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.

Congress returns from its August recess with a long list of things to do and not a lot of time to do them. The fiscal year ends Sept. 30, and it’s possible that lawmakers will fail to finish work not only on the annual appropriations bills, but also on any short-term spending bill to keep the government open.

Meanwhile, Medicare has announced the first 10 drugs whose prices will be negotiated under the Inflation Reduction Act of 2022. Exactly how the program will work remains a question, however. Even how the process will begin is uncertain, as drugmakers and other groups have filed lawsuits to stop it.

This week’s panelists are Julie Rovner of KFF Health News, Rachel Cohrs of Stat, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, and Alice Miranda Ollstein of Politico.

Panelists

Rachel Cohrs
Stat News

@rachelcohrs

Read Rachel's stories

Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico

@JoanneKenen

Read Joanne's stories

Alice Miranda Ollstein
Politico

@AliceOllstein

Read Alice's stories

Among the takeaways from this week’s episode:

• Hard-line Republicans are refusing to back even a temporary government spending bill, suggesting a government shutdown looms — with repercussions for health programs. While the Senate and House have come to intra-chamber agreements on subjects like community health center funding or even have passed spending bills, Congress as a whole has been unable to broker an overarching deal.
• A coalition of House Republicans is falsely claiming that global HIV/AIDS funding through PEPFAR promotes abortion and is battling efforts to extend the program’s funding. PEPFAR is a bipartisan effort spearheaded by then-President George W. Bush and credited with saving millions of lives.
• The PEPFAR fight underscores the dysfunction of the current Congress, which is struggling to fund even a highly regarded, lifesaving program. Another example is the months-long blockade of military promotions by a freshman Republican senator, Alabama’s Tommy Tuberville, a member of the Senate Armed Services Committee. His objections over an abortion-related Pentagon policy have placed him at odds with top military leaders, who recently warned that his heavy-handed approach is weakening military readiness.
• The Biden administration recently announced new staffing requirements for nursing homes, as a way to get more nurses into such facilities. But how long will compliance take, considering ongoing nursing shortages? And the drug industry is reacting to the news of which 10 drugs will be up first for Medicare negotiation, with much left to be sorted out.
• In abortion news, a Texas effort to block patients seeking abortions from using the state’s roads is spreading town to town — and, despite being dubiously enforceable, it could still have a chilling effect.

Also this week, Rovner interviews Meena Seshamani, who leads the federal Medicare program, about the plan to start negotiating drug prices.

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

Julie Rovner: JAMA Health Forum’s “Health Systems and Social Services — A Bridge Too Far?” by Sherry Glied and Thomas D’Aunno.

Alice Miranda Ollstein: The Washington Post’s “Heat’s Hidden Risk,” by Shannon Osaka, Erin Patrick O’Connor, and John Muyskens.

Rachel Cohrs: The Wall Street Journal’s “How Novartis’s CEO Learned From His Mistakes and Got Help From an Unlikely Quarter,” by Jared S. Hopkins.

Joanne Kenen: Politico’s “How to Wage War on Conspiracy Theories,” by Joanne Kenen, and “Court Revives Doctors’ Lawsuit Saying FDA Overstepped Its Authority With Anti-Ivermectin Campaign,” by Kevin McGill.

Also mentioned in this week’s episode:

• The Washington Post’s “Highways Are the Next Antiabortion Target. One Texas Town Is Resisting,” by Caroline Kitchener.
• KFF Health News’ “Biden Administration Proposes New Standards to Boost Nursing Home Staffing,” by Jordan Rau.
• Stat’s “The Curious Case of J&J’s Stelara, The Unluckiest Drug on Medicare’s List,” by Rachel Cohrs.

Click to open the transcript

Transcript: Welcome Back, Congress. Now Get to Work.

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

Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Sept. 7, at 10 a.m. As always, news happens fast, and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Rachel Cohrs of Stat News.

Rachel Cohrs: Good morning.

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

Joanne Kenen: Hi, everybody.

Rovner: And Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Hello.

Rovner: Later in this episode, we’ll have an interview with Meena Seshamani, who runs the Medicare program for the federal government, with an update on the Medicare drug negotiation debate as, we’ll discuss, the first 10 drugs that will be subject to negotiation were announced last week. But first, this week’s news. So Labor Day is behind us, and Congress is back — sort of. The Senate is back. The House returns next week. And there are lots of questions to be answered this fall, starting with whether or not Congress can finish the annual spending bills before the start of fiscal 2024 on Oct. 1. Spoiler: They cannot. But there’s also a real question whether Congress can even pass a short-term bill to keep the government running while lawmakers continue to work on the rest of the appropriations. As of now, what do you guys think are the odds that we’re going to end up with some kind of government shutdown at the end of the month?

Ollstein: Well, it’s whether it happens at the end of the month or at the end of the year, really. Folks seem pretty convinced that it will happen at some point. It could be short-lived. But, yeah, like you said, you have some hard-line House Republicans who say they won’t support even a temporary stopgap bill without spending cuts, policy changes, without sort of extracting some of their demands from leadership. And you could work around that in the House by cobbling together a coalition of Republicans and Democrats. But that also puts [House Speaker Kevin] McCarthy’s leadership in jeopardy. And so, we’re having sort of the same dynamic play out that we saw earlier this year, trying to navigate between the hard-line House Republicans and, you know, the more vulnerable swing districts’ members. So it’s … tough.

Rovner: Yeah, it’s the Republicans from districts that [President Joe] Biden won … basically.

Ollstein: Yeah. And so you have this weird game of chicken right now where both the House and Senate are trying to pass whatever they can to give themselves more leverage in the ultimate House-Senate negotiations. They think, OK, if we pass five bills and they only pass one, you know, then we have the upper hand. So we’ll see where that goes.

Rovner: It’s funny, because the Senate has been a well-oiled machine this year on the spending bills, which is unusual. I was about to say I will point out that there are two women: the chairman and ranking member. But that’s actually also true in the House. We do have women running the appropriations process this year. But I was amused that Kevin McCarthy, sometime during August, a couple of weeks ago, said, you know, very confidently, well, we’ll pass a short-term spending bill. You know, we won’t let the government shut down. And by the next day, the hard-line Republicans, the right wing, were saying, yeah, no you won’t. You’re going to have to deal with us first. And, obviously, there’s lots of health stuff that’s going to get caught up in that. The end of the fiscal year also marks the end of funding authority for a number of prominent programs. This is not the same as the appropriations programs whose authorizations lapse can continue, although things can get complicated. PEPFAR, the two-decade-old bipartisan program that provides AIDS and HIV prevention and treatment around the world, is one of those programs that, at least as of now, looks pretty stuck. Alice, is there any movement on this? We’ve talked about it before.

Ollstein: Not yet. So the latest we know, and we got this last night, is that [Foreign Relations Committee] Chairman [Bob] Menendez in the Senate is floating a new compromise. Basically, supporters of PEPFAR have been pushing for the full five-year standard reauthorization. And a coalition of House Republicans who are claiming that PEPFAR money is going to abortion say they want no reauthorization at all. They just want the program to sort of limp along through appropriations. So between five years and zero, Menendez is now suggesting a three-year extension. There is a huge desire not to just have the one-year funding patch because that would kick all of this into the heat of the 2024 season. And if you think the debate is ugly now over abortion and federal spending, just wait until 2024.

Kenen: I mean, this … [unintelligible] money … it’s saved tens of millions of lives — and with bipartisan support in the past.

Rovner: It was a Republican initiative.

Kenen: Right. It was President Bush, George the second.

Rovner: George W. Bush. Yeah.

Kenen: And they’re not saying they’re actually going out and using the AIDS dollars to conduct, to actually do abortions. They’re saying that there’s, you know, they’re in the world of abortion and they’re promoting abortion, etc., etc. So the conversation gets really, really, really, really muddled. Under U.S. law, they cannot use U.S. dollars for abortion under the Hyde Amendment, you know, all sorts of other foreign policy rules. So it’s hard to overstate how important this program has been, particularly in Africa. It has saved millions and millions of lives. And I think Alice might have broken the story originally, but it got caught up in abortion politics, and it caught people by surprise. This is not something … everything in Washington gets caught up in politics, except this! So I think it’s been quite shocking to people. And it’s, I mean — life-and-death sounds like a, you know, it’s a Washington cliché — this is life-and-death.

Ollstein: Yeah, absolutely. And, you know, even though the program won’t shut down if they don’t manage to get a reauthorization through, you know, I talked to people who run PEPFAR services in other countries, and they said that, you know, having this year-to-year funding and instability and uncertainty — you know, they won’t be able to hire, they won’t be able to do long-term planning. They said this will really undermine the goal to eliminate HIV transmission by 2030.

Cohrs: Oh, I actually did just want to jump in about another Sept. 30 deadline, because there was a big development this week. I know we were just talking about long-term planning. There is funding for community health centers that’s expiring at the end of September as well. DSH cuts could go into effect for hospitals. We do this routine every so often, but the House is actually more in step than the Senate on this issue; they released — at least Republicans released — a draft legislation, where all three committees of jurisdiction are in agreement about how to proceed. There are some transparency measures in there.

Rovner: The three committees in the House.

Cohrs: In the House. Yes, yes, we’re talking about the House. Yeah. So, they have reconciled their differences here and are hoping to go to the floor this month. So, I think they are out of the gate first, certainly with some sort of longer-term solution here. Again, could get punted. But I think it is a pretty big development when we’re talking about these extenders that the industry cares about very much.

Kenen: Congress is so polarized that it can’t even do the things that it agrees on. And we have seen this before where CHIP [Children’s Health Insurance Program] got caught up a few years ago. Community health clinics have gotten caught right in that same bill, right? But, you know, we really have this situation where it’s so dysfunctional they can’t even move fully on things that everybody likes. And community health centers date back to the early ’60s. However, they got a really big expansion, again, under second President Bush. And they’re popular, and they serve a need, and everybody likes them.

Rovner: They got a bigger expansion under the Affordable Care Act.

Kenen: Right, but they, you know — but I think that the Bush years was like the biggest in many years. And then they got more. So again, I mean, are they going to shut their doors? No. Is it going to be a mess? It is already a mess. They can’t — they don’t know what’s coming next. That’s no way to run a railroad or a health clinic.

Rovner: All right, well, one more while we’re on the subject of abortion-related delays: Alabama Sen. Tommy Tuberville is still blocking Senate approval of routine military promotions to protest the Biden administration’s policy of allowing funding for servicewomen and military dependents to travel for abortions if they’re posted to states where it’s banned. Now, the secretaries of the Army, Navy, and Air Force are joining together to warn that Tuberville’s hold is threatening military readiness. Tuberville apparently went on Fox News last night and said he’s got more people who are coming to support him. Is there any end to this standoff in sight? I mean, people seem to be getting kind of upset about it. It’s been going on since, what, February?

Ollstein: Yeah, there is not yet an end in sight. So far, all of the attempts to pressure Tuberville to back down have only hardened his resolve, it seems, you know, and he’s gone beyond sort of his original statement of, you know, all of this is just to get rid of this policy that doesn’t pay for abortions; it just allows people to travel out of state if they’re stationed — they don’t get to choose where they’re stationed — if they’re stationed somewhere where abortion is not legal or accessible. And so now he’s making claims about other things in the military he considers too woke. He’s criticized some of these individual nominees themselves that he’s blocking, which was not sort of part of the original stand he took. And so, it’s tough, and there isn’t enough floor time to move all of these and go around him. And so this pressure campaign doesn’t seem to be really making any headway. So I don’t really see how this gets resolved at this point.

Kenen: Except that other Republicans are getting a little bit more public. I mean, they were sort of letting him run out for a while. And there’s more Republicans who are clearly getting enough of this. But I mean, unless McConnell can really get him to move — and we don’t know what’s gone on behind closed doors, but we’re certainly not seeing any sign of movement. In fact, as Alice said, he’s digging in more. I mean, like, Marines and woke are not the two words you usually hear in one sentence, but in his worldview, they are. So, I think it’s unprecedented. I mean, I don’t think anyone’s ever done this. It’s not like one or two people. It’s like the entire U.S. military command can’t move ahead.

Rovner: I’ve been doing this a very long time, and I don’t remember anything quite like this. Well, the one thing that we do expect to happen this fall is legislation on — and Rachel, you were referring to this already — sort of health care price transparency and PBMs, the pharmacy benefit managers. Where are we with that? They were supposed to work on it over the August break. Did they?

Cohrs: They were supposed to work on it. The House was clearly working on it and reconciling some of their differences. They’re planning to introduce legislative text on Friday. So, I think Democrats aren’t on board yet, so things could change from the draft they had been circulating early this week. But again, Republicans don’t really need Democrats to move forward, at least in the House. The Senate has been pretty quiet so far. Not to say that no work has gone on, but they certainly weren’t ready for the rollout in the same way that the House was. You know, I think there are still some big questions about, you know, what they’re planning to accomplish with insulin policy, how they’re planning to fit together this jigsaw puzzle of PBM transparency and reforms that have come out of different committees. And I think it’ll come down to [Senate Majority Leader] Sen. Schumer making some tough choices. And from my understanding, that hasn’t quite happened yet. But if the actual showdown happens November, December, they still have some time.

Rovner: Yeah. Now they’re not going out early. They’re clearly going to be fighting over the appropriation. So, the legislative committees have plenty of time to work on these other things. All right. Well, let’s turn to Medicaid for a moment. The quote-unquote “unwinding” continues as states move to redetermine who remains eligible for the program and who doesn’t following the pandemic pause. As predicted, it’s been a bit of a bumpy road. And now it seems a bunch of states have been incorrectly dropping children from Medicaid coverage because their parents are no longer eligible. That’s a problem because nationwide, income limits for children’s eligibility is higher than parents’. In some states, it is much higher. I remember after Hurricane Katrina, in Louisiana, parents were only eligible if they earned 15% of poverty. Somebody said 50, and the Medicaid director said, “No, 15, one-five.” Whereas kids are eligible to, I believe it’s 200% of poverty. And I think that’s a national level.

Kenen: Now, in some states it’s higher.

Rovner: Yes. But I say this is happening in a bunch of states because federal government won’t tell us how many or which ones. We do know it’s more than a dozen, but this is the second time the administration has admonished states for wrongly canceling Medicaid coverage. And they wouldn’t say which states were involved at that time either. Is this an effort to keep this as apolitical as possible, given that the states most likely to be doing this are red states who are trying to remove ineligible people from Medicaid as fast as they can, that they’re trying to sort of keep this from becoming a Republican versus Democrat thing.

Ollstein: It seems like, from what we’re hearing, that the administration is really wary of publicly picking a fight with these states. They want the states to work with them. And so, even if the states are going about this in a way they think is totally wrong, they don’t want to just put them publicly on blast, because they think that’ll make them, again, double down and refuse to work with the government at all. And so, they’re trying to maintain some veneer of cooperation. But at the same time, you’re having, you know, millions of people, including children, falling through the cracks. And so, you know, we have sort of this sternly-worded-letter approach and we’ll see if that accomplishes anything, and if not, you know, what measures can be taken. You know, the administration also created a way for states to hit pause on the process and take a little more time and do a little more verification of people’s eligibility. And some — a couple states — have taken advantage of that, and it’s been successful in, you know, having fewer people dropped for paperwork reasons, but it’s not really happening in the states where it sort of most needs to happen, according to experts.

Rovner: The administration has had fingers pointed at it, too, because apparently it approved some of these plans from the states that were going to look at total family income without realizing that, oh, that meant that kids who are still eligible could end up losing coverage because their parents are no longer eligible.

Kenen: Right. And I also read something yesterday that in some cases it’s sort of a technical issue rather than a “how much outreach and what your intentions are,” that it’s a programing issue, which is related to what Julie just said about the plan. So, it’s not that these states set about to drop these kids, and there may be some kind of goodwill to fix it, in which case you don’t want to get in — and I don’t know that it’s 100% red states either. So —

Rovner: No, that’s clear. We assume, because they’re the ones going fastest, but we do not know.

Kenen: Right, so that there seems to be some kind of — the way it was set up, technically, that can be remedied. And if it’s a technical fix as opposed to an ideological fight, you don’t really want to — you want to figure out how to reprogram the computer or whatever it is they have to do and then go back and catch the people that were lost. So, they’ve been pretty low-key about politicizing rewinding in general. But on the kids, I think they’re going to be even more — CHIP passed, another thing with bipartisan support that’s a mess. I mean, it seems to be the theme of the day. But, you know, CHIP was created on a bipartisan basis, and it’s always been sustained on a bipartisan basis. So, I think that the issue, I don’t know how technically easy it is to fix, but there’s a big difference in how the administration goes after someone that’s intentionally doing something versus someone who wrote their computer programmer set something up wrong.

Rovner: Well, we will definitely keep on this one.

Kenen: But it’s a big mess. It’s a lot of kids.

Rovner: It is a big mess. And let’s turn to the thing that is not bipartisan in Congress, and that is —

Kenen: That’ll be a bigger mess.

Rovner: — Medicare drug negotiations. Yes. While we were away, the federal government released its much-anticipated list of the 10 brand-name drugs that will be the first tranche up for potential price negotiation. I say potential, because the companies have the option of negotiating or not — sort of — and because there are now, I think, nine lawsuits challenging the entire program. My interview with Medicare administrator Meena Seshamani will get into the nuts and bolts of how the negotiation program is supposed to work. But Rachel, tell us a little bit about the drugs on the list and how their makers are trying to cancel this entire enterprise before it even begins.

Cohrs: Sure. So, a lot of these drugs that we’re seeing on the list are blood thinners. Some are diabetes medications. There are drugs for heart failure, rheumatoid arthritis, Crohn’s disease, and there’s also a cancer treatment, too. But I think overall, the drugs were chosen because they have high cost to Medicare. And it was —

Rovner: So that either could mean a lot of people use an inexpensive drug —

Cohrs: Yes.

Rovner: — or a few people use a very expensive drug.

Cohrs: Correct. And it was Wall Street’s favorite parlor game to try to guess what drugs were going to be on this list of 10 drugs that are going to be the guinea pigs to go through this program for the very first time. But it was interesting, because there were a few surprises. Medicare officials were using newer data than Wall Street analysts had access to. So, there were a couple drugs, especially further down on the list, that people used more in the period CMS [Centers for Medicare & Medicaid Services] was studying than had been used previously. So, we saw a couple very interesting instances of a drug being chosen for the list, even though it just kind of fell through the cracks. It was J&J’s [Johnson & Johnson’s] Stelara. It’s a Crohn’s disease treatment, and it does have competition coming in the market soon, but just because of a fluke of kind of when it was approved by the FDA, it just missed cutoffs for some of these exemptions and is now subject to some pretty significant discounts through the program.

Rovner: We’ll link to your very sad story about Stelara.

Cohrs: Sad for the company, but not sad for the patients who will hopefully be paying less for this medication. And there’s also the case of Astellas [Pharma Inc.], which makes a prostate cancer drug that’s very expensive. A lot of people expected that to be selected, but actually wasn’t. And Astellas had sued the Biden administration already before the list came out and then had to withdraw their lawsuit yesterday because their argument that they were going to be harmed by this legislation was made much weaker by the fact that they weren’t selected for this first year of the program. So, who knows? They could dust off their arguments a year from now or two years from now. But it was interesting to see kind of some of these surprises on the list. Again, there are still several, like you mentioned, outstanding lawsuits in several different jurisdictions. I think the main one that we’re watching is by the [U.S.] Chamber of Commerce, which requested a preliminary injunction by the end of this month. So, we’ll see if that comes through. But it is a very long road to 2026. There might be a new administration by then. So, I think there are still a lot of questions about whether this reaches the finish line. But I think it’s a very important step for CMS to get this list out there in the world.

Rovner: So, I spent some time digging in my notes from earlier years, and I dug up notes from an interview I did on Aug. 26 with a spokesperson from the drug industry about how the Medicare drug benefit, quote, “impact the ability of companies to research new medicines. And if that happens, the elderly would be the ones hurt the most.” That quote, by the way, was from Aug. 26 of 1987. Some things truly never change. But is this maybe, possibly, the beginning of the end of drugmakers being able to charge whatever they want in the United States? Because it’s the only country where they can.

Cohrs: Oh, they can still charge whatever they want. This law doesn’t change that. It just changes the fact that Medicare won’t be paying whatever drugmakers happen to charge for an unlimited amount of time. Like, they can still charge whatever they want to Medicare for as long as they can get on the market before they’re selected for this negotiation program. But certainly there could be significant cost — significant savings to Medicare, even if those prices are high. And it’s just kind of a measure that forces price reductions, even if the generic or biosimilar market isn’t functioning to lower those prices through competition.

Kenen: Right. And it’s only Medicare. So, people who are not on Medicare — insurance companies also negotiate prices, but they’re not the government. It’s different. But I mean, these drugs are not going to start being, you know, three bucks.

Rovner: But they may stop being 300,000.

Kenen: Well, we don’t know, because there are some people who think that if Medicare is paying less, they’re going to charge everybody else more. We just don’t know. We don’t know what their behavior is going to be. But no, this does not solve the question of affordability of medication in the United States.

Rovner: The drug companies certainly think it’s the camel’s nose under the tent.

Kenen: They have some medicine for camels’ noses that they can charge a lot of money for, I’m sure.

Rovner: I bet they do. While we are on the subject of things that I have covered since the 1980s, last week the Biden administration finally put out its regulation requiring that nursing homes be staffed 24/7/365 by, you know, an actual nurse. One of the first big reconciliation bills I covered was in 1987 — that was a big year for health policy — and it completely overhauled federal regulation of nursing homes, except for mandating staffing standards, because the nursing homes said they couldn’t afford it. Basically, that same fight has been going on ever since. Except now the industry also says there aren’t enough nurses to hire, even if they could afford it. Yet patient advocates say these admittedly low staffing ratios that the Biden administration has put out are still not enough. So, what happens now? Is this going to be like the prescription drug industry, where they’re going to try to sue their way out of it? Or is it going to be more like the hospital transparency, where they’re just not going to do it and say, “Come and get us”?

Kenen: My suspicion is litigation, but it’s too soon to know. I assume that either one of the nursing home chains — because there are some very big corporations that own a lot of nursing homes — there are several nursing home trade industry groups, for-profit, nonprofit. Does one owner — is in an area where there is a workforce shortage, because that does exist. I mean, I’d be surprised if we don’t see some litigation, because when don’t we see that? I mean, it’s rare. That’s the norm in health care, is somebody sues. Some of the workforce issues are real, but also this proposal doesn’t go into effect tomorrow. It’s not like — but I mean, there are issues of the nursing workforce. There are issues about not just the number of nurses, but do we have them in the right places doing the right jobs? It’s not just RNs [registered nurses]; there are also shortages of other direct care workers. I did a story a few months ago on this, and there are actually nursing homes that have closed entire wings because they don’t have enough staff, and those are some of the nonprofits. There are nursing issues.

Rovner: And a lot of nursing home staff got sick at the beginning of the covid pandemic, and many of them died before there were good treatments. I mean, it’s always been a very hard and not very well-paid job to care for people in nursing homes. And then it became a not very pleasant, not very well-paid, and very deadly job. So I don’t think that’s probably helping the recruitment of people to work in nursing.

Kenen: Right, but the issue — I think a lot of people, when you have your first family experience with a nursing home or, you know, or those of us reporters who hadn’t been familiar with them until we went and did some stories on them, I think people are surprised at how little nursing there actually is. It’s nurses’ aides; it’s, you know, what they used to call licensed practical nurses or nursing assistants; and CNAs, certified nursing assistants. They’re various; different states have different names. But these are not four-year RNs. The amount of actual nursing — forget doctors. I mean, there’s just not a lot of RNs in nursing homes. There’s not a lot of doctors who spend time in nursing homes. A lot of the care is done through people with less training. So, this is trying to get more nurses in nursing homes. And there’s been a lot of stories about inadequate care. KFF Health News — I think it was Jordan Rau who did them. There have been some good stories about particularly nights and weekends, just really nobody there. These are fragile people. And they wouldn’t be in a nursing home if they weren’t fragile people. There are a lot of horror stories. At the same time, there are some legitimate — How fast can you do this? And how well can you do it? And can you do it across the country? I mean, it’s going to take some working out, but I don’t think anybody thinks that nursing home care in this country is, you know, a paragon of what we want our elders to experience.

Rovner: And the nursing home industry points out, truthfully, that most nursing home payments now come from Medicaid, because even people who start out being able to afford it themselves often run out of money and then they end up — then they qualify for Medicaid. And Medicaid in many states doesn’t pay very much, doesn’t pay nursing homes very much. So it’s hard for these companies. We’re not even talking about the private equity companies. A lot of nursing homes operate on the financial edge. I mean, there are —our long-term care policy in this country is, you know, just: What happens, happens, and we’ll worry about it later. And this has been going on for 50 years. And now we have baby boomers retiring and getting older and needing nursing home care. And at some point, this is all going to come to a head. All right. Well, let us turn to abortion. This week marks the second anniversary of the Texas abortion ban, the so-called heartbeat bill, that bans most abortion and lets individuals sue other individuals for helping anyone getting an abortion, which the Supreme Court, if you’ll recall, allowed to take effect months before it formally overturned Roe v. Wade. And, I guess not surprisingly, Texas is still in the news about abortion. This time. The same people who brought us Texas SB 8, which is the heartbeat bill, are going town by town and trying to pass ordinances that make it illegal to use roads within that town’s borders to help anyone obtain an abortion. They’re calling it abortion “trafficking.” Now, it’s not only not clear to me whether a local ordinance can even impact a state or an interstate highway, which is what these laws are mostly aimed at; but how on earth would you enforce something like this, even if you want to?

Ollstein: So, my impression is that they do not want to. These are not meant to be practical. They are not meant to be enforced, because how would you do it other than implementing a very totalitarian checkpoint system? This is meant to —

Rovner: Yes, have you been drinking and are you on your way to get an abortion?

Ollstein: Right. Right, right, right. So, it seems like the main purpose is to have a chilling effect, which it very well could have, even if it doesn’t stand up in court. You know, you also have this situation that we’ve had play out in other ways, where people are challenging laws in courts for having a chilling effect, and courts are saying, look, you have to wait till you actually get prosecuted and challenge it, you know, do an as-applied challenge. If you can’t challenge unless there’s a prosecution but there’s no prosecutions, then you sort of just have it hanging over your head like a cloud.

Kenen: Like Alice said, there’s no way you could do this. Like, what do you do, stop every car and give every person a pregnancy test? Are you going to, like, have, you know, ultrasounds on the E-ZPass monitors? Like, you go through it, it checks your uterus. So, I mean, it’s just not — you can’t do this. But I think one of the things that was really interesting in one of the stories I read about it, I think it was in The Washington Post, was that when they interviewed people about it, they thought it was trafficking, like really trafficking, that there were pregnant woman being kidnapped and forced to have an abortion. So even if you’re pro-choice, you might say, “Oh, I’m against abortion trafficking. I mean, I don’t want anyone to be forced to have an abortion.” You know, so, it’s — the wording and the whole design of it is, they know what they’re doing. I mean, they want to create this confusion. They want to create a disincentive. There’s no way — you know, radar guns? I mean, it’s just, there’s no way of doing this. But it is part of the effort to clamp down even further on a state that has already really, really, really clamped down.

Rovner: Although, I mean, if one could sue and if one could then know about something that’s happening and then you could presumably take the person to court and say, I know you were pregnant and now you’re not, and somebody took you in a car to New Mexico or whatever …

Kenen: You can’t even prove — how do you prove that it wasn’t a miscarriage?

Rovner: That’s —

Kenen: Right? I mean …

Rovner: I’m not saying — I’m not talking about the burden of proof. I’m just saying in theory, somebody could try to have a case here. I mean, but we certainly know that Texas has done a very good job creating a chilling effect, because we still have this lawsuit from the women who were not seeking abortions, who had pregnancy complications and were unable to get health-saving and, in some cases, lifesaving care promptly. And that’s still being litigated. But meanwhile, we have, you know, just today a study out from the Guttmacher Institute that showed that despite how well these states that are banning abortion have done in banning abortion, there were presumably more abortions in the first half of 2023 than there were before these bans took effect, because women from ban states were going to states where it is not banned. And there has been, ironically, better access in those states where it is not banned. I can’t imagine that this is going to please the anti-abortion community. One would think it would make them double down, wouldn’t it?

Ollstein: We know that people are leaving their states to obtain an abortion. We also know that that’s not an option for a lot of people, and not just because a lot of people can’t afford it or they can’t take time off work, they can’t get child care — tons of reasons why somebody might not be able to travel out of state. They have a disability, they’re undocumented. We also have — it’s become easier and easier and easier to obtain abortion pills online through, you know, a variety of ways: individual doctors in more progressive states, big online pharmacies are engaged in this, overseas activist groups are engaged in this. And so, you know, that’s also become an option for a lot of people. And anti-abortion groups know that those are the two main methods. People are still continuing to have abortions. And so, they’re continuing to just throw out different ways to try to either, you know, deter people or actually block them from either of those paths.

Rovner: This fight will also continue on. So, that is this week’s news. Now we will play my interview with Meena Seshamani, and then we will come back and do our extra credits.

Hey, “What the Health?” listeners, you already know that few things in health care are ever simple. So, if you like our show, I recommend you also listen to “Tradeoffs,” a podcast that goes even deeper into our costly, complicated, and often counterintuitive health care system. Hosted by longtime health care journalist and friend Dan Gorenstein, “Tradeoffs” digs into the evidence and research data behind health care policies and tells the stories of real people impacted by decisions made in C-suites, doctors’ offices, and even Congress. Subscribe wherever you listen to your podcasts.

I am pleased to welcome back to the podcast Dr. Meena Seshamani, deputy administrator and director of the Center for Medicare at the Centers for Medicare & Medicaid Services. Meena was with us to talk generally about Medicare’s new prescription drug negotiation program earlier this summer. But now that the first 10 drugs subject to negotiation have been announced, we’re pleased to have her back. Welcome.

Meena Seshamani: Thank you for having me.

Rovner: So, remind our listeners, why hasn’t Medicare been able to negotiate drug prices until now — they negotiate prices of everything else — and what changed to make that happen?

Seshamani: That’s right. It was because of the Medicare law that Medicare did not have the ability to negotiate drugs. And thanks to the new drug law, the Inflation Reduction Act, now Medicare has the ability to negotiate the prices of the highest-cost drugs that don’t have competition. And that is part of the announcement that we had on what the first 10 drugs are that have been selected.

Rovner: So, as you say, last week, for the first time and in time for the Sept. 1 deadline, Medicare announced the list of the first 10 drugs that will be part of the first round of price negotiations. Why these 10 specifically? I imagine it’s not a coincidence that the list includes some of the drugs whose ads we see the most often on TV: drugs like Eliquis, Xarelto, and Jardiance, which I of course know how to pronounce because I see the ads all the time.

Seshamani: Well, the process of selection really was laid out in the drug law and also through the guidance that we put out that we had incorporated everybody’s comment for. So, what we did is we started with the, you know, over 7,500 drugs that are covered in the Part D Medicare prescription drug program. From there, we picked those drugs that had been on the market for seven years for a drug product or 11 years for a larger molecule or biologic product that did not have competition. And then from there, there are various exemptions and exclusions that, again, are laid out in the law: for example, drugs that have low Medicare spend, of less than $200 million; drugs that are plasma-derived products; certain orphan drugs. An orphan drug is a drug that is indicated for a rarer disease. So that, again, those specific criteria are laid out in the law and in our guidance. And then there were opportunities for manufacturers to apply, for example, for a small biotech exemption; if their drug was, you know, 80% of their, you know, Medicare Part D revenue, they could say, “Hey, I’m a small biotech.” Again, a lot of these criteria were laid out in the law. Or for a manufacturer of a biosimilar, which is kind of like a generic drug for one of these biologic drugs, they could say, “Hey, we have a biosimilar that’s going to be coming on the market, has a high likelihood of coming on the market, so you should delay negotiating” the brand, if you will, drug. So, again, all of these steps were laid out in the drug law, and those are the steps and criteria that we followed that came to that list of 10 drugs that we published.

Rovner: I did see the makers of one drug — and forgive me, I can’t remember which one it was — saying, “But our drug isn’t that expensive.” On the other hand, their drug is used by a lot of people on Medicare. So, it’s not just the list price of the drug, right? It’s how much it costs Medicare overall.

Seshamani: That’s right. The list is made up of those drugs that have the highest gross total cost to the program — so, price per unit times units of volume that is used.

Rovner: So, how does this negotiation process work? What happens now? Now we have this list of 10 drugs.

Seshamani: Yeah, a lot of this is also laid out in the law, and then we fleshed out further in our guidance. So, from the list of 10 drugs, on Oct. 1, manufacturers now have to decide if they want to participate in the negotiation program. It is a voluntary program. It is our hope that they will come to the table and want to negotiate, because I think we all have shared goals of improving access and affordability and really driving innovation for the cures and therapies that people need. So, Oct. 1, they sign agreements for the negotiation program if they decide to participate. And Oct. 2 is the deadline for gathering data. We put out what’s called an information collection request to say, this is the kind of data we’re thinking about collecting. We got lots of comments and incorporated that. So, that provides the framework for the data that we’re requesting both from the manufacturer of the selected drug, but also, there are aspects open to the public on, you know, how the drug benefits populations, for example. So that’s Oct. 2. Then we’re going to have patient-focused listening sessions, a session for each drug, for patients, their caregivers, you know, other advocates, to be able to share what they see as the benefits of the drugs that are selected. And, we will have meetings with each of the manufacturers. All of that information will come together in an initial offer that CMS will make Feb. 1, 2024, and that is a date that is stipulated in the law. The manufacturer then has about 30 days to evaluate that. If they like that offer, they can agree. If they want, they can make a counteroffer. From that counteroffer, CMS has the ability to agree or to say, “You know, we don’t agree, so let’s now have a series of negotiation meetings.” There can be up to three negotiation meetings that provides that back-and-forth, ultimately leading to an agreed-upon what’s called maximum fair price in the law. And those maximum fair prices are published by Sept. 1, 2024. Again, that Sept. 1 is stipulated in the law. And also as part of this process, CMS will publish a narrative about that negotiation process — you know, the data that was received, you know, the back-and-forth, and also we’ll publish ultimately the maximum fair prices that are agreed to.

Rovner: And does that maximum fair price just apply to Medicare?

Seshamani: The maximum fair price just applies to Medicare. The information will be available. I mean, we don’t have any authority. You know, the commercial sector, they do their own negotiations, and they will continue to do so. But part of this is an opportunity to really further the conversation about how drugs impact the lives of people. We have an opportunity now with some drugs that have been on the market for quite a while, right? Minimum of seven years or 11 years, to see how these drugs work in the real world, in people’s communities, so that we can incorporate that into what it is that we need and want for people to be healthy, to stay out of the hospital, to live meaningful lives. So it’s really an opportunity to further that conversation. And a lot of that data, a lot of those listening sessions, that will all go into our negotiation process and will be part of the narrative that we publish.

Rovner: And what happens if the drug company says either we don’t want to negotiate or we don’t like our final offer? If they say they don’t want to play, what happens?

Seshamani: Julie, I will say again, to start with, we are hopeful that the drug companies will come forward and will want to negotiate because, again, through many conversations that we have had, we do have shared goals of access and affordability and really driving innovation and procures and therapies that people need. And it is a choice for drug companies if they want to participate or not, as stipulated in the law. If a drug company decides not to sign, you know, the negotiation agreement, not to participate in negotiation, then we would refer them to the Department of Treasury for an excise tax. That excise tax is also described in the law. If a drug company has this excise tax applied, they can get out of paying the excise tax. If, No. 1, they decide to come to the table and negotiate, or No. 2, if they exit the Medicare and Medicaid market. So those are kind of their off-ramps, if you will, for that excise tax.

Rovner: So they don’t have to participate in the negotiation, but they also don’t have to participate in Medicare and Medicaid.

Seshamani: Correct.

Rovner: So I saw a lot of complaining last week with the first group of drugs that this is really only going to benefit the people on Medicare who take those drugs. But, in fact, if there really is a lot of money saved, the benefits could go well beyond this, right?

Seshamani: Yeah, I think two points. So, yes, this negotiation is for, you know, some of the highest-cost drugs to the Medicare program that don’t have competition. And the negotiated drug prices apply to the Medicare program. However, as we talked about, this really drives a conversation around drugs and really grounding this negotiation process in the clinical benefit that a drug provides. Considering things like if a drug is easier for someone to take and it’s easier for a caregiver, that can have tangible improvements to the health of the person they’re caring for, right? And I think we have that opportunity to really drive the conversation. And as we know in many aspects of health care, people look to Medicare to see what Medicare is doing. And also, the transparency around providing that narrative of the negotiation, publishing the maximum fair prices that are agreed to. That’s all data that anybody can use as they would like. And I think the second piece that’s important to remember is that negotiation is one very important piece of a very big change to Medicare prescription drug coverage. You know, alongside the $2,000 out-of-pocket tab that’s going to go into effect in 2025, the no-cost vaccines, $35 copay cap for insulin that have already gone into effect. So, really, it is part of a larger sea change in Medicare drug coverage that will help millions of people and their families. You know, I did a roundtable with seniors as we were rolling out the insulin copay cap. And one woman was telling me that she was providing money to her brother every month so that he could pay for his insulin on Medicare. So, really, I mean, this has tremendous impact not just for people on Medicare, but their families, their communities, and really furthers the conversation for the entire system.

Rovner: I was actually thinking of more nitty-gritty money, which is if you save money for Medicare, premiums will be lower for people who are getting drug coverage, and taxpayers will save money, too, right? I mean, this is not just for these people and their families.

Seshamani: Our priority is being able to reach agreement on a fair price for the people who rely on these medications for their lives and the American taxpayer in the Medicare program.

Rovner: I know you can’t comment on lawsuits, and there are many lawsuits already challenging this. But the drug companies, one of their major arguments is that if you limit what they can charge for their drugs, particularly in the United States, the last country where they can charge whatever they want for their drugs, they will not be able to afford to keep the pipeline going to discover more new, important drugs. This is an argument they’ve been making since, I told somebody earlier, since I covered this in the late 1980s. What is your response just to that argument?

Seshamani: Well, I think there were several articles, many articles were written about this on the day that the 10 selected drugs were published. They were published before the stock market opened. And there really was no impact on the stocks of the companies. There were many financial pieces written about this. So I think that is one indication of the fact that the pharmaceutical industry is strong, it is thriving, and it is designed to innovate. And what we’re hoping to do through this negotiation program is really reward the kinds of innovations that we all need, the cures and therapies that people need. Recently, the venture fund that backed Moderna invested in a new startup for small molecules. Bayer has recently invested a billion dollars in the U.S. So you see, the industry very much is thriving. That is what the stock market response also shows. And it’s also the way that we are approaching negotiation to make sure that we’re rewarding the kinds of innovations that people need.

Rovner: Well, Meena Seshamani, thank you so much. I hope we can come back to you as this negotiation process for the first time proceeds.

Seshamani: Absolutely. Thanks again, Julie.

Rovner: OK. We are back, and it’s time for our extra-credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Alice, why don’t you go first this week?

Ollstein: Yeah, I picked a very sad story from The Washington Post about how people who have schizophrenia are a lot more vulnerable to extreme heat. And it’s rare to find one of these health care stories where you’re just astonished. You know, I had no idea about this. You know, it really walks through not only are people more vulnerable for mental health reasons, you know, it profiles this terrible story of a guy in Phoenix who wandered off into the desert and died because he was experiencing paranoid delusions. But also, just physically, people with schizophrenia have difficulty regulating their body temperature. A lot of medications people take make people more dehydrated, less able to cope. And just an astonishingly high percentage of people hospitalized and killed by extreme heat have these mental illnesses. Of course, they’re also more likely to have housing instability or be out on the street. So just a fascinating piece, and I hope it spurs cities to think of ways to address it. One other small thing I want to compliment is it just, technically, on this article online, they have a little widget where you can convert all of the temperatures cited in the lengthy story from Fahrenheit to Celsius. And I just really appreciated that for allowing, you know, no matter where you live, you sort of get what these high temperatures mean.

Rovner: Yeah, graphics can be really helpful sometimes. Rachel.

Cohrs: Yeah. So I chose a story in The Wall Street Journal and the headline is “How Novartis’s CEO Learned From His Mistakes and Got Help From an Unlikely Quarter,” by Jared S. Hopkins. And I think it was a really interesting and rare look inside one of these pharmaceutical companies. And Novartis hired a Wall Street analyst, Ronny Gal, to help advise them. And I think I had read his analysis before he crossed over to Novartis. So I think it was interesting to just hear how that has integrated into Novartis’ strategy and just how they’re changing their business. But I think as we’re, you know, having these conversations about drug pricing and how strategies are changing due to some of these policies, it is helpful to look at who these executives are listening to and what they’re prioritizing, whose voices in this decision-making process that really has impacts for so many people who are waiting for treatments. And I think there are tough choices that are made all the time. So I just thought it was very illuminating and helpful as we’re talking about how medicines get made in D.C.

Rovner: Yeah, maybe there will be a little more transparency to actually how the drug industry works. We will see. Joanne.

Kenen: With Julie’s permission, I have two that are both short and related. I wrote a piece for Politico Nightly called “How to Wage War on Conspiracy Theories,” and I liked it because it really linked political trends and disinformation and attempts to debunk, with very parallel things going on in the world of health care and efforts to the motivations and efforts to sow trust and what we do and do not know about how to debunk, which we’re not very good at yet. And then the classic example, of course, is the related AP story, which has a very long headline, so bear with me. It’s by Kevin McGill: “Court Revives Doctors’ Lawsuit Saying FDA Overstepped Its Authority With Anti-Ivermectin Campaign.” And, basically, it’s that the 5th Circuit, a conservative court that we’ve talked about before, is saying that the FDA is allowed to inform doctors, but it can’t advise doctors. And I’m not really sure what the difference is there, because if the FDA is informing doctors that ivermectin, we now know, does not work against covid, and it can in fact harm people, there’s ample data, that the FDA is not allowed to tell doctors not to use it. So the ivermectin campaign is a form of disinformation, or misinformation, whatever you want to call it, that at the very beginning, people had, you know, there were some test-tube experiments. We had nothing else. You can sort of see why people wanted … might have wanted to try it. But we have lots and lots and lots of good solid clinical research and human beings and, no, it does not cure covid. It does not improve covid. And it can be damaging. It’s for parasites, not viruses.

Rovner: It can cure worms. Well, I’m going to channel my inner Margot Sanger-Katz this week and choose a story from a medical journal, in this case the Journal of the American Medical Association. Its lead author is Sherry Glied, who’s dean of the NYU Robert F. Wagner Graduate School of Public Service and former assistant HHS [Department of Health and Human Services] secretary for planning and evaluation during the Obama administration — and I daresay one of the most respected health policy analysts anywhere. The piece is called “Health Systems and Social Services — A Bridge Too Far?” And it’s the first article I’ve seen that really does question whether what’s become dogma in health policy over the past decade that — tending to what are called social determinants of health, things like housing, education, and nutrition — can improve health as much as medical care can. Rather, argues Glied, quote, “There are fundamental mismatches between the priorities and capabilities of hospitals and health systems and the task of addressing social determinants of health,” and that, basically, medical providers should leave social services to those who are professional social service providers. That is obviously a gross oversimplification of the argument of the piece, however, but I found it really thought-provoking and really, for the first time, someone saying, maybe we shouldn’t be spending all of this health care money on social determinants of health. Maybe we should let social service money go to the social service determinants of health. Anyway, we will see if this is the start of a trend or just sort of one outlier voice. OK, that is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks, as always, to our amazing engineer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me, or X me, or whatever. I’m still there @jrovner, also on Bluesky and Threads. Rachel?

Cohrs: I’m @rachelcohrs on X.

Rovner: Alice.

Ollstein: @AliceOllstein.

Rovner: Joanne.

Kenen: @JoanneKenen on Twitter, @joannekenen1 on Threads.

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

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America’s pharmaceutical giants are suing this summer to block the federal government’s first effort at drug price regulation.

Last year’s Inflation Reduction Act included what on its face seems a modest proposal: The federal government would for the first time be empowered to negotiate prices Medicare pays for drugs — but only for 10 very expensive medicines beginning in 2026 (an additional 15 in 2027 and 2028, with more added in later years). Another provision would require manufacturers to pay rebates to Medicare for drug prices that increased faster than inflation.

Those provisions alone could reduce the federal deficit by $237 billion over 10 years, the Congressional Budget Office has calculated. That enormous savings would come from tamping down drug prices, which are costing an average of 3.44 times — sometimes 10 times — what the same brand-name drugs cost in other developed countries, where governments already negotiate prices.

These small steps were an attempt to rein in the only significant type of Medicare health spending — the cost of prescription drugs — that has not been controlled or limited by the government. But they were a call to arms for the pharmaceutical industry in a battle it assumed it had won: When Congress passed the Medicare prescription drug coverage benefit (Part D) in 2003, intense industry lobbying resulted in a last-minute insertion prohibiting Medicare from negotiating those prices.

Without any guardrails, prices for some existing drugs have soared, even as they have fallen sharply in other countries. New drugs — some with minimal benefit — have enormous price tags, buttressed by lobbying and marketing.

AZT, the first drug to successfully treat HIV/AIDS, was labeled “the most expensive drug in history” in the late 1980s. Its $8,000-a-year cost was derided as “inhuman” in a New York Times op-ed. Now, scores of drugs, many with much less benefit, cost more than $50,000 a year. Ten drugs, mostly used to treat rare diseases, cost over $700,000 annually.

Pharmaceutical manufacturers say high U.S. prices support research and development and point out that Americans tend to get new treatments first. But recent research has shown that the price of a drug is related neither to the amount of research and development required to bring it to market nor its therapeutic value.

And selling drugs first in the U.S. is a good business strategy. By introducing a drug in a developed country with limited scrutiny on price, manufacturers can set the bar high for negotiating with other nations.

Here are just a few of the many examples of drug pricing practices that have driven consumers to demand change.

Exhibit A is Humira, the best-selling drug in history, earning AbbVie $200 billion over two decades. Effective in the treatment of various autoimmune diseases, its core patent — the one on the biologic itself — expired in 2016. But for business purposes, the “controlling patent,” the last to expire, is far more important since it allows an ongoing monopoly.

AbbVie blanketed Humira with 165 peripheral patents, covering things like a manufacturing step or slightly new formulation, creating a so-called patent thicket, making it challenging for generics makers to make lower-cost copycats. (When they threatened to do so, AbbVie often offered them valuable deals not to enter the market.) Meanwhile, it continued to raise the price of the drug, most recently to $88,000 a year. This year, Humira-like generics (called biosimilars for its type of molecule) are entering the U.S. market; they have been available for a fraction of the price in Europe for five years.

Or take Revlimid, a drug by Celgene (now part of Bristol Myers Squibb), which treats multiple myeloma. It won FDA approval to treat that previously deadly disease in 2006 at about $4,500 a month; today it retails at triple that. Why? The company’s CEO explained price hikes were simply a “legitimate opportunity” to improve financial “performance.”

Since it must be taken for life to keep that cancer in check, patients who want to live (or their insurers) have had no choice but to pay. Though Revlimid’s patent protection ran out in 2022, Celgene avoided meaningful price-cutting competition by offering generic competitors “volume-limited licenses” to its patents so long as they agreed to initially produce a small share of the drug’s $12 billion monopoly market.

Par Pharmaceutical, another drugmaker, maneuvered to create a blockbuster market out of a centuries-old drug, isoproterenol, through a well-meaning FDA program that gave companies a three-year monopoly in exchange for performing formal testing on drugs in use before the agency was formed.

During those three years, Par wrapped its branded product, Vasostrict, used to maintain blood pressure in critically ill patients, with patents — including one on the compound’s pH level — extending its monopoly eight additional years. Par raised the price by 5,400% between 2010 and 2020. When the covid-19 pandemic filled intensive care units with severely ill patients, that hike cost Americans $600 million to $900 million in the first year.

And then there is AZT and its successors, which offer a full life to HIV-positive people. Pills today contain a combination of two or three medicines, the vast majority including one similar to AZT, tenofovir, made by Gilead Sciences. The individual medicines are old, off-patent. Why then do these combination pills, taken for life, sometimes cost $4,000 monthly?

It’s partly because many manufacturers of the combination pills have agreements with Gilead that they will use its expensive branded version of tenofovir in exchange for various business favors. Peter Staley, an activist with HIV, has been spearheading a class-action suit against Gilead, alleging “collusion.” The negotiated price for these pills is hundreds of dollars a month in the United Kingdom, not the thousands charged in the U.S.

Faced with such tactics, 8 in 10 Americans now support drug price negotiation, giving Congress and the Biden administration the impetus to act and to resist Big Pharma’s legal challenges, which many legal experts view as a desperate attempt to stave off the inevitable.

“I don’t think they have a good legal case,” said Aaron Kesselheim, who studies drug pricing at Harvard Medical School. “But it can delay things if they can find a judge to issue an injunction.” And even a year’s delay could translate into big money.

Yes, American patients are lucky to have first access to innovative drugs. And, sadly, patients in countries that refuse to pay up once in a while go without the latest treatment. But more sadly, polling shows, large numbers of Americans are forgoing prescribed medicines because they can’t afford them.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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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.

A divided three-judge federal appeals court panel has ruled that a lower court was wrong to try to reverse entirely the FDA’s approval of the abortion drug mifepristone. The panel did find, however, that the agency violated regulatory rules in making the drug more easily available and that those rules should be rolled back. In practice, nothing changes immediately, because the Supreme Court has blocked the lower court’s order that the drug effectively be removed from the U.S. market — for now.

The case is pivotal for the future of reproductive health, as the pill is part of a regimen that is now the most common way American women terminate early pregnancies and is also widely used by doctors to manage miscarriages.

Meanwhile, as President Joe Biden’s Inflation Reduction Act turns one, Medicare officials are preparing to unveil which 10 drugs will be the first to face price negotiation under the new law.

This week’s panelists are Julie Rovner of KFF Health News, Shefali Luthra of The 19th, Sarah Karlin-Smith of the Pink Sheet, and Alice Miranda Ollstein of Politico.

Panelists

Shefali Luthra
The 19th

@shefalil

Read Shefali's stories

Sarah Karlin-Smith
Pink Sheet

@SarahKarlin

Read Sarah's stories

Alice Miranda Ollstein
Politico

@AliceOllstein

Read Alice's stories

Among the takeaways from this week’s episode:

• Wednesday’s federal appeals court decision siding with conservative medical groups challenging mifepristone regulations has perhaps the biggest implications for the drug’s distribution via telemedicine, which has been key to securing abortion access for people in areas where abortion is unavailable.
• The ongoing legal threat to mifepristone is reverberating through the drug industry, as drugmakers worry challenges to the FDA’s scientific authority could cause serious problems for future drug development — especially in an industry that takes big financial risks on getting products approved.
• Texas is suing Planned Parenthood over past Medicaid payments made to the program, charging that the health organization “defrauded” the state, even though the claims were made while a court had specifically allowed Planned Parenthood to remain in the program. Still, the lawsuit emphasizes just how far Texas has gone, and will go, to maintain the legal authority to not support Planned Parenthood, even in its non-abortion work.
• The federal government is expected to release the list of 10 pharmaceuticals subject to Medicare price negotiations by Sept. 1. The drugs’ identities are the subject of much educated speculation, as Congress laid out in the law how drugs qualify for consideration — though even stakeholders in the drug industry are wondering which specific drugs will be up for discussion.
• A national survey of pharmacists finds drug shortages are widespread and leading to rationing at the pharmacy level. A lack of incentives to produce generic drugs is complicating supply-chain problems, leaving fewer options when there are manufacturing or other types of issues with a particular drugmaker.

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

Julie Rovner: Time’s “She Wasn’t Able to Get an Abortion. Now She’s a Mom. Soon She’ll Start 7th Grade,” by Charlotte Alter.

Sarah Karlin-Smith: MIT Technology Review’s “Microplastics Are Everywhere. What Does That Mean for Our Immune Systems”? by Jessica Hamzelou.

Shefali Luthra: The Atlantic’s “Right Price, Wrong Politics,” by Annie Lowrey.

Alice Miranda Ollstein: Politico’s “We’re on the Cusp of Another Psychedelic Era. But This Time Washington Is Along for the Ride,” by Erin Schumaker and Katherine Ellen Foley.

Also mentioned in this week’s episode:

• States Newsroom/The Georgia Recorder’s “Study Cited by Texas Judge in Abortion-Pill Case Under Investigation,” by Sofia Resnick.
• Stat’s “From Drug Shortages to High Prices, U.S. System’s Shortcomings Have Deep Roots,” by Matthew Herper.

Click to open the transcript

Transcript: Abortion Pill’s Legal Limbo Continues

KFF Health News’ ‘What the Health?’

Episode Title: Abortion Pill’s Legal Limbo Continues

Episode Number: 310

Published: Aug. 17, 2023

Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, Aug. 17, 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: Sarah Karlin-Smith of the Pink Sheet.

Sarah Karlin-Smith: Hi, everybody.

Rovner: And Shefali Luthra of The 19th.

Shefali Luthra: Hello.

Rovner: So, no interview this week but plenty of news, particularly for the middle of August, so we will get right to it. The breaking news this week is about abortion and about a Texas abortion case, because 2023. Technically, this news is out of New Orleans, where on Wednesday a three-judge panel of the 5th Circuit federal Court of Appeals upheld, in part, a lower-court decision from Texas that found that the FDA was wrong to approve the abortion pill mifepristone back in the year 2000. Before we get any further in this discussion, we should point out that this decision does not impact the immediate availability of abortion pills. The Supreme Court earlier this spring issued a stay of the lower-court ruling, meaning nothing will change until the full outcome of the case is determined, presumably by the Supreme Court at some point, probably next year. But, Alice, remind us of what this case was about and then what the decision means.

Ollstein: Yeah. So this case is: A coalition of different anti-abortion medical groups that formed last year, specifically formed in the district that a very conservative judge was in charge of down in Texas, brought the case there. And they are going after both the original FDA approval of mifepristone more than two decades ago and a bunch of decisions the agency has made since then to make the pills easier for patients to obtain, like allowing mail delivery, like allowing their use longer into pregnancy than before — 10 weeks versus seven weeks — allowing nonphysicians to prescribe the pills, a bunch of different things.

Rovner: And allowing for a lower dose of the pill actually.

Ollstein: Yes, yes.

Rovner: Which is going to get significant in a second. Go ahead.

Ollstein: Definitely. We should talk about the labeling chaos that could result from this. But so basically, the lower-court judge went all in, agreed with everything they said, essentially, and more or less ordered a national ban. That got stayed. It remains stayed for now, but the 5th Circuit has now weighed in and endorsed some but not all of those arguments. They said, look, the statute of limitations has passed us by on challenging the original FDA approval of the drugs, but they sided with the groups in ordering FDA to get rid of all of those other subsequent decisions. And so this, if upheld by the Supreme Court — we know the Biden administration is already planning to appeal — would really put the pills out of reach for a lot of people. So, it would be a sharp curtailment, but not the total ban the groups were seeking.

Rovner: Yeah, Shefali, and this was obviously what the appeals court had been leaning towards anyway. We know that because that was what they had done before the Supreme Court overruled it. And certainly we know that Justice [Samuel] Alito and I believe Justice [Clarence] Thomas would also do this. So, there’s every reason to believe that this could well be the final outcome. What would it mean? So, the pill would still be approved, but only in the form it was allowed to be distributed before 2016?

Luthra: Precisely, which would be quite significant. You mentioned, right, the need to relabel pills based on the different formulation. We would have pills technically only approved up until seven weeks of pregnancy, although doctors could prescribe them off-label, through 12 weeks in all likelihood. But the telemedicine implications are probably some of the biggest, especially in states where they’ve seen large numbers of out-of-state patients coming for abortion care, right, because they’re near states with bans. Those clinics have really relied on telemedicine because it means they can see more people, and it’s quite safe, right? It’s endorsed by the World Health Organization. You don’t need someone to come in for two, in some cases three visits to get a couple of pills and take them at home. And to lose that would really just cut capacity and make abortions, which are already very difficult to obtain, even in states where it’s legal but there just aren’t as many clinics — like a Kansas, a New Mexico, etc. — if not impossible, very nearly so, just because the math doesn’t work in terms of providers versus patients in need.

Rovner: And the piece of this that I really don’t understand, and I read through the entire decision yesterday afternoon, was they said that the plaintiffs in the case cannot challenge the approval of the generic version of the drug, which was approved in 2019. But of course, the generic version of the drug was approved under the then-rules that that are now going to be rolled back. So you would — would you have a case for the brand name and the generic would have different labeling requirements? It seems very confusing.

Luthra: I think there are a lot of questions that are still open about what this means, right, not only for mifepristone but just for the precedents of FDA approval of medications at large, especially as we’ve seen so many more FDA-approved drugs become more politicized. And, I mean, that’s one of the reasons that so many medical groups have expressed deep concern about this case. It just opens a tremendous can of worms looking well beyond abortion and puts us in pretty uncharted territory for what comes next.

Rovner: And the drug industry is kind of freaked out. Sarah, I guess you could talk to this. I mean, the reliability of FDA approval is now called into question if anybody can basically go to court and say, “Nope, FDA, you shouldn’t have done that,” and possibly win, right?

Karlin-Smith: Right. I mean, they don’t want the scientific sort of authority of the FDA questioned. And I think, you know, like a lot of hot-button political issues where there’s maybe not a good side for them to be on, the pharmaceutical companies tend to try and stay out of abortion politics as much as they can. But some executives and so forth did join amicus briefs in this case because they are concerned about the precedent of FDA approval decisions being able to be challenged in court. And if nothing else, I think drug companies really, and any business to an extent, relies on, like, certainty. And so just having the loss of that certainty that an FDA decision really means, what it means is problematic for them. But I think also these are companies that sort of are based in science and medicine and would definitely prefer to have the assurance that those are the people that approved their drugs and kind of give that seal of approval and it means what it says.

Rovner: Yeah, and the drug industry, I think more than many others, which depends on long shots a lot. I mean, there’s just a lot of dry holes in the drug industry; you spent a lot of time and a lot of money on a drug that ends up not going anywhere. So if you spend a lot of time and a lot of money on a drug that does what it’s supposed to do and gets approved, I think that that could certainly dampen the enthusiasm if then a court could come and say, “Oops, nope.”

Karlin-Smith: And the reputation we talk a lot about, like drug pricing, on this show — the reputation of the FDA and the perceived quality and trustworthiness of its decisions is kind of why the drug companies can charge, to some degree, the prices they charge for their medicines versus, say, you know, we compare it to the supplement industry, which is very loosely regulated, and their claims are not really backed up in the same way by science and medicine. And you can buy those for much cheaper at the store. So their whole business model is really threatened by this.

Rovner: Yeah.

Ollstein: And I think it’s worth noting that one of the three judges on the panel wanted to go further and fully strip FDA approval from the drug, but he was overruled by his other two colleagues. But still, he wrote that dissenting opinion. And that could come into play if and when the Supreme Court takes this up.

Rovner: And he, of course, raised the specter of the Comstock Act, that 1800s-era anti-vice law that apparently some anti-abortion groups are hoping to sort of bring back into the 21st century — Are we in the 22nd century? I’m losing track — and try to figure out if you can just make all of this illegal.

Ollstein: Yes. Judge [James] Ho, who was appointed by [then-President Donald] Trump to the 5th Circuit, and his opinion went a lot further than his colleagues’ in embracing the arguments made by the challengers. So how much influence that has on the process going forward will be really interesting. You know, the Comstock Act has to do with things sent through the mail, and the concern from a lot of legal experts and medical groups is that the interpretation that Judge Ho and these groups are making could mean that sending anything that could potentially be used for an abortion, even if it’s medical equipment that’s also used for other things, could be in jeopardy. And this would be mail delivery. Even sending something to a state where abortion is protected by law could be challenged under this federal rule. And so, we’re definitely in a “throw things at the wall and see what sticks” kind of era. And this is one of the things they’re throwing at the wall.

Rovner: Yeah, just because nothing changes for now doesn’t mean that nothing is going to change. And we will obviously keep a very close eye on this. So last week we talked about a controversy surrounding one of the scientific studies that [District] Judge [Matthew] Kacsmaryk, the lower-court judge, relied on in his ruling. The study was by the Charlotte Lozier Institute. It found that women who had medical abortions were more likely to go to a hospital emergency room within 30 days than women who had surgical procedures. And we talked about how that paper is currently under review by the publisher of the journal the paper appeared in. During the discussion, I apparently misspoke about the paper’s findings, suggesting that it was just the raw number of ER visits that rose along with increased use of medication abortion rather than the rate of the visits. But nonetheless, this study is very much an outlier in three decades of research into the safety of the drug. And I say three decades because it was available in Europe many years before it was available in the United States. And the drug has otherwise been found to have very few serious complications, right?

Luthra: Right. I think you’re absolutely correct, Julie. The study remains an outlier. There remain serious methodological questions about how it came to its findings. And we have an incredibly rich body of research that continues to grow, that shows exactly what you said, which is that the complication rate for medication abortions remains incredibly low. Most people do not require follow-up medical care, especially not in an emergency room. And the reliance on that study in particular was quite striking because of what an outlier it is in the larger medical body of research.

Rovner: And it didn’t actually come up in the appeals court ruling, although they did say, and fair point, they acknowledged that the complication, the serious complication rate, is very low. But if it’s being used by a lot of people and we now know that medication abortion is more than half of all abortions, a very small percentage of a whole lot of people is still a fair number of people. Whether that is enough people to actually create the kind of havoc in emergency rooms that’s been suggested is a different question. But I think that the appeals court justices were fairly careful in the way they worded that. So the mifepristone ruling was not the only news this week about a Texas abortion case. Another Texas abortion case in front of Judge Kacsmaryk in fact: He held a hearing earlier this week in a case brought by the state of Texas to require Planned Parenthood to pay back more than a billion dollars in Medicaid reimbursements, not for abortions, but for family planning and other medical services covered by Medicaid. This one is a weird case even by Texas standards, right?

Ollstein: Yeah, and I’ll say that they’re suing them for more than a billion dollars, but they were only paid by Medicaid in the lower millions. You know, 17-ish million is what Planned Parenthood told me. So, the 1.8 billion is for penalties and damages. They’re accusing them of defrauding the state. So, there has been a many-years’ fight over Planned Parenthood’s participation in Medicaid in Texas specifically, also in other states. Planned Parenthood says that, you know, because lower courts for years blocked the state’s attempt to kick them out of Medicaid, they were perfectly allowed to continue providing nonabortion services, like contraception, tests, whatever, and be reimbursed for that. And the state coming back later and saying that they knowingly defrauded the Medicaid program, they see it as a political attack on them and their ability to keep providing services in the state.

Rovner: There was a court stay on Texas’ desire to kick them out of the Medicaid program, right, so at least at the time it was legal for them to bill Medicaid, and Texas paid the Medicaid claims that they billed, right?

Luthra: I think it’s also helpful to situate this in just a really long history of Texas doing whatever it can to get Planned Parenthood away from government dollars, including turning down millions in federal funding, starting their own state health program for reproductive health, just so that they could have the legal authority to not include Planned Parenthood. This is not really new, but it just is so striking because of the money at stake, because of sort of the tactics, and because of the implications in a world where Planned Parenthood isn’t even providing abortions in Texas anymore.

Rovner: This goes back probably before some of you guys were born, the efforts to sort of defund Planned Parenthood from state and federal dollars, even in states where Planned Parenthood never provided abortions. And there are a number of states where they never provided abortions. But there is a line in the Medicaid statute itself about free choice of providers for patients, and that’s what has been relied on. Lower courts have relied on that for years and years. Congress tried to change it and couldn’t. Texas is actually, I think, the first state that’s ever successfully gotten a court ruling that said they can cut Planned Parenthood out of their Medicaid program. So, it was not odd for Planned Parenthood, while this litigation was going on, to say, “We’re just going to continue to provide women who come to us with family planning and other health care services that we’ve been providing under Medicaid for generations.” But now we’ll see what Judge Kacsmaryk has to say. And then I imagine this will get appealed and we will see where this one ends up, too. Well, finally this week in reproductive health, the American College of Obstetricians and Gynecologists announced the introduction of an online abortion training program, which has been a year in the making, that will give all OB-GYN residents, even in states with abortion bans, access to at least the basics in abortion care and in caring for early pregnancy loss, which is all often the same care. But I have to wonder whether this is going to make students any more willing to do their residencies in states that effectively restrict the rights to practice medicine according to evidence-based standards. I know we’ve talked about this before, but we’re looking at what could be a serious shortage of just women’s reproductive health care in general in abortion ban states, right, if the supply of students wanting to go there to do their residencies and hence stay on afterwards is going to start to dry up?

Ollstein: I mean, it’s already happening for sure. Applications are going down in these ban states. And, you know, when I saw the online curriculum, that’s better than nothing. But all the medical students and residents I’ve spoken to really stress that, in order to be trained and, for some specialties, board-certified, you need practical experience; you need to personally participate in many, many, many abortions to be fully qualified as a physician. And they really stress that the more you do, the more different complications you’re able to observe. And if you only do a few or none and just do online curriculum, you’re not going to be really prepared for a miscarriage situation or any of the many things that could come up in the future. And these could be life-or-death moments. And so to not have people trained and ready to respond in certain states where it’s already hard to recruit people because of, you know, it’s just seen as a less desirable place to be, this is yet another factor. On top of that, you have state attorneys general who have been very litigious and threatening to providers. And so, I’m hearing that that fear is making people not want to practice in particular states.

Luthra: And I think another factor that we don’t often sort of say out loud, but that’s really relevant when it comes to OB-GYNs in training, is that the majority of OB-GYNs are women. And given the age of when people finish medical school, etc., many of them are pursuing residency when they’re at a stage in their life where they might consider getting pregnant, which means that the risks are not just professional or educational; in many cases they are quite personal, and that’s a factor that many people are considering as well.

Rovner: And even the male OB-GYNs in training, many of them are married to women and, again, same age, thinking about, it’s time to start a family. Also, it’s not just the residents themselves, but the residents’ families. I’ve seen that sort of from both sides. We should point out, I mean, there are training programs now and they’re obviously — you know, it’s only been a year, so it’s hard to sort of create these things out of whole cloth — but where residents can travel to other states to get some hands-on experience and training that they want. But again, one of the things we forget sometimes about residents is they don’t earn a lot of money and it’s a disruption. I mean, it’s hard enough to move to a place to do your residency; to then have to sort of pick up and move someplace else for a couple of months to do a rotation is not terribly convenient either. So this is obviously still all being sorted out. But the education of sort of the next generation of reproductive health providers is definitely under question here, right?

Ollstein: And it’s not just the time needed; it’s often the money, because if these people are doing their residency at a public university hospital in a ban state, that public university hospital, under the state law, is afraid to give any money to support them going to another state for training. And so often people either have to apply for grants from foundations to cover that expense or even pay out of their own pockets. So, it’s a real heavy lift.

Rovner: It is. Well, in other news, and there is other news this week, President [Joe] Biden is taking a victory lap as the Inflation Reduction Act, that omnibus health-slash-energy-slash-tax bill, turns 1. But the fate of the highest-profile health policy in that law, calling for Medicare to negotiate the prices of some very expensive drugs, is still in some doubt, as drugmakers sue to try to block the program. Sarah, where is this, and when do we expect to get that list of the first 10 drugs the government wants to negotiate the price of? That’s due soon, right?

Karlin-Smith: Right. So the list is due by Sept. 1 at the latest. So that is a week, I think, from this Friday, or no, a little bit longer than that. But the expectation, I think, is we may get it before Sept. 1, because that’s the Friday before Labor Day weekend.

Rovner: Oh, I don’t know. They love to drop stuff the Friday before Labor Day.

Karlin-Smith: Sometimes they do, and sometimes they also want to take a break too. So, we’re expecting that list of 10 drugs, which would be — their negotiated prices would go into effect in 2026. There’s lots of reasonably well-educated guesses of what those drugs are, because the law sort of lays out how they select them and we have a general sense of how much money is spent on certain drugs in the U.S. and so forth. But Medicare has the most up-to-date data. So, there are still companies that kind of have a sense of, “Oh, I might be on the edge,” depending on how their sales have been in Medicare the past few years. So, people are really curious.

Rovner: Coincidentally or not so coincidentally, I’ve seen some of the speculation, and it is all of the drugs that you see all of those ads for, if you watch, if you still watch, you know, commercial television, on the news or on cable TV. I mean, there are so many ads, and it’s like, surprise, these are all the drugs that are on the likely list that Medicare is going to want to do something about the price of. I assume that is not a coincidence. I’m being snide.

Karlin-Smith: I think some of it is, right, to qualify for the list, you have to be in sort of the top spending categories. And part of that means you’re most likely to have to treat large populations of people. So when you get to drugs like that, like anticoagulants — I think there’s a few expected to be up there — blood thinners, some anti-diabetic medicines, trying to think of some of the other examples. These are kind of mass-market drugs that a lot of people, particularly in the Medicare population, need these medicines. Some cancer medicines, anti-inflammatory drugs. So, it’s not particularly surprising that you would see advertisements for them. And in a lot of cases, too, these are drugs that have some amount of brand competition for them. So, there are two newer blood thinners that might be on there. So, you know, that tends to lead to advertisement when there’s competition in a space. Same for the diabetes medicines and the anti-inflammatories; there’s a lot of expensive biologics in that space that compete.

Rovner: Well, when I’m in charge of the FDA, they’re not going to be able to use, like, songs from the ’60s and ’70s anymore, because that just makes me crazy. Well, meanwhile, in something related to this, drug shortages seem to be getting worse. There’s a new survey from the American Society of Health-System Pharmacists that found that 99% of the 1,100 hospital pharmacists that responded said they were currently managing drug shortages, and one-third said those shortages are forcing them to ration, delay, or cancel treatment. And these aren’t minor drugs. They include cancer chemotherapies, anesthesia drugs, other things that can be difficult to get but important when you need them. Sarah, is this a manufacturing problem, or a marketing problem, or both? I mean, why are drug shortages so much worse now? It’s not all supply chain, is it?

Karlin-Smith: There’s some supply chain, and I think there’s still some supply chain issues that started during covid that are still impacting people. There are manufacturing concerns, depending on the company. You know, drug shortages have gotten a lot of attention recently, but really for probably the past decade or so that I’ve been covering the drug industry and following shortages, the reasons have tended to be the same: They tend to be older, sterile, injectable drugs that are harder to make. But yet, because they have gone generic, the prices have gone down so low that players tend to leave. So only a few players stay in the market because of the pricing situation. So then if they have any manufacturing problem, it can very easily lead to a shortage. Generic companies argue that, you know, there’s just not a lot of incentive for them to invest in redundancy or certain even manufacturing capabilities that might help prevent shortages. So, for better or worse, there really hasn’t been a lot of change in the reasons for these shortages over the years; it’s just that they keep happening.

Rovner: Yeah, well, it’s funny. Matthew Herper over at Stat News has kind of a provocative piece about all of this, suggesting, as you say, that the shortages right now are, in large part, due to the incentives to find the cheapest generics, but that this new Medicare negotiation process — which includes a different clock; it will be based on time on the market rather than time under patent — could encourage drugmakers to do the opposite thing, to sit on new drugs until they can test for all possible uses because they don’t want to bring them to market until they think they can make the most money, because that’s going to determine how long before there can be competition. I mean, is this ever really going to work, being a purely capitalist market?

Karlin-Smith: I mean, there are definitely people, you know, in the shortage space that have argued that some of the current shortages make a good case for public manufacturing of drugs. And actually, it might surprise some people, but the U.S. has engaged in the past in public manufacturing. There are some efforts going on now, like in California; they’re looking into some public manufacturing. So that’s on the generic side. On some of the other situations that Matthew Herper is describing with the IRA, it’s a bit more complicated because essentially the IRA does give companies some amount of time on the market without negotiation. But a lot of drugs, they have all these multiple indications. And so companies are just trying to figure out potentially how they can game their products to make the most amount of money before they’re subject to negotiation. And I know Medicare is quite aware of some of this stuff and is thinking about how they can set up their regulations to protect against that. But not everything is within their control. So we’ll see what happens, because there is concern, you know, particularly I think in the orphan or rare disease space, that a company may delay getting a rare disease indication based on when they think they might get subject to drug negotiations.

Rovner: Every time you think, Oh, they can just lower the price of drugs, it’s super, super complicated. All right. Well, finally this week, there’s something I’ve been trying to get to for a couple of weeks: Before Congress left for the August recess, it passed, on a bipartisan vote, a bill that could finally dethrone UNOS, the United Network for Organ Sharing. UNOS has been the outside organization handling the collection and distribution of human organs for transplant since the federal government began the federal transplant program in 1984. Over the years, UNOS has been roundly criticized for its handling, or mishandling, of the system. But the legislation that originally created the federal organ transplant program had been interpreted not to allow anyone else to compete for the contract to run the network. So, this legislation changes that, for the first time letting other entities see if they can do a better job so maybe fewer people will die waiting for transplanted organs. This feels a lot more important than the attention that it got, I think because there was so much else happening as Congress was leaving town. Or does it feel important to me because I spent so many years and so many hours watching Congress fight over this?

Karlin-Smith: I think it is important. There’s certainly been a lot of big exposés of problems in the system over the years. And there’s also been a lot of, when I’ve covered this more closely in the past, like, tensions between different parts of the country in sort of figuring out how organs are allocated and which parts of regions get impacted or not. So there has always been, like, political dynamics here. I think the underlying thing to watch with this overhaul is that part of what goes on here is we just don’t have enough organs for the number of people that need it. So, you can certainly make improvements and make sure that all the organs we have get to people and get done in the fairest way possible, because there have been lots of concerns around equity issues, particularly that Black people and other people of different ethnicities have not been, you know, getting the organs they deserve. But the question becomes, you know, can anybody do anything about a shortage of organs, and how do you really handle that? I think there’s always going to be tensions on this topic if you don’t have enough organs.

Rovner: Yeah, these were the ultimate formula fights, if you will. You know, it’s usually over money. In the ’90s and early 2000s, it was literally over organs, over, you know, how far you could ship donated organs and whether the large transplant centers should keep more because they do more organ transplants and therefore are more likely to have success. And boy, this fight has been going on for a very long time, but this is at least a step, I think, towards resolving it. All right. Well, that is this week’s news. We will take a quick break and then we will come back and do our extra credit. Hey, “What the Health?” listeners, you already know that few things in health care are ever simple. So, if you like our show, I recommend you also listen to “Tradeoffs,” a podcast that goes even deeper into our costly, complicated, and often counterintuitive health care system, hosted by longtime health care journalist and friend Dan Gorenstein. “Tradeoffs” digs into the evidence and research data behind health care policies and tells the stories of real people impacted by decisions made in C-suites, doctor’s offices, and even Congress. You can subscribe to “Tradeoffs” wherever you get your podcasts. OK, we are back and it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it; we will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Shefali, why don’t you go first this week?

Luthra: My piece is from The Atlantic, by Annie Lowrey. The headline is “Right Price, Wrong Politics.” It is incredibly smart. It is about how there is all this conversation about people wanting to move to states where they have access to health care protected, whether that is abortion or gender-affirming care, etc., etc. There is one problem, which is that those states are largely ones where it is much more expensive to live, because of housing prices. And if you want to live in a place where you can afford a home, those are often the states with restrictions on health care. I love this piece. I think there is so much conversation about, Why don’t people simply move to a place where state laws reflect what they would like? And the answer is it’s really not attainable for most people. And I think she does a great job of explaining why that is and putting it in the context of policy choices and not just sort of individual human elements.

Rovner: I was super jealous of this piece. It was like, Oh, yeah, of course. Alice.

Ollstein: I chose a piece by a couple of my colleagues, and it’s called “We’re on the Cusp of Another Psychedelic Era. But This Time Washington Is Along for the Ride.” And it’s about how much bipartisan support there is in Congress right now for making psychedelics more available as medicine to treat things like PTSD [post-traumatic stress disorder] or depression. There are just a lot more clinical trials going on right now and just support for making them available through the VA [Department of Veterans Affairs] as sort of a test of how a broader population might respond. You know, we’re talking about things like psilocybin, things like ketamine, things like ecstasy, that have shown a lot of promise in having a therapeutic benefit for mental health conditions that have resisted other forms of treatment. So, fascinating stuff.

Rovner: It is. Sarah.

Karlin-Smith: I took a look at a piece in MIT Tech Review called “Microplastics Are Everywhere. What Does That Mean for Our Immune Systems?” And it just does a good job of helping you understand what the research has shown about how these very tiny particles may impact your immune cells and then impact our ability to fight off diseases and maybe even lead to more challenges with antibiotics and antibiotic resistance. And I’ve been fascinated by all the coverage of this, because this — huge problem and, you know, they talk about them being in our air and in the deepest part of the ocean. And, you know, it’s just one of those things that we have to kind of grapple with as a society, like health, economic consequences, and so forth. So, it’s worth looking at.

Rovner: More things to keep us awake at night.

Karlin-Smith: Exactly.

Karlin-Smith: A list of more things to keep us awake at night. My story this week is one of the most talked about on social media. It’s from Time, and it’s called “She Wasn’t Able to Get an Abortion. Now She’s a Mom. Soon She’ll Start 7th Grade,” by Charlotte Alter. And as the headline indicates, it’s kind of a gutting piece about a 12-year-old in Mississippi who was raped in her own yard, was too scared to tell anyone, and ended up having a baby at age 13. It’s another story about all those things that are, quote, “made up,” or not supposed to happen. Except they did. She might have been eligible for a rape exception, except there are no abortion providers left in the state, and her mother didn’t know that rape exceptions were a possibility. In the end, the closest place for her to have gotten an abortion was Chicago, which was too far and too expensive for her family. So now she has a son while she’s going to middle school. I’m sure we will see more of these as time progresses. All right. That is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks, as always, to our amazing engineer, Francis Ying. And as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me or X me or whatever. I’m still there, @jrovner, also on Bluesky and Threads. Shefali?

Luthra: I’m @shefalil.

Rovner: Alice.

Ollstein: @AliceOllstein.

Rovner: Sarah.

Karlin-Smith: I’m @SarahKarlin or @sarahkarlin-smith.

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 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.

Ohio voters — in a rare August election — turned out in unexpectedly high numbers to defeat a ballot measure that would have made it harder to pass an abortion-rights constitutional amendment on the ballot in November. The election was almost a year to the day after Kansas voters also stunned observers by supporting abortion rights in a ballot measure.

Meanwhile, the percentage of Americans without health insurance dropped to an all-time low of 7.7% in early 2023, reported the Department of Health and Human Services. But that’s not likely to continue, as states boot from the Medicaid program millions of people who received coverage under special eligibility rules during the pandemic.

This week’s panelists are Julie Rovner of KFF Health News, Emmarie Huetteman of KFF Health News, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, and Rachel Roubein of The Washington Post.

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Emmarie Huetteman
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Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico

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Rachel Roubein
The Washington Post

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Read Rachel's stories

Among the takeaways from this week’s episode:

• It should not have come as much of a surprise that Ohio voters sided with abortion-rights advocates. Abortion rights so far have prevailed in every state that has considered a related ballot measure since the Supreme Court overturned Roe v. Wade, including in politically conservative states like Kentucky and Montana.
• Moderate Republicans and independents joined Democrats in defeating the Ohio ballot question. Opponents of the measure — which would have increased the threshold of votes needed to approve state constitutional amendments to 60% from a simple majority — had not only cited its ramifications for the upcoming vote on statewide abortion access, but also for other issues, like raising the minimum wage.
• A Texas case about exceptions under the state’s abortion ban awaits the input of the state’s Supreme Court. But the painful personal experiences shared by the plaintiffs — notable in part because such private stories were once scarce in public discourse — pressed abortion opponents to address the consequences for women, not fetuses.
• The uninsured rate hit a record low earlier this year, a milestone that has since been washed away by states’ efforts to strip newly ineligible Medicaid beneficiaries from their rolls as the covid-19 public health emergency ended.
• The promise of diabetes drugs to assist in weight loss has attracted plenty of attention, yet with their high price tags and coverage issues, one thorny obstacle to access remains: How could we, individually and as a society, afford this?
• Lawmakers are asking more questions about the nature of nonprofit, or tax-exempt, hospitals and the care they provide to their communities. But they still face an uphill battle in challenging the powerful hospital industry.

Also this week, Rovner interviews Kate McEvoy, executive director of the National Association of Medicaid Directors, about how the “Medicaid unwinding” is going as millions have their eligibility for coverage rechecked.

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

Julie Rovner: KFF Health News’ “How the Texas Trial Changed the Story of Abortion Rights in America,” by Sarah Varney.

Joanne Kenen: Fox News’ “Male Health Care Leaders Complete ‘Simulated Breastfeeding Challenge’ at Texas Hospital: ‘Huge Eye-Opener’,” by Melissa Rudy.

Rachel Roubein: Stat’s “From Windows to Wall Art, Hospitals Use Virtual Reality to Design More Inclusive Rooms for Kids,” by Mohana Ravindranath.

Emmarie Huetteman: KFF Health News’ “The NIH Ices a Research Project. Is It Self-Censorship?” by Darius Tahir.

Also mentioned in this week’s episode:

• Politico’s “Abortion Rights Won Big in Ohio. Here’s Why It Wasn’t Particularly Close,” by Madison Fernandez, Alice Miranda Ollstein, and Zach Montellaro.
• KFF Health News’ “Seeking Medicare Coverage for Weight Loss Drugs, Pharma Giant Courts Black Influencers,” by Rachana Pradhan.
• Stat’s “Alarmed by Popularity of Ozempic and Wegovy, Insurers Wage Multi-Front Battle,” by Elaine Chen.

click to open the transcript

Transcript: On Abortion Rights, Ohio Is the New Kansas

KFF Health News’ ‘What the Health?’Episode Title: On Abortion Rights, Ohio Is the New KansasEpisode Number: 309Published: Aug. 10, 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 for KFF Health News, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping a day early this week, on Wednesday, Aug. 9, at 3:30 p.m. As always, news happens fast, and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico.

Joanne Kenen: Hey, everybody.

Rovner: Rachel Roubein of The Washington Post.

Rachel Roubein: Hi, everybody.

Rovner: And my colleague and editor here at KFF Health News Emmarie Huetteman.

Emmarie Huetteman: Hey, everyone. Glad to be here.

Rovner: So later in this episode, we’ll have my interview with Kate McEvoy, executive director of the National Association of Medicaid Directors. She’s got her pulse on how that big post-public health emergency “Medicaid unwinding” is going. And she’ll share some of that with us. But first, this week’s news. I guess the biggest news of the week is out of Ohio, which, in almost a rerun of what happened in Kansas almost exactly a year ago, voters soundly defeated a ballot issue that would have made it harder for other voters this fall to reverse the legislature’s strict abortion ban. If you’re having trouble following that, so did they in Ohio. [laughs] This time, the fact that the abortion rights side won wasn’t as much of a surprise because every statewide abortion ballot question has gone for the abortion rights side since Roe v. Wade was overturned last year. What do we take away from Ohio? Other than it looked a lot like … the split looked a lot like Kansas. It was almost 60-40.

Kenen: It shows that there’s a coalition around this issue that is bigger than Democrat or Republican. Ohio was the classic swing state that has turned into a conservative Republican-voting state — not on this issue. This was clearly independents, moderate Republicans joined Democrats to … 60-40, roughly, is a pretty big win. Yes, we’ve seen it in other states. It’s still a pretty big win.

Roubein: I agree. And I think one of my colleagues, Patrick Marley, and I spent some time just driving around and traveling Ohio in July. And one of the things that we did find is that — this ballot measure to increase the threshold for constitutional amendments is 60% — it had in some, in many, ways turned into a proxy war over abortion. But, in some ways, both sides also didn’t talk about abortion when they were, you know, canvassing different voters. You know, they use different tools in the toolbox. I was following around someone from Ohio Right to Life and, you know, he very much said, “Abortion is the major issue to me.” But, you know, they tried to kind of bring together the side that supported this. Other issues like legalizing marijuana and raising the minimum wage, and, you know, the abortion rights side was very much a part of, you know, the opposition here. But when some canvassers went out — my colleague Patrick had traveled and followed some, and some, you know, kind of focused on other issues like, you know, voters having a voice in policy and keeping a simple majority rule.

Rovner: Yeah, I think it’s important — for those who have not been following this as closely as we have — what the ballot measure was was to make future ballot measures — and they said they were not going to have them in August anymore, which, this was the last one — in order to amend the constitution by referendum, you would need a 60% majority rather than a 50% majority. And just coincidentally, there is an abortion ballot measure on Ohio’s ballot for November, and it’s polling at about 58%. But, yes, this would have applied to everything, and it was defeated.

Kenen: And it’s part of a larger trend. It began before the overturning of Roe v. Wade. Over the last couple of years, you’ve seen conservative states move to tighten these rules for ballot initiatives. And that’s because more liberal positions have been winning. I mean, Medicaid, the Medicaid expansion on the ballot, has won, and won big. Only one was even close …

Rovner: In very red states!

Kenen: They often won very big in a number of very, very conservative states, places like Idaho and Nebraska. So, you know, there’s always been … the conventional wisdom is that, you know, the political parties are more extreme than many voters, that the Democratic Party is for the left and the Republican Party is for the right. And there are a lot of people who identify with one party or the other but aren’t … who are more moderate or, in this case, more liberal on Medicaid. And Medicaid … what was it, seven states? I think it’s seven. Seven really conservative states. And then the abortion has won in every single state. And there’s a little bit of conversation and it’s … very early. And I don’t know if it’s going to go anywhere, but if I’ve heard it and written a bit about it, conservative lawmakers have heard about it, too, which is there are groups interested in trying to get some gun safety initiatives on ballots. So that’s complicated. And it may not happen. But they’re seeing, I mean, that’s the classic example of both a criminal justice and a public health issue — so we can talk about it — a classic example where the country is much more in the center.

Rovner: Well, let us move to Texas, because that’s where we always end up when we talk about abortion. You may remember that lawsuit where several women who nearly died from pregnancy complications sued the state to clarify when medical personnel are able to intercede without being subjected to fines and/or jail sentences. Well, the women won, at least for a couple of days. A Texas district judge who heard the case ruled in their favor, temporarily blocking the Texas ban for women with pregnancy complications. But then the state appealed, and a Texas appeals court blocked the lower-court judge’s blocking of part of the ban. If you didn’t follow that, it just means that legally nothing has changed in Texas. And now the case goes to the Texas Supreme Court, which has a conservative majority. So we pretty much know what’s going to happen. But whether these women ultimately win or lose their case may not be the most important thing. And, to explain why I’m going to do my extra credit early this week. It’s by my KFF Health News colleague Sarah Varney. It’s called “How the Texas Trial Changed the Story of Abortion Rights in America.” She writes that this trial was particularly significant because it put abortion foes on the defensive by graphically depicting harm to women of abortion bans — rather than to fetuses. And it’s also about the power of people publicly telling their stories. I’ve done a lot of stories over the years about women whose very wanted pregnancies went very wrong, very late. And, I have to tell you, it’s been hard to find these women. And when you find them, it’s been really hard to get them to talk to a journalist. So, the fact that we’re seeing more and more people actually come out publicly, you know, may do for this issue what, you know, perhaps what gay rights, you know, what people coming out as gay did for gay marriage? I don’t know. What do you guys think?

Kenen: Well, I think these stories have been really compelling, but they’re also, they’re the most dramatic and maybe easiest to push back. But it’s, you know, there’s a whole lot of other reasons women want abortions. And the focus — and it’s life and death, so the focus, quite rightfully, has to be on these really extreme cases. But that’s not … it’s still in some ways shifting attention from the larger political discussion about choice and rights. But, clearly, some of these states, we’ve seen so many stories of women who, their lives are at stake, their doctors know it, and they just don’t think they have the legal power; they’re afraid of the consequences if they’re second-guessed. There are tremendous financial and imprisonment [risks] for a doctor who is deemed to have done an unnecessary abortion. And this idea that’s taken hold … among some conservatives is that there’s never a need for a medical abortion. And that’s just not true.

Rovner: And yet, I mean, what this trial and a lot of things in Sarah’s piece too point out is that that line between miscarriage and abortion is really kind of fuzzy in a lot of cases. You know, if you go to the hospital with a miscarriage and they’re going to say, “Well, did you initiate this miscarriage?” And we’ve seen women thrown in jail before for losing pregnancies, with them saying, “You know, you threw yourself down the stairs to end this pregnancy.” That actually happened, I think it was in Indiana. So this is —

Kenen: And miscarriage is very common.

Rovner: That was what I was saying.

Kenen: Early miscarriage is very common. Very, very common.

Huetteman: One of the things that’s so striking about the past year, since Dobbs overturned Roe v. Wade ,is that we’ve seen this kind of national education about what pregnancy is and how dangerous it can be and how care needs to really be flexible to meet those sorts of challenges. And this actually got me thinking about something that another familiar voice on this podcast, Alice Miranda Ollstein, and some colleagues wrote this morning about the Ohio outcome, which is they pointed out that the anti-abortion movement really hasn’t evolved in terms of the arguments that they’re making in the past year about why abortion should continue to be less and less available. Meanwhile, we’ve got these, like, really incredible, really emotional, moving stories from women who have experienced this firsthand. And that’s a hard message to overcome when you’re trying to reach voters in particular.

Rovner: And it’s interesting; both sides like to take — you know, they all go to the hardest cases. So, for years and years, the anti-abortion side has, you know, has gone to the hardest cases. And that’s why they talk about abortion in the ninth month up till birth, which isn’t a thing, but they talk about it. And you know, now the abortion rights side has some hard cases now that abortions are harder to get. Well, while we are on the subject of Texas lawsuits, States Newsroom — and thank you for sending this my way, Joanne — has a story reporting that the publisher of the scientific paper that both the lower court judge and the appeals court judges used to conclude that the abortion drug mifepristone causes frequent complications — it does not — is being reviewed for potential scientific misconduct. The paper comes from the Charlotte Lozier Institute, which is the research arm of the anti-abortion group the Susan B. Anthony List. Sage, which is the publisher of the journal that the paper appeared in, has posted something called an expression of concern, saying that the publisher and editor, quote, “were alerted to potential issues regarding the representation of data in the article and author conflicts of interest. SAGE has contacted the authors of this article and an investigation is underway.” This was sort of a whistleblower by a pharmacist who looked at the way the data in this paper was put together and says, “No, that’s really very misleading.” I don’t think I’ve ever seen this, though; I’ve never seen a scientific paper that’s now being questioned for its political bent, a peer-reviewed scientific paper. I mean, this could change a lot of things, couldn’t it?

Kenen: Well, not if people decide that they still think it’s true. I mean, look at — you know, the vaccine autism paper was retracted. That wasn’t initially political. It’s become more political over the years; it wasn’t political at the time. That was retracted. And people have been jumping up and down screaming, “It was retracted! It was retracted!” And, you know, millions of people still believe it. So, I mean, legally, I’m not sure how much it changes. I mean, I thought we had all heard that there were flaws in this study. This article was good because I hadn’t been aware of how deeply flawed and in all the many ways it was flawed. And also the whistleblower yarn was interesting. I’m not sure how much it changes anything.

Rovner: Well, I’m thinking not in terms of this case. And by the way, I think we didn’t say this, that the study was of emergency room visits by women who’d had either surgical or medical abortions. And the contention was that medical abortions were more dangerous than surgical abortions because more women ended up in the emergency room. But as several people have pointed out, more people ended up in the emergency room after medical abortions because there have been so many more medical abortions over the years. I mean, you don’t actually have to be a data scientist to see some of the problems.

Kenen: Right. And some of them also weren’t that — really, were nervous, and they didn’t know what was normal and they went to the ER because they were scared and they really were safe. They were not — they didn’t need — you know, they just weren’t sure how much pain and discomfort or bleeding you’re supposed to have. And they went and they were reassured and were sent home. So it’s not even that they really had a medical emergency or that they were harmed.

Rovner: Or that they had a complication.

Kenen: Right. There were many flaws pointed out with this research.

Rovner: But my broader question is, I mean, if people are going to start questioning the politics of scientific papers, I mean, I could see the other side going after this.

Kenen: Well, there’s climate science, too, that’s bad. I mean, I don’t think this is actually unique. I think it’s egregious. But there were studies minimizing the risk of smoking, which was also a political business, commercial. Climate is certainly political. I mean, I think this is sort of the most politicized and most acute example, but I don’t think it’s the only one.

Roubein: And I think, Julie, as you’d mentioned, I think when [U.S. District Judge] Matthew Kacsmaryk in Texas came down with his decision — you know, for instance, there are media outlets — that my colleagues at the Post did a story just kind of unpacking some of the kind of flaws and some of the studies that were used to make, you know, a court decision.

Rovner: Yeah, to give the judge what he assumes to be evidence that this is a dangerous drug. So it’s — yeah.

Kenen: Which he came in believing, we know, from the profiles of him and his background.

Rovner: Right. All right, well, let us move on. The official Census Bureau estimate of how many people lack health insurance won’t be out until next month. But the Department of Health and Human Services is out with a report based on that other big federal population survey that shows the uninsured rate early this year was at its lowest level since records started being kept, which I think was in the 1980s: 7.7%. Now, that’s clearly going to be the high point for the fewest number of people uninsured, at least for a while, because clearly not all of the millions of people who are losing or about to lose their Medicaid coverage are going to end up with other insurance. But I remember — Joanne, you will, too — when the rate was closer to 18% … was a huge news story, and the thing that triggered the whole health reform debate in the first place. I’m surprised that there’s been so little attention paid to this.

Kenen: Because, you know … [unintelligible] … it’s so yesterday. And also, as you alluded to, you know, we’re in the middle of the Medicaid unwinding. So the numbers are going up again now. And we don’t know. We know that it’s a couple of million people. I think 3 million might be the last —

Rovner: I think it’s 4 [million], it’s up to 4.

Kenen: Four, OK. And some of them will get covered again and some of them will find other sources of coverage. But right now, there’s an uptick, not a downtick.

Roubein: And I think when you look at just, like, estimates of what the insured and the uninsured rates would be in 2030, like, the CMS’ [Centers for Medicare & Medicaid Services] analysis, one of the other questions is, you know, whether the enhanced Obamacare subsidies continue past 2025. So there’s Medicaid and then there’s also some other kind of question marks and cliffs coming up on how and whether it will fluctuate.

Rovner: No, it’s worth watching. And remember, when the census numbers come out, those will be for 2022. Well, moving on, we have two stories this week looking at the potential cost of those breakthrough obesity drugs, but through two very different lenses. One is from my KFF Health News colleague Rachana Pradhan, details how the makers of the current “it” drug, Ozempic, which is Novo Nordisk, in an effort to get the votes to lift the Medicare payment ban on weight loss drugs, is quietly contributing large amounts of money to groups like the Congressional Black Caucus Foundation and the Congressional Hispanic Caucus Institute. It’s sort of a backdoor lobbying that’s pretty age-old, but that doesn’t mean it doesn’t work. The other story, by Elaine Chen at Stat, looks at how health insurers are pushing back hard against the off-label use of diabetes medications that also work to help people lose weight. They’re doing things like allowing the more expensive weight loss drugs only if people have tried and failed other methods or disallowing them if the other methods had been slightly successful. So, if you take a lesser drug and you lose enough weight, they won’t let you take the better drug because, look, you lost weight on the other drug. We’ve talked about this, obviously, before: These drugs, on the one hand, have the potential to make a lot of people both healthier and happier. There’s a study out this week that shows that Mounjaro, the Eli Lilly drug, actually reduces heart disease by 20%.

Kenen: In people who have heart disease.

Rovner: Right, in people who have heart disease.

Kenen: It’s not lowering everybody’s risk.

Rovner: But still, I mean, everybody’s — well, I mean, there are medical indications for using these drugs for weight loss. But if everybody who wants them could get them, it would literally break the bank. Nobody can afford to give everybody who’s eligible for these drugs these drugs. Is the winner here going to be the side with the most effective lobbying, or is that too cynical?

Huetteman: Isn’t that always the winner? Speaking of cynical.

Rovner: Yeah, in health care.

Kenen: Well, I mean, I also think there’s questions about, like, these drugs clearly are really wonderful for people who they were designed for; you don’t have to be on insulin. They’re having not just weight loss and diabetes. There are apparently cardiac and other — you know, these are probably really good drugs. But there are a lot of people who do not have diabetes or heart disease who want them because they want to lose 20 pounds. And some of them are being told you have to take it for the rest of your life. I mean, I just know this anecdotally, and I’m sure we all know it anecdotally.

Rovner: Right. It’s like statins.

Kenen: Yes.

Rovner: Or blood pressure medication. If you stop taking your blood pressure medication, your blood pressure goes back up.

Kenen: Right. So, I mean, should the goal for the weight loss be, “OK, this is going to help you take off that weight and then you’re going to have to maintain it through diet and exercise and healthy lifestyle,” blah, blah, blah, which is hard for people. We know that. Or are we putting healthy people on a really expensive drug that changes an awful lot of things about their body indefinitely? We don’t have safety data for lifelong use in otherwise healthy people. So, you know, I’m always a little worried because even the best clinical trial is small compared to the entire — it’s small and it’s time-limited. And maybe these drugs are going to turn out to be absolutely phenomenal and we’re going to all live another 20 healthy years. But maybe not, you know. Or maybe they’re going to be really great for a certain subpopulation, but, you know, we’re not going to want to put it in the water supply. So, I still think that there’s this sort of pell-mell rush. And I think it’s partly because there’s a lot of money at stake. And it’s also, like, most people who are overweight have tried to lose it, and it’s very difficult to lose and maintain weight. So, you know, people want an easier way to do it. And I think the other thing is right now it’s an injection. There are side effects for some people on discomfort. There probably will be an oral version, a pill, sometime fairly soon, which will open — you know, there are people who don’t want to take a shot who would take a pill. It also means you might be able to tell — I mean, I don’t know the science of the pills, but it would make sense to me that you could take a lower dose, you know, maybe ease into it without the side effects, or could you stay on it longer with fewer problems? I mean, we’re just the very beginning of this, but it’s a huge amount of money.

Rovner: Yeah. You could see — I mean, my big question, though, is why can’t we force the drugmakers to lower the price? That would, if not solve the problem, make it a lot better. I mean, really, we’re going to have to wait until there is generic competition?

Kenen: It’s not just this.

Rovner: Yeah.

Kenen: I mean, it’s all sorts of cancer treatments and it’s hepatitis treatments. And it’s, I mean, there’s a lot of expensive drugs out there. So, this one just has a lot of demand because it makes you skinny.

Rovner: Well, that was the thing. We went through this with the hepatitis C drugs, which were really super expensive. It’s much more like that.

Kenen: Well, they seemed super expensive at the time —

Rovner: Not so much anymore.

Kenen: — but maybe for a thousand dollars, in retrospect.

Rovner: All right. Well, let’s move on. So, speaking of powerful lobbies, let’s talk about hospitals. Iowa Republican Sen. Chuck Grassley and Massachusetts Democrat Elizabeth Warren — now, there is an unlikely couple — are among those asking the IRS to more carefully examine tax-exempt hospitals to make sure they’re actually benefiting the community in exchange for not paying taxes, which is supposed to be the deal. Now, Sen. Grassley has been on this particular hobbyhorse for many, many years, I think probably more than 20, but not much ever seems to come of this. I can’t tell you how many workshops I’ve been to on, you know, how to measure community benefits that tax-exempt hospitals are providing. Any inkling that this time is going to be any different?

Roubein: Well, hospitals don’t tend to be sort of the losers. They try and kind of frame themselves as, like, “We’re your sort of friendly neighborhood hospital,” and every — I mean, every congressman, most congressmen have, you know, hospitals in their district. So they they get lobbied a lot, though, you know — I mean, this is a different issue, but particularly on the House side, hospitals are facing site-neutral payments, which if that actually went through Congress would be a loss. So yeah, but lawmakers have found it in general hard to take on the hospital industry.

Rovner: Yeah, very much so.

Kenen: Yeah. I mean, I think that we think of nonprofits and for-profits as, they’re different, but they’re not as different as we think they are, in that, you know, nonprofits are getting a tax break and they have to reinvest their profits. But it doesn’t mean they’re not making a lot of money. Some of them are. I mean, some of them have, you know, we’ve all walked into fancy nonprofits with, you know, fancy art and marble floors and so on and so forth. And we’ve all been in nonprofits that are barely keeping their doors open. So it’s your tax status. It’s not really, you know, your ethical status or the quality of care. I mean, there’s good nonprofits, there’s good for-profits. You know, this whole thing is like, if I were a hospital, I would be getting this huge tax break, and what am I doing to deserve it? And that’s the question.

Rovner: And I think the argument is, you know, that the 7.7% uninsured we were talking about, that hospitals are supposed to be providing care as part of their community benefit that the federal government now is ending up paying for. I think that’s sort of the frustration. If nonprofit hospitals were doing what they were supposed to do, it would cost federal and state governments less money, which always surprises me because this is not gone after more. I mean, Grassley has spent his whole career working on various types of government fraud. So this is totally in line for him. But it’s never just seemed to be a big priority for any administration.

Huetteman: There’s a little bit of an X factor here. Look at the fact that Grassley and Warren are talking about this publicly now. Maybe I’m just really optimistic from all the journalism we’ve been doing about projects like “Bill of the Month.” But the reality is that a lot of people are now seeing reporting that’s showing to them what nonprofit hospitals are actually doing when it comes to pursuing patients who don’t pay bills. And what it means to have community benefit comes into question a lot when you talk about wage garnishment, suing patients who are low-income for their medical debt. These are things that journalists have uncovered over and over again, happening at — ding, ding, ding — nonprofit hospitals. It’s harder to argue that hospitals are just doing their best for people when you have these stories of poor people who are losing their homes over unpaid medical bills, for instance. And I think that right now, when we’re in this political moment where health care costs are so, so potent to people and so important, I mean, could we see that this will actually be more effective, that we’re heading towards something that’s more effective? Maybe.

Rovner: Well, repeats the journalist, as we all are, the power of storytelling. Definitely the public is primed. I imagine that’s why they’re doing it now. We’ll see what comes of it.

Kenen: think the public is primed for bad practices. I’m not sure how many patients understand if the hospital they go to is a nonprofit or a for-profit. I think the public understands that everything in health care costs too much and that there are bad actors and greed. There’s a difference between profit and greed, and I think many people would say that we’re now in an era of greed. And not everybody in the health care sector — before anybody calls us up and shouts, “Not everybody who provides care is greedy” — but we’ve seen, you know, it is clearly out there. You know, you had Zeke Emanuel on a couple of weeks ago. Remember what he said, that, you know, 10 years ago, some people still liked their health care and now nobody likes their health care, rich or poor.

Rovner: Yeah, he’s right. All right. Well, that is this week’s news. Now, we’ll play my interview with Kate McEvoy of the National Association of Medicaid Directors about how the Medicaid unwinding is going. And one note before you listen: Kate frequently refers to the federal CMCS, which is not a misspeak; it stands for the Center for Medicaid and CHIP Services, which is the branch of CMS, the Centers for Medicare & Medicaid Services, that deals with Medicaid. So, here’s the interview:

I am pleased to welcome to the podcast Kate McEvoy, executive director of the National Association of Medicaid Directors, which is pretty much exactly what the name says, a group where state Medicaid officials can share information and ideas. Kate, welcome to “What the Health?”

Kate McEvoy: Good afternoon. Thanks for having me.

Rovner: Obviously, the Medicaid unwinding, which we have talked about a lot on the podcast, is Topic A for your members right now. Remind us again which Medicaid recipients are having their coverage eligibility rechecked? It’s not just those in the expansion group from the Affordable Care Act, right?

McEvoy: It’s not, no. Each and every person served by the country nationwide has to be reevaluated from an eligibility standpoint this year.

Rovner: What do we know about how it’s going? We’re seeing lots of reports that suggest the vast majority of people losing coverage are for paperwork reasons, not because they’ve been found to be no longer eligible. I know you recently surveyed your members. What are they telling you about this?

McEvoy: So, I first want to say this is an unprecedented task and it’s obviously historically significant for everyone served by the program. The volume of the work, and also the complexity, makes it a challenging task for all states and territories. But what we are seeing to date is a few things. First, we have seen an incredible effort on the part of states and territories to saturate really every means of communicating with their membership, really getting out that message around connecting with the programs, especially if an individual has moved during the period of the pandemic, which is very typical for people served by Medicaid. So that saturation of messaging and use of new means of connecting with people, like texting, really does represent a tremendous advance for the Medicaid program that has traditionally relied on a lot of complex, formal, legal notices to people. So that seems like a very positive thing. What we are seeing, and this is not unexpected, is that, you know, for reasons related to complex life circumstances and competing considerations, many people are not responding to those notices, no matter how we are transmitting those messages. And so that is a piece that is of great interest and concern to all of us, notably Medicaid directors wanting to make sure that eligible folks do not lose coverage simply because they are not responsive to the requests for more information. So we’re at a point where we’re beyond that initial push around messaging and now are really focused on means of protecting people who remain eligible, either through automatic review of their eligibility — the ex parte process — or by restoring them through such means as reconsideration. That’s really the main focus right now.

Rovner: And there’s that 90-day reconsideration window. Is that … how does that work?

McEvoy: So the federal law gives this period of 90 days to families and children within which they can be renewed with very little effort, essentially removing the responsibility to complete a new application. We also have long-standing help to people called “presumptive eligibility.” So if someone goes to a federally qualified health center or, more unfortunately, goes to the hospital, many of those types of providers can restore someone’s eligibility. So those are important protective pieces. We also know from the survey that you mentioned of our membership that many states and territories are extending those reconsideration protections to all coverage groups — also including older adults and people with disabilities.

Rovner: So are there any states that are doing anything that’s different and innovative? I remember when CHIP [the federal Children’s Health Insurance Program] was being stood up — and boy, that was a long time ago, like 1999 — South Carolina put flyers in pizza boxes, and some other state put flyers in sneaker boxes for back-to-school stuff. Are there better ways to maybe get ahold of these people?

McEvoy: So I think the answer is: a lot of different channels. Our colleagues in Louisiana have a partnership with Family Dollar stores to essentially feature this information on receipts. There’s a lot of work at pharmacy counters. Some of the big chain pharmacies have QR codes and other means of prompting people around their Medicaid eligibility. There’s going to be a big push for the back-to-school effort. And I think CMS and states are really interested, particularly in ensuring that children do not lose coverage even if their parents have regained employment and they’re no longer eligible. Another thing that’s going on is a lot of innovation in the means of enabling access to information. So many states have put in place personal apps through which people can track their own eligibility. There’s interest and some uptake of the so-called pizza-tracker function — so you can kind of see where you’re situated in that pipeline — and also a lot of use of automation to help call people back if they’re trying to get to state call centers. So really, all of those types of strategies … we’re seeing a huge amount of effort across the country.

Rovner: How’s the cooperation going with the Department of Health and Human Services? I know that … they seem to be not happy with some states. Are they being helpful, in general?

McEvoy: They’re being extraordinarily helpful. I would say that we often talk about Medicaid representing a federal-state equity partnership, and we’ve seen that manifest from the beginning of the first notice of the certainty around the start of the unwinding. CMCS has consistently offered guidance to states. They work with states using a mitigation approach as opposed to moving rapidly to compliance. We feel mitigation is the best way of essentially working out the strategies that are going to best protect continuing eligibility for people at the state level. And we really appreciate CMS’ efforts on that. We understand they do have to ensure accountability across the country, and we’re mutually committed to that.

Rovner: You better explain mitigation strategies.

McEvoy: Yeah, so this is a year where we are calling the question on eligibility standards that help ensure that the pathway to Medicaid coverage is a smooth one, and also that there is continuity of coverage. So, for any state that wasn’t yet meeting all those standards, CMCS essentially entered into an agreement with the state or territory to say, here is how you will get there. And that could have involved some means of improving the automatic renewals for Medicaid. It could have meant relying on an integrated eligibility processes. There are a lot of different tools and strategies that were put in place, but essentially that is a path to every state and territory coming into full compliance.

Rovner: Is there anything unexpected that’s happening? I know so much of this was predicted, and it was predicted that the states that went first that, you know, were really in a hurry to get extra people off of their rolls seem to be doing just that: getting extra people off of their rolls. Are you surprised at the differences among states?

McEvoy: I think that there have definitely been differences among states in terms of the tools they have used from a system standpoint, but I don’t see any differences in terms of retention of eligible people. That remains a shared goal across the entire country. And again, this is a watershed point where we have the opportunity to bring everyone to the same standards, ongoing, so that we help to prevent some of the heartache of the eligibility process for folks ongoing.

Rovner: Anything else I didn’t ask?

McEvoy: Well, I think that piece around the reconsideration period is particularly important. We are struck by there being probably less literacy around that option, and that’s something we want to continue to promote. The other piece I’d wind up by saying is that the Medicaid program is always available for people who are eligible. So in the worst-case scenario in which an otherwise eligible person loses coverage, they can always come back and be covered. This is in contrast to private insurance that may have an annual open enrollment period. Medicaid, as you know, is available on a rolling basis, and we want to keep reinforcing that theme so that no one goes with a gap in coverage.

Rovner: Kate McEvoy, thank you very much. And I hope we can call you back in a couple of months.

McEvoy: I would be very happy to hear from you.

Rovner: OK. We are back and it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. I did mine already. Emmarie, why don’t you go next?

Huetteman: My story this week comes from KFF Health News, my colleague Darius Tahir. He has a story called “The NIH Ices a Research Project. Is It Self-Censorship?” Now, the story talks about the fact that the former head of NIH Francis Collins, was, as he was leaving, announcing an effort to study health communications. And we’re talking about not just doctor-to-patient communications, but actually also how mass communications impact American health. But as Darius found out, the acting director quietly ended the program as NIH was preparing to open its grant applications. And officials who spoke with us said that they think political pressure over misinformation is to blame. Now, we don’t have to look too far for examples of conservative pressure over misinformation and information these days. In particular, there’s a notable one from just last month out of a Louisiana court, the federal court decision that blocked government officials from communicating with social media companies. You really don’t have to look too far to see that there’s a chilling effect on information. And we’re talking about the NIH was going to study or rather fund studies into communication and information. Not misinformation, information: how people get information about their health. So it’s a pretty interesting example and a really great story worth your read.

Rovner: And I’ve done nothing but preach about public health communication for three years now.

Kenen: It’s a very good story.

Rovner: Yeah, it was a really good story. Rachel, you’re next.

Roubein: All right. This story is called “From Windows to Wall Art, Hospitals Use Virtual Reality to Design More Inclusive Rooms for Kids,” by Stat News, by Mohana Ravindranath. And I thought this story was really interesting because she kind of dived into what Mohana called “a budding movement to make architecture more inclusive” for the people and patients who are spending a lot, a lot of time in hospital walls. And what some researchers are doing is using virtual reality to essentially gauge how comfortable children who are patients are in hospital rooms. And she talked to researchers at Berkeley who were using these, like, virtual reality headsets to kind of study and explore mocked-up hospital rooms. And, I didn’t know a ton about this field. I mean, apparently it’s not new, but it’s this kind of growing sort of movement to make patients more comfortable in the space that they’re inhabiting for perhaps long periods of time.

Rovner: I went to a conference on architecture, hospital architecture, making it more patient-centered, 10 years ago. But my favorite thing that I still remember from that is they talked about putting art on the ceiling because people are either in bed or they’re in gurneys. They’re looking up at the ceiling a lot. And ceilings are scary in hospitals. So that was one of the things that I took away from that. OK, Joanne, now it’s your turn.

Kenen: OK. This is from Fox News. And yes, you did hear that right. It’s by Melissa Rudy, and the headline is “Male Health Care Leaders Complete ‘Simulated Breastfeeding Challenge’ at Texas Hospital: ‘Huge Eye-Opener’.” So at Covenant Health, they had a bunch of high-level guys in suits pretend they were nursing and/or pumping mothers, and they had to nurse every three hours for 20 minutes at a time. And they found it was quite difficult and quite cumbersome and they didn’t have enough privacy. And as one of them said, “There was no way to multitask.” But trust me, if you have two kids, you have to figure that out, too. So it was a really good story.

Rovner: Some of these things that we feel like should be required everywhere, but it was a great read; it was a really good story. OK, that is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks this week to Zach Dyer, sitting in for the indefatigable Francis Ying. And as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me or X me or whatever; I’m @jrovner. And also on Bluesky and Threads. Rachel?

Roubein: @rachel_roubein — that’s on Twitter.

Rovner: Joanne.

Kenen: In most places I’m @JoanneKenen. On Threads, I’m @joannekenen1.

Rovner: Emmarie.

Huetteman: And I am @emmarieDC.

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

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My first exposure to pharmaceutical shortages happened in 2017 as a new-to-practice nurse working on an inpatient oncology unit. A hurricane in Puerto Rico had left the U.S. short of sodium chloride minibags. Health care providers nationwide were tasked to modify standard medication preparation and administration practices, such as changing medications from IV to oral delivery, avoiding prepping IV lines with saline, or providing IV drugs by push rather than infusion. I was working in a heavily resourced academic institution. It felt absurd that I couldn’t even appropriately administer medications, but I figured this was an emergency.

Eventually, the shortage ended. But it was not an isolated incident.

The recent spotlight on shortages of essential medicines, such as cancer therapies and ADHD drugs, has brought attention to a longstanding public health crisis. Prescription drug shortages across drug classes have been on the radar of our governing bodies for decades. Nearly 10 years ago, up to 83% of oncologists surveyed could not prescribe a preferred chemotherapy agent due to shortages. Yet, the problem persists, with new shortages being identified at alarming rates. Recent reports indicate drug shortages grew by 30% in the past year. At the end of 2022, there were national shortages of 295 medications, including essentials like anesthetics, chemotherapies, and antibiotics.

Continue to STAT+ to read the full story…

Medicare and Medicaid patients will make up 92% of the market for lecanemab, according to Eisai Co., which sells the drug under the brand name Leqembi. In addition to the company’s $26,500 annual price tag for the drug, treatment could cost U.S. taxpayers $82,500 per patient per year, on average, for genetic tests and frequent brain scans, safety monitoring, and other care, according to estimates from the Institute for Clinical and Economic Review, or ICER. The FDA gave the drug full approval July 6. About 1 million Alzheimer’s patients in the U.S. could qualify to use it.

Patients with early Alzheimer’s disease who took lecanemab in a major clinical trial declined an average of five months slower than other subjects over an 18-month period, but many suffered brain swelling and bleeding. Although those side effects usually resolved without obvious harm, they apparently caused three deaths. The great expense of the drug and its treatment raises questions about how it will be paid for, and who will benefit.

“In the history of science, it’s a significant achievement to slightly slow down progression of dementia,” said John Mafi, a researcher and associate professor of medicine at the David Geffen School of Medicine at UCLA. “But the actual practical benefits to patients are very marginal, and there is a real risk and a real cost.”

To qualify for Leqembi, patients must undergo a PET scan that looks for amyloid plaques, the protein clumps that clog the brains of many Alzheimer’s patients. About 1 in 5 patients who took Leqembi in the major clinical test of the drug developed brain hemorrhaging or swelling, a risk that requires those taking the drug to undergo frequent medical checkups and brain scans called MRIs.

In anticipation of additional costs from the Leqembi drug class, the Centers for Medicare & Medicaid Services in 2021 increased monthly premiums for Medicare patients by 15%, and premiums may rise again in 2024 after a slight decline this year.

Such increases can be a significant burden for many of the 62 million Medicare subscribers who live on fixed incomes. “Real people will be affected,” Mafi said. He contributed to a study that estimated lecanemab and related care would cost Medicare $2 billion to $5 billion a year, making it one of the most expensive taxpayer-funded treatments.

In its analysis, ICER suggested that Leqembi could be cost-effective at an annual price of $8,900 to $21,500. In an interview, David Rind, ICER’s chief medical officer, said $10,000 to $15,000 a year would be reasonable. “Above that range doesn’t seem like a good place,” he said.

Whatever its price, patients may be delayed getting access to Leqembi because of the relative shortage of specialists capable of managing the drug, which will require genetic and neuropsychological testing as well as the PET scan to confirm a patient’s eligibility. A similar drug, Eli Lilly’s donanemab, is likely to win FDA approval this year.

Already there are long waits for the testing needed to assess dementia, Mafi said, noting that one of his patients with mild cognitive impairment had to wait eight months for an evaluation.

Such testing is not readily at hand because of the paucity of effective treatment for Alzheimer’s, which has helped to make geriatrics a relatively unappealing specialty. The United States has about a third as many dementia specialists per capita as Germany, and about half as many as Italy.

“Time is of the essence” for the neuropsychological testing, Mafi said, because once a patient’s cognitive ability declines below a certain threshold, they become ineligible for treatment with the drug, which was tested only in patients in the earliest stages of the disease.

Mafi’s study estimates that patients without supplemental Medicare coverage will have to pay about $6,600 out-of-pocket for each year of treatment. That could put it out of reach for many of the 1 in 7 “dual eligible” Medicare beneficiaries whose income is low enough to simultaneously qualify them for state Medicaid programs. Those programs are responsible for about 20% of physician bills for drug infusions, but they don’t always cover the full amount.

Some practitioners, such as cancer centers, cover their Medicaid losses by receiving higher rates for privately insured patients. But since almost all lecanemab patients are likely to be on government insurance, that “cross-subsidization” is less of an option, said Soeren Mattke, director of the Center for Improving Chronic Illness Care at the University of Southern California.

This poses a serious health equity issue because “dual eligibles are low-income patients with limited opportunities and education, and at higher risk of chronic illnesses including dementia,” Mattke said in an interview. Yet many doctors may not be willing to treat them, he said. “The idea of denying access to this group is just appalling.”

Eisai spokesperson Libby Holman said the company was reaching out to specialists and primary care physicians to make them aware of the drug, and that reimbursement options were improving. Eisai will provide the drug at no cost to patients in financial need, she said, and its “patient navigators” can help lock down insurance coverage.

“A lot of clinicians are excited about the drug, and patients are hearing about it,” said David Moss, chief financial officer of INmune Bio, a company that has another Alzheimer’s drug in development. “It’s a money center for infusion centers and MRI operators. It provides reasons for patients to come into the office, which is a billing thing.”

Outstanding doubts about Leqembi and related drugs have given urgency to efforts to monitor patient experiences. CMS is requiring Leqembi patients to be entered into a registry that tracks their outcomes. The agency has established a registry, but the Alzheimer’s Association, the leading advocacy group for dementia patients, is funding its own database to track those being treated, offering physician practices $2,500 to join it and up to $300 per patient visit.

In a letter to CMS on July 27, a group of policy experts said CMS should ensure that any and all Leqembi registries create and share data detailed enough for researchers and FDA safety teams to obtain a clear picture of the drug’s real-world profile.

The anti-amyloid drugs like lecanemab have created a polarized environment in medicine between those who think the drugs are a dangerous waste of money and those who believe they are a brilliant first step to a cure, said ICER’s Rind, who thinks lecanemab has modest benefits.

“People are as dug in on this as almost anything I’ve ever seen in medicine,” he said. “I don’t think it’s healthy.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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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 Biden administration continued a bipartisan, decades-long effort to ensure that health insurance treats mental illnesses the same as other ailments, with a new set of regulations aimed at ensuring that services are actually available without years-long waits or excessive out-of-pocket costs.

Meanwhile, two more committees in Congress approved bills this week aimed at reining in the power of pharmacy benefit managers, who are accused of keeping prescription drug prices high to increase their bottom lines.

This week’s panelists are Julie Rovner of KFF Health News, Anna Edney of Bloomberg, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, and Sarah Karlin-Smith of the Pink Sheet.

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Anna Edney
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Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico

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Sarah Karlin-Smith
Pink Sheet

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Among the takeaways from this week’s episode:

• The Biden administration’s new rules to enforce federal mental health parity requirements include no threat of sanctions when health plans do not comply; noncompliance with even the most minimal federal rules has been a problem dating to the 1990s. Improving access to mental health care is not a new policy priority, nor a partisan one, yet it remains difficult to achieve.
• With the anniversary of the 988 Suicide & Crisis Lifeline, more people are becoming aware of how to access help and get it. Challenges remain, however, such as the hotline service’s inability to connect callers with local care. But the program seizes on the power of an initial connection for someone in a moment of crisis and offers a lifeline for a nation experiencing high rates of depression, anxiety, and suicide.
• In news about the so-called Medicaid unwinding, 12 states have paused disenrollment efforts amid concerns they are not following renewal requirements. A major consideration is that most people who are disenrolled would qualify to obtain inexpensive or even free coverage through the Affordable Care Act. But reenrollment can be challenging, particularly for those with language barriers or housing insecurity, for instance.
• With a flurry of committee activity, Congress is revving up to pass legislation by year’s end targeting the role of pharmacy benefit managers — and, based on the advertisements blanketing Washington, PBMs are nervous. It appears legislation would increase transparency and inform policymakers as they contemplate further, more substantive changes. That could be a tough sell to a public crying out for relief from high health care costs.
• Also on Capitol Hill, far-right lawmakers are pushing to insert abortion restrictions into annual government spending bills, threatening yet another government shutdown on Oct. 1. The issue is causing heartburn for less conservative Republicans who do not want more abortion votes ahead of their reelection campaigns.
• And the damage to a Pfizer storage facility by a tornado is amplifying concerns about drug shortages. After troubling problems with a factory in India caused shortages of critical cancer drugs, decision-makers in Washington have been keeping an eye on the growing issues, and a response may be brewing.

Also this week, Rovner interviews KFF Health News’ Céline Gounder about the new season of her “Epidemic” podcast. This season chronicles the successful public health effort to eradicate smallpox.

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

Julie Rovner: The Nation’s “The Anti-Abortion Movement Gets a Dose of Post-Roe Reality,” by Amy Littlefield.

Joanne Kenen: Food & Environment Reporting Network’s “Can Biden’s Climate-Smart Agriculture Program Live Up to the Hype?” by Gabriel Popkin.

Anna Edney: Bloomberg’s “Mineral Sunscreens Have Potential Hidden Dangers, Too,” by Anna Edney.

Sarah Karlin-Smith: CNN’s “They Took Blockbuster Drugs for Weight Loss and Diabetes. Now Their Stomachs Are Paralyzed,” by Brenda Goodman.

Also mentioned in this week’s episode:

• CNN’s “Medicaid Disenrollments Paused in a Dozen States After Failure to Comply With Federal Rules,” by Tami Luhby.
• Abortion, Every Day’s “Why Are OBGYNs Being Forced to Go to Texas?” by Jessica Valenti.
• Politico’s “GOP Looks to Spending Fights for Wins on Abortion, Trans Care, Contraception,” by Alice Miranda Ollstein.
• KFF Health News’ “A Year With 988: What Worked? What Challenges Lie Ahead,” by Colleen DeGuzman.

click to open the transcript

Transcript: Another Try for Mental Health ‘Parity’

KFF Health News’ ‘What the Health?’Episode Title: Another Try for Mental Health ‘Parity’Episode Number: 307Published: July 27, 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 for KFF Health News, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, July 27, at 10 a.m. As always, news happens fast and things might have changed by the time you hear this. So, here we go. We are joined today via video conference by Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico.

Joanne Kenen: Hi, everybody.

Rovner: Sarah Karlin-Smith, the Pink Sheet.

Sarah Karlin-Smith: Hi, Julie.

Rovner: And Anna Edney of Bloomberg News.

Edney: Hello.

Rovner: Later in this episode, we’ll have my interview with my KFF colleague Céline Gounder about the new season of her podcast “Epidemic,” which tracks one of the last great public health success stories, the eradication of smallpox. But first, this week’s news. I want to start this week with mental health, which we haven’t talked about in a while — specifically, mental health parity, which is both a law and a concept, that mental ailments should be covered and reimbursed by health insurance the same way as a broken bone or case of pneumonia or any other — air quotes — “physical ailment.” Policymakers, Republican and Democrat, and the mental health community have been fighting pretty much nonstop since the mid-1990s to require parity. And despite at least five separate acts of Congress over that time — I looked it up this week — we are still not there yet. To this day, patients with psychiatric illnesses find their care denied reimbursement, made difficult to access, or otherwise treated as lesser. This week, the Biden administration is taking another whack at the issue, putting out proposed rules it hopes will start to close the remaining parity gap, among other things by requiring health plans to analyze their networks and prior authorization rules and other potential barriers to care to ensure that members actually can get the care they need. What I didn’t see in the rules, though, was any new threat to sanction plans that don’t comply — because plans have been not complying for a couple of decades now. How much might these new rules help in the absence of a couple of multimillion-dollar fines?

Edney: I had that same question when I was considering this because I didn’t see like, OK, like, great, they’re going to do their self-policing, and then what? But I do think that there’s the possibility, and this has been used in health care before, of public shaming. If the administration gets to look over this data and in some way compile it and say, here’s the good guys, here’s the bad guys, maybe that gets us somewhere.

Rovner: You know, it strikes me, this has been going on for so very long. I mean, at first it was the employer community actually that did most of the negotiating, not the insurers. Now that it’s required, it’s the insurers who are in charge of it. But it has been just this incredible mountain to scale, and nobody has been able to do it yet.

Kenen: And it’s always been bipartisan.

Rovner: That’s right.

Kenen: And it really goes back to mostly, you know, the late Sen. [Paul] Wellstone [(D-Minn.)] and [Sen. Pete] Domenici [(R-N.M.)], both of whom had close relatives with serious mental illness. You know, Domenici was fairly conservative and traditional conservative, and Wellstone was extremely liberal. And they just said, I mean, this — the parity move began — the original parity legislation, at least the first one I’m aware of. And it was like, I think it was before I came to Washington. I think it was in the ’80s, certainly the early — by the ’90s.

Rovner: It was 1996 when when the first one actually passed. Yeah.

Kenen: I mean, they started talking about it before that because it took them seven or eight years. So this is not a new idea, and it’s not a partisan idea, and it’s still not done. It’s still not there.

Edney: I think there’s some societal shift too, possibly. I mean, we’re seeing it, and maybe we’re getting closer. I’ve seen a lot of billboards lately. I’ve done some work travel. When I’m on the road, I feel like I’m always seeing these billboards that are saying mental health care is health care. And trying to hammer that through has really taken a long time.

Rovner: So while we are on the subject of mental health, one of the good things I think the government has done in the last year is start the 988 Suicide & Crisis Lifeline, which turned 1 this month. Early data from shifting the hotline from a 10-digit number to a three-digit one that’s a lot easier to remember does suggest that more people are becoming aware of immediate help and more people are getting it. At the same time, it’s been able to keep up with the demand, even improving call answering times — I know that was a big concern — but there is still a long way to go, and this is hardly a panacea for what we know is an ongoing mental health crisis, right?

Karlin-Smith: This is a good first step to get people in crisis help without some of the risks that we’ve seen. If you go towards the 911 route, sometimes police are not well trained to handle these calls and they end in worse outcomes than necessary. But then you have to have that second part, which is what we were talking about before, which is the access to the longer-term mental health support to actually receive the treatment you need. There’s also some issues with this hotline going forward in terms of long-term funding and, you know, other tweaks they need to work out to make sure, again, that people who are not expecting to interact with law enforcement actually don’t end up indirectly getting there and things like that as well.

Kenen: Do any of you know whether there’s discussion of sort of making people who don’t remember it’s 988 and they call 911 — instead of dispatching cops, are the dispatchers being trained to just transfer it over to 988?

Rovner: That I don’t know.

Kenen: I’m not aware of that. But it just sort of seems common sense.

Rovner: One thing I know they’re working on is, right now I think there’s no geolocation. So when you call 988, you don’t necessarily get automatically referred to resources that are in your community because they don’t necessarily know where you’re calling from. And I know that’s an effort. But yeah, I’m sure there either is or is going to be some effort to interact between 988 and 911.

Kenen: It’s common sense to us. It doesn’t mean it’s actually happening. I mean, this is health care.

Rovner: As we point out, this is mental health care, too.

Kenen: Yeah, right.

Rovner: It’s a step.

Kenen: But I think that, you know, sort of the power of that initial connection is something that’s easy for people to underestimate. I mean, my son in college was doing a helpline during 2020-2021. You know, he was trained, and he was also trained, like, if you think this is beyond what a college-aged volunteer, that if you’re uncertain, you just switched immediately to a mental health professional. But sometimes it’s just, people feel really bad and just having a voice gets them through a crisis moment. And as we all know, there are a lot of people having a lot of crisis moments. I doubt any of us don’t know of a suicide in the last year, and maybe not in our immediate circle, but a friend of a friend, I mean, or, you know — I know several. You know, we are really at a moment of extreme crisis. And if a phone call can help some percentage of those people, then, you know, it needs to be publicized even more and improved so it can be more than a friendly voice, plus a connection to what, ending this repetition of crisis.

Rovner: I feel like the people who worked hard to get this implemented are pretty happy a year later at how, you know — obviously there’s further to go — but they’re happy with how far they’ve come. Well, so, probably the only thing worse than not getting care covered that should be is losing your health coverage altogether, which brings us to the Medicaid unwinding, as states redetermine who’s still eligible for Medicaid for the first time since the start of the pandemic. Our podcast colleague Tami Luhby over at CNN had a story Friday that I still haven’t seen anywhere else. Apparently 12 states have put their disenrollments on pause, says Tami. But we don’t know which 12, according to the KFF disenrollment tracker. As of Wednesday, July 26, at least 3.7 million people have been disenrolled from the 37 states that are reporting publicly, nearly three-quarters of those people for, quote, “procedural reasons,” meaning those people might still be eligible but for some reason didn’t complete the renewal process. The dozen states on pause are apparently ones that HHS [the Department of Health and Human Services] thinks are not following the renewal requirements and presumably ones whose disenrollments are out of line. The Centers for Medicare & Medicaid Services, which is overseeing this, is not naming those states, but this points up exactly what a lot of people predicted would happen when states started looking at eligibility again, that a lot of people who were quite likely still eligible were simply going to lose their insurance altogether, right?

Edney: Yeah, it seemed like there was a lot of preparation in some ways to anticipating this. And then, yeah, obviously you had the states that were just raring to go and try to get people off the rolls. And yeah, it would be very interesting to know what those 12 are. I think Tami’s reporting was stellar and she did a really good job. But that’s, like, one piece of the puzzle we’re missing. And I know CMS said that they’re not naming them because they are working well with them to try to fix it.

Rovner: The one thing we obviously do know is that there are several states that are doing this faster than is required — in fact, faster than is recommended. And what we know is that the faster they do it, the more likely they are going to have people sort of fall between the cracks. The people who are determined to be no longer eligible for Medicaid are supposed to be guided to programs for which they are eligible. And presumably most of them, unless they have, you know, gotten a really great job or hit the lottery, will still be eligible at least for subsidies under the Affordable Care Act. And they’re supposed to be guided to those programs. And it’s not clear yet whether that’s happening, although I know there are an awful lot of people who are watching this pretty closely. There were over 90 million people on Medicaid by the end of the pandemic, by the point at which states no longer had to keep people on. That’s a lot more people than Medicaid normally has. It’s usually more around 70 or even 80 million. So there’s excess people. And the question is what’s going to happen to those people and whether they’re going to have some sort of health insurance. And I guess it’s going to be more than a couple of months before we know that. Yes, Joanne.

Kenen: I think that it’s important to remember that there’s no open enrollment season for Medicaid the way there is for the ACA, so that if you’re disenrolled and you get sick and you go to a doctor or a hospital, they can requalify you and you can get it again. The problem is people who think that they’re disenrolled or are told that they’re disenrolled may not realize. They may not go to the doctor because they think they can’t afford it. They may not understand there’s a public education campaign there, too, that I haven’t seen. You know, if you get community health clinics, hospitals, they can do Medicare, Medicaid certification. But it’s dangerous, right? If you think, oh, I’m going to get a bill I can’t afford and I’m just going to see if I can tough this out, that’s not the way to take care of your health. So there’s that additional conundrum. And then, you know, I think that HHS can be flexible on special enrollment periods for those who are not Medicaid-eligible and are ACA-eligible, but most of them are still Medicaid-eligible.

Rovner: If you get kicked off of Medicaid, you get an automatic special enrollment for the ACA anyway.

Kenen: But not forever. If the issue is it’s in a language you don’t speak or at an address you don’t live in, or you just threw it out because you didn’t understand what it was — there is institutional failures in the health care system, and then there’s people have different addresses in three years, particularly poor people; they move around. There’s a communication gap. You know, I talked to a health care system a while ago in Indiana, a safety net, that was going through electronic health records and contacting people. And yet that’s Indiana and they, you know, I think it was Tami who pointed out a few weeks ago on the podcast, Indiana is not doing great, in spite of, you know, really more of a concerted effort than other states or at least other health systems, not that I talk to every single health system in the country. I was really impressed with how proactive they were being. And still people are falling, not just through the cracks. I mean, there’s just tons of cracks. It’s like, you know, this whole landscape of cracks.

Rovner: I think everybody knew this was going to be a big undertaking. And obviously the states that are trying to do it with some care are having problems because it’s a big undertaking. And the states that are doing it with a little bit less care are throwing a lot more people off of their health insurance. And we will continue to follow this. So it is the end of July. I’m still not sure how that happened.

Kenen: ’Cause after June, Julie.

Rovner: Yes. Thank you. July is often when committees in Congress rush to mark up bills that they hope to get to the floor and possibly to the president in that brief period when lawmakers return from the August recess before they go out for the year, usually around Thanksgiving. This year is obviously no exception. While Sen. Bernie Sanders [(I-Vt.)] at the Health, Education, Labor and Pensions Committee has delayed consideration of that primary care-community health center bill that we talked about last week until September, after Republicans rebelled against what was supposed to have been a bipartisan bill, committee action on pharmacy benefit managers and other Medicare issues did take place yesterday in the Senate Finance Committee and the House Ways and Means Committee. Sarah, you’re following this, right? What’s happening? And I mean, so we’ve now had basically all four of the committees that have some kind of jurisdiction over this who’ve acted. Is something going to happen on PBM regulation this year?

Karlin-Smith: Actually, five committees have acted because the House Ed[ucation] and Workforce Committee has also acted on the topic. So there’s a lot of committees with a stake in this. I think there’s certainly set up for something for the fall, end of the year, to happen in the pharmacy benefit manager space. And there’s a decent amount of bipartisanship around the issue, depending on exactly which committee you’re looking at. But even if the policies that haven’t gotten through haven’t been bipartisan, I think there’s general bipartisan interest among all the committees of tackling the issue. The question is how meaningful, I guess, the policies that we get done are. Right now it looks like what we’re going to end up with is some kind of transparency measure. It reminded me a little bit of our discussion of the mental health stuff [President Joe] Biden is doing going forward. Essentially what it’s going to end up doing is get the government a lot of detailed data about how PBMs operate, how this vertical integration of PBMs — so there’s a lot of common ownership between PBMs, health insurance plans, pharmacies and so forth — may be impacting the cost of our health care and perhaps in a negative way. And then from that point, the idea would be that later Congress could go back and actually do the sort of policy reforms that might be needed. So I know there are some people that are super excited about this transparency because it is such an opaque industry. But at the same point, you can’t kind of go to your constituents and say, “We’ve changed something,” right away or, you know, “We’re going to save you a ton of money with this kind of legislation.”

Rovner: You could tell how worried the PBMs are by how much advertising you see, if you still watch TV that has advertising, which I do, because I watch cable news. I mean, the PBMs are clearly anxious about what Congress might do. And given the fact that, as you point out and as we’ve been saying for years, drug prices are a very bipartisan issue — and it is kind of surprising, like mental health, it’s bipartisan, and they still haven’t been able to push this as far as I think both Democrats and Republicans would like for it to go. Is there anything in these bills that surprised you, that goes further than you expected or less far than expected?

Karlin-Smith: There’s been efforts to sort of delink PBM compensation from rebates. And in the past, when Congress has tried to look into doing this, it’s ended up being extremely costly to the government. And they figured out in this set of policies sort of how to do this without those costs, which is basically, they’re making sure that the PBMs don’t have this perverse incentive to make money off of higher-priced drugs. However, the health plans are still going to be able to do that. So it’s not clear how much of a benefit this will really be, because at this point, the health plans and the PBMs are essentially one and the same. They have the same ownership. But, you know, I do think there has been some kind of creativity and thoughtfulness on Congress’ part of, OK, how do we tackle this without also actually increasing how much the government spends? Because the government helps support a lot of the premiums in these health insurance programs.

Rovner: Yeah. So the government has quite a quite a financial stake in how this all turns out. All right. Well, we will definitely watch that space closely. Let us move on to abortion. In addition to it being markup season for bills like PBMs, it’s also appropriations season on Capitol Hill, with the Sept. 30 deadline looming for a completion of the 12 annual spending bills. Otherwise, large parts of the government shut down, which we have seen before in recent years. And even though Democrats and Republicans thought they had a spending detente with the approval earlier this spring of legislation to lift the nation’s debt ceiling, Republicans in the House have other ideas; they not only want to cut spending even further than the levels agreed to in the debt ceiling bill, but they want to add abortion and other social policy riders to a long list of spending bills, including not just the one for the Department of Health and Human Services but the one for the Food and Drug Administration, which is in the agriculture appropriations, for reasons I’ve never quite determined; the financial services bill, which includes funding for abortion in the federal health insurance plan for government workers; and the spending bill for Washington, D.C., which wants to use its own taxpayer money for abortion, and Congress has been making that illegal pretty much for decades. In addition to abortion bans, conservatives want riders to ban gender-affirming care and even bar the FDA from banning menthol cigarettes. So it’s not just abortion. It’s literally a long list of social issues. Now, this is nothing new. A half a dozen spending bills have carried a Hyde [Amendment] type of abortion ban language for decades, as neither Republicans nor Democrats have had the votes to either expand or take away the existing restrictions. On the other hand, these conservatives pushing all these new riders don’t seem to care if the government shuts down if these bills pass. And that’s something new, right?

Kenen: Over abortion it’s something new, but they haven’t cared. I mean, they’ve shut down the government before.

Rovner: That’s true. The last time was over Obamacare.

Kenen: Right. And, which, the great irony is the one thing they — when they shut down the government because Obamacare was mandatory, not just discretionary funding, Obamacare went ahead anyway. So, I mean, minor details, but I think this is probably going to be an annual battle from now on. It depends how hard they fight for how long. And with some of these very conservative, ultra-conservative lawmakers, we’ve seen them dig in on abortion, on other issues like the defense appointees. So I think it’s going to be a messy October.

Rovner: Yeah, I went back and pulled some of my old clips. In the early 1990s I used to literally keep a spreadsheet, and I think that’s before we had Excel, of which bill, which of the appropriations bills had abortion language and what the status was of the fights, because they were the same fights year after year after year. And as I said, they kind of reached a rapprochement at one point, or not even a rapprochement — neither side could move what was already there. At some point, they kind of stopped trying, although we have seen liberals the last few years try to make a run at the actual, the original Hyde Amendment that bans federal funding for most abortions — that’s in the HHS bill — and unsuccessfully. They have not had the votes to do that. Presumably, Republicans don’t have the votes now to get any of these — at least certainly not in the Senate — to get any of these new riders in. But as we point out, they could definitely keep the government closed for a while over it. I mean, in the Clinton administration, President [Bill] Clinton actually had to swallow a bunch of new riders because either it was that or keep the government closed. So that’s kind of how they’ve gotten in there, is that one side has sort of pushed the other to the brink. You know, everybody seems to assume at this point that we are cruising towards a shutdown on Oct. 1. Does anybody think that we’re not?

Kenen: I mean, I’m not on the Hill anymore, but I certainly expect a shutdown. I don’t know how long it lasts or how you resolve it. And I — even more certain we’ll have one next year, which, the same issues will be hot buttons five weeks before the elections. So whatever happens this year is likely to be even more intense next year, although, you know, next year’s far away and the news cycle’s about seven seconds. So, you know, I think this could be an annual fight and for some time to come, and some years will be more intense than others. And you can create a deal about something else. And, you know, the House moderates are — there are not many moderates — but they’re sort of more traditional conservatives. And there’s a split in the Republican Party in the House, and we don’t know who’s going to fold when, and we don’t — we haven’t had this kind of a showdown. So we don’t really know how long the House will hold out, because some of the more moderate lawmakers who are — they’re all up for reelection next year. I mean, some of them don’t agree. Some of are not as all or nothing on abortion as the —

Rovner: Well, there are what, a dozen and a half Republicans who are in districts that President Biden won who do not want to vote on any of these things and have made it fairly clear to their leadership that they do not want to vote on any of these things. But obviously the conservatives do.

Kenen: And they’ve been public about that. They’ve said it. I mean, we’re not guessing. Some of them spoke up and said, you know, leave it to the states. And that’s what the court decided. And they don’t want to nationalize this even further than it’s nationalized. And I think, you know, when you have the Freedom Caucus taking out Marjorie Taylor Greene, I mean, I have no idea what’s next.

Rovner: Yeah, things are odd. Well, I want to mention one more abortion story this week that I read in the newsletter “Abortion, Every Day,” by Jessica Valenti. And shoutout here: If you’re interested in this issue and you don’t subscribe, you’re missing out. I will include the link in the show notes. The story’s about Texas and the exam to become a board-certified obstetrician-gynecologist. The board that conducts the exam is based in Dallas and has been for decades, and Texas is traditionally where this test has been administered. During the pandemic, the exam was given virtually because nothing was really in person. But this year, if a doctor wants to become board-certified, he or she will have to travel to Texas this fall. And a lot of OB-GYNs don’t want to do that, for fairly obvious reasons, like they are afraid of getting arrested and sent to prison because of Texas’ extreme anti-abortion laws. And yikes, really, this does not seem to be an insignificant legal risk here for doctors who have been performing abortions in other states. This is quite the dilemma, isn’t it?

Karlin-Smith: Well, the other thing I thought was interesting about — read part of that piece — is just, she was pointing out that you might not just want to advertise in a state where a lot of people are anti-abortion that all of these people who perform abortions are all going to be at the same place at the same time. So it’s not just that they’re going to be in Texas. Like, if anybody wants to go after them, they know exactly where they are. So it can create, if nothing else, just like an opportunity for big demonstrations or interactions that might disrupt kind of the normal flow of the exam-taking.

Kenen: Or violence. Most people who are anti-abortion are obviously not violent, but we have seen political violence in this country before. And you just need one person, which, you know, we seem to have plenty of people who are willing to shoot at other people. I thought it was an excellent piece. I mean, I had not come across that before until you sent it around, and there’s a solution — you know, like, if you did it virtually before — and I wasn’t clear, or maybe I just didn’t pay attention: Was this certification or also recertification?

Rovner: No, this was just certification. Recertification’s separate. So these are these are young doctors who want to become board-certified for the first time.

Kenen: But the recertification issues will be similar. And this is a yearly — I mean, I don’t see why they just don’t give people the option of doing it virtual.

Rovner: But we’ll see if they back down. But you know, I had the same thought that Sarah did. It’s like, great, let’s advertise that everybody’s going to be in one place at one time, you know, taking this exam. Well, we’ll see how that one plays out. Well, finally this week, building on last week’s discussion on health and climate change and on drug shortages, a tornado in Rocky Mount, North Carolina, seriously damaged a giant Pfizer drug storage facility, potentially worsening several different drug shortages. Sarah, I remember when the hurricane in Puerto Rico seemed to light a fire under the FDA and the drug industry about the dangers of manufacturing being too centralized in one place. Now we have to worry about storage, too? Are we going to end up, like, burying everything underground in Fort Knox?

Karlin-Smith: I think there’s been a focus even since before [Hurricane] Maria, but that certainly brought up that there’s a lack of redundancy in U.S. medical supply chains and, really, global supply chains. It’s not so much that they need to be buried, you know, that we need bunkers. It’s just that — Pfizer had to revise the numbers, but I think the correct number was that that facility produces about 8% of the sterile kind of injectables used in the U.S. health system, 25% of all Pfizer’s — it’s more like each company or the different plants that produce these drugs, it needs to be done in more places so that if you have these severe weather events in one part of the country, there’s another facility that’s also producing these drugs or has storage. So I don’t know that these solutions need to be as extreme as you brought up. But I think the problem has been that when solutions to drug shortages have come up in Congress, they tend to focus on FDA authorities or things that kind of nibble around the edges of this issue, and no one’s ever really been able to address some of the underlying economic tensions here and the incentives that these companies have to invest in redundancy, invest in better manufacturing quality, and so forth. Because at the end of the day these are often some of the oldest and cheapest drugs we have, but they’re not necessarily actually the easiest to produce. While oftentimes we’re talking about very expensive, high-cost drugs here, this may be a case where we have to think about whether we’ve let the prices drop too low and that’s sort of keeping a market that works if everything’s going perfectly well but then leads to these shortages and other problems in health care.

Rovner: Yeah, the whole just-in-time supply chain. Well, before we leave this, Anna, since you’re our expert on this, particularly international manufacturing, I mean, has sort of what’s been happening domestically lit a fire under anybody who’s also worried about some of these, you know, overseas plants not living up to their safety requirements?

Edney: Well, I think there are these scary things happen like a tornado or hurricane and everybody is kind of suddenly paying attention. But I think that the decision-makers in the White House or on Capitol Hill have been paying attention a little bit longer. We’ve seen these cancer — I mean, for a long time not getting anything done, as Sarah mentioned — but recently, it’s sort of I think the initial spark there was these cancer drug shortages that, you know, people not being able to get their chemo. And that was from an overseas factory; that was from a factory in India that had a lot of issues, including shredding all of their quality testing documents and throwing them in a truck, trying to get it out of there before the FDA inspectors could even see it.

Kenen: That’s always very reassuring.

Edney: It is. Yeah. It makes you feel really good. And one bag did not make it out of the plant in time, so they just threw acid on it instead of letting FDA inspectors look at it. So it’s definitely building in this tornado. And what might come out of it if there are a lot of shortages, I haven’t seen huge concern yet from the FDA on that front. But I think that it’s something that just keeps happening. It’s not letting up. And, you know, my colleagues did a really good story yesterday. There’s a shortage of a certain type of penicillin you give to pregnant people who have syphilis. If you pass syphilis on to your baby, the baby can die or be born with a lot of issues — it’s not like if an adult gets syphilis — and they’re having to ration it, and adults aren’t getting treated fully for syphilis because the babies need it more so, and so this is like a steady march that just keeps going on. And there’s so many issues with the industry, sort of how it’s set up, what Sarah was talking about, that we haven’t seen anybody really be able to touch yet.

Rovner: We will continue to stay on top of it, even if nobody else does. Well, that is this week’s news. Now we will play my interview with KFF’s Céline Gounder, and then we will come back and do our extra credit. I am pleased to welcome back to the podcast Dr. Céline Gounder, KFF senior fellow and editor-at-large for public health, as well as an infectious disease specialist and epidemiologist in New York and elsewhere. Céline is here today to tell us about the second season of her podcast, “Epidemic,” which tells the story of the successful effort to eradicate smallpox and explores whether public health can accomplish such big things ever again. Céline, thank you for joining us.

Céline Gounder: It’s great to be here, Julie.

Rovner: So how did you learn about the last steps in the journey to end smallpox, and why did you think this was a story worth telling broadly now?

Gounder: Well, this is something I actually studied back when I was in college in the ’90s, and I did my senior thesis in college on polio eradication, and this was in the late ’90s, and we have yet to eradicate polio, which goes to show you how difficult it is to eradicate an infectious disease. And in the course of doing that research, I was an intern at the World Health Organization for a summer and then continued to do research on it during my senior year. I also learned a lot about smallpox eradication. I got to meet a lot of the old leaders of that effort, folks like D.A. Henderson and Ciro de Quadros. And fast-forward to the present day: I think coming out of covid we’re unfortunately not learning what at least I think are the lessons of that pandemic. And I think sometimes it’s easier to go back in time in history, and that helps to depoliticize things, when people’s emotions are not running as high about a particular topic. And my thought was to go back and look at smallpox: What are the lessons from that effort, a successful effort, and also to make sure to get that history while we still have some of those leaders with us today.

Rovner: Yes, you’re singing my song here. I noticed the first episode is called “The Goddess of Smallpox.” Is there really a goddess of smallpox?

Gounder: There is: Shitala Mata. And the point of this episode was really twofold. One was to communicate the importance of understanding local culture and beliefs, not to dismiss these as superstitions, but really as ways of adapting to what was, in this case, a very centuries-long reality of living with smallpox. And the way people thought about it was that in some ways it was a curse, but in some ways it was also a blessing. And understanding that dichotomy is also important, whether it’s with smallpox or other infectious diseases. It’s important to understand that when you’re trying to communicate about social and public health interventions.

Rovner: Yeah, because I think people don’t understand that public health is so unique to each place. I feel like in the last 50 years, even through HIV and other infectious diseases, the industrialized world still hasn’t learned very well how to deal with developing countries in terms of cultural sensitivity and the need for local trust. Why is this a lesson that governments keep having to relearn?

Gounder: Well, I would argue we don’t even do it well in our own country. And I think it’s because we think of health in terms of health care, not public health, in the United States. And that also implies a very biomedical approach to health issues. And I think the mindset here is very much, oh, well, once you have the biomedical tools — the vaccines, the diagnostics, the drugs — problem solved. And that’s not really solving the problem in a pandemic, where much of your challenge is really social and political and economic and cultural. And so if you don’t think about it in those terms, you’re really going to have a flat-footed response.

Rovner: So what should we have learned from the smallpox eradication effort that might have helped us deal with covid or might help us in the future deal with the next pandemic?

Gounder: Well, I think one side of this is really understanding what the local culture was, spending time with people in community to build trust. I think we came around to understanding it in part, in some ways, in some populations, in some geographies, but unfortunately, I think it was very much in the crisis and not necessarily a long-term concerted effort to do this. And that I think is concerning because we will face other epidemics and pandemics in the future. So, you know, how do you lose trust? How do you build trust? I think that’s a really key piece. Another big one is dreaming big. And Dr. Bill Foege — he was one of the leaders of smallpox eradication, went on to be the director of the CDC [Centers for Disease Control and Prevention] under President [Jimmy] Carter — one of the pieces of advice he’s given to me as a mentor over the years is you’ve got to be almost foolishly optimistic about getting things done, and don’t listen to the cynics and pessimists. Of course, you want to be pragmatic and understand what will or won’t work, but to take on such huge endeavors as eradicating smallpox, you do have to be very optimistic and remind yourself every day that this is something you can do if you put your mind to it.

Rovner: I noticed, at least in the first couple of episodes that I’ve listened to, the media doesn’t come out of this looking particularly good. You’re both a journalist and a medical expert. What advice do you have for journalists trying to cover big public health stories like this, like covid, like things that are really important in how you communicate this to the public?

Gounder: Well, I think one is try to be hyperlocal in at least some of your reporting. I think one mistake during the pandemic was having this very top-down perspective of “here is what the CDC says” or “here is what the FDA says” or whomever in D.C. is saying, and that doesn’t really resonate with people. They want to see their own experiences reflected in the reporting and they want to see people from their community, people they trust. And so I think that is something that we should do better at. And unfortunately, we’re also somewhat hampered in doing so because there’s been a real collapse of local journalism in most of the country. So it really does fall to places like KFF Health News, for example, to try to do some of that important reporting.

Rovner: We will all keep at it. Céline Gounder, thank you so much for joining us. You can find Season 2 of “Epidemic,” called “Eradicating Smallpox,” wherever you get your podcasts.

Gounder: Thanks, Julie.

Rovner: OK, we’re back. It’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Sarah, why don’t you go first this week?

Karlin-Smith: Sure. I took a look at a piece from Brenda Goodman at CNN called “They Took Blockbuster Drugs for Weight Loss and Diabetes. Now Their Stomachs Are Paralyzed,” and it’s a really good deep dive into — people probably have heard of Ozempic, Wegovy — these what are called GLP-1 drugs that have been used for diabetes. And we’ve realized in higher doses even for people without diabetes, they often are very helpful at losing weight, that that’s partially because they slow the passage of food through your stomach. And there are questions about whether for some people that is leading to stomach paralysis or other extreme side effects. And I think it’s a really interesting deep dive into the complicated world of figuring out, Is this caused by the drug? Is it caused by other conditions that people have? And then how should you counsel people about whether they should receive the drugs and the benefits outweighing the risks? So I think it’s like just a good thing for people to read when you sort of hear all this hype about a product and how great they must be, that it’s always a little bit more complicated than that. And it also brought up another aspect of it, which is how these drugs may impact people who are going to get surgery and anesthesia and just the importance of communicating this to your doctor so they know how to appropriately handle the drugs. Because if you still have food content in your stomach during a surgery, that can be extremely dangerous. And I thought just that aspect alone of this story is really interesting, because they talk about people maybe not wanting to even let their doctors know they’re on these drugs because of stigma surrounding weight loss. And just again, once you get a new medicine that might end up being taken by a lot of people, the complications or, you know, there’s the dynamics of how it impacts other parts of medicine, and we need to adjust.

Rovner: Yeah. And I think the other thing is, you know, we know these drugs are safe because people with diabetes have been taking them for, what, six or seven years. But inevitably, anytime you get a drug that lots more people take, then you start to see the outlier side effects, which, if it’s a lot of people, can affect a lot of people. Joanne.

Kenen: I have a piece from FERN, which is the Food & Environment Reporting Network and in partnership with Yale Environ 360, and it’s by Gabriel Popkin. And it’s called “Can Biden’s Climate-Smart Agriculture Program Live Up to the Hype?” And I knew nothing about smart agriculture, which is why I found this so interesting. So, this is an intersection of climate change and food, which is obviously also a factor in climate change. And there’s a lot of money from the Biden administration for farmers to use new techniques that are more green-friendly because as we all know, you know, beef and dairy, things that we thought were just good for us — maybe not beef so much — but, like, they’re really not so good for the planet we live on. So can you do things like, instead of using fertilizer, plant cover crops in the offseason? I mean, there’s a whole list of things that — none of us are farmers, but there’s also questions about are they going to work? Is it greenwashing? Is it stuff that will work but not in the time frame that this program is funding? How much of it’s going to go to big agribusiness, and how much of it is going to go to small farmers? So it’s one hand, it’s another. You know, there’s a lot of low-tech practices. We’re going to have to do absolutely everything we can on climate. We’re going to have to use a variety of — you know, very large toolkit. So it was interesting to me reading about these things that you can do that make agriculture, you know, still grow our food without hurting the planet, but also a lot of questions about, you know, is this really a solution or not? But, you know, I didn’t know anything about it. So it was a very interesting read.

Rovner: And boy, you think the drug companies are influential on Capitol Hill. Try going with big agriculture. Anna.

Edney: I’m going to toot my own horn for a second here —

Rovner: Please.

Edney: — and do one of my mini-investigations that I did, “Mineral Sunscreens Have Potential Hidden Dangers, Too.” So there’s been a lot of talk: Use mineral sunscreen to save the environment or, you know, for your own health potentially. But they’re white, they’re very thick. And, you know, people don’t want to look quite that ghostly. So what’s been happening lately is they’ve been getting better. But what I found out is a lot of that is due to a chemical — that is what people are trying to move away from, is chemical sunscreens — but the sunscreen-makers are using this chemical called butyloctyl salicylate. And you can read the article for kind of the issues with it. I guess the main one I would point out is, you know, I talked to the Environmental Working Group because they do these verifications of sunscreens based on their look at how good are they for your health, and a couple of their mineral ones had this ingredient in it. So when I asked them about it, they said, Oh, whoops; like, we do actually need to revisit this because it is a chemical that is not recommended for children under 4 to be using on their bodies. So there’s other issues with it, too — just the question of whether you’re really being reef-safe if it’s in there, and other things as well.

Rovner: It is hard to be safe and be good to the planet. My story this week is by Amy Littlefield of The Nation magazine, and it’s called “The Anti-Abortion Movement Gets a Dose of Post-Roe Reality.” It’s about her visit to the annual conference of the National Right to Life Committee, which for decades was the nation’s leading anti-abortion organization, although it’s been eclipsed by some others more recently. The story includes a couple of eye-opening observations, including that the anti-abortion movement is surprised that all those bans didn’t actually reduce the number of abortions by very much. As we know, women who are looking for abortions normally will find a way to get them, either in state or out of state or underground or whatever. And we also learned in this story that some in the movement are willing to allow rape and incest exceptions in abortion bills, which they have traditionally opposed, because they want to use those as sweeteners for bills that would make it easier to enforce bans, stronger bans, things like the idea in Texas of allowing individual citizens to use civil lawsuits and forbidding local prosecutors from declining to prosecute abortion cases. We’re seeing that in some sort of blue cities in red states. It’s a really interesting read and I really recommend it. OK. That is our show for this week. As always, if you enjoyed the podcast, you can subscribe where ever 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 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 @jrovner, and I’m on Bluesky and Threads. Joanne.

Kenen: @joannekenen1 at Threads.

Rovner: Sarah.

Karlin-Smith: I’m @SarahKarlin or @sarah.karlinsmith, depending on which of these many social media platforms you’re looking at, though.

Rovner: Anna.

Edney: @annaedney on Twitter and @anna_edneyreports on Threads.

Rovner: You can always find us here next week where we will always be in your podcast feed. Until then, be healthy.

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PhRMA, the brand-drug industry trade group, lost three members over a span of five months following the passage of Democrats’ drug pricing reform law last year. How large members navigate their exits could be instructive to other firms making decisions about their continued membership in the future. Much of PhRMA’s revenue comes from company dues, so exits hurt the group’s bottom line.

Continue to STAT+ to read the full story…

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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.

2023 will likely be remembered as the summer Arizona sizzled, Vermont got swamped, and nearly the entire Eastern Seaboard, along with huge swaths of the Midwest, choked on wildfire smoke from Canada. Still, none of that has been enough to prompt policymakers in Washington to act on climate issues.

Meanwhile, at a public court hearing, a group of women in Texas took the stand to share wrenching stories about their inability to get care for pregnancy complications, even though they should have been exempt from restrictions under the state’s strict abortion ban.

This week’s panelists are Julie Rovner of KFF Health News, Rachel Cohrs of Stat, Shefali Luthra of The 19th, and Alice Miranda Ollstein of Politico.

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Shefali Luthra
The 19th

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Alice Miranda Ollstein
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Among the takeaways from this week’s episode:

• Tensions over abortion access between the medical and legal communities are coming to the fore in the courts, as doctors beg for clarification about bans on the procedure — and conservative state officials argue that the law is clear enough. The risk of being hauled into court and forced to defend even medically justified care could be enough to discourage a doctor from providing abortion care.
• Conservative states are targeting a Biden administration effort to update federal privacy protections, which would make it more difficult for law enforcement to obtain information about individuals who travel outside a state where abortion is restricted for the procedure. Patient privacy is also under scrutiny in Nebraska, where a case involving a terminated pregnancy is further illuminating how willing tech companies like Meta are to share user data with authorities.
• And religious freedom laws are being cited in arguments challenging abortion bans, with plaintiffs alleging the restrictions infringe on their religious rights. The argument appears to have legs, as early challenges are being permitted to move forward in the courts.
• On Capitol Hill, key Senate Democrats are holding up the confirmation process of President Joe Biden’s nominee as director of the National Institutes of Health to press for stronger drug pricing reforms and an end to the revolving-door practice of government officials going to work for private industry.
• And shortages of key cancer drugs are intensifying concerns about drug supplies and drawing attention in Congress. But Republicans are skeptical about increasing the FDA’s authority — and supply-chain issues just aren’t that politically compelling.

Also this week, Rovner interviews Meena Seshamani, director of the Center for Medicare at the Centers for Medicare & Medicaid Services at the Department of Health and Human Services.

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

Julie Rovner: Los Angeles Times’ “Opinion: Crushing Medical Debt Is Turning Americans Against Their Doctors,” by KFF Health News’ Noam N. Levey.

Rachel Cohrs: The New York Times’ “They Lost Their Legs. Doctors and Health Care Giants Profited,” by Katie Thomas, Jessica Silver-Greenberg, and Robert Gebeloff.

Alice Miranda Ollstein: The Atlantic’s “What Happened When Oregon Decriminalized Hard Drugs,” by Jim Hinch.

Shefali Luthra: KFF Health News’ “Medical Exiles: Families Flee States Amid Crackdown on Transgender Care,” by Bram Sable-Smith, Daniel Chang, Jazmin Orozco Rodriguez, and Sandy West.

Also mentioned in this week’s episode:

• Stat’s “From Rapid Cooling Body Bags to ‘Prescriptions’ for AC, Doctors Prepare for a Future of Extreme Heat,” by Karen Pennar.
• Politico’s “The Sleeper Legal Strategy That Could Topple Abortion Bans,” by Alice Miranda Ollstein.

click to open the transcript

Transcript: Let’s Talk About the Weather

KFF Health News’ ‘What the Health?’Episode Title: Let’s Talk About the WeatherEpisode Number: 306Published: July 20, 2023

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

Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, July 20, 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: Hello.

Rovner: Rachel Cohrs, of Stat News.

Rachel Cohrs: Hi, everybody.

Rovner: And Shefali Luthra of The 19th.

Shefali Luthra: Hello.

Rovner: Later in this episode we’ll have my interview with Meena Seshamani, director of the Center for Medicare at the Center for Medicare & Medicaid Services at the Department of Health and Human Services. She has an update on drug price negotiations, Medicare Advantage payments, and more. But first, this week’s news. So let’s talk about the weather. Seriously, this summer of intense heat domes in the South and Southwest, flash floods in the East, and toxic air from Canadian wildfires almost everywhere below the border has advertised the dangers of climate change in a way scientists and journalists and policymakers could only dream about. The big question, though, is whether it will make any difference to the people who can actually do something about it. I hasten to point out here that in D.C., it’s normal — hot and humid for July, but nothing particularly out of the ordinary, especially compared to a lot of the rest of the country. Is anybody seeing anybody on the Hill who seems at the least alarmed by what’s going on?

Ollstein: Not other than those who normally speak out about these issues. You’re not seeing minds changed by this, even as the reports coming out, especially of the Southwest, are just devastating — I mean, especially for unhoused people, just dying. I was really interested in the story from Stat about doctors moving to start prescribing things to combat heat, like prescribing air conditioners, prescribing cooling packs and other things, really looking at heat as a medical issue and not just a feature of our lives that we have to deal with.

Rovner: Well, emergency rooms are full of patients. You can now burn yourself walking on the sidewalk in Arizona. You know, last summer was not a great summer for a lot of people, particularly in California and in western Canada. But this year, it’s like everywhere across the country, everybody’s having something that’s sort of, oh, a hundred-year something or a thousand-year something. And yet we just sort of continue on blithely.

Ollstein: And just quickly, what really hits me is how much of a vicious cycle it can create, because the more people use air conditioners, those give off heat and make the bigger situation worse. So making it better for yourself makes it worse for others. Same with driving. You know, the worse the weather is, the more people have to drive rather than bike or walk or take public transit. And so it gets into this vicious cycle that can make it worse for everyone and create these so-called heat islands in these cities.

Rovner: All right. Well, let us move on to a more familiar topic: abortion and reproductive health. In case you’re wondering why it’s hard to keep track of where abortion is legal, where it’s banned, and where it’s restricted, let’s talk about Iowa. When we last checked in, last week, state lawmakers had just passed a near-total ban after the state Supreme Court deadlocked over a previous ban and the Republican governor, Kim Reynolds, was poised to sign it. Then what happened?

Luthra: The governor signed the ban right as the hearing for the ban concluded in which Planned Parenthood and another abortion clinic in the state sued, arguing, right, that this is the exact same as the law that was just struck down and therefore should be struck down again. And this judge said that he wouldn’t rush to his ruling. He wanted to, you know, give it the time that it deserved so he wouldn’t be saying anything on Friday, which meant as soon as the law was signed, it took effect. It was in effect for maybe a little over 72 hours, essentially through the weekend. And then on Monday, the judge came and issued a ruling blocking the law. And even that is temporary, right? It only lasts as long as this case is proceeding. And one of the reasons Republicans came back and passed this ban is they are hopeful that something has changed and that this time around the state Supreme Court will let the six-week ban in Iowa stand, which really just would have quite significant implications for the Midwest, where it’s been kind of slower to restrict abortion than the South has been because of the role the courts have played in Ohio, in Iowa, blocking abortion bans, and we could very soon see restrictions in Iowa, in Indiana, potentially in Ohio, depending on how the election later this year goes. And it will look like a very different picture than it did even six months ago.

Rovner: And for the moment, abortion is legal in Iowa, right?

Luthra: Correct.

Rovner: Up to 20 weeks?

Luthra: Up to 20, 22, depending on how you count.

Rovner: But as you say, that could change any day. And it has changed from day to day as we’ve gone on. Well, if that’s not confusing enough, there are a couple of lawsuits that went to court in Texas and Missouri, and neither of them is actually challenging an abortion ban. In Texas, women who were pregnant and unable to get timely care for complications are suing to clarify the state’s abortion ban so patients don’t have to literally wait until they are dying to be treated. And in Missouri, there’s a fight between two state officials over how to describe what a proposed state ballot measure would do, honestly. So what’s the status of those two suits? Let’s start with Texas. That was quite a hearing yesterday.

Luthra: It is really devastating to watch. And the hearing continues today, Thursday. And we are hearing from these women who wanted to have their pregnancies, developed complications where they knew that the fetus would not be viable, could not get care in the state. One of them who came to the State of the Union earlier this year, she had to wait until she was septic before she could get care. Another woman traveled out of state. Another one had to give birth to a baby that died four hours after being born, and she knew that this baby wouldn’t live. And it’s really striking to watch just how obviously difficult it is for these women to relive this thing that happened to them, clearly one of the worst things in their lives, maybe the worst thing. And the state’s arguments are very interesting, too, because they appear to be trying to suggest that it is actually not that the law is unclear, but that doctors are just not doing their jobs and they should do, you know, the hard work of medicine by understanding what exceptions mean and interpreting laws that are always supposed to be a little ambiguous.

Ollstein: So when states were debating abortion bans and really Republicans were tying themselves in knots over this question of exemptions — How should the exemptions be worded? Should there be any exemptions at all? Who should they apply to? — a lot of folks on the left were yelling at the time that that’s the wrong conversation, that exemptions are unworkable; even if you say on paper that people can get an abortion in a medical emergency, it won’t work in practice. And this is really fodder for that argument. This is that argument playing out in real life, where there is a medical exemption on the books, and yet all of these women were not able to get the care they needed, and some have suffered permanent or somewhat permanent repercussions to their health and fertility going forward. As more states debate their own laws, and some states with bans have even tried to go back and clarify the exemptions and change them, I wonder how much this will impact those debates.

Rovner: Yeah, I mean, if you just say that doctors are being, you know, cowards basically by not providing this care, think of it from the doctor’s point of view, and now we see why hospital lawyers are getting involved. Even if there’s a legitimate medical reason, they could get dragged into court and have to pay tens or hundreds of thousands of dollars in legal fees just to prove that their medical judgment was correct. You can kind of see why doctors are a little bit reluctant to do that.

Ollstein: And just to stress, these laws were not written by doctors. These laws were written by politicians, and they include language that medical groups have pointed out doesn’t translate to the actual practice of medicine. Some of these bans’ exceptions’ language use terms like irreversible, and they’re like, “That’s not something we say in medicine. That doesn’t fit with our training. We don’t think in terms of that.” Also, terms like life-threatening: It’s like, OK, well, is it imminently life-threatening? And even then, what does that mean? How close does someone need to be to losing their life in order to act?

Rovner: And pregnancy itself is life-threatening.

Ollstein: Right. Or something could be life-threatening in a longer-term way, you know, down the road. Other conditions like diabetes or cancer could be life-threatening even if it won’t kill you today or tomorrow. So this is a real battle where medicine meets law.

Rovner: Well, in Missouri, it’s obviously not nearly as dramatic, but it’s also — you can see how this is playing out in a lot of these states. This is basically a fight between the state attorney general and the state auditor over how much an abortion ban might end up costing the state. They’re really sort of fighting this as hard as they can. It’s basically to make it either more or less attractive to voters, right?

Ollstein: It’s similar to some of the gambits we saw in Michigan to keep the measure off the ballot or put it on the ballot in a way that some would say would be misleading to voters. So I think you’re seeing this more and more in these states after so many states, including pretty conservative states, voted in favor of abortion rights last year. You know, the right is afraid of that continuing to happen, and so they’re looking at all of these technical ways — through the courts, through the legislatures, whatever means they can — to influence the process. And Democrats cry that this is antidemocratic, not giving people a say. Republicans claim that they’re preventing big-money outside groups from influencing the process. And I think this is going to be a huge battle. Missouri and Ohio are up next in terms of voting. And after that, you have Florida and Nevada and a bunch of other states in the queue. And so this is going to continue to be something we’re discussing for a while.

Luthra: And to flag the case in Ohio, what’s happening there, right, is the state is having voters vote onto whether to make it harder to pass constitutional amendments. There’s an election in August that would raise the threshold to two-thirds. And what we know from all of the evidence why they don’t typically have August referenda in Ohio is because the turnout is very, very low, and they are expecting that to be very low. And they’ve made it explicit that the reason they want to make it harder to pass constitutional amendments is, in fact, the concern around Ohio’s proposed abortion protection.

Rovner: Of course, that’s what they said about Kansas last year, that people wouldn’t vote because it was in the summer, so — but this is a little bit more obtuse. This is whether or not you’re going to change the standard for passing constitutional change that would enshrine abortion. So, yeah, clearly —

Luthra: It’s hard to get people excited about votes on voting.

Rovner: Yeah, exactly. An underlying theme for most of this year has been efforts by states that restrict or ban abortion to try to prevent or at least keep tabs on patients who leave the state to obtain a procedure where it is legal. Attorneys general in a dozen and a half states are now protesting a Biden administration effort to protect such information under HIPAA, the medical records privacy provisions of the Health Insurance Portability and Accountability Act. Alice, you’ve written about this. What would the HIPAA update do, and why do the red states oppose it?

Ollstein: The HIPAA update, which was proposed in April, and comment closed in June, and so we’re basically waiting for a final rule — at some point, you know, it can take a while — but it would make it harder for either law enforcement or state officials to obtain medical information about someone seeking an abortion, either out of state or in state under one of these exemptions. This would sort of beef up those protections and require a subpoena or some form of court order in order to get that data. And you have sort of an interesting pattern playing out, which you’ve seen just throughout the Biden administration, where the Biden administration hems and haws and takes an action related to abortion rights and the left says it’s not good enough and the right says it’s wild overreach and unconstitutional and they’re going to sue. And so that’s what I was documenting in my story.

Rovner: Is it 18 red states saying —

Ollstein: Nineteen, yes, yeah.

Rovner: Nineteen red states saying that this is going too far.

Ollstein: They say they want to be able to obtain that data to see if people are breaking the law.

Rovner: Well, Shefali, you wrote this week about sort of a related topic, whether states can use text or social media messages as evidence of criminal activity. That sounds kind of chilling.

Luthra: Yeah, and this is, I think, a really interesting question. We saw it in this case in Nebraska, where a sentencing for one of the defendants is happening today in fact. And I want to be careful in how I talk about this because it concerns a pregnancy that was terminated in April of 2022, before Roe was even overturned. But it sort of offered this test case, this preview for: If you do have law enforcement going after people who have broken a state’s abortion laws, how might they go about doing that? What statutes do they use to prosecute? And what information do they have access to? And the answer is potentially quite a lot. Organizations like Meta and Google are quite cooperative when it comes to government requests for user data. They are quite willing to give over history of message exchanges, history of your searches, or of, you know, where you were tracked on Google Maps. And the bigger question there is how likely are we to see individual prosecutors, individual states, going after patients and their families, their friends for breaking abortion laws? Right now, there’s been some hesitation to do that because the politics are so terrible. But if they do go in that direction, people’s internet user data is, in most states, unprotected. There is no federal law protecting, you know, your Facebook messages. And it could be quite a useful piece of information for people trying to build a case, which should raise concern for anyone trying to access care.

Rovner: Yeah, this is exactly why women were taking their period-tracking apps off of their phones, to worry about the protection of quite personal information. Well, finally this week on the abortion front, we have talked so, so much about how conservative Christians complain that various abortion and even birth control laws violate their religious beliefs. Well, now representatives of several other religions, including Judaism and even some of the more liberal branches of Christianity, say that abortion bans violate their right to practice their religion. This is going on in a bunch of different states. I think the first one we talked about was Florida, I think a year ago. Are any of these lawsuits going anywhere? Do we expect this to end up before the Supreme Court at some point?

Ollstein: So most of them are in state court, not federal. I mean, it’s always possible it could go to the Supreme Court. A couple of them are in federal court and a couple of them have already reached the appeals court level. But the experts I talked to for my story on this said this is mainly going to have an impact in state courts and how they interpret state constitutions. A lot of states have stronger language around religious protections than the federal Constitution, including some laws that pretty conservative state leaders passed in the last few years, and I doubt they expected that same language would be cited to defend abortion rights. But here we are. And yeah, a Missouri court recently ruled that the lawsuit can go forward, the religious challenge to the state’s abortion ban. It’s a coalition of a bunch of different faith leaders bringing that challenge. And in Indiana, they won a preliminary ruling on that case. And there are others pending in Kentucky, Florida, a bunch of other states. And so, yeah, I think this definitely has legs.

Rovner: Yeah, we’re all learning an awful lot about court procedure in lots of different states. Let us move to Capitol Hill, where Congress is in its annual July race to the August recess. Seriously, this is actually a month in which Congress typically does get a lot done. Maybe not so much this year. One perhaps unexpected holdup in the U.S. Senate is where the confirmation of Monica Bertagnolli, President Biden’s nominee to head the National Institutes of Health, is being held up not by a Republican but by two Democrats: health committee chair Bernie Sanders, another member of the committee, Elizabeth Warren. Rachel, what is going on with this?

Cohrs: Sen. Bernie Sanders has long wanted the Biden administration to be more aggressive on drug pricing. And there is one issue in particular that Sen. Sanders has wanted the NIH specifically to use to challenge drug companies’ patents or at least put some pricing protections in there for drugs that are developed using publicly funded research. And the laws that the NIH potentially could use to challenge these companies for high-priced medications have never been used in this way. And Sen. Sanders is using his bully pulpit and the main leverage he has, which is over nominations, to get the White House’s attention. And I think the White House’s position here is that they have done more than any administration in the past 20 years to lower drug prices.

Rovner: Which is true.

Cohrs: It is true. And — but Sen. Sanders still is not satisfied with that and wants to see commitments from the White House and from NIH to do more.

Rovner: And Sen. Elizabeth Warren.

Cohrs: Sen. Elizabeth Warren, yes, who my colleague Sarah Owermohle first reported had some concerns over the revolving door at NIH and wanted a commitment that the nominee wouldn’t go to lobby or work for a large pharmaceutical company for four years after leaving the position, and I don’t know that she’s agreed to that yet. So I don’t see where this resolves. It’s tough, because we’re looking so close to an election, and I think there are big questions about what breaks this logjam. But it certainly has slowed down what looked like a very smooth and noncontroversial nomination process.

Rovner: Yeah, I mean, obviously, you know, we’ve seen many, many times over the years nominations held up for other reasons — I mean, basically using them as leverage to get some policy aim. It’s more rare that you see it on the president’s own party but obviously, you know, not completely unprecedented. Certainly in this case we have a lot of things to be worked out there. Well, Sen. Sanders also seems to be threatening the reauthorization of one of his very pet programs, the bipartisanly popular community health centers. His staff this week put out a draft bill and announced a markup before sharing it with Republicans on the committee. Now Ranking Member Bill Cassidy, who also supports the community health centers program — almost everybody in Congress supports the community health centers program — Cassidy complains there’s no budget score, that the bill includes programs from outside the committee’s jurisdiction, and other details that can be very important. Is Sanders trying to make things partisan on purpose, or is this just sloppy staff work?

Cohrs: Honestly, I can’t answer that question for you, but I don’t think that it’s going to result in a productive outcome for the community health centers. And I think we have in recent years seen significant cooperation between the chair and ranking member, but with Lamar Alexander, with Richard Burr, with Patty Murray, you know, we have seen a lot civility on this committee in the recent past, and that appears to have ended. And I think Sen. Cassidy’s response that he hadn’t seen the legislation publicly was, I think, telling. We don’t usually see that kind of public fighting from a committee chair.

Rovner: He put out a press release.

Cohrs: Right, put out a press release. Yeah. This is not what we usually see in these committees. And it is true that Sen. Sanders’ bill is so much more money than I think is usually given to community health centers in this reauthorization process. I think it’s true that the bill that he dropped touches issues that would anger almost every other stakeholder in the health care system. And I don’t think Sen. Cassidy quite envisioned that. And he introduced his own bill that would have introduced —

Rovner: Cassidy introduced his own bill.

Cohrs: Yes, Sen. Cassidy introduced his own bill last week that would have continued on with what the House Energy and Commerce Committee had passed unanimously earlier this summer to give community health centers a more modest boost in funding for two years.

Rovner: And obviously, there’s some urgency to this because the authorization runs out at the end of September and now we’re in July and they’re going to go away for August. So this is obviously something else that we’re going to need to keep a fairly close eye on. Well, meanwhile, elsewhere, as in at the Senate Finance Committee, which oversees Medicare and Medicaid, we’re starting to see legislation to regulate PBMs — pharmacy benefit managers — or are we? Rachel, we’ve come at this several times this year. How close are we getting?

Cohrs: We’re getting closer. And I think that two key committees are really feeling the heat to get their proposals out there before the end of the year. The first, like you mentioned, was the Senate Finance Committee, which is planning a markup next week, right before senators leave for August recess. They’ve asked for feedback from CBO [the Congressional Budget Office] around the end of August recess so that they’ll be ready to go. But I think it’s no secret that their delay in marking anything up or introducing anything has slowed down this process. And in the House, I know the Ways and Means Committee is trying to put together their own proposal and find time for a markup, whereas the House Energy and Commerce Committee, which also has jurisdiction over many of these issues, is frustrated, because they got their bill introduced, they had all the full regular order of subcommittee and then full committee hearings and then markups, got this bill unanimously out of their committee, and now everyone’s kind of waiting around on these two committees with jurisdiction over the Medicare program to see what they’re going to put together before any larger package can be compiled.

Rovner: Well, you know things are heating up when you start seeing PBM ads all over cable news. So even if you don’t understand what the issue is, you know that it’s definitely in play on Capitol Hill. Well, while we’re on the subject of drug prices, we have another lawsuit trying to block Medicare’s drug price negotiation, this one filed by Johnson & Johnson. Why so many? Wouldn’t these drug companies have more clout if they got together on one big suit, or is there some strategy here to spread it out and hope somebody finds a sympathetic judge?

Ollstein: Yes, I think the latter is exactly what they’re doing, because if they were to all kind of band together, then it would be putting all their eggs in one basket. And this way we see most of the companies have filed in different jurisdictions. I think Johnson & Johnson did file in the same court as Bristol Myers Squibb did, so I think it’s not a perfect trend. But generally what we are seeing is that the trade groups like the [U.S.] Chamber of Commerce and PhRMA [the Pharmaceutical Research and Manufacturers of America] kind of have their own arguments that they’re making in different venues. The drug manufacturers themselves have their own arguments that they’re making in their own venues, and they’re spreading out across the country in some typically more liberal courts and circuits and some more conservative. But I think that it’s important to note that the Chamber of Commerce so far is the only one that’s asked for a preliminary injunction, in Ohio. That is kind of the motion that, if it’s approved, could potentially put a stop to this program even beginning to go into effect. So they’ve asked for that by Oct. 1.

Rovner: And remember, I guess we’re supposed to see the first 10 drugs from negotiation in September, right?

Cohrs: By Sept. 1, yes.

Rovner: By Sept. 1.

Cohrs: Pretty imminently here.

Rovner: Also happening soon. Well, before we stop with the news this week, I do want to talk briefly about drug shortages. This has come up from time to time, both before and during the pandemic, obviously, when we had supply chain issues. But it seems like something new is happening. Some of these shortages seem to be coming because generic makers of some drugs just don’t find them lucrative enough to continue to make them. Now we’re looking at some major shortages of key cancer drugs, literally causing doctors to have to choose who lives and who dies. Are there any proposals on Capitol Hill for addressing this? It’s kind of flying below the radar, but it’s a pretty big deal.

Cohrs: I think we’ve seen Congressman Frank Pallone make this his pet issue in the reauthorization of PAHPA [Pandemic and All-Hazards Preparedness Act], which is the pandemic preparedness bill, which also expires on Sept. 30. So, you know, they have a full plate.

Rovner: Which we will talk about next week because they’re marking it up today.

Cohrs: Exactly. Yes. So but what we have seen is that Democrats in the House Energy and Commerce Committee have made this a top priority to at least have something on drug shortages in PAHPA. And I think my colleague John Wilkerson watched a hearing this week and noted that the chair of the committee, Cathy McMorris Rodgers, seemed more open to adding something than she had been in the past. But again, I think it’s kind of uncertain what we’ll see. And Sen. Bernie Sanders did add a couple of drug shortage policies to his version of PAHPA in the HELP Committee [Senate Committee on Health, Education, Labor and Pensions]. So I think we are seeing some movement on at least some policies to address it. But the problem is that the supply chain is not sexy and Republicans are not crazy about the idea of giving the FDA more authority. I think there is just so much skepticism of these public health agencies. It’s a hard systemic issue to crack. So I think we may see something, but it’s unclear whether any of this would provide any immediate relief.

Rovner: Everybody agrees that there’s a problem and nobody agrees on how to solve it. Welcome to Capitol Hill. OK, that is this week’s news. Now we will play my interview with Medicare chief Meena Seshamani, and then we’ll come back and do our extra credit. I am pleased to welcome to the podcast Meena Seshamani, deputy administrator and director of the Center for Medicare at the Centers for Medicare & Medicaid Services at the Department of Health and Human Services. That must be a very long business card.

Meena Seshamani: [laughs]

Rovner: Translated, that means she’s basically in charge of the Medicare program for the federal government. She comes to this job with more than the requisite experience. She is a physician, a head and neck surgeon in fact, a PhD health economist, a former hospital executive, and a former top administrator there at HHS. Meena, welcome to “What the Health?” We are so happy to have you.

Seshamani: Thank you so much for having me, Julie.

Rovner: So, our podcast listeners will know, because we talk about it so much, that the biggest Medicare story of 2023 is the launch of a program to negotiate prescription drug prices and hopefully bring down the price of some of those drugs. Can you give us a quick update on how that’s going and when patients can expect to start to see results?

Seshamani: Absolutely. The new prescription drug law, the Inflation Reduction Act, really has made historic changes to the Medicare program. And to your point, people are seeing those results right now. There is now a $35 cap on what someone will pay out-of-pocket for a month’s supply of covered insulin at the pharmacy, which is huge. I’ve met with people all over the country. Sometimes people are spending up to $400 for a month’s supply of this lifesaving medication. Also, vaccines at no cost out-of-pocket. And a lot of this leads to what you’re mentioning with the drug negotiation program, a historic opportunity for Medicare to negotiate drugs. In January, we put out a timeline of the various pieces that we’re putting in place to stand up this negotiation program. Along that timeline, we have released guidance that describes the process that we will undergo to negotiate, what we’ll think about as we’re engaging in negotiation. And the first 10 drugs for negotiation that are selected will be announced on Sept. 1. And that will then lead into the negotiation process.

Rovner: And as we’ve mentioned — I think it was on last week’s podcast — there’s a lot of lawsuits that are trying to stop this. Are you confident that you’re going to be able to overcome this and keep this train on the tracks?

Seshamani: Well, we don’t generally comment on the lawsuits. I will say that we are implementing this law in the most thoughtful manner possible. From the day that the law was enacted, we have been meeting with drug manufacturers, health plans, patient groups, health care providers, you know, experts in the field, to really understand the complexity of the drug space and what we can do with this opportunity to really improve things, improve access and affordability to have innovative therapies for the cures that people need.

Rovner: Well, while we are on that subject, we — not just Medicare, but society at large — is facing down a gigantic conundrum. The good news is that we’re finally starting to see drugs that can treat or possibly cure such devastating ailments as Alzheimer’s disease and obesity. But those drugs are currently so expensive, and the population that could benefit from them is so large, they could basically bankrupt the entire health care system. How is Medicare approaching that? Obviously, in the Alzheimer’s space, that could be a very big deal.

Seshamani: Well, Julie, we are committed to helping ensure that people have timely access to innovative treatments that can lead to improved care and better outcomes. And in doing this, we take into account what the Medicare law enables coverage for and what the evidence shows. So with Alzheimer’s, CMS underwent a national coverage determination. And consistent with that, Medicare is covering the drug when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry. And this is very important because it will enable us to gather more information on patient outcomes as we continue to see innovations in this space. And you mentioned obesity. In the Medicare law, there is a carve-out for drugs for weight loss.

Rovner: A carve-out meaning you can’t cover them.

Seshamani: Correct. It says that the Medicare Part D prescription drug program will not cover drugs for weight loss. So we are looking at the increasing evidence. And for example, where there is a drug that is used for diabetes, for example, you know, then it can certainly be covered. And this is an area that we are continuing to partner with our colleagues in the FDA on and that we’d like to partner with the broader community to continue to build the evidence base around benefits for the Medicare population as we continue to evaluate where we want to make sure that people have access.

Rovner: But are you thinking sort of generally about what to do about these drugs that cost sometimes tens of thousands of dollars a year, hundreds of thousands of dollars a year, that half the population could benefit from? I mean, that cannot happen, right, financially?

Seshamani: Well, Julie, this is where the new provisions in the new drug law really come into play. Thinking from access for people for the high-cost drugs, I think we all know what a financial strain the high cost of drugs have created for our nation’s seniors, where now, in 2025, there will be a $2,000 out-of-pocket cap, that people will not have to pay out-of-pocket more than $2,000, which enables them to access drugs. And on the other side, as we talked about with drug negotiation, where for drugs that have been in the market for seven years or 11 years, if they are high-cost drugs, they could potentially be selected for negotiation where we can then, you know, as we laid out in the guidance that we put out, look at what is the benefit that this drug provides to a population? What are the therapeutic alternatives? And then also consider things like what’s the cost of producing that drug and distributing it? How much federal support was given for the research and development of that drug? And how much is the total R & D costs? So I think that there are several tools that we’ve been given in the Inflation Reduction Act that demonstrate how we are continuing to think about how we can ensure that Medicare is delivering for people now and in the future.

Rovner: Well, speaking of things that are popular but also expensive, let’s talk briefly about Medicare Advantage. More and more beneficiaries are opting for private plans over traditional, fee-for-service Medicare. But the health plans have figured out lots of ways to game the system to make large profits basically at taxpayers’ expense. Is there a long-term plan for Medicare Advantage or are we just going to continue to play whack-a-mole, trying to plug the loopholes that the plans keep finding?

Seshamani: You know, as now we have 50% of the population in Medicare Advantage, Medicare Advantage plays a critical role in advancing our vision for the Medicare program around advancing health equity, expanding access to care, driving innovation, and enabling us to be good stewards of the Medicare dollar. And that vision that we have is reflected in all of the policies that we have put forward to date. And I might add that those policies really have been informed by engagement with everyone who’s interested in Medicare Advantage. We did a request for comment and got more than 4,000 suggestions from people. This has now come out in recent policies like cracking down on misleading marketing practices so that people can get the plan that best suits their needs; ensuring clear rules of the road for prior authorization and utilization management so we can make sure that people are accessing the medically necessary care that they need; things like improving network adequacy, particularly in behavioral health, so people can access the health care providers in the networks of the plans; and then the work that we’re doing around payment, to make sure that we’re paying accurately, updating the years that we use for data, looking at the coding patterns of Medicare Advantage. And again, this is all work that is important to make sure that the program is really serving the people in the Medicare program.

Rovner: So, as you know, we’ve done big investigative projects here at KFF Health News about both medical debt and nonprofit hospitals not living up to their responsibilities to the community. As the largest single payer of hospitals, what is Medicare doing to try and address requirements for charity care, for example?

Seshamani: Well, the. IRS oversees the requirements for community benefit, which is how hospitals maintain or get a nonprofit status. We have certainly worked with the Consumer Financial Protection Bureau and the Department of Treasury on, for example, issuing a request for information, seeking public comment on, you know, medical credit cards. But even beyond that, I think this is an example of where we need to bring more payment accuracy and transparency in the health care system. So, for example, we have recently just proposed strengthening hospital price transparency so that people can know what is the cost of services, standard charges that hospitals provide. We also are adding quality measures to hospitals, particularly around issues around health equity, making sure that hospitals are screening patients for social needs. And we’re also tying increasingly our payment programs to making sure that those underserved populations are receiving excellent care, so again, really trying to drive transparency, quality, and access through all of the work that we’re doing with hospitals.

Rovner: But can you leverage Medicare’s power? Obviously, you know, that was what created EMTALA [the Emergency Medical Treatment and Labor Act], was leveraging Medicare’s power. Can you leverage it here to try and push some of these hospitals to do things they seem reluctant to do?

Seshamani: Where we have our levers in the Medicare program, we absolutely are working with hospitals around issues of equity, so as I mentioned, you know, really embedding equity not only in our quality requirements but also in hospital operations — for example, that as part of their operations they need to be looking at health equity. You know, where we are looking at how they are providing care and addressing issues of patient safety. So, we continue to look into all of these angles, and where we can support good practices. For example, we just proposed in our inpatient prospective payment system rule that when hospitals are taking care of homeless patients, that can be considered in their payment, because we have found through our analyses that additional resources are being used to make sure that those patients are supported for all of their needs, and we’re encouraging hospitals to code for these social needs so that we can continue to assess with them where resources and supports are needed to provide the kind of care that we all want for our populations.

Rovner: Last question, and I know that this is big, so it’s almost unfair. One of the reasons we know that it’s getting so expensive to manage medical costs is the increasing involvement of private equity in health care. What’s the Biden administration doing to address this growing profit motive?

Seshamani: Yeah, Julie, I’ll come back to, you know, what I alluded to before around transparency. We are really committed to transparency in health care, and we are continuing to focus on gathering data that sheds light on what is happening in the health care market so that we can be good stewards of the taxpayer dollar. So I mentioned our work in hospital price transparency, where we have streamlined the enforcement process; we have proposed to require standard ways that hospitals are reporting their charges and standard locations where they have to put a footer on the hospital’s homepage so that people can find that data easily. In Medicare Advantage, we are requiring more reporting for the medical loss ratio for plans to report spending on supplemental benefits like dental, vision, etc. And we really want to hone in on where else we can gather more data to be able to enable all of us to see what is happening in this dynamic health care market; what’s working? What isn’t? And so we’re very interested in getting ideas.from everyone of where more data can be helpful to enable us to then enact policies that can make sure that the health care industries and the market are really serving people in the most effective way possible.

Rovner: Well, you’ve got a very big job, so I will let you get back to it. Thank you so much, Meena Seshamani.

Seshamani: Thank you for having me.

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 kffhealthnews.org and in our show notes on your phone or other mobile device. Shefali, why don’t you go first this week?

Luthra: Sure. So mine is from KFF Health News by a dream team, Bram Sable-Smith, Daniel Chang, Jazmin Orozco Rodriguez, and Sandy West. The headline is “Medical Exiles: Families Flee States Amid Crackdown on Transgender Care.” And I mean, it’s exactly what it sounds like. It’s this really person-grounded, quite deeply reported story about how restrictions on gender-affirming health care, especially for young people, are forcing families to leave their homes. And this is a really tough thing for people to do, you know, leave somewhere where you’ve lived for 10 years or longer and go somewhere where you don’t have ties. Moving is quite expensive. And I think this is a really important look at something that we anecdotally know is happening, haven’t seen enough really great deep dives on, and is something that potentially will happen more and more as people are forced to leave their homes if they can afford to do so because they don’t feel safe there anymore.

Rovner: Yeah, and this is the issue of doing these social issues state by state by state, just what’s happening now. Alice.

Ollstein: So I chose a piece from The Atlantic called “What Happened When Oregon Decriminalized Hard Drugs,” by Jim Hinch. It was really fascinating. On the one side, they say this is evidence that the policy has failed, that decriminalizing possession of small amounts of cocaine, heroin, all hard drugs, has been a failure because overdoses have actually gone up since then. But other experts quoted in this article say that, look, we tried the punitive war on drugs model for decades and decades and decades before declaring it a failure; how can we evaluate this after just a few years? It just takes more time to make this transition and takes more time to, you know, ramp up treatment and services for people, and because this happened three years ago, it was disrupted by the pandemic and, you know, services were not able to reach people, etc. So a really fascinating look.

Rovner: Yes, it’s quite the social experiment that’s going on in Oregon. Rachel.

Cohrs: So mine is from The New York Times, a group of reporters and a new series called “Operating Profits.” And the headline is “They Lost Their Legs. Doctors and Health Care Giants Profited.” And I think I’m just really excited to see more about this line of reporting about overutilization in health care and how certain payment incentives — I mean, they made a story about payment incentives in hospital outpatient departments and how pay rates change really personal and interesting, and it’s important. So, I mean, all these really dense rules that we’re seeing drop this summer do really have implications for patients. And there are bad actors out there who are kind of capitalizing on that. So I felt it was like really responsible reporting, mostly focused on one physician who, you know, was doing procedures that he shouldn’t have and other doctors ultimately were left to clean up the damage for these patients. And they had amputations that they maybe shouldn’t have had, which is such a serious and devastating consequence. I thought that was very important reporting, and I’m excited to see what’s next.

Rovner: Yeah, I’m looking forward to seeing the rest of the series. Well, my story this week is in the Los Angeles Times from my KFF Health News colleague Noam Levey, who’s been working on a giant project on medical debt. It’s called “Crushing Medical Debt Is Turning Americans Against Their Doctors.” And it points out something I hadn’t really thought about before, that outrageous and unexpected bills are undermining public confidence in medical providers and the medical system writ large. And so far, nobody’s doing very much about it. To quote from Noam’s piece, “Hospitals and doctors blame the government for underpaying them and blame insurers for selling plans with unaffordable deductibles. Insurers blame providers for obscene prices. Everyone blames drug companies.” Well, it’s going to take a lot of time to dig out of this hole, but probably it would help if everybody stopped digging. OK. That is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks, as always, to our 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 @jrovner, and I’m on Threads @julie.rovner. Shefali.

Luthra: I’m @shefalil.

Rovner: Alice.

Ollstein: @AliceOllstein.

Rovner: Rachel.

Cohrs: I’m @rachelcohrs.

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

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The reasons can vary, from quality control failures at manufacturing plants to surging demand, including significant interest that has at times squelched availability of drugs taken for weight loss.

But the problem is not easily fixed. Most active pharmaceutical ingredients are made in China, and boosting production in the U.S. is not like flipping a switch. Many of the drugs in short supply are generics made in India, where regulators often find serious production lapses. So what to do? Along with a colleague, Marta Wosińska, a senior fellow in economic studies at The Brookings Institution, has three ideas to alleviate shortages of generic sterile injectable medicines, in particular. They suggest the U.S. government should provide incentives to upgrade facilities and create a buffer inventory. But they also argue hospital purchasing is in need of an overhaul. We discussed the possibilities; our conversation has been lightly edited. 

I’ve been writing about drug shortages on and off for many years, but the problem never goes away. And now, it seems even worse. Obviously, something has to change. But what exactly has been lacking with our policies to date?

Continue to STAT+ to read the full story…