The HostJulie 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.
This week, the eyes of the nation are on Texas, where a federal judge who formerly worked for a conservative Christian advocacy group is set to decide whether the abortion pill mifepristone can stay on the market. Mifepristone is half of a two-pill regimen that now accounts for more than half of the abortions in the United States.
Meanwhile, Novo Nordisk, another of the three large drug companies that dominate the market for diabetes treatments, has announced it will cut the price of many of its insulin products. Eli Lilly announced its cuts early this month. But the push for more affordable insulin from activists and members of Congress is not the only reason for the change: Because of quirks in the way the drug market works, cutting prices could actually save the companies money in the long run.
This week’s panelists are Julie Rovner of KHN, Jessie Hellmann of CQ Roll Call, Sarah Karlin-Smith of the Pink Sheet, and Alice Miranda Ollstein of Politico.
PanelistsJessie Hellmann CQ Roll Call @jessiehellmann Read Jessie'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:
- The federal judge examining the decades-old approval of mifepristone could issue a decision at any time after a hearing largely behind closed doors, during which he appeared open to restricting access to the drug.
- Democratic governors seek to counter the chill of Republican states’ warnings to pharmacies about distributing mifepristone, and a separate lawsuit in Texas seeks to set a precedent for punishing people who aren’t medical providers for assisting someone in obtaining an abortion.
- In pandemic news, Congress is moving forward with legislation that would force the Biden administration to declassify intelligence related to the origins of covid-19, while the editor of Cochrane Reviews posted a clarification of its recently published masking study, noting it is “inaccurate” to say it found that masks are not effective.
- Top federal health officials sent an unusual letter to Florida’s surgeon general, warning that his embrace of vaccination misinformation is harmful, even deadly, to Americans. While covid vaccines come with some risk of negative health effects, contracting covid carries a higher risk of poor outcomes.
- Novo Nordisk’s announcement that it will cut insulin prices puts pressure on Sanofi, the remaining insulin maker that has yet to adjust its prices.
- The Veterans Health Administration will cover Leqembi, a new Alzheimer’s drug. The decision comes as Medicare considers whether it will also cover the drug. Experts caution that new drugs shaking up the weight-loss market could prove costly for Medicare.
- Washington is eyeing changes to federal rules that would affect the practice of medicine. One change would force health plans to speed up “prior authorization” decisions by health insurers and increase transparency around denials, which supporters say would help patients better access needed care. Another proposal would ban noncompete clauses in contracts, including in health care. Arguments for and against the change both cite the issue of physician burnout — though they disagree on whether the ban would make the problem better or worse.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: “Tradeoffs” podcast’s “The Conservative Clash Over Abortion Bans,” by Alice Miranda Ollstein and Dan Gorenstein
Alice Miranda Ollstein: Politico’s “Sharpton Dodges the Spotlight on Latest Push to Ban Menthol Cigarettes,” by Julia Marsh
Sarah Karlin-Smith: Allure’s “With New Legislation, You Can Expect More Recalls to Hit the Beauty Industry,” by Elizabeth Siegel and Deanna Pai
Jessie Hellmann: The New York Times’ “Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs,” by Christina Jewett and Ellen Gabler
Also mentioned in this week’s podcast:
- CQ Roll Call’s “Noncompete Rule Puts Doctors, Hospitals at Odds,” by Jessie Hellmann
- Cochrane’s “Statement on ‘Physical Interventions to Interrupt or Reduce the Spread of Respiratory Viruses’ Review,” by Karla Soares-Weiser, editor-in-chief
- The “Osterholm Update” podcast’s “Truth in the Midst of Political Theater,” by Michael Osterholm and Chris Dall
- Stat’s “Denied by AI: How Medicare Advantage Plans Use Algorithms to Cut Off Care for Seniors in Need,” by Casey Ross and Bob Herman
KHN’s ‘What the Health?’Episode Title: Judging the Abortion PillEpisode Number: 289Published: March 16, 2023
[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]
Julie Rovner: Hello and welcome back to KHN’s “What the Health?” I’m Julie Rovner, chief Washington correspondent at Kaiser Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, March 16, 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: Jessie Hellmann of CQ Roll Call.
Jessie Hellmann: Hello.
Rovner: And Sarah Karlin-Smith the Pink Sheet.
