KFF Health News' 'What the Health?': Biden Wins Early Court Test for Medicare Drug Negotiations
The Host
Julie Rovner
KFF Health News
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 federal judge in Texas has turned back the first challenge to the nascent Medicare prescription-drug negotiation program. But the case turned on a technicality, and drugmakers have many more lawsuits in the pipeline.
Meanwhile, Congress is approaching yet another funding deadline, and doctors hope the next funding bill will cancel the Medicare pay cut that took effect in January.
This week’s panelists are Julie Rovner of KFF Health News, Alice Miranda Ollstein of Politico, Rachel Cohrs of Stat, and Lauren Weber of The Washington Post.
Panelists
Alice Miranda Ollstein
Politico
Rachel Cohrs
Stat News
Lauren Weber
The Washington Post
Among the takeaways from this week’s episode:
- Rep. Cathy McMorris Rodgers (R-Wash.), chair of the powerful House Energy and Commerce Committee, announced she would retire at the end of the congressional session, setting off a scramble to chair a panel with significant oversight of Medicare, Medicaid, and the U.S. Public Health Service. McMorris Rodgers is one of several Republicans with significant health expertise to announce their departures.
- As Congress’ next spending bill deadline approaches, lobbyists for hospitals are feverishly trying to prevent a Medicare provision on “site-neutral” payments from being attached.
- In abortion news, anti-abortion groups are joining the call for states to better outline when life and health exceptions to abortion bans can be legally permissible.
- Senate Finance Chairman Ron Wyden (D-Ore.) is asking the Federal Trade Commission and the Securities and Exchange Commission to investigate a company that collected location data from patients at 600 Planned Parenthood sites and sold it to anti-abortion groups.
- And in “This Week in Health Misinformation”: Lawmakers in Wyoming and Montana float bills to let people avoid getting blood transfusions from donors who have been vaccinated against covid-19.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: Stateline’s “Government Can Erase Your Medical Debt for Pennies on the Dollar — And Some Are,” by Anna Claire Vollers.
Alice Miranda Ollstein: Politico’s “‘There Was a Lot of Anxiety’: Florida’s Immigration Crackdown Is Causing Patients to Skip Care,” by Arek Sarkissian.
Rachel Cohrs: Stat’s “FTC Doubles Down in Welsh Carson Anesthesia Case to Limit Private Equity’s Physician Buyouts,” by Bob Herman. And Modern Healthcare’s “Private Equity Medicare Advantage Investment Slumps: Report,” by Nona Tepper.
Lauren Weber: The Wall Street Journal’s “Climate Change Has Hit Home Insurance. Is Health Insurance Next?” by Yusuf Khan.
Also mentioned on this week’s podcast:
- The Washington Post’s “U.S. Investigates Alleged Medicare Fraud Scheme Estimated at $2 Billion,” by Dan Diamond, Lauren Weber, and Dan Keating.
- Super Bowl ads from Pfizer, Power to the Patients, and the American Values 2024 super PAC.
- KFF Health News’ “Rapper Fat Joe Says No One Is Making Sure Hospitals Post Their Prices,” by Julie Appleby.
click to open the transcript
Transcript: Biden Wins Early Court Test for Medicare Drug Negotiations
KFF Health News’ ‘What the Health?’Episode Title: Biden Wins Early Court Test for Medicare Drug NegotiationsEpisode Number: 334Published: Feb. 15, 2024
[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It 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, Feb. 15, 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: Lauren Weber of The Washington Post.
Lauren Weber: Hello, hello.
Rovner: And Rachel Cohrs of Stat News.
Rachel Cohrs: Hi everyone.
Rovner: No interview this week, but we do have a special Valentine’s Day surprise. But first, the news. We’re going to start this week in federal district court, where the drug industry has lost its first legal challenge to the Biden administration’s Medicare drug price negotiation program, although on a technicality. Rachel, which case was this, and now what happens?
Cohrs: This was the capital “P” PhRMA trade association. And this case was a little bit of a stretch, anyways, because they were trying to find some way to get a judge in Texas to hear it. Because the broader strategy is for companies and trade groups to spread out across the country and try to get conflicting decisions from these lower courts.
Rovner: Which would force the Supreme Court to take it?
Cohrs: Exactly, yes. Or make it more likely. So PhRMA, in this case, they had recruited, there’s a national group that represents infusion centers and that was headquartered in Texas. The judge ultimately ended up ruling that this association didn’t follow the right procedure to qualify for judicial review and threw them off the case. And then they were like, well, if you throw them off the case, then there’s nobody in Texas, you can’t hear this here. So that was the ultimate decision there, but this could come back up. It was dismissed without prejudice. So this isn’t the end of the road for this lawsuit.
And it’s important to keep in mind that this wasn’t a ruling on any of the substance of the arguments. And trade groups generally are going to have less of an argument for standing, or it’s going to be a harder argument than the companies themselves that actually have drugs up for negotiation.
Rovner: And they’re suing too, the drug companies?
Cohrs: They are suing too. Yeah, just for everybody to keep on your calendars, there’s a judge in New Jersey who is hoping to have a quadruple oral argument on four of these cases, so stay tuned. That could be coming early next month. But these are very much moving. I think we are going to get insight on some of these arguments pretty soon, but this case is not quite that test case yet.
Rovner: All right, well, we’ll get to it eventually. Well, moving on to Capitol Hill. When we were taping last week, Sen. Bernie Sanders was holding his much-publicized hearing to grill drug company CEOs about their too-high prices. Rachel, you were there. Did anything significant happen?
Cohrs: I think it was kind of expected. I don’t think we were trying to find any innovative legislative solutions here. Honestly, it seemed, just from a candid take, that a lot of these lawmakers were not very well-prepared for questioning. There were a couple of notable exceptions, but we didn’t learn a whole lot new about why drug prices are high in the United States, how our system works differently from other countries.
I did find some useful nuggets in the CEO’s testimony about how low the net prices are for some of their medications, that they’re already offering a 70% discount, a 90% discount, which to me just kind of put into perspective some of the discounts we could be hearing in the Medicare negotiation program. That oh, even if it’s a 90% discount, that might not even be different from what they’re paying now. So just interesting to file a way for the future, but I think it was mostly a non-event for the CEOs who, for some reason, had to, under the threat of subpoena, come make these arguments. So it seemed like much ado about not a whole lot of substance.
Rovner: That was sort of my theory going in, but you always have to watch just in case. Well, also on Capitol Hill, the chairman of the powerful House Energy and Commerce Committee announced she will retire at the end of the Congress. Cathy McMorris Rodgers, who’s a Republican from Washington, was in her first term as chair of the committee that oversees parts of Medicare, all of Medicaid, as well as the entire U.S. Public Health Service.
I imagine this is going to set off a good bit of jockeying to take her place. And why would somebody step down early from such a powerful position? Do we have any idea?
Cohrs: Have you seen …? Oh, go ahead.
Ollstein: Facing Congress is what you say? Yes. This is part of a wave of retirements we’ve been seeing recently, including from some other committee chairs who could have theoretically continued to be powerful committee chairs for several years to come. People are taking this as part of the bad sign for Republicans. Either a sign that they don’t believe they’re going to hold the majority after this November’s election, or they’re just so fed up with the struggles they’ve had governing over the last few years and the inability to get anything done. And people are thinking, well, maybe I can get something done in a different role, not in Congress, because certainly, we’re not doing too much here to be proud of.
Rovner: Yeah, I feel like Cathy McMorris Rodgers is kind of this poster child for a very conservative Republican who’s not the far-right-wing MAGA type, who actually wants to do legislation. She just wants to do Republican legislation, and that seems to be getting harder in the House.
Ollstein: Right, right. And there’s a concern that, particularly on the right within Republicans, that we’re losing a health policy brain trust. We’re losing the people that have been really integral to a lot of the nitty-gritty policy work over the years, and they’re not being replaced with people who have that interest. They’re being replaced with people who are more focused on culture wars and other things. And so there’s concern in the future about the ability to cobble together things like Medicare reimbursement rates, or these technical things that aren’t really part of the culture wars.
Rovner: Yeah, I think we mentioned at some point that Mike Burgess is also retiring, also high up on the Energy and Commerce Committee. And he’s a doctor who’s really had his hands into some of this really nerdy stuff, like on Medicare physician reimbursement. And that will be obviously just a big loss of institutional memory there.
Cohrs: For the future of the committee, I know congressman Brett Guthrie has kind of thrown his hat in the ring to succeed her. Unclear who exactly is going to win this race, but he is the chairman of the health subcommittee, does bring some health expertise. So the E&C committee deals with a lot of different priorities, but if he were to succeed her, then I think we would see, at least at the top of the committee, some of the expertise remain.
Rovner: Well, meanwhile, in all of this jockeying, the next round of temporary government funding bills expires on March 1 and March 8, respectively, which is getting pretty close. And that brings back efforts to cancel the 3.4% pay cut that doctors got for Medicare patients in January. Where are we on funding, and are any of these health issues that people are out lobbying on going to make it into this next round? Is there going to be a next round?
Cohrs: Yeah, we don’t know if there’s going to be a next round, I don’t think. But at least the sources I’ve talked to have said that a full cancellation of the 3.4% cut for Medicare or payments to doctors is off the table at this point. They are hoping to do some sort of partial relief. They haven’t decided on percentages for that yet. And it’s unclear how much money will be available from pay-fors. It is still very much squishy, not finalized, two, three weeks out from the deadline, but I think …
Rovner: Two weeks.
Cohrs: There is some agreement on some relief, which has not been the case thus far for doctors. So I think that’s a positive sign.
