors are afraid to say anything.

Ollstein: Yeah, absolutely. I mean, it’s a really chilling and litigious environment right now. And I think, as more and more of these stories start to come forward, I think that is spurring the debates you’re seeing in a lot of states right now about adding or clarifying or expanding the kind of exceptions that exist on these bans. So you have very heated debates going on right now in Utah and Tennessee and in several states around, you know, should we add more exceptions because there are some Republican lawmakers who are looking at these really tragic stories that are trickling out and saying, “This isn’t what we intended when we voted for this ban. Let’s go back and revisit.” Whether exceptions even work when they are on the books is another question that we can discuss. I mean, we have seen them not be effective in other states and people not able to navigate them.

Rovner: We’ve seen a lot of these stories about women whose water broke early and at what point is it threatening her life? How close to death does she have to be before doctors can step in? I mean, we’ve seen four or five of these. It’s not like they’re one-offs. The other story this week is from the Daily Beast. It’s about a 28-year-old Tennessee woman whose fetus had anomalies with its heart, brain, and kidneys. That woman also had to leave the state at her own expense to protect her own health. Is there a point where anti-abortion forces might realize they are actually deterring women who want babies from getting pregnant for fear of complications that they won’t be able to get treated?

Ollstein: Most of the pushback I’ve seen from anti-abortion groups, they claim that the state laws are fine and that doctors are misinterpreting them. And there is a semantic tug of war going on right now where anti-abortion groups are trying to argue that intervening in a medical emergency shouldn’t even count as an abortion. Doctors argue, no, it is an abortion. It’s the same procedure medically, and thus we are afraid to do it under the current law. And the anti-abortion groups are saying, “Oh, no, you’re saying that in bad faith; that doesn’t count as an abortion. An abortion is when it’s intended to kill the fetus.” So you’re having this challenging tug of war, and it’s not really clear what states are going to do. There’s a lot of state bills on this making their way through legislatures right now.

Rovner: And doctors and patients are caught in the middle. Well, finally this week, Eli Lilly announced it would lower, in some cases dramatically, the list prices for some of its insulin products. You may remember that, last year, Democrats in Congress passed a $35-per-month cap for Medicare beneficiaries but couldn’t get those last few votes to apply the cap to the rest of the population. Lilly is getting very good press. Its stock price went up, even though it’s not really capping all the out-of-pocket costs for insulin for everybody. But I’m guessing they’re not doing this out of the goodness of their drugmaking heart, right, Rachel?

Cohrs: Probably not. Even though there’s a quote from their CEO that implied that that was the case. I think there was one drug pricing expert at West Health Policy Center, Sean Dickson, who is very sharp on these issues, knows the programs well. And he pointed out that there’s a new policy going into effect in Medicaid next year, and it’s really, really wonky and complicated. But I’ll do my best to try to explain that, generally, in the Medicare program, rebates are capped, or they have been historically, at the price of the drug. So you can’t charge a drugmaker a rebate that’s higher than the cost. But …

Rovner: That would make sense.

Cohrs: Right. But that math can get kind of wonky when there are really high drug price increases and then that math gets really messed up. But Congress, I want to say it was in 2021, tweaked this policy to discourage those big price increases. And they said, you know what? We’re going to raise the rebate cap in Medicaid, which means that, drugmakers, if you are taking really big price increases, you may have to pay us every time someone on Medicaid fills those prescriptions. And I think people thought about insulin right away as a drug that has these really high rebates already and could be a candidate disproportionately impacted by this policy. So I thought that was an interesting point that Sean made about the timing of this. That change is supposed to go into effect early next year. So this could, in theory, save Lilly a lot of money in the Medicaid program because we don’t know exactly what their net prices were before.

Rovner: But this is very convenient.

Cohrs: It’s convenient. And there’s a chance that they’re not really losing any money right now, depending on how their contracts work with insurers. So I think, yeah, there is definitely a possibility for some ulterior motives here.

Rovner: And plus, the thing that I learned this week that I hadn’t known before is that there are starting to be some generic competition. The three big insulin makers, which are Lilly, Sanofi, and Novo Nordisk, may actually not become the, almost, the only insulin maker. So it’s probably in Lilly’s interest to step forward now. And, you know, they’re reducing the prices on their most popular insulins, but not necessarily their most expensive insulin. So I think there’s still money to be made in this segment. But they sure did get, you know, I watched all the stories come across. It’s, like, it’s all, oh, look at this great thing that Lilly has done and that everything’s going to be cheap. And it’s, like, not quite. But …

Cohrs: But it is different. It’s a big step. And I think …

Rovner: It is. It is.

Cohrs: Somebody has to go first in breaking this cycle. And I think it will be interesting to see how that plays out for them and whether the other two companies do follow suit. Sen. Bernie Sanders asked them to and said, you know, why don’t you just all do the same thing and lower prices on more products? So, yeah, we’ll see how it plays out.

Weber: Day to day, I mean, that’s a huge difference for people. I mean, that is a lot of money. That is a big deal. So, I mean, you know, no matter what the motivation, at the end of the day, I think the American public will be much happier with having to pay a lot less for insulin.

Rovner: Yeah, I’m just saying that not everybody who takes insulin is going to pay a lot less for insulin.

Weber: Right. Which is very fair, very fair.

Rovner: But many more people than before, which is, I think, why it got lauded by everybody. Although I will … I wrote in my notes, please, someone mention Josh Hawley taking credit and calling for legislation. Sen. Hawley from Missouri, who voted against extending the $35 cap, as all Republicans did, to the rest of the population, put out a tweet yesterday that was, like, this is a great thing and now we should have, you know, legislation to follow up. And I’m like: OK.

Cohrs: You’ll have to check on that. I actually think Hawley may have voted for it.

Rovner: Oh, a-ha. All right.

Cohrs: There were a few Republicans.

Rovner: Thank you.

Cohrs: It’s not enough, though.

Rovner: Yeah, I remember that they couldn’t get those last few votes. Yes, I think [Sen. Joe] Manchin voted against. He was the one, the last Democrat they couldn’t get right. That’s why they ended up dropping …

Cohrs: Uh, it had to be a 60-vote threshold, so …

Rovner: Oh, that’s right.

Cohrs: Yeah.

Rovner: All right. Good. Thank you. Good point, Rachel. All right. Well, that is the news for this week. Now it is 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. Alice, why don’t you go first this week?

Ollstein: Yeah. So I did the incredible New York Times investigation by Hannah Dreier on child labor. This is about undocumented, unaccompanied migrant children who are coming to the U.S. And the reason I’m bringing it up on our podcast is there is a health angle. So HHS [the Department of Health and Human Services], their Office of Refugee Resettlement has jurisdiction over these kids’ welfare and making sure they are safe. And that is not happening right now. The system is so overwhelmed that they have been cutting corners in how they vet the sponsors that they release the kids to. Of course, we remember that there were tons of problems with these kids being detained and kept for way too long and that being a huge threat to their physical and mental health. But this is sort of the pendulum has swung too far in the opposite direction, and they’re being released to people who in some cases straight up trafficking them and in other cases just forcing them to work and drop out of school, even if it’s not a trafficking situation. And so this reporting has already had an impact. The HHS has announced all these new initiatives to try to stop this. So we’ll see if they are effective. But really moving, incredible reporting.

Rovner: Yeah, it was an incredible story. Lauren.

Weber: I’m going to shout out my former KHN colleague Brett Kelman. I loved his piece on, I guess you can’t call it a medical device because it wasn’t approved by the FDA, which is the point of the story. But this device that was supposed to fix your jaw so you didn’t have to have expensive jaw surgery. Well, what it ended up doing is it messed up all these people’s teeth and totally destroyed their mouths and left them with a bunch more medical and dental bills. And, you know, what I find interesting about the story, what I find interesting about the trend in general is the problem is, they never applied for anything with the FDA. So people were using this device, but they didn’t check, they didn’t know. And I think that speaks to the American public’s perception that devices and medical devices and things like this are safe to use. But a lot of times the FDA regulations are outdated or are not on top of this or the agency is so understaffed and not investigating that things like this slipped through the cracks. And then you have people — and it’s 10,000 patients, I believe, that have used this tool — that did not do what it is supposed to do and, in fact, injured them along the way. And I think that the FDA piece of that is really interesting. It’s something I’ve run into before looking at air cleaners and how they fit the gaps of that. And I think it’s something we’re going to continue to see as we examine how these agencies are really stacking up to the evolution of technology today.

Rovner: Yeah, capitalism is going to push everything. Rachel.