Sarah Karlin-Smith: Hi, Julie.
Rovner: So, we have more than enough news. Let us get right to it. We will start this week with abortion. And, of course, that means we will start in Texas. On Wednesday, federal District Judge Matthew Kacsmaryk held a four-hour hearing in Amarillo on a lawsuit charging that the FDA wrongly approved the abortion pill mifepristone back in the year 2000 and that he, Judge Kacsmaryk, should substitute his legal judgment for the FDA’s medical judgment and order the FDA to take it off the market. What was said at the hearing? Well, we don’t really know because only 18 reporters were allowed in. They weren’t allowed to take any electronic devices in with them. And there’s no audio and no transcript. But, Alice, I know you’ve been trying to follow this from afar, like I have. What do we know about what happened and when might we expect a ruling?
Ollstein: So we can expect a ruling literally at any time. Hopefully not while we are taping right now. The judge did say that he would rule as soon as possible, although with four hours of oral arguments to sift through, that could take a bit of time. I always bank on a Friday evening news dump, because that’s when it tends to happen.
Rovner: I keep reminding people that’s when the ACA [Affordable Care Act] ruling came down.
Rovner: Came down on the Friday before Christmas at 7:30 at night.
Ollstein: Exactly. Thankfully, some great reporters were able to make it and provided us with some updates about this. It was really fascinating. The judge definitely, as we anticipated from his record of working for conservative, explicitly anti-abortion organizations before he was confirmed to this judgeship, he did seem open to taking the steps that the challengers were asking for in restricting access to this medication. I think the question really is whether he is going to go for a full ban or — what a lot of the questions during oral arguments centered around — was around rolling back more recent FDA rules that allowed people to get the pills by telemedicine, by mail delivery. And so there is some question as to … if going all the way back to a 20-year-old FDA approval and overturning it is a bridge too far. Maybe these more recent agency rules are sort of more justifiable in having the court go after them. So, we’re all just on high, high alert, refreshing pages over here.
Rovner: Yeah. Once again, remind us of why this could have national impact, this one judge in Amarillo, Texas?
Ollstein: Yeah. So these anti-abortion medical groups incorporated in Amarillo specifically so that they could get in front of this judge who has a record of being an abortion opponent. And so this is an example of “judge shopping,” which is an increasingly common practice. So this could have national implications because it’s going after the federal regulations around these pills. Really, this will mainly impact blue and purple states, where the pills are still legal and still used today. A bunch of states have already banned them and put restrictions on all forms of abortion or just the pills. And so this really will squeeze states where their use is protected.
Rovner: And I think abortion rights organizations are freaked out because everybody thinks, well, it’s just one judge. You’ll go up to the next level and you’ll get it, you know, you’ll get it stayed. Except in this case, the next level is the 5th Circuit Court of Appeals, which is just as conservative. And we seem to do a lot of anti-abortion rulings. And then if you go above the 5th Circuit Court of Appeals, you’re at the Supreme Court, which just overturned Roe v. Wade. So if this judge rules for the plaintiffs in this case, there’s not a lot of hope, I guess, from the abortion rights side that anything could be overturned, right?
Ollstein: It also gets into really interesting stuff about what is on the labels of these different drugs. Pro-abortion rights and other medical groups have been pushing the FDA to officially add miscarriage management to the label of mifepristone, so that if it is banned in this case, people can still access it for that. That has not happened. It is used for miscarriage management off-label. That is the real risk of people losing access; they’re not just for abortion. Again, there are two pills that have been used for abortions together for the past 20 years, and the other one, misoprostol, there could be restrictions put on it through this case, but because it officially is labeled and marketed for non-abortion purposes, it’s harder to ban.
Rovner: It’s a stomach ulcer drug.
Rovner: All right. Well, assuming that the pill is not pulled from the market, the squabble over whether pharmacies will stock it continues. As we discussed at some length last week, Walgreens caved to threats of prosecution from Republican attorneys general and waffled on whether they’ll sell the pills, even in some states where abortion remains legal. Now, a group of Democratic governors are not so subtly urging seven other national pharmacy chains to pay no attention to those Republican attorneys general threats. Have we heard from any of the other pharmacy chains about whether they will or won’t sell mifepristone in the wake of Walgreens getting raked over the coals by both sides?
Ollstein: Total radio silence. And I think that the backlash to Walgreens is the reason for that. I think they saw what happened. They saw Walgreens getting really slammed from both sides. You know, you have anti-abortion folks slamming Walgreens for saying they’ll sell the pills anywhere in the country. And you have pro-abortion rights people mad at Walgreens for saying that they won’t sell them in some places. So it’s kind of a no-win situation. And the other pharmacies, I’m sure, are looking at that and saying, why would we stick our necks out getting certification from the drugmakers to sell the pills in the first place? It’s going to still take a while and who knows what could happen by the? And so why would we prematurely come out and say what we’re doing when we have no idea?
Rovner: Yeah, and I remind people for the millionth time that it’s not that Walgreens was going to stop selling them. None of the pharmacies have started selling them yet because it was only in January that FDA said for the first time that they could, which, as Alice points out, may be one of the things that this judge in Texas rolls back, if he doesn’t try to roll back the entire approval of the pill. One more on abortion: Also in Texas, the ex-husband of a woman who got an abortion last summer is suing three of her friends for, quote, “wrongful death” for allegedly helping her obtain abortion medication. His evidence largely comes from screenshots from a group chat, raising more calls for better privacy protections for electronic information. Meanwhile, it’s not even totally clear that the abortion was illegal last July, because there was some legal back and forth about whether Texas’ trigger law abortion ban was actually triggered when Roe was overturned the month before. If the ex-husband wins this suit, though, I’m wondering how much of a reaction there is going to be to nonmedical providers being found liable for damages. He’s suing them for $1,000,000. We keep hearing about this, but to my knowledge, it hasn’t actually happened yet, that nobody’s been convicted, I don’t think anywhere of, you know, abetting someone having an abortion, particularly a nonmedical provider.
Karlin-Smith: And then I mean, it seems like, again, it’s designed to have these chilling effects on people and get people to think twice before they do things they otherwise would. And I know this story raises the issue of whether there’ll be more pressure on tech companies to encrypt all data and messages, which would be interesting to see, you know, how companies react going forward. But we already know that …
Rovner: How the tech companies react.
Karlin-Smith: Right. I think we already have seen that doctors who take oaths and hold certain ethical standards to protect people’s health and life have felt like they’ve been put in very challenging situations between the law and what the best care they normally provide for their patients with abortion. So if doctors feel this way, if regular people feel like they’re also going to be on the hook for something, I would be more concerned, in the sense that regular people would feel even less protected. The medical providers, which tend to work for companies that have, you know, lawyers to help them guide them through their decision-making. And, you know, they have various types of insurance as well to help them through this stuff. So it does seem like it could have a big chilling effect if this ex-husband wins in any way.
Rovner: Yes. I mean, the point here is to just further isolate women who are pregnant and don’t want to be, for whatever reason, from reaching out, not just to medical providers, but to their friends, or at least, I guess, reaching out in some way other than in person. We will see how this one plays out. All right. Well, let’s talk about covid, which we haven’t done for a while. First, the reignited fight over the lab leak versus wet-market-origin theory. I have studiously tried to steer away from this because the one thing just about every expert agrees on is that we will probably never know for sure where covid-19 came from. And to quote Michael Osterholm, the esteemed epidemiologist at the University of Minnesota, we have to be prepared for the future for both events: another spillover event and for the lab leak. Still, the House moved forward with a bill this week, already passed by the Senate the week before, to require the declassification of some intelligence related to covid’s origins. Jessie, you covered it. What would the bill do? And is … do we think the president is going to sign this?
Hellmann: So the president hasn’t said yet if he will veto it, but if he does, it would be his first time vetoing something, if I’m not mistaken. So it could be a bad look if he does decide to make that decision. It passed the House 419 to 0. There were 16 non-voting members. It passed the Senate unanimously a few weeks ago, so I can’t imagine that he would veto it. And, basically, what the bill does, it would require the director of national intelligence to declassify information on covid-19 origins within 90 days and send the declassified report to Congress. It’s not clear how much that will illuminate. There’s so many questions about this. The intelligence community is still pretty divided on this issue, despite the Department of Energy, intelligence community saying a few weeks ago that they think it could have arose from a lab leak, though they said that with low confidence. So, it’s not really clear what information we’ll get from this.