Ollstein: Yeah. Overall, the chatter is about the need for yet another CR [continuing resolution] because the work is not getting done in time to meet these deadlines. That seems to be where we’re headed. Obviously, that will piss off a lot of members on the right who don’t want another CR, who didn’t want the last couple CRs. And so once again, we are staring down a possible shutdown.
Rovner: And I had forgotten, somebody reminded me, that even if they get another temporary funding bill, starting in April, there are automatic cuts if they’re not finished with this year’s funding bills. Which, I don’t know, is there any indication that they’re going to be finished with them by April either? I have not seen a lot of progress here. They’ve been fighting over other things, which is fine to fight over other things, but I’m not noticing a lot happening on the spending bills.
I’m seeing a lot of shaking heads. I guess nobody else is noticing either. Well, we will obviously keep watching that space because next week, we will only be one week away.
Well, another Medicare policy that supporters are hoping to get into one or another of these spending bills is creating something called more site-neutral payments in Medicare. Currently, Medicare pays hospitals and hospital outpatient departments, and sometimes even hospital-owned physician practices, more than it pays non-hospital affiliated providers for the exact same service.
The theory is that hospitals need higher payments because they have higher fixed costs, like keeping emergency rooms open 24/7. But it costs Medicare many billions of taxpayer dollars for this differential in payments. And this has become quite the lobbying frenzy for the hospital industry, yes?
Cohrs: Yes. I think it’s something that they can all get on board with hating, and I think they view it similarly to the drug pricing debate as a slippery slope. The policy Congress really is looking at now is a $3 billion, very small slice of all the services that could potentially be subjected to site-neutral payments. But the whole pie here is $150 billion potentially for Medicare.
We’re talking hundreds of billions of dollars for commercial payments. So I think they are really pushing to get to lawmakers, especially, from what I’ve talked to Senate Republicans, they are just not on board with it, they’re worried about the rural hospitals. And if they can connect to those things, which they have been successful in doing so far, they’re just not going to get very far.
I mean, if you look at the Senate Finance Committee, you have Mike Crapo from Idaho, Republican leadership. You have [John] Barrasso from Wyoming. There’s really just so many rural states that even Chuck Grassley, who is a moderate on a lot of health policy issues, talked about his rural hospitals in Iowa as soon as I asked him about this. So they’re not there yet right now, but I think hospitals are trying to keep it that way.
Rovner: And it was ever thus that the Senate is much more rural-focused than the House because pretty much every single senator has at least part of a rural area that they represent. Lauren, you wanted to add something?
Weber: Yeah, I just wanted to say, I always find it funny when rural hospitals come up as a cudgel by the big hospital associations, who don’t seem to look out for them the vast majority of the time when they’re closing. But as you pointed out, the Senate is much more rural-focused. So I do agree with all of you all, that I question whether or not this will have much ground to gain.
Rovner: Yeah. And the other thing that I keep wanting to point out is that there’s all this talk on Capitol Hill among Republicans of cutting the spending bills, the appropriations, and we’re going to balance the budget. Well, there’s just not enough money in the appropriation bills to do anything to the deficit. The money is in things like Medicare. I mean, that’s where, if you really want to make a dent in the deficit, you’re going to do it. And, as we’re seeing with this particular fight, every time they want to do something that’s going to save money, it’s going to hurt somebody. And I mean, there are obviously legitimate concerns about rural hospitals that are in trouble, particularly in states that haven’t expanded Medicaid, but that’s one of the reasons. It’s not so much the spending bills that make it hard to do anything about the deficit. It’s fights like these.
Meanwhile, for better or worse, another reason that Medicare costs so much is that it’s subject to a lot of fraud. Lauren, I have seen a lot of Medicare fraud stories over the years, but you’ve got one that was discovered in a pretty novel way. So tell us about it.
Weber: Yeah, my colleagues Dan Diamond, Dan Keating, and I found out early last week — we got a tip from the National Association of ACOs [Accountable Care Organizations] saying that they had seen this massive spike in catheter billing. When we did some digging into the companies they had identified — and to be clear, that spike of catheter billing was worth an alleged $2 billion in billings to Medicare. So when we talk about site-neutral payments, that’s almost what you would get for site-neutral payments: the $2 billion in Medicare fraud, but regardless.
So my colleagues and I dug in. So Dan, Dan, and I called around, and we found links between the seven companies that were charging Medicare for catheters that folks never received. I want to point out, I spoke to this lovely woman in Ponta Vedra Beach, Florida. She’s 74, Aileen Hatcher, who spotted this diligently going through her Medicare form, but as she said, she went to her — literally, these are her words — she’s like, “I went to my old lady luncheon and told them all this was on my Medicare statement.” And they said, “Oh, we don’t read those because we don’t pay Medicare the money. So we don’t read the explanation of benefits to see what we’ve been charged.”
And, unfortunately, I think that is what happens a lot of times with Medicare fraud. It goes unnoticed because folks aren’t the ones paying the dollars. But the bottom line is this was so large and so many people called into Medicare that Dan and I discovered that there is an ongoing federal investigation. Three of the companies, former owners that I called, confirmed to me that FBI had interviewed them or was talking to them about these folks that had taken over the companies and started charging Medicare this much money. And Dan also got some sources on that front as well.
So, I mean, it’s a pretty massive Medicare fraud scheme. I’ll give a call-out here. If anyone here has been affected by catheter and Medicare fraud, please give me an email. We’d love to hear more. I think it speaks to the fact that Medicare fraud — we all know this because we cover this — Medicare fraud is as old as time. It continues to happen, especially durable medical equipment Medicare fraud. But this is so much money. And it is wild that even though we talked to so many people that called Medicare over and over and over again, these folks were able to get away with billing for a very long time.
Rovner: What I found really fascinating about the story, though, is that it was the doctors in the ACOs that spotted it because — we’ve talked about these accountable care organizations — they’re accountable for how much it costs to take care of their patients.
The patients aren’t paying for it, as they point out, but these doctors, it’s coming right out of their bonuses and what they’re charged and how much they get for Medicare. So there’s finally somebody with a real incentive to spot this kind of fraud, because, basically, it was taking money from them. Right?
Weber: That’s exactly right. I think that’s why they were so hot to have some movement on this because, as they pointed out, they could lose millions of dollars in bonuses for better taking care of their patients.
It’s wild that it gets to this point. Like I said, we had all these people that called in to Medicare and many fraud lawyers we talked to said, “Look, why aren’t the NPIs [National Provider Identifiers] turned off?” Great question.
Rovner: Yeah. Anyway, I was fascinated by this story, and as I told Lauren earlier, I’m not a big fan of Medicare fraud stories just because there are so many of them. But this one is like, oh, maybe we finally have somebody … the ACOs can become bounty hunters for Medicare fraud, which would not be a bad thing.
All right, well, moving on to abortion this week, we have spent a lot of time talking about how doctors who perform abortions and patients who need them in emergencies have been trying to get state officials to spell out when the exceptions to state bans apply. Well, now it seems that it’s the other side looking for clarification.
Stat News reports that several anti-abortion groups have joined doctors and patients in urging the Texas Medical Board to spell out which conditions would qualify for the exception to the ban, and not subject doctors who guess wrong to potential prison terms and loss of their medical licenses.
Meanwhile, legislation moving through the House in South Dakota, endorsed by multiple anti-abortion groups, would require the state to make a video explaining how its ban works and under what circumstances. Alice, what’s going on here?
Ollstein: I think it’s this interesting confluence and it’s an interesting development because, at first, anti-abortion groups were insisting that the laws were perfectly clear. And that doctors were either willfully or mistakenly misinterpreting them. As more and more stories came forward of women being turned away while experiencing a medical emergency and suffering harm as a result, a lot of those women are part of lawsuits now.
They were saying the law is fine. In some cases, these anti-abortion groups wrote the laws themselves or advised on them saying, your interpretation is what’s wrong. The law is fine. But I think as so many of these stories are coming out, that’s not proving enough. And now they’re going back and saying, OK, well, maybe there do need to be some clarifications. They don’t want changes. There’s different camps because some people do want changes. Some people say, OK, we need more exceptions. We need more carve-outs to avoid these painful stories. Whereas other anti-abortion forces and elected officials say, no, we don’t need to change the law. We just need to clarify it and explain it. And so I think that’s going to be an ongoing tension.
Rovner: Yeah, I know one of the big themes earlier in this whole fight — I won’t say earlier this year, it was mostly last year — was redefining things as not abortions. That if you’re terminating an ectopic pregnancy, that’s not an abortion. Well, that is an abortion.
Ollstein: Medically, yes.
Rovner: So apparently, the … right. The renaming has not worked so far. So now I guess they’re trying to clarify things. Lauren, you wanted to add something?
Weber: Yeah, I just wanted to say, when you kick things to the medical board, I think people see that as an unbiased unpolitical organization. But medical boards are often appointed by the governor. So, in this case, Gov. [Greg] Abbott. And also take Ohio, for example: I believe that one of their medical board leaders is the head of the right-to-life movement.
I haven’t looked at Texas’. But kicking it to the medical board to make a decision — putting aside the fact that most medical boards are incredibly inadequate at their actual job, which is disciplining doctors, they’re not necessarily known for their competence — is that you also deal with some of the politics involved in this as well.
Rovner: So in South Dakota, it would kick this to the South Dakota Department of Health, which, of course, is controlled by the governor, who’s a Republican and pro-lifer. And so it’s hard to imagine what sort of doing a video explaining this is going to do to clarify things any further than they already think the law has gone. But at least … I’m fascinated by the effort here, that this is going on in multiple states. Speaking of state legislators, in Missouri, they’re working on a bill to create an abortion ban exception for children 12 and under — obviously thinking of the 10-year-old in Ohio in 2022 [who] had to go to Indiana to get a pregnancy terminated. But one Republican state senator complained that “a 1-year-old could get an abortion under this.” This is a serious question: Should legislators have to pass a basic biology test to make laws about reproductive health? As we know, 1-year-olds cannot get pregnant.