Cohrs: So my extra credit this week is actually an opinion piece, in Stat, and the headline is “Nonprofit Hospitals Are Failing Americans. Their Boards May Be a Reason Why.” It was written by Sanjay Kishore and Suhas Gondi. I think the part that really stood out to me is they analyzed the backgrounds and makeups of hospital boards, especially nonprofit hospitals. I think they analyzed like 20 large facilities. And the statistic that really surprised me was that, I think, 44% of those board members came from the financial sector representing investment funds, real estate, and other entities. Less than 15% were health care workers, 13% were physicians, and less than 1% were nurses. And, you know, I’ve spent a lot of time and we’ve spent a lot of time thinking about just how nonprofit hospitals are operating as businesses. And I think a lot of other publications have done great work as well making that point. But I think this is just a stark statistic that shows these boards that are supposed to be holding these organizations accountable are thinking about the bottom line, because that’s what the financial services sector is all about, and that there’s so much disproportionately less clinical representation. So obviously hospitals need admin sides to run, and they are businesses, and a lot of them don’t have very large margins. But the statistics just really surprised me as to the balance there.

Rovner: Yeah, I felt like this is one, you know, we’ve all been sort of enmeshed in this, you know, what are we going to do about the nonprofit hospitals that are not actually acting as charitable institutions? But I think the boards had been something that I had not seen anybody else look at until now. So it’s a really interesting piece. All right. Well, my story this week is the other big investigation from The New York Times. It’s called “A Drug Company Exploited a Safety Requirement to Make Money,” by Rebecca Robbins. And it’s about those same risk-mitigation rules from the FDA that are at the heart of those abortion drug lawsuits we talked about a few minutes ago. Except in this case, the drug company in question, Jazz Pharmaceuticals, somehow patented its risk-mitigation strategy as the distribution center — it’s actually called the REMS [Risk Evaluation and Mitigation Strategies] — which is managed to fend off generic competition for the company’s narcolepsy drug. It had also had a response already. It has produced a bipartisan bill in the Senate to close the loophole — but [I’ll] never underestimate the creativity of drugmakers when it comes to protecting their profit. It’s quite a story. OK. That’s our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks, as always, to our ever-patient producer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth — all one word — at kff.org. Or you can tweet me. I’m @jrovner. Alice?

Ollstein: @AliceOllstein

Rovner: Rachel.

Cohrs: @rachelcohrs

Rovner: Lauren.

Weber: @LaurenWeberHP

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

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

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.

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Sarah Karlin-Smith
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Alice Miranda Ollstein
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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.

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

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

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

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

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Alice Miranda Ollstein
Politico

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Sandhya Raman
CQ Roll Call

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Read Sandhya's stories

Sarah Varney
KHN

@sarahvarney4

Read Sarah's stories

Among the takeaways from this week’s episode:

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

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

Click to open the transcript

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

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

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

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

Alice Miranda Ollstein: Good morning.

Rovner: Sandhya Raman of CQ Roll Call.

Sandhya Raman: Good morning.

Rovner: And my KHN colleague Sarah Varney.

Sarah Varney: Hey.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Rovner: We will definitely have you back.

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

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

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

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

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

Rovner: And yet … 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Raman: Yes, yes.

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

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

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

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

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

Varney: Can I just add something? 

Rovner: Yes.

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

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

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

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

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

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

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

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

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

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

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

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

Among the takeaways from this week’s episode:

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

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

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

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

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

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

Also mentioned in this week’s podcast:

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

TRANSCRIPT

Click here for a transcript of the episode.

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

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

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

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

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

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

Alice Miranda Ollstein: Good morning.

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

Margot Sanger-Katz: Hello.

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

Sarah Karlin-Smith: Hi, everybody.

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

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

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

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

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

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

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

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

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

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

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

Karlin-Smith: Right.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Rovner: Yeah, in the year 2000.

Karlin-Smith: Right. Which is actually …

Rovner: Right at the end of the Clinton administration.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Sanger-Katz: It sure looks that way.

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

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

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

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

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

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

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

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

Rovner: Like candy stripers.

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

Rovner: Hospitals are very clever. Margot.

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

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

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

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

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

Karlin-Smith: I’m @SarahKarlin

Rovner: Margot?

Sanger-Katz: @sangerkatz

Rovner: Alice.

Ollstein: @AliceOllstein

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

‘The Writing to Me Was on the Wall’

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

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

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

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

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

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

Opportunity in Long Covid

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

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

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

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

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

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

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

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

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

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

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

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