Rovner: And this is just basically Congress saying, well, we don’t know, but we want to know what you know.
Rovner: Is that basically where we are?
Hellmann: Exactly. And there’s also, like, a lot of hearings going on right now in Congress where they’re starting to bring people and talk about this. And I think last week, or was it this week, a select committee had a closed meeting with the Department of Energy about their report. So there’s definitely a lot of interest in this.
Rovner: We will definitely see how this plays out. Well, another thing, we are still fighting about, three years in, the efficacy of masks. A couple of weeks ago, the gold-standard scientific organization, the Cochrane Review[s], put out a meta-analysis of mask studies conducted over the years that concluded there was not sufficient evidence to demonstrate that masks help stop the spread of respiratory illnesses. Well, as so often happens with conditional findings like those, mask opponents immediately trumpeted that the study shows that masks don’t work, which is not what the study showed. Now, in a fairly rare step, the editor of the Cochrane Review herself has posted a clarification of the summary of the study, which we will post in the show notes, but I will quote from it: “Commentators have claimed that a recently updated Cochrane Review shows that, quote, ‘Masks don’t work,’ quote, which is an inaccurate and misleading interpretation.” So what’s that line again? A lie travels around the world before the truth can even get out of bed. Is that where we are with masks now? We’ve gotten to the point where there’s this huge belief that masks don’t work. And the fact is, like the origin of covid, we don’t actually know.
Karlin-Smith: I think that the “don’t actually know” is maybe not the best way to put it. There are things we do know, and that’s some of what, you know, has tried to be clarified in the past week or so from this, although there is that ultimate question of: Is it too little, too late, and are people already sort of set in their views? And that’s the sort of thing for different types of researchers to figure out in terms of how you convince people of various evidence and stuff. But, you know, I think one line that stuck out to me is, in The New York Times piece, trying to dissect the nuance of this review. And it is really nuanced and you really have to appreciate those nuances. You know, they say is what we learn from the Cochrane Review is that particularly before the pandemic, distributing masks didn’t lead people to wear them. And thus, if a mask is going to work, but you don’t wear it, it’s not going to work. And you know, people who have been sort of anti-mask to some degree have said, well, but that does show masks don’t work, because if we can’t get people to wear masks, what does it matter? Of course, for people that want to wear a mask or, you know, are comfortable wearing a mask, there’s also plenty of evidence that shows well-fitting, quality masks will block covid. So you shouldn’t think on an individual level, “Let me throw away my N95. It’s not doing me any good.” It certainly is doing you good. And we have, you know, laboratory research and other research to prove that. So, you know, The New York Times did a really good job of dissecting what was really studied, how much was studied, pre-covid, post-covid, what they looked at, and to try and help people understand where we’re at, which is definitely, again, that there can be benefits to wearing masks. There are differences in population benefits versus individual benefits. And when you think about the population benefits, too, sometimes I think you also have to think about even small, subtle benefits on a population level can make a big difference. So even if mask-wearing isn’t the be-all and end-all some people maybe want you to think about, but it helps lower transmission and lowers cases on a population level, you know, that can translate to hundreds of thousands or even millions less cases, which can then lead, you know, to whatever corresponding number of deaths. So I think it’s also thinking about that, you know, something doesn’t have to be 100% effective in stopping transmission to be really valuable on a societal level.
Rovner: They could have summarized it as “Masks don’t work if people don’t wear them, and it’s hard to get people to wear them.” That would have been accurate. Right?
Karlin-Smith: But the other question is: How do we figure out how to get people to wear them if they do work?
Rovner: Well, but that’s not what this study was about.
Ollstein: I found this whole reaction really depressing. And it’s been huge on Capitol Hill. It’s been coming up at all of these hearings with Republican members citing this and flatly declaring that it shows that masks don’t work, using it to go after officials like CDC Director [Rochelle] Walensky and excoriate her for recommending masks. And it just feels like we’ve learned nothing. Like Sarah was saying, we have not learned the difference between individual and population-level benefits. Everything is so black and white. Either something is completely effective or completely ineffective. There’s no nuance around reducing risk, and everyone keeps talking about how the next pandemic is inevitable. And it just feels like we absolutely have not learned anything from this one.
Rovner: Yeah, if you’d asked me three years ago where we would be in three years, this is not the place I would have predicted. Speaking of covid misinformation, this week the directors of the Food and Drug Administration and the Centers for Disease Control and Prevention took the rare step of writing a joint letter to Florida Surgeon General Joseph Ladapo — I assume that’s how he pronounces his name — warning that his claims that the covid vaccine is causing an upswing in adverse events are, quote, “incorrect, misleading and could be harmful to the American public.” Sarah, I’ve never seen a joint letter from the FDA and the CDC, certainly not to a state official. I mean, they must have been very unhappy about this.
Karlin-Smith: Yeah, I think it was a unique step. But also, Robert Califf at the FDA has made going after what he calls, you know, scientific misinformation, a key part of his commissionership. He often makes the claim that he feels like misinformation is what is killing so many Americans. So it wasn’t surprising in the sense that he felt the need to publicly respond in this way, particularly when you have an individual of such high stature in the state making claims that he feels are potentially dangerous to people. And a lot of what the Florida surgeon general said, again, has a little nugget of truth, but has largely been debunked in the way he’s framing it. So, yes, we do know there is some risk of these myocarditis, these negative heart effects from these covid mRNA vaccines. But we also know that getting covid actually poses a higher risk of these heart events. So it’s a trade-off that most people argue you would prefer to go with the vaccine than that. And so, the fact that, you know, you have such a high-level health official in a state perpetuating anti-vaccine sentiments, I think is why you see Califf and Walensky really feeling like they had to respond, though I’m a little bit perplexed as to why they decided to do it at this particular moment. But I think it’s because he actually addressed them first with a letter. But, you know, this surgeon general has been doing this for a while now.
Rovner: He’s been the surgeon general for a while, and he’s been saying things outside the mainstream, shall we say, for a while. Well, I want to turn to drug prices because there’s a lot of news there, too. Another one of the big three diabetes drugmakers, Novo Nordisk, has followed Eli Lilly’s lead in announcing it will slash the cost of many of its insulin products by up to 75%. First question, how much pressure will this put on Sanofi, the last of the drug companies that dominate the diabetes drug market? Are they almost inevitably going to follow?
Karlin-Smith: I think most people think it is inevitable, although maybe not for the reasons we’re all thinking. Some of it is just that peer pressure. But a big thing that sort of comes out in this: Sean Dickson, to give him credit, at West Health was sort of the first person I saw point this out. There’s changes in the law related to Medicaid rebates and what these companies will essentially, you know, the discounts they have to give Medicaid coming up, that when you raise your prices faster than inflation, because these insulin products have had their prices raised so much over the years, they were going to have to start owing the government money soon for their drugs instead of the government reimbursing them. So that’s seen as really probably one of the key reasons why these changes are happening when they’re happening, which is not to, like, take any credit away from all the advocates who have pushed for lower insulin prices over the years. Certainly, this law and regulation that was passed was designed, in fact, to motivate companies to do this. So, you know, there’s a cynical way of looking at it, and there’s another way of working at it. But, you know, I do think most people expect Sanofi to follow through, particularly if they think it’s going to impact their formulary placement, in terms of how they compete with these products. But then also just, you know, from a PR perspective, it’s not going to look good for them to be that last holdout.
Rovner: But this sort of leads to my next question. I haven’t seen anybody mention this yet, but I can’t help but think that particularly Lilly and Novo Nordisk are happy to cut the prices on insulin and get lots of good press, as you point out, because both of them are sitting on giant blockbuster drugs to treat obesity. Novo already has FDA approval for Wegovy, which is the same drug as its diabetes drug Ozempic, just in a larger dose. While Lilly already has the diabetes drug Mounjaro, whose clinical trials for obesity have shown it may be even more effective than Wegovy in helping people lose weight. Am I missing something here, or are these companies about to make a killing on other drugs?
Karlin-Smith: No, I mean, that’s one point. And I think, you know, Novo Nordisk is more reliant on insulin and diabetes products in general than Eli Lilly and Sanofi, which have broader profiles. But one thing to note is most of the insulin drugs that are getting list price cuts are older insulin. So, you know, Novo Nordisk notably did not cut the price of one of their newer insulins … in their announcement this week. So again, you have to look at which particular products they’re cutting and why. But there’s big concern about how the use of some of these diabetes medicines to treat obesity will impact budgets because such a large percentage of the U.S. population is overweight.
Rovner: You’re just getting to my next question.
Karlin-Smith: That’s what … I assumed you were thinking of this Medicare issue. Right now Medicare does not cover drugs for weight loss, but the thought process is, if they change that, because these drugs are much more effective than prior weight loss drugs have been, you know how will Medicare pay for these? So that’s another big drug pricing debate coming down the pike.
Rovner: I was just going to say, I mean, this is the thing that I’ve been thinking about, you know, and I guess the complication with Medicare … there’s a piece in the New England Journal of Medicine this week by a bunch of drug price researchers that said, well, maybe the cost-benefit for Medicare wouldn’t be quite as good as it would be for the younger population, because obesity is not such a factor for shortening your life if you’re over 65 than if you’re under 65. But as others point out, it’s unlikely that private insurers are going to start covering this medication if Medicare doesn’t. So you’ve got this sort of place where you’ve got these very promising drugs that are currently very expensive, many in the neighborhood of $1,300 a month, which is not what most people can afford, if insurance isn’t covering it. But the promise of working … and you’ve got all these rich people buying it from heaven-knows-what doctor. So there is actually a shortage. But this is expensive enough that if they can’t push the price down, it has the potential to really impact the entire cost of the health care system. Right?
Karlin-Smith: Right. I’ve seen people writing about this the way we were talking about the Alzheimer’s drugs if Medicare was decided to cover it for all patients who qualify for Alzheimer’s, some of the drugs that came out, how they would essentially have to raise premiums and the implications there. They remind me also of, a number of years ago now, when some new cholesterol-lowering medicines came out that were really pricey. And what would happen to Medicare if they got prescribed and used widely? That, of course, didn’t happen. In part, perhaps, because payers curtail these to some degree. This is going to become a really interesting public discussion because the costs issue, but it’s also sort of about how we think about obesity and weight loss. And for a long time, there’s been sort of a stigma attached to weight loss and weight loss products and people not thinking about it as a medical condition, something where you really need to try other things before you get a medicine or get a medical procedure. It’s sort of a personal failure, a cosmetic issue, issues of self-control … and the fact that these drugs are much more successful than previous weight loss medicines, which tended to not help people lose very much weight and had a lot more side effects, some of them were fairly dangerous.
Rovner: And got pulled off the market.
Ollstein: For killing people.
Karlin-Smith: You’re going to confront a lot of issues head-on in figuring out how to deal with this, because it’s not just about price. It’s sort of thinking about what we consider a disease and what we’re willing to treat as a medical condition.
Rovner: Yeah, I think this is going to be a really big debate going forward. Well, you mentioned Alzheimer’s. And speaking of Alzheimer’s, the Veterans [Health] Administration has announced that it will offer patients with Alzheimer’s disease, that newest Alzheimer’s drug, Leqembi, is that how you pronounce it? It received accelerated approval from the FDA in January. That means more evidence needs to be presented to assure its safety and efficacy. Sarah, is this drug really better/safer than Aduhelm, which it’s a chemical cousin of, right? And that’s the one that we had all the fighting over last year. So what do we think Medicare is going to do with this drug?
Karlin-Smith: So we do have some evidence that this drug does seem to be an improvement over Aduhelm, even though Leqembi only got an accelerated approval so far from the FDA. FDA is already evaluating the drug for full approval because in that interim between when they filed the accelerated approval, they actually pretty much wrapped up a Phase 3 clinical trial that looked at outcomes and did show some benefit on cognition and so forth. There’s certainly a debate out there as to how meaningful that benefit was, but they have shown a hard clinical benefit in trials, not just changed a laboratory marker that is predictive of Alzheimer’s. So that is significant for the company. But it’s just that FDA and then I think CMS hasn’t really considered that further data yet. And so I think there is a good chance that if FDA grants the drug full approval, which I think is pretty likely, will reconsider it, and they maybe were just sort of buying them some time because, again, it is going to be a bit of a challenge to figure out how to operationalize this. The VA, if you compare to Medicare, I was looking yesterday, you know, the VA probably has a few hundred thousand people that might qualify for this drug versus Medicare potentially has upwards of 6 million or so forth. So the different budget process and the VA also has more ability to negotiate drug prices with the company than Medicare does right now for this particular product.
Rovner: So very first-world problems. We finally have drugs to treat things that we’ve been trying to treat effectively for a long time, except that we can’t afford them. So we’re going to … I imagine this debate is going to also continue. Well, finally this week, I wanted to talk briefly about the practice of medicine and the role of the federal government, even though that’s sort of what we’ve been talking about this entire time. Jessie, you wrote about the Biden administration’s rules barring noncompete clauses in employment this week. Obviously, this is something that transcends health care. Apparently, even Starbucks doesn’t want its trained baristas going to work for local competitors. But how does this affect health care?
Hellmann: Yeah, so from what I’ve heard, noncompetes are really rampant in the health care. Especially between physicians and group practices in hospitals. So I’ve seen a lot of doctors submitting comments to the FTC telling them, and some of these is begging them to finalize this rule. There have been … the American Academy of Family Physicians has come out really strongly in favor of the rule. Basically, the argument is that it contributes to burnout, when doctors can’t leave jobs they’re unhappy in. And it also contributes to workforce shortages. If you’re in a noncompete agreement saying that you can’t work at a competitor within a 10- or 20-mile radius and you’re really unhappy in your job, but you might feel compelled to just go work somewhere else. On the other side, you have the American Hospital Association coming out really forcefully against this rule, which is not a good sign and, obviously, very powerful in Washington. And they’re kind of using the covid pandemic as the impetus to try to block this, arguing that providers are really burned out right now. People are leaving the workforce. We really can’t afford to lose people at this time to competitors, and this will make it harder for us to retain and recruit workers. Both sides are making the same arguments in different ways.
Rovner: We’ll wait on these rules. Well, the other big intra-health care dispute that federal officials are being asked to weigh in on is prior authorization. That’s when insurers make it cumbersome for patients to get care their doctors want them to have. The idea is to prevent doctors from providing unnecessary or unnecessarily expensive care. But doctors say it just throws up barriers that make it harder even to get fairly typical care and puts patients at risk by delaying their treatment. I honestly thought this got taken care of in the Affordable Care Act, which incorporated the provisions of the patients’ bill of rights that Congress had been arguing about for the entire decade leading up to the ACA. But now the Biden administration has proposed rules that would require insurers to at least respond faster to prior authorization requests, although that wouldn’t start until 2026. This is actually one of the American Medical Association’s top issues. Is this just another example of people who are not doctors trying to practice medicine, i.e., the insurance companies, and does the federal government really have a role in all of this?
Karlin-Smith: I think this is a tough issue because usually the insurance companies do have doctors that are trying to make these decisions. What you see are doctors actually in medical practice, not an insurance company, complaining about as they’re often not the peers that they say they are. So, you know, you might have a cardiologist making a decision regarding a prior authorization that relates to something in the orthopedic field. So there’s questions about whether the people that really have enough knowledge are making the calls.
Rovner: Or, God forbid, they have nurses making these calls, too.
Karlin-Smith: But it’s one of these issues that’s really tough because there is a sort of in some cases, I think, a need and a reason to have prior authorization. And it can be useful because not all doctors are willing to, you know, maybe try the cheapest alternative for patients when one does exist. There are some, you know, to use the term, sort of, “quacks” out there that sometimes recommend things that the medical establishment overall would agree you shouldn’t be using on patients. But it’s just that the way this is, like, in the real world, it’s sort of gotten out of control, I guess, in some ways. The best way … where legitimate medical care is being denied, patients are going through prior authorization for refills of prescription drugs they clearly have benefited from and have been on for years. So it’s a tricky situation because there is certainly, for the government, an economic reason to have some degree of prior authorization. It’s just figuring out how to get the good out of it, where it actually can benefit and help, even both protect patients financially and medically without hurting patients, and particularly patients that don’t understand how to navigate the system and push back against bad decisions on prior auth.
Hellmann: There is also a really interesting story in Stat this week about the role of artificial intelligence and algorithms in making some of these decisions. So I do have questions about that. It does seem like I have been hearing more and more from doctors lately about how burdensome prior auth has been. I did a story a few months ago about prior authorization requirements for opioid treatment programs, and providers are saying it takes a long time to get approval. Sometimes you get denials for seemingly no reason, like people who need opioid treatment. Some of these people are really vulnerable, and once you decide you need care, you kind of want to get them at that moment. And they might not want to go through an appeals process. And that’s something that the administration has acknowledged is an issue, too. They say that they’re going to look at it.
Rovner: I remember when most of the health beat was actually refereeing these disputes between pieces of the medical establishment, so … there are other things that the administration is busy with in the health care realm. Well, that is the news for this week. Now it is time for our extra-credit segment — that’s where 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: I took a look at a story in Allure magazine: “With New Legislation, You Can Expect More Recalls to Hit the Beauty Industry.” And it’s a good explainer on modernizations to FDA’s regulations of cosmetics that passed in the end of the year in Congress. It’s the first overhaul since World War II. They say it gives the FDA some pretty big new authorities, like they can mandate the recall of a beauty product if it’s contaminated. Before they basically just had to beg companies to voluntarily do that, which in many cases companies don’t want products that might harm people to be on the market. But sometimes for whatever reason, they might not move as you want. And so it’s important for FDA to have that authority. You know, it also will do things like disclose common allergens to protect people, gives FDA a lot of new funding to help implement this. You know, I think it’s a pretty big consumer bill and it was kind of like an interesting thing to look at a different part of health policy we don’t often talk about. One thing that the story brings up that’ll be interesting to see and I know has been sort of a tension with leading up to whether this law would ever get passed, was how small companies will be able to handle this, and will it put basically small beauty out of business over big companies that know how to handle FDA and its regulations? So we’ll look to see what happens to your smaller cosmetic brands moving forward.
Rovner: Indeed. Jessie.
Hellmann: My extra credit is a story from The New York Times called “Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs.” And this is an angle I hadn’t really thought about: That $21 billion opioid settlement came with an agreement that distributors place stricter limits on drug suppliers to individual pharmacies and scrutinized their dispensing activity. But it doesn’t just apply to opioids. It applies to all controlled substances. So we’re seeing medications like Xanax and Adderall get caught up in this. And pharmacies are saying, like, it’s making it hard for them to fill prescriptions for patients and some of whom have had them for a really long time. And I don’t know, like, if anyone else has heard about the Adderall shortage — I don’t know if you would classify this as a shortage — but it’s an angle that I hadn’t really thought of. Like, it might not just be supply-chain issues.
Rovner: Yeah, I’ve heard about the Adderall shortage. I mean, I think there’s been a lot of coverage of that. So, yeah, I thought that was a really interesting story, too. Alice.
Ollstein: Yes. I chose a story by my colleagues up in New York, my colleague Julia Marsh, which is about the debate in New York over a flavored-cigarette ban and how it is dividing the civil rights community. And so, you have some civil rights leaders saying that we should ban menthol cigarettes because they have caused a lot of health harms to the Black community. They have long been marketed in ways that target the Black community. They’re in some ways more addictive than non-flavored tobacco. So they’re in support of this ban. And then you have Al Sharpton and some other civil rights leaders on the other side warning that such a ban and the enforcement of such a ban will lead to more police interaction with the Black community, more targeting, and potentially more deaths, which is what we’ve seen in the past. And so a fascinating piece about some …
Rovner: Deaths from law enforcement. Not from cigarettes.
Ollstein: Exactly. Well, yes, it’s kind of “damned if you do, damned if you don’t” on this issue. But a fascinating look at this and what could be a preview as the debates around this at the national level ramp up. So we’ve already seen this happen in California and some other states. Now, the debate is really hot in New York, but it could indicate some of the arguments we might hear if it really moves forward at the national level.
Rovner: Well, my extra credit this week is the latest episode of our competitor podcast “Tradeoffs,” which you really should also listen to regularly, by the way. It’s called “The Conservative Clash Over Abortion Bans,” and it’s actually by Alice here. And it’s a really close look at those exceptions to abortion bans, like for life or health. That’s something that we’ve talked about quite a bit here, except this looks at it from the viewpoint of how it’s dividing the anti-abortion community, which is really interesting. So, super helpful. Everybody listen to it. Thank you, Alice. 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 ever-patient producer, Francis Ying. As always, you can email us your comments or questions. We’re at whatthehealth — all one word — @kff.org. Or you can tweet me. I’m @jrovner. Alice?
Rovner: We will be back in your feed next week. Until then, be healthy.
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