Ollstein: I mean, this was a more glaring example. We see this over and over in a lot more subtle ways, too, where doctors and medical societies are pointing out that these laws are drafted using language that is not medically accurate at all. And it can be small things in terms of when someone should qualify for a medical exemption to an abortion ban. Some states have language around if it would cause “irreversible damage.” That’s not a term doctors use in that circumstance, things like that. Or a major bodily function would be impaired if they don’t get an abortion. Well, what is a major bodily function? That’s not defined. And so, yes, this was an almost laughable example of this, but I think that it’s a sign of something more pervasive and maybe less obvious.
Rovner: Yeah, I mean, I have listened to a lot of state debates with a lot of legislators saying things that are, as I say, kind of laughably inaccurate. Sorry, Lauren.
Weber: Oh, I would just say as a Missourian and as someone who lived in Missouri until a year ago, this gentleman, in particular, it does seem like has a history of making somewhat inflammatory statements that he knows will be picked up by the media. I mean, I think he brought a flamethrower to an event. I mean, I think that’s part of the shtick. But welcome to Missouri politics. You never know what you’re going to get.
Ollstein: And of course, we have the famous assertion that people can’t get pregnant as a result of rape because the body knows how to shut it down, which is obviously not …
Rovner: Which happened in a Missouri Senate race.
Ollstein: Yes. Yep. Exactly. So Missouri, once again, covering itself in glory.
Rovner: All right, well, something we haven’t talked about a lot recently are crisis pregnancy centers, which are usually storefronts for anti-abortion organizations that often lure women seeking abortions by offering free pregnancy tests and ultrasounds so that they can then talk them into carrying their pregnancies to term. The centers are getting more and more public support from states. One estimate is that government support totaled some $344 million in fiscal 2022. So that was a couple of years back. And increasingly as abortion clinics close in states with bans, crisis pregnancy centers, which typically don’t have medical professionals on staff and aren’t technically medical facilities, may be the only resource available to pregnant women. It seems that could have some pretty serious ramifications. Yes?
Ollstein: I mean, I think people don’t realize just how vast the network of these centers are. They outnumber abortion clinics by a lot in a lot of states, including states that support abortion rights. They’re very, very pervasive. And this is becoming a huge focus for the anti-abortion movement. It was basically the theme of this year’s March for Life, was these sort of resources. In part, it is an attempt to show a kinder face of the movement and change public opinion. Obviously, like we discussed, there are all these painful stories coming out about people being denied care. And so promoting these stories of places that provide some form of something, some services, it’s not necessarily medical care, but …
Rovner: They provide diapers and strollers and car seats. I mean, they do actually … many of them actually provide services for babies once they’re born.
Ollstein: Right. Right, right, right. And so I think there is going to be a huge focus on this in the policy space, both in terms of directing more taxpayer funding to these centers, which progressives vehemently oppose.
And so I think this is going to be a big focus going forward. It already has in Texas. Texas has directed a lot of money towards what they call alternatives to abortion, which include these centers. And so I think it’s going to be a big focus going forward.
Rovner: Well, one other thing about crisis pregnancy centers, because they are not medical facilities, they are not subject to HIPAA medical privacy rules. And it turns out that is important. According to an investigation by Senate Finance Committee Chairman Ron Wyden, a company gathered and sold location data for people whose phones were in or around 600 separate Planned Parenthood locations, without the patients’ consent, to use an anti-abortion advertising.
Wyden is asking the SEC and the FTC to investigate the company, but this raises broader questions about information privacy, particularly in the reproductive health space. I remember right after Roe v. Wade was overturned, there were lots of warnings to women who were using period-tracking apps and other things about the concern about people who you may not want to know your private medical situation being able to find out your private medical situations. Is there any indication that there’s any way from the federal government point of view to crack down on this?
Ollstein: So I don’t know about that specifically, but there is a bigger effort on privacy and digital privacy and how it relates to abortion. We’re still waiting on the release of the final HIPAA rule from the Biden administration, which will extend more protections around abortion data, I think. But, because it’s HIPAA, it does only apply to certain entities and these centers are not among them. Another area I’ve been hearing concern about is research. A researcher at a university who is studying people who have abortions or don’t have abortions, their data is not protected. And so they are very stressed out about that, and that’s compromising medical research right now. So there’s a lot of these different areas of concern. And as we so often see, technology evolves a hell of a lot faster than government evolves to regulate it and address it. And that is just an ongoing concern.
Rovner: Yes, it is. And at some point, we’ll talk about artificial intelligence, but not today. Actually, right now, I want to turn to the Super Bowl. Yes, the Super Bowl. In between all the ads for blockbuster movies, beer, cars, and snack foods, and, right, a football game, there were three ads aimed directly at health policy issues.
In one, the nonprofit price transparency advocacy group Power to the Patients got musicians Jelly Roll, Lainey Wilson, and Valerie June to basically call hospitals and insurance companies greedy. It’s not clear to me if this was a free PSA or if this group paid for it, but I suspect the latter.
Does anybody know who this group is? They seem to have lots of access to big names for what seems to be a kind of obscure health issue. I mean, everybody’s for transparency, but I don’t think I’ve ever seen a Super Bowl ad about it.
Cohrs: This is not their first Super Bowl. It’s backed by Cynthia Fisher who is married to the CEO of Sam Adams, parent company. And he’s also a member of the Koch family. But she has been passionate about health care price transparency for years. I mean, was in President [Donald] Trump’s ear, has made the legal argument that the authority existed under the Affordable Care Act. Lobbied to get these regulations passed. And she has definitely employed unusual or unorthodox techniques, like Super Bowl ads, like painting murals, like hosting parties and concerts for health staff and health policy people in D.C. And I think she’s also lobbying for the codification of these transparency regulations.
And it is a little wonky, but I think her frustration is that she lobbied so hard to get these price transparency regulations and everyday people don’t even know that it should be available for them. And obviously academics disagree over how useful that information is for everyday people. But I think she has just taken it upon herself to do the PR campaign for these regulations that she believes could help people make more educated decisions about care that isn’t necessarily emergency care, like MRIs, that kind of thing. So she’s been around for years and has been very active.
I think Fat Joe is another celebrity that she’s brought onto the case. Jelly Roll — I hadn’t seen him do an event with her before or an ad. But I think there’s an ever-expanding cast of celebrities where this is just … it seems like a pretty noncontroversial issue. So I mean, Busta Rhymes, like French Montana, there’s been a lot of people involved in this campaign and I expect it to be ongoing.
Rovner: I feel like she’s kind of the Mark Cuban of price transparency, where Mark Cuban is all into drug prices. Alice, you want to add something?
Ollstein: Well, it’s just funny to me because, as we’ve discussed many, many times on this podcast, transparency goes not very far in helping actual patients. And so it’s funny that a group called Power to the Patients is going all in on this issue when, as we know, the vast majority of health care people need they cannot shop around for and, even when they can, it’s not something people are always able or willing to do.
And so transparency gets a lot of bipartisan support and sounds good in theory, but we’ve seen in terms of what’s been implemented so far in terms of hospital prices, et cetera, that it doesn’t do that much to bring down prices or empower people.
Rovner: Although, I don’t know, getting famous people to care about health policy can’t be a terrible thing. Lauren, did you want to add something too?
Weber: No, I just wanted to say, I mean, I will say as much as we’re all clear on price transparency, what this all means, the Super Bowl is a new audience. So, I mean, if you’re going to spend your money, at least you’re spending it — and that was the most watched TV program, I believe, of all time — so you’re spending it in a way that you’re getting some eyeballs on it.
Rovner: All right, well, that was not the only ad. Next, a company that clearly did pay for its ad was Pfizer, which used a soundtrack by Queen and talking paintings and statues to celebrate science and declare war on cancer. This is also one I don’t think I had seen before. I mean, what is Pfizer up to here? I mean, obviously, Pfizer can afford a Super Bowl ad. There’s no question about that, but why would they want to?
Cohrs: I mean, Pfizer has not been performing great financially lately. And I think they pulled out of the lobbying organization biome and chose to spend money on a Super Bowl ad, which I think is a really interesting choice. I mean, I don’t know what the dues are, but a Super Bowl ad is an expensive thing.
And I think there has been this attack on science, as a whole, and I think there’s an outstanding question of how to rebuild trust. And I think that this was Pfizer’s unorthodox tactic of trying to equate themselves with more credible, historical scientists who are less controversial. Yeah, my colleague did a good story on it.
Rovner: Yeah, like Einstein.
Cohrs: Right.
Rovner: Well, we’ll link to all of these ads. If you haven’t seen them there, they’re definitely worth watching. Well, finally, and in keeping with the occasional politics that does creep into Super Bowl ads, the super PAC supporting the presidential candidacy of independent anti-vaxxer Robert F. Kennedy Jr. paid $7 million for an ad that was basically a remake of the 1960 ad for his uncle John F. Kennedy, when he was running for president, which provoked an outcry from several of his Kennedy cousins who have repeatedly disavowed RFK Jr.’s candidacy and his causes.
For his part, the candidate apologized to his family members and said he didn’t have anything to do with the ad directly, because it was the super PAC. But then he pinned it to his Twitter profile, where he has more than 2½ followers. I can’t help but wonder if they’re going after football fans who actually believe the whole Taylor Swift-Travis Kelsey thing is a conspiracy.
No comment on Robert F. Kennedy Jr. and pissing off his entire family? We will move ahead then.
Speaking of conspiracy theories, in “This Week in Health Misinformation,” we have — drum roll — blood transfusions. Seems that there are a significant number of people who believe that getting blood from someone who has been vaccinated against covid, using the mRNA vaccines, will somehow change their DNA or otherwise harm them. And state legislators are listening.
In Wyoming, a state representative has introduced a bill that would require the labeling of blood from a covid-vaccinated donor. So prospective recipients could refuse it, at least in nonemergency situations. And in Montana, there’s a bill that would go even further, banning blood donations from the covid-vaccinated. That one appears to not be going anywhere, but this could have serious implications. It would create blood shortages, I imagine, even in rural areas where fewer people are vaccinated than in some of the urban areas. But I mean, this strikes me as not an insignificant kind of movement.
Ollstein: Well, it seems troubling on two fronts. One, we already have blood shortages and we already have dangerously low vaccination rates and not just covid vaccination rates. The hesitancy and anti-vax sentiment is spilling over into routine childhood vaccinations and all kinds of things.
And so I think anything that appears to give that sort of stigma and conspiracy a veneer of credibility, like state law for instance, threatens to further entrench those trends.
Rovner: All right, well, that is this week’s news. We will do our extra credits in a minute, but first, as promised, we have the winners of the KFF Health News “Health Policy Valentines” contest. This year’s winner, and we will post the link to the poem and its accompanying illustration, is from Jennifer Reck.
It goes, “Darling, this Valentine’s Day, let’s grab our passports and fly away to someplace where the same drugs cost a fraction of what they do in the States.” I have asked the panel to each choose a finalist of their own to read. So, Lauren, why don’t you start?
Weber: “The paperwork flirts with my affections, a dance of denials, full of rejections. My heart yearns for you, my sweet medication, but insurance insists on prior authorization.”
Rovner: And who’s that from?
Weber: That’s from Sally Nix. Excellent work, Sally.
Rovner: Alice.
Ollstein: OK, I have one from Kara Gavin. It’s “My love for you, darling, is blinding / Like a clinical trial pre-findings / But I fear we shall part / And I’ll lose my heart/ Because of Medicaid unwinding!” Very topical.
Rovner: Very. Rachel.
Cohrs: OK, this is from Andrea Ferguson. “Parental love is beautiful and guess what makes it stronger? A paid parental leave policy to stay with baby longer.”
Rovner: Very nice. Thank you all who entered. And we’ll do this again next year. All right, now it is time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read, too. As always, don’t worry if you miss it. We will post the links on the podcast page at kffhealthnews.org and in our show notes on your phone or other mobile device. Alice, why don’t you go first this week?
Ollstein: I have a piece from my colleague Arek Sarkissian, down in Florida, and it is about how the state’s immigration law is deterring immigrants from seeking health care. And one of the areas they’re most concerned about is maternal health care. We already are in a maternal health crisis and the law requires hospitals that receive Medicaid funding to ask people about their immigration status when they come in for care. What a lot of people don’t know is that they don’t have to answer, but this fear of being asked and potentially being flagged for deportation enforcement, et cetera, is making people avoid care. And so there’s just a lot of concern about this and a lot of attempts to educate folks in the immigrant community. Obviously, Florida has a very large immigrant community. And it just reminded me of the fears that were happening early in the pandemic when the public charge rule under Trump was in effect and it was deterring immigrants from seeking care.
And in the middle of a pandemic, when we’re dealing with an infectious disease that doesn’t care if you have citizenship or not, having a large segment of the population avoid care is dangerous for everyone.
Rovner: Indeed. Lauren.
Weber: So I chose an article titled “Climate Change Has Hit Home Insurance. Is Health Insurance Next?” by Yusuf Khan in The Wall Street Journal. And, I mean, look, the insurers are — they’re looking out for their bottom line. And the bottom line is that climate change does have health impacts. So the question is, will that start to hit premiums? The sad answer, in part of this article, is that, unfortunately, the people often most affected by climate change don’t have health insurance. So that may not affect premiums as much as we expect, but I think this is a really fascinating test case of how when climate change comes for your money, you’ll start to see it validated more. So I’ll be curious to see how this plays out with the various health insurers.
Rovner: Yeah, obviously, we’re already seeing people not being able to get home insurance in places like Florida and California because of increasing fires and increasing hurricanes and increasing flooding in some places. Rachel?
Cohrs: So mine is a package deal. It’s two stories related to private equity investment in health care. The first is a piece in Modern Healthcare by Nona Tepper on a Medicare Advantage report by the Private Equity Stakeholder Project. And it just kind of highlighted the downturn in investment in Medicare Advantage, like marketing companies and brokers, consultants.
And I thought it was an interesting take because, I think so often, we see reporting about how private equity is expanding its investment in a certain sector. But this, I think, was an interesting indicator where, oh, it’s turning downward so dramatically. And I think that it’s interesting to track the tail end of more regulation or whatever rule comes out. How does that impact investment? And we talk a lot about that in the pharmaceutical space. But I thought this was a great interesting creative take on the Medicare Advantage side of things.
And also just highlighting some reporting from my colleague Bob Herman about the FTC doubling down on the Welsh Carson’s anesthesia case to limit private equity’s physician buyouts. So the FTC is taking on Welsh Carson, a powerful private equity firm, and other private equity firms asked for the case to be dismissed. And Bob does a great job breaking down these really complicated arguments by the FTC as to why they’re not backing down. They’re not going to cut a deal, they want this case to go forward.
So it will be interesting to watch as this develops, but I think Bob makes a great argument. There are applications for other cases as well and for the FTC and being able to attack these complex corporate arrangements where they’re using subsidiaries to drive prices up for physician services and other things. So definitely worth a read from Bob.
Rovner: Yes, another theme of the Federal Trade Commission getting more and more involved in health care in general and private equity in health care in particular. My extra credit this week is from Stateline by Anna Claire Vollers, and it’s called “Government Can Erase Your Medical Debt for Pennies on the Dollar — And Some Are.” It’s about how a growing number of states and cities are buying up and forgiving medical debt for their residents. Backers of the plans point out that medical debt is a societal problem that deserves a societal solution. And that relieving people’s debt burdens can actually add to economic growth. So it’s a good return on a small investment. It’s obviously not going to solve the medical debt problem, but it may well buy some government goodwill for some of the people of these states and cities.
All right, that is our show. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks, as always, to our technical guru, Francis Ying, and to Stephanie Stapleton, filling in this week as our editor. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X, @jrovner, or @julierovner at Bluesky and @julie.rovner at Threads. Lauren, where are you these days?
Weber: Still just on Twitter @LaurenWeberHP, or X, I guess.
Rovner: Alice.
Ollstein: On X @AliceOllstein and on Bluesky @alicemiranda.
Rovner: Rachel.
Cohrs: I’m @rachelcohrs on X and also getting more engaged on LinkedIn lately. So feel free to follow me there.
Rovner: We will be back in your feed next week. Until then, be healthy.
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KFF Health News' 'What the Health?': The Struggle Over Who Gets the Last Word
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Julie Rovner
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Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.
The Supreme Court in March will hear oral arguments in two very different cases that boil down to the same question: How much power do “experts” in health and science deserve? At stake is the future accessibility of the abortion pill mifepristone, and the ability of government officials to advise social media companies about misinformation.
Meanwhile, abortion opponents are preparing action plans in case Donald Trump retakes the White House. While it’s unlikely Congress will have enough votes to pass a national abortion ban, a president can take steps to make abortion far less available, even in states where it remains legal.
This week’s panelists are Julie Rovner of KFF Health News, Sandhya Raman of CQ Roll Call, Joanne Kenen of Johns Hopkins University and Politico Magazine, and Sarah Karlin-Smith of the Pink Sheet.
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Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico
Sarah Karlin-Smith
Pink Sheet
Sandhya Raman
CQ Roll Call
Among the takeaways from this week’s episode:
- Abortion opponents are preparing for the possibility of a second Trump presidency. Among ways the former GOP president could influence policy without Congress is by installing an activist secretary of Health and Human Services, possibly allowing a political appointee to overrule decisions made by FDA employees.
- While President Joe Biden is embracing abortion rights, Donald Trump is highlighting two conflicting truths: that he appointed the Supreme Court justices who helped overturn the constitutional right to an abortion and that embracing abortion restrictions could drive away voters.
- The federal government is making its initial offers on 10 expensive pharmaceuticals targeted for Medicare price negotiations. But the process is private, so it is unknown what those offers are.
- Two pharmaceuticals that have been in the headlines — the controversial Alzheimer’s disease drug Aduhelm and the insulin Levemir — will soon be pulled from the market. The decisions to discontinue them play into an ongoing debate in drug development: When is innovation worth the price?
- “This Week in Health Misinformation” features an article by KFF Health News’ Amy Maxmen about how what once were fringe views questioning science are now becoming more mainstream.
Also this week, Rovner interviews Samantha Liss, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” feature, about a husband and wife billed for preventive care that should have been fully covered. If you have an outrageous or confounding medical bill you’d like to share with us, you can do that here.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: ProPublica’s “Amid Recall Crisis, Philips Agrees to Stop Selling Sleep Apnea Machines in the United States,” by Debbie Cenziper, ProPublica, and Michael D. Sallah, Pittsburgh Post-Gazette.
Joanne Kenen: The New York Times’ “Elmo Asked an Innocuous Question,” by Callie Holtermann.
Sarah Karlin-Smith: The Texas Tribune’s “Texas Attorney General Requests Transgender Youths’ Patient Records From Georgia Clinic,” by Madaleine Rubin.
Sandhya Raman: The Associated Press’ “Community Health Centers Serve 1 in 11 Americans. They’re a Safety Net Under Stress,” by Devi Shastri.
Also mentioned on this week’s podcast:
- Politico’s “The Anti-Abortion Plan Ready for Trump on Day One,” by Alice Miranda Ollstein.
- The 19th’s “The Tools Trump Cold Use to Curb Abortion Access if He’s Elected,” by Shefali Luthra and Mel Leonor Barclay.
- The New York Times’ “How Trump Could Institute a Backdoor Federal Abortion Ban,” by Mary Ziegler.
- CQ Roll Call’s “GOP Pivots on Abortion Stance as 2024 Nears,” by Ariel Cohen and Sandhya Raman.
click to open the transcript
Transcript: The Struggle Over Who Gets the Last Word
KFF Health News’ ‘What the Health?’Episode Title: The Struggle Over Who Gets the Last WordEpisode Number: 332Published: Feb. 1, 2024
[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It 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 are taping this week on Thursday, Feb. 1, 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 Johns Hopkins University and Politico Magazine.
Joanne Kenen: Good morning, everybody.
Rovner: Sandhya Raman of CQ Roll Call.
Sandhya Raman: Hello, everyone.
Rovner: And Sarah Karlin-Smith of the Pink Sheet.
Sarah Karlin-Smith: Morning.
Rovner: Later in this episode, we’ll have my interview with KFF Health News’ Samantha Liss, who reported and wrote the latest KFF Health News-NPR “Bill of the Month.” This month’s patient — actually, patients — got unexpected bills for care that should have been fully covered.
Before we get to this week’s news, it is February, so that means we want your health policy valentines. We will put a link to submit in our show notes. It’s on our web page at kffhealthnews.org. Show us, and your valentine, your affection for nerdy health policy topics. Winners will get read on the podcast and shared on our webpage and social media. The top poem will get its own illustration by our amazing in-house artist, Oona Tempest, so get those entries in.
OK, now the news. We will start this week in federal court where March is starting to look like “Health Policy Month.” At the 5th Circuit in New Orleans, judges will hear arguments in the case Braidwood v. Becerra, which challenges the very popular provision of the Affordable Care Act that requires insurers to cover a long list of preventive services at no out-of-pocket cost to patients. Fun fact: This is the provision in question in the latest “Bill of the Month,” which you will hear about in a few minutes. Another fun fact: The lower-court decision in this case came from Judge Reed O’Connor, whose name might sound familiar because he was the judge who tried to strike down the entire Affordable Care Act back in 2018. Somebody remind us why the plaintiffs here think the preventive services mandate is unlawful and should be stricken?
Raman: One of the issues that they have in this case is that certain types of this preventative care are in question — so, some of the things related to women’s health, vaccines, PrEP for preventing HIV, and just the moral issues that they have that those things do not necessarily need to be applied to under their plan. It’s some of those things in particular that come up.
Rovner: Yeah. I think in this case it seems to be mostly PrEP. It seems to be mostly about not wanting to encourage homosexual behavior, as the plaintiffs are saying, which is a rerun of what we had with the birth control cases, which went on, also for this provision of the ACA. No matter what happens in this case, Braidwood is sure to be appealed to the Supreme Court, which already has two health-related cases set for March oral arguments.
On March 18, the justices will hear Murthy v. Missouri, which challenges the government’s ability to coordinate with social media companies to downplay medical misinformation. The attorneys general of Louisiana and Missouri are arguing that the Biden administration essentially worked to censor conservative views. The Murthy in this case is Surgeon General Vivek Murthy, on whose behalf the Justice Department called the lower-court ruling seeking to bar communication between the White House and federal health agencies with social media companies, quote, “novel, unbounded, startling, radical, and ill-defined.” This could be a really important case for those trying to rein in medical misinformation, right? I mean, it’s obviously a really delicate thing. What serves as medical misinformation when the government gets to say, “Really, it should be at least de-algorithming,” if that’s a word, “this stuff because it’s not correct.”
Karlin-Smith: Right. I think one of the questions here is was the government collaborating and just sort of discussing and flagging these concerns to the companies, or did they exercise some sort of undue leverage here? Which is a big debate. Obviously, a private company has different ability to also regulate speech on its platform than the government does. So that’s another element to the case. I think sometimes people get confused about what your free speech rights are when you’re not directly dealing with the government in the U.S.
Rovner: Yes, there’s no guaranteed free speech in a private space like social media. I mean, they are not government-run. Although, I guess one of the arguments here is that they may be government-involved. I guess that’s what this case is supposed to try and create the guidelines for, but it’ll be … I’m looking forward to actually listening to these oral arguments.
Well, the following week, on March 26, the Supreme Court will hear the case FDA v. Alliance for Hippocratic Medicine, which is the one where conservative doctors challenged the original year 2000 approval of the abortion pill mifepristone. Technically, the justices are no longer considering canceling the original approval. They’re considering rolling back the FDA’s loosening of restrictions on the drug in 2016. But still, that alone could be a big deal, right? Sandhya, you’ve been following this, have you?
Raman: Yeah. Yeah. The Supreme Court decided at the end of last year that they would be taking up the case. So this week they set the actual oral arguments that we can look forward to. That’s going to be the first big abortion case that they’re going to hear since Dobbs. We have another abortion case coming up in April related to emergency health care. I think that it is interesting that it’s not over the full approval of the drug, it’s the regulations, but if you …
Rovner: Well, that’s because the 5th Circuit rolled back the original decision.
Raman: Yes. But I think that if you look at how much the regulations have changed since the original approval, there’s been a lot of expansion in just how it can be used, who can prescribe it, where it can be used, that kind of thing. So even if they were to rule to rescind some of those regulations and keep the original approval in place, that could have a huge effect in terms of who can get it. I mean, since the initial approval, we’ve been allowed to distribute it by mail, we’ve been allowed to do by telehealth to prescribe it. Just the length into pregnancy that it can be used, there’s been a lot of changes there. So we’ll have that to watch. The briefs have all started coming in, at least in favor of keeping the regulations as they are. We’ve had a huge lawmaker brief from a lot of Democrats. We had one from a lot of the pharmaceutical companies, including some big ones like Pfizer and Biogen.
Rovner: Yeah. I noticed in the PhRMA brief — or the pharmaceutical companies’ brief; I don’t believe it was from PhRMA the organization yet. But they did say that they were worried that if the court even were to uphold the 5th Circuit decision, which doesn’t cancel the approval but would cancel all of the changes since 2016, that that would basically freeze in place the use of drugs as we discover new uses for the same drugs. I mean, if you can’t relabel and put them out in a different way for different things, that would be a big hit to the drug industry, which, Sarah, spends a lot of time repurposing existing drugs, right? That’s a big part of drug development.
Karlin-Smith: Right. Improving upon a drug once it gets approved, expanding the label to treat different conditions is a big thing. The underlying tension for the pharmaceutical industry here is that there is a concern that this is the courts weighing in on sort of questioning the scientific judgment of the FDA in a way that would just make our whole drug approval regulatory system not function well for the industry, regardless of whether you’re talking about an abortion drug or a cancer drug or an arthritis drug. That’s really why there’s so much engagement from folks who are not necessarily here to argue about abortion politics. It’s just this concern that there’s certain scientific expertise and deference that we feel like the FDA should have, and that there’s concern that courts don’t really have that ability to accurately second-guess their judgments there.
Rovner: This really harkens back to what we’ve been talking about for the last couple of weeks with this big Supreme Court case on Chevron deference, which is basically the question of whether judges get to decide how to interpret federal laws or whether courts get to decide. This obviously would be a big deal because judges are not generally people with the expertise that doctors and scientists at the FDA have, right? Isn’t that sort of a big piece of this case too?
Kenen: Yes. We know that this particular court is anti-abortion. If they had just sort of a birthday cake wish, they would make the abortion pill go away. The question is where are they going to come down on who gets to decide? Is this an FDA decision or is this a legal decision elsewhere in the system? That’s the mystery. We really don’t know. In some ways, too, with the prior case we were just talking about, about preventive care, the USP has a lot of … the U.S. Preventive …
Rovner: Services Task Force.
Kenen: Who decides? What’s their authority? Which is part of the underlying legal battle in that case. So, are they anti-abortion? Yeah. Six, we know, are. Are they anti-FDA? Are they going to find some legal rationale for pulling this out of the FDA, with leaving other drugs in the FDA? That’s sort of part of what we’ll be watching for. Not just us. I mean, that’s what it comes down to.
Rovner: I was going to say, even the social media case, I mean, all of these cases are basically about scientific expertise and who gets to have the last say on questions of science and medicine. I mean, literally, all of these cases are about the same thing when you come right down to it.
So while we are on the subject of abortion, former South Carolina governor and, still, Republican presidential candidate Nikki Haley has been dodging questions about a federal abortion ban by pointing out that if neither party has 60 votes in the Senate, nothing can pass. Which is true as long as there’s still a filibuster. Well, it seems that the anti-abortion movement took that as a challenge. Two of our podcast colleagues, Shefali Luthra and Alice [Miranda] Ollstein, have eye-opening stories this week about all the things that President Donald Trump could do, if he’s elected again, without Congress. Some of those are things that he did in his first term that President Biden reversed, but some are new ones too. They’re already vetting people to carry out those policies. It looks like they want to be ready on day one. At least the anti-abortion forces want to be ready on day one, to do kind of a full-court press on anything that they consider to be abortion related.
Raman: Yeah, I think there have been, in the past, some of these policies that have gone back and forth between each administration. So something like Title X, the family planning program. Depending on if we have a Democrat or a Republican in office, they change what some of the regulations are there, but then …
Rovner: They basically kick Planned Parenthood in or out.
Raman: Yeah, things like that. Or like the Mexico City policy, which does something in a similar … but for overseas funding. And we’ve had also a ton of different new regulations since the Dobbs decision, in the Biden administration making it a little easier if you are, in certain cases, needing an abortion and are in the VA, in the Defense Department, things like that, that have been big issues for a lot of Republicans. So they would also have to — it’s more of a new territory to figure out how to roll back some of those compared to some of the things that they have a standard plan on.
But if you look at both of our podcast colleagues’ stories, one that stuck out to me was just kind of how they would have the FTC [Federal Trade Commission] try to crack down on abortion by mail, which comes back to the court case we were just discussing, abortion medication, abortion. And just how you could reinterpret some of the existing regulations that we do have regardless of what happens at the Supreme Court.
Karlin-Smith: I was going to say one thing that really stuck out to me in one of The New York Times pieces about this was how even the Trump administration could basically have their HHS [Department of Health and Human Services] secretary override FDA decisions, because we sort of forget that, actually, the way Congress has written a lot of the laws, actually, the HHS secretary has that ultimate authority around drug approvals. We just sort of take it for granted, I think, that for the most part they delegate that to FDA and the political appointees stay out of it. That’s another thing they raise is you could have sort of a more activist HHS secretary that could interfere with what does or doesn’t get approved by FDA. So there’s some pretty norm-ending ideas there for the government.
Rovner: I will say that I do remember Kathleen Sebelius came in and overrode an FDA … about contraception coverage decision. President [Barack] Obama made it clear that he asked Secretary Sebelius to override the FDA, but I think that was more to protect the FDA. Made it clear that this was a policy decision, not a medical decision. I know that they struggled with that a lot. For exactly the reason that you’re saying, that they didn’t want this to become normal, to have the secretary override the decision of the FDA.
Kenen: But that was a big controversy and someone at the FDA quit over it. I think it was the women’s health person. In that case, it was narrow. It was about, if I’m remembering correctly, Julie has a, sometimes, better memory, it was under-18 access to the morning-after pill, right? It was about 10 or 12 years ago.
Rovner: It was 2011 because it was the night my dog had her leg surgery and I had to come back to the office at 1 in the morning because we didn’t think that the secretary was going to override this decision.
Kenen: No, I said 10 to …
Rovner: I remember it really vividly.
Kenen: … 10 to 12 years ago. Yes, it was, then, 12 years ago. There hasn’t been a high-level repetition of that that I can think — of a HHS override. I mean, that’s one reason why the former FDA commissioners maybe … Julie, you and I were both at Aspen that year. It was maybe eight years ago or nine years ago where all the former FDA commissioners came together and called for the FDA to become an autonomous agency, sort of like the SEC [Securities and Exchange Commission], which was a proposal that then fell in a pond and was never heard from again. But that would prevent that kind of political interference. I mean, I actually spoke to a former FDA commissioner sort of recently and said, “Whatever happened to that?” And he said, “Wait.” So apparently they haven’t totally forgotten. We’re going to see reiterations of this fight over absolutely everything for the indefinite future: Who gets to decide?
Rovner: Yeah, I do think, like I was saying, that this is basically all about who gets to make medical and scientific decisions and whose, quote-unquote, “opinion” holds. Well, before we get off of this totally, both Alice’s and Shefali’s story, and an op-ed by University of California-Davis law professor Mary Ziegler, who’s also been on this podcast, talk about the revival of the Comstock Act. We have talked about this before and we surely will again, but somebody remind us what this 1873 law does and how it could be applied to abortion.
Karlin-Smith: In simple terms, it’s to prevent sending what are considered, quote-unquote, “obscene materials” through the mail. What that can refer to has been interpreted in different ways over the years. I mean, some of the … when it’s from the 1800s, it’s before we had medication abortion. It’s before we had the internet and telemedicine and all of these things. So there’s a lot of room that people have seen for just how it can be reinterpreted now with a lot of different things in place compared to over a 100-and-some years ago, and just how that can work in certain favors.
Rovner: I think I’ve said this before, now that we’re talking about the Comstock Act again, I realize that Anthony Comstock, who it is named after, was not a member of Congress. He was just an anti-smut crusader, basically. I believe the phrase, “You can’t send anything lewd or obscene through the mail.” This would be how they could sort of use it to say that anything abortion or possibly even contraception could be lewd or obscene. With all of this, that the Republicans are getting ready, or at least the anti-abortion groups are getting ready to do, Sandhya, you have a story out this week pointing out that abortion is not something Republicans are emphasizing on the campaign trail. Why not? There seems to be an awful lot of enthusiasm on that side.
Raman: It is pretty interesting. I mean, even if at this point it’s looking like we’re going to have the Round Two of the Trump-Biden matchup, if you look at how Trump, and then even Nikki Haley, have been messaging, all their ads, all that, they have not been as strong on anti-abortion issues as they have in the past. They’re both people that — both of them I’ve covered addressing annual Susan B. Anthony List events. I’ve covered March for Life where Trump has addressed them. They’ve both been very strong on this issue. And then, as you look at it now, neither of them have been really strong on committing to signing a national ban. Haley has really sidestepped the issue in a lot of the interviews that she’s done, just because, like you said, the Senate filibuster. I think even Trump has … they’ve been messaging on him being the most pro-life president that they’ve had. He’s just kind of sidestepped it as well, just kind of emphasizing other things. If you look at the advertising they’ve been doing, it’s not focused on this. It’s such a stark contrast to what the Biden campaign has done, which has really gone all in on abortion rights. They even had an all-reproductive-rights-themed rally a couple weeks ago.
Kenen: When Trump did the town hall on Fox, two, three weeks ago, whenever that was, he had it both ways, which meant that there’s a film clip to use whoever you’re advertising to. Within a minute and a half or two minutes or whatever it was, Trump took credit for knocking down Roe. He took credit for … “I accomplished that.” In other words, he appointed the justices or some of the justices that voted for that. So he took credit for finally being the one to get rid of abortion after 50 … get rid of Roe after 50 years. He was very …
Rovner: Which is true.
Kenen: It’s true. Well, both things he said were true because he took credit for that. So there’s your film clip one for that ad, or that message, or that social media, or whatever, direct mail. Whatever you want to use it for. It’s “I am the one.” And it’s true. And then, in the next breath, he said, “But we have to win elections.” He’s also said he’s for a … is it rape and incest or just rape? I think it was both. He’s for that exception. And then he talked about, “Face reality, we have to win.” Which is also a true statement if you’re running for president. You have to win or you don’t get to do these things that you’ve promised. So, I mean, he’s not the first politician or the last to try to have it both ways. It was interesting that he had it both ways, both accurately, in a two-minute conversation.
Rovner: Not that uncommon for him, though …
Kenen: No, but …
Rovner: To take both sides of an issue at the same time.
Kenen: He was so unabashed about it, it was sort of interesting that, “I did this, but maybe I won too much. Maybe it wasn’t …” I mean, at the polls, abortion has won.
Rovner: Yeah.
Kenen: Anytime there’s been a single-issue vote on abortion, the pro-choice people have won every ballot initiative since Dobbs.
Rovner: Yeah. And yet the other ironic thing, I mean, Sandhya, you already mentioned this, that the Biden administration is going all in on abortion because they know that Democratic women and independent women in most polls are supportive of abortion rights and not supportive of the Dobbs decision. On the other hand, Biden himself is an unlikely messenger for this. He’s a Catholic man of a certain age. He’s always been uncomfortable with this issue. He was pro-life early in his career. There was a joke that he didn’t even say “abortion,” I think, until a year into his presidency. There was an actual website that said, “Has Joe Biden said the word abortion yet?” So is he going to be able to bring along all of these people because they’re just going to, “If you support abortion rights, you’ll just vote for anybody not named Donald Trump”?
Raman: I mean, I think that we’ve already seen some of these different abortion-oriented groups really mobilize or kind of illustrate, commit how much money they’re going to spend, all the on-the-ground stuff they’re going to do to get him reelected. They have called out some of the things that he’s done, some of the regulations we’ve already talked about, that kind of thing. But I do get the sense that some of them are frustrated that we haven’t done enough. But I mean you could say the same for the other side. There’s always more that people want. Given the limitations of government when you don’t have the trifecta, and even when you do have the trifecta, if you don’t have enough of a majority to get some of your golden-ticket items done. So I think that it will be interesting to watch. I mean, we even, going forward, for the State of the Union coming up, they’ve already announced that they’re going to have … one of the guests is Kate Cox, the Texas woman who had to travel when she wasn’t able to get the court order to get the emergency abortion.
Rovner: Yeah.
Kenen: I mean, it’s a turnout issue. We know that voters are not enthusiastic about either candidate. We know that, right? I mean, will that change as the election gets closer? Who knows? But right now, many polls are finding that America’s not crazy about this particular rematch. So what are the issues that motivate people who are lukewarm to actually vote? This is going to be on both sides. This is going to be an issue, but the intensity in many ways is going to be on the Democratic side because they’re, just like it used to be, the one fighting for change. The one on the out is the one more likely to have that voter intensity. For 50 years, it was the Republicans. For the last 18 months, it’s been the Democrats. Vice President [Kamala] Harris has been talking about this. A lot of the other surrogates are talking about this. So this is a “Will this make you get out of whatever else you were going to do that Tuesday, or early vote, and actually vote?” It’s going to be one of the key issues in turnout.
Karlin-Smith: I think that’s a great point, that that is another reason why there’s so much Republican messaging on some of these other issues, on immigration, on crime and things like that. Because when it’s not a single-issue thing like the ballot — they’re still winning tons of races for governor and things like that. Maybe focusing on those issues might be good for them to boost some of the turnout.
Rovner: Well, another big issue that voters care about is drug prices. We actually have a lot of drug news this week. The federal government, just this morning, sent out its first set of proposed prices for the 10 drugs they have selected for Medicare price negotiation. Of course, they’re not telling us those prices because this is a private negotiation. But Sarah, did anything jump out at you from what they’ve said about kicking off this process?
Karlin-Smith: I think right now what the Biden administration is trying to do is just sort of publicize that this process is happening. Because again, this is a big political issue, an election thing that they’re hoping will motivate voters. But at the same time, it’s a little bit of a dud in some ways because the government can’t say what they’re offering and the companies don’t necessarily seem inclined to put out any information on this yet. So it’s going to be a pretty private process, potentially all the way up until this fall, in September, when we’ll get some public information. But I think the Biden administration just wants to keep ramming it into voters’ heads that, “Hey, we’re doing work to try and lower drug prices for people as much as we can.”
Rovner: Of course, the drug industry still hopes that some court will overrule and stop this whole thing, right?
Karlin-Smith: Right. There was actually oral arguments yesterday in one of the challenges from AstraZeneca to … that they’re hoping courts will intervene. I think some of the initial reporting from that was that the judge was fairly skeptical of some of AstraZeneca’s arguments, such as that there’s sort of a due process or taking of property that the government is not allowed to do here. The judge was basically saying, “Well, nobody is forcing you to participate in the Medicare program and sell your drugs there.” So some initial, at least, positive signs for the government in those oral arguments.
Rovner: Yeah. Although, as we know, they have a long way to go. In the individual-drug news category, remember when we were talking all about the controversial Alzheimer’s drug, Aduhelm, pretty much every week? Well, it is back and it’s sort of gone, or going, at least. Drug company Biogen is giving up ownership and prematurely ending a trial that was supposed to confirm the drug’s effectiveness in treating early Alzheimer’s. Sarah, you followed this from the very beginning. What do you take away from this whole saga? I mean, at one point, Aduhelm was going to be the answer, and then it was going to break Medicare because it costs so much. And then it was going to make people sick because it had side effects. And now it’s just going away.
Karlin-Smith: There’s so many layers to this story, but the quick version of it is, basically, FDA sort of controversially approved this drug over a lot of skepticism of whether it was actually going to be beneficial to patients. They use sort of a controversial measure that the drug reduced these amyloid plaques in the brain, but there were a lot of questions, including by outside scientists and so forth, as to whether this would actually improve the lives of patients with Alzheimer’s in terms of helping them function and memory. There’s a lot of side effects to the drug. Of course, the third layer of this is it was priced quite costly. What ended up happening was Medicare said, “We will only cover this drug at this point in time if it’s used in a clinical trial.” Part of what happened, I think in large part because of that, is there was no uptake of this product, no sales. That’s really why Biogen has pulled the plug here. The other element of this is that Biogen also has another Alzheimer’s drug that was approved fairly shortly thereafter that actually has better data to show there’s some benefit in actually improving people’s cognition. So again, they’re not necessarily invested in pushing forward a drug where they face all these payment challenges and have less solid data. The question now becomes, what does FDA do here? Do they officially go through the process and make sure … force Biogen to pull it off the market? What do they do about this clinical trial that they were supposed to be conducting to confirm the benefit? And what does science lose if that just gets stopped? I’m not sure if anyone will feel like there’s a need to complete that at this point. But it does raise interesting questions to me because I think about 1,500 or something patients were actually already enrolled in participating in that study.
Rovner: But I do think it’s important to emphasize that since Aduhelm was sort of all the rage, the big debate, we actually are finally seeing some drugs that do appear to have more benefit than cost for early Alzheimer’s. I mean, not a cure, but at least a slowing of the deterioration, right?
Karlin-Smith: I guess I think people are sort of cautiously optimistic about these drugs. They’re excited. Nobody thinks these are the holy grail yet of Alzheimer’s treatments. I think even some of the CEOs of the companies working on them have acknowledged that, but they do seem to offer some benefit. Again, there’s still a lot of these brain-swelling safety events that can be fairly devastating. So I think people are going to be watching really closely. Because usually what we know when a drug is initially approved is a fraction of what we end up knowing over time. So I think it’s still early days, but there is some hope that we finally sort of maybe cracked the code on some of the mechanisms of action of how to treat Alzheimer’s.
Kenen: Like with other drugs in cancer, elsewhere, sometimes you just need the first-draft drug. Hopefully, this isn’t the best we’re going to get. These new drugs that are showing some promise and some slowing down is sort of a proof of concept. Yes, you can make a drug that works. In other fields, too, you ended up … the first drug wasn’t a great drug, but it was a leap ahead in terms of understanding the science. So the fact that we have anything that does anything, scientists do consider that they don’t really understand Alzheimer’s, but it matters that there’s some effect. It’s not next week or next year, but there’s a goal that you can see. I think if you’re an Alzheimer’s researcher who’s spent their life not seeing a lot of tangible results, this is like a glimmer. Maybe more than a glimmer. I mean, this is like, “OK, we’re learning how to do this.”
Karlin-Smith: That was actually one of Biogen’s arguments, I think, for why Aduhelm should have been approved in the first place. Maybe even some folks at the FDA basically saying, “Look, we know this maybe isn’t the home run, but if you don’t approve these products, people are just going to leave this space and not invest in it and not keep trying to bring forth drugs.” I mean, there are people that vehemently disagree with that argument, that that’s the best way to encourage the right innovation for this country, but that wasn’t an argument you saw from industry and even some at the FDA, I think.
Kenen: But I wasn’t talking about Aduhelm specifically. I mean, the other ones that are in the pipeline that are coming out. I mean, it’s new and we don’t really know much about them yet. But the past Alzheimer’s drugs were basically useless or really limited use. These might be what we will later look back on as the first draft as opposed to another failure.
Rovner: I want to move on to another drug that’s being discontinued. European mega drugmaker Novo Nordisk has announced its ending production of a long-acting insulin, Levemir — I think that’s how you pronounce it — that, coincidentally, is one of the insulins that it slashed prices on last year under pressure from lawmakers. The announcement came the same week the company announced it would double the availability in the U.S. of its blockbuster weight loss drug, Wegovy, and the same week that the company hit $500 billion in market value. While there are substitutes for the insulin, for Levemir, many of its patients say this particular product is the best one for them, and there isn’t a one-to-one substitute. I guess this is a reminder that for drug companies, the prime goal is turning profits for their shareholders. I mean, they’re making a lot more money off of these weight loss drugs than they are off their diabetes drugs. We know that the weight loss drugs were in shortage because they couldn’t make enough of them. So you don’t have to be really good at math to kind of put two and two together here, right?
Raman: Right. I’m not sure they’re necessarily even hiding that fact, to some degree. They basically lowered the prices of a lot of these insulin products because of changes in the Medicaid rebate program, where because these products had their prices raised so much over the years, they were going to be subject to new inflation penalties, where they’d essentially owe Medicaid money if they didn’t lower the price. So now you have these older insulin products with lower prices that don’t make them as much money. And Novo Nordisk, in the insulin space, has innovated over the years and made some improvements. So they want to focus on selling their insulin products that they can sell at a higher price point. But again, you get patients who say, “Look, this older drug, actually, I personally, think works better.” And there’s a benefit to patients that it’s cheaper. This is, I think, an old story in the pharmaceutical space that sometimes is looked upon by lawmakers, which is, they innovate and they push patients onto newer products, but is the innovation really worth the price or should people have some way to choose the older product for the lower price if they think it works fine for them?
Rovner: Speaking of drug company profits, the CEOs of Merck and Johnson & Johnson have voluntarily agreed to testify before the Senate Health Committee — meaning that Chairman Bernie Sanders won’t have to subpoena them after all. The hearing is scheduled for Feb. 8. But it’s not about any specific legislation, this is just a chance for Sanders to lecture the CEOs about their high prices, Sandhya?
Raman: Essentially, yes. I think, also, it’s been such a big issue for him. Even if you look back when we had the various nominees, that they wanted to … that would go through his committee where he said that he really wanted more action on this. So I think it’ll be interesting what he brings up, and if there’s a clear pathway of something to move forward since this has been such a big issue for him for a while.
Rovner: Well, he successfully made me want to watch this hearing. We’ll see how it goes. All right. Well, let us turn to “This Week in Health Misinformation.” In addition to that case that the Supreme Court will hear, that we talked about at the top, we have a story from my new KFF Health News colleague, Amy Maxmen, about how what used to be fringe anti-science views are now mainstream among Republicans in general. Vaccine hesitancy has gone up. And that’s hesitancy even to long-proven childhood vaccines, not just the covid vaccine. While trust in science in general has dropped, according to numerous polls. In Florida, Gov. Ron DeSantis has made public health conspiracies part of his platform. And as a presidential candidate, he said he would’ve considered nominating noted conspiracy theoretician and anti-vaxxer Robert F. Kennedy Jr. to run the CDC [Centers for Disease Control and Prevention]. I’ve certainly seen more pushback in my reporting of things that people used to agree on. I assume you guys have too. I mean, it harkens right back to our original theme of who gets trusted when they talk about science and medicine.
Karlin-Smith: I think one of the interesting things that Amy’s story really points out very well, that people have been talking about a lot since the beginning of the covid era, is that this anti-science or anti-vaccine attitude has really become embedded in people’s personal identity and personal politics in a new way. Once it becomes part of your political identity, the experts are saying, it becomes much harder to change people’s views. That’s seen as one of the key problems right now, because, again, providing facts or just rebutting the information doesn’t seem to work when you’re basically sort of attacking somebody’s core identities and beliefs.
Rovner: Yeah, it’s an interesting subject, how we’re sort of freezing a lot of these things in place.
Kenen: Well, it’s also tied up with liberty and freedom in a way that has been part of the anti-vax movement for a long time, but it was a much smaller thread. Right now, this individual liberty or medical freedom, “You don’t have the right to mandate anything,” that “It’s my body.” Now, that’s fine if it’s really only your body, but when you’re talking about infectious diseases, it’s everybody’s bodies. Anti-vaxxing is across the … there are people on both the left and right who are against vaccination. That has changed in the intensity and the politicization on the right, during covid and since covid, and this medical freedom movement, which is sort of a subsection of libertarianism. We tend to talk about anti-vaxxers and anti-vaccination because that’s the most salient thing in the last few years, but there is a broader distrust of expertise, period. Scientific expertise, medical expertise, everything. I mean, some of you know I’m writing a book. We turned in the first draft this very morning. Misinformation is part of the book, and disinformation. This decline, when I was researching … it wasn’t that America was a really trusting society. I was surprised. Going back in history, we’ve always [had] pretty high distrust rates of many major institutions, but it’s much higher in health, medicine, science, public health right now.
Rovner: It’s not just the U.S. We’re seeing this around the world, basically, since the pandemic.
Kenen: It’s tied into the pandemic. It’s tied into the research of populism, a right-wing form of populism. It’s tied into a whole anxiety. The last few years have been really hard on people. Science didn’t have the answers and quick fixes that people wanted, because science is incremental, and people wanted instantaneous fixes. They didn’t understand the incremental changing nature of science, and scientists didn’t always explain it well enough. So it’s here to stay for the near future. It’s pretty insidious because it’s way beyond vaccines.
Rovner: I’m sure we will talk about it more. Well, that is this week’s news. Now we will play my “Bill of the Month” interview with Samantha Liss, and then we will come back with our extra credits.
I am pleased to welcome to the podcast my colleague Samantha Liss, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” installment. Thanks for joining us, Sam.
Samantha Liss: Hi.
Rovner: So, this month’s patients, a husband and wife, got some mysterious bills for preventive care that they thought should have been free. Tell us who they are and what they got.
Liss: Yeah. So this month we bring you Chantal Panozzo and her husband. They live outside Chicago. And they underwent their first colonoscopies last year, after turning 45.
Rovner: Then, as we say, the bill came. Now, colonoscopies are very much on the list of preventive services that are supposed to be available at no out-of-pocket cost to patients. So there really shouldn’t even have been a bill. How much was the bill and what was it for?
Liss: Yeah. So their insurance company paid for the screening, but there was a separate $600 charge for something called “surgical trays.” Supplies you’d expect to be covered.
Rovner: Yeah. It’s like saying, “We’re going to charge you rent for lying on our table.”
Liss: Exactly.
Rovner: Chantal Panozzo knew that there shouldn’t be a charge. After getting no good explanation from her insurer or the gastroenterology practice, she went to complain. She went pretty much everywhere she could, right?
Liss: Yeah. Chantal is a savvy consumer, and she was furious. She lodged an appeal with her insurer, she filed a formal complaint with state regulators in Illinois, and she wrote to her elected officials.
Rovner: So what eventually happened?
Liss: She won, but she’ll tell you she did not feel victorious. Her insurer waived the bills for her and her husband, and they didn’t owe anything, but it was a months-long slog. I think seven months in total.
Rovner: Just to be clear, it was actually the insurer that she appealed to, and she won that appeal.
Liss: Yeah. I think part of what helped push that appeal along was her complaint to the Illinois Department of Insurance.
Rovner: So, doing all of those things apparently helped. It turns out that the couple uncovered quite the loophole in the preventive services mandate. What is that and how can others avoid falling into the same trap?
Liss: Yeah. Under the law, the insurer bears the legal burden to pay for preventative care. There’s no requirement on providers to bill a certain way. So I think as we tell all our folks who read and listen to our “Bill of the Month” series, never pay the first bill. Wait until you get your explanation of benefits, and if something doesn’t feel right, ask questions.
Rovner: So basically, people can go in and get care that they expect and should be free and get random charges, and they can complain about those, right?
Liss: Exactly. And I think Chantal’s example shows sometimes you have to fight so hard and for so long to get something waived that you shouldn’t have been charged for to begin with. It’s maddening and it ticks people off.
Rovner: And if all else fails, you can send your bill to us.
Liss: Yes, please do.
Rovner: Sam Liss, thank you very much.
Liss: Thanks.
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. Joanne, you have my favorite this week, why don’t you go first?
Kenen: I told Julie that Elmo didn’t want her to get sad if I was going to do this one, and she didn’t. I’m sure almost everybody saw the Elmo phenomenon this week. The particular story that I’m referring to is by Callie Holtermann in The New York Times, “Elmo Asked an Innocuous Question.” And then there’s this wonderful sub-headline, “Elmo was not expecting it to open a yawning chasm of despair.” Elmo tweeted or X’ed, whatever you call it … I mean, it wasn’t really Elmo, it was his human. Elmo is just checking in, “How is everybody doing?” There were tens of thousands of views. Last time I looked, there were more than 16,000 responses. I did not read all 16,000, but people really are not happy. And they told Elmo that. It just became this sort of mass confessional to Elmo of all the things that people were feeling despair about. And then Elmo ended up saying something like, “Wow, Elmo is glad he asked.” So I don’t know if Elmo has now become our national shrink, but to a certain extent this week, he was.
Rovner: Absolutely. Sarah?
Karlin-Smith: I looked at a piece from The Texas Tribune about not quite an amazing topic, maybe. The “Texas Attorney General Requests Transgender Youths’ Patient Records From Georgia Clinic,” by Madaleine Rubin. It basically looks at a trend where Texas seems to be trying to not only control what is happening to the care of transgender children within their state, but trying to maybe intimidate or prevent care from happening out of state by going after telehealth providers, but maybe even trying to request records related to people that have traveled outside of the state to get care because they can’t get it in the state. It reminds me a bit of some of what some of these states are also trying to do in the abortion space as well, but raises interesting questions about whether the state really has the authority to interfere here and so forth.
Rovner: Yeah, Texas is obviously fighting this border issue, too, with the federal government. So Texas is trying to basically see how far it can press its authority, in general. Sandhya?
Raman: My pick this week is called “Community Health Centers Serve 1 in 11 Americans. They’re a Safety Net Under Stress.” It’s from Devi Shastri at The AP. I just thought it was a great look at some of the challenges, some new, some evergreen for the 1,400 federal community health centers that provide medical care, social services, and so much for so many folks in the country. It just looks at some of the issues. In Congress, there’s always the periodic federal funding drama of just, “When will community health centers get funded?” And, “They can’t long-term plan on that.” That and just how the staffing concerns, whether it’s money or quality of life, or just how they can address new health equities and things like that.
Rovner: It was a really good story. My extra credit this week is from ProPublica. It’s a coda to a series of stories that they’ve been working on, and we’ve been talking about over the past several years, after reporters at our fellow nonprofit newsroom helped uncover serious defects in the CPAP breathing machines manufactured by Philips Respironics, and the company’s failure to report complaints about the foam in those machines crumbling and getting into patient’s lungs. The company finally issued a recall. Then, apparently, the replacement foam also started to deteriorate, which also became a subject of the series. Now the GAO is investigating the FDA’s oversight of medical devices, and a federal criminal probe is being sought for Philips. And now, at least, the company will stop selling the machines in the United States. So journalism works, particularly when reporters keep at it. And boy, did they keep at it on this story.
OK, that is our show. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left a review; that helps other people find us, too. Special thanks, as always, to our technical guru, Francis Ying, and our editor, Emmarie Huetteman. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X, @jrovner, or @julierovner at Bluesky and @julie.rovner at Threads. Joanne, where are you hanging out these days?
Kenen: I’m mostly on Threads @joannekenen1.
Rovner: Sarah?
Karlin-Smith: I am @SarahKarlin or @sarahkarlin-smith.
Rovner: Sandhya?
Raman: I’m still with X and on Bluesky, @Sandhya@Writes.
Rovner: We will be back in your feed next week. Until then, be healthy.
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Surge in Syphilis Cases Leads Some Providers to Ration Penicillin
When Stephen Miller left his primary care practice to work in public health a little under two years ago, he said, he was shocked by how many cases of syphilis the clinic was treating.
For decades, rates of the sexually transmitted infection were low. But the Hamilton County Health Department in Chattanooga — a midsize city surrounded by national forests and nestled into the Appalachian foothills of Tennessee — was seeing several syphilis patients a day, Miller said. A nurse who had worked at the clinic for decades told Miller the wave of patients was a radical change from the norm.
What Miller observed in Chattanooga is reflective of a trend that is raising alarm bells for health departments across the country.
Nationwide, syphilis rates are at a 70-year high. The Centers for Disease Control and Prevention said Jan. 30 that 207,255 cases were reported in 2022, continuing a steep increase over five years. Between 2018 and 2022, syphilis rates rose about 80%. The epidemic of sexually transmitted infections — especially syphilis — is “out of control,” said the National Coalition of STD Directors.
The surge has been even more pronounced in Tennessee, where infection rates for the first two stages of syphilis grew 86% between 2017 and 2021.
But this already difficult situation was complicated last spring by a shortage of a specific penicillin injection that is the go-to treatment for syphilis. The ongoing shortage is so severe that public health agencies have recommended that providers ration the drug — prioritizing pregnant patients, since it is the only syphilis treatment considered safe for them. Congenital syphilis, which happens when the mom spreads the disease to the fetus, can cause birth defects, miscarriages, and stillbirths.
Across the country, 3,755 cases of congenital syphilis were reported to the CDC in 2022 — that’s 10 times as high as the number a decade before, the recent data shows. Of those cases, 231 resulted in stillbirth and 51 led to infant death. The number of cases in babies swelled by 183% between 2018 and 2022.
“Lack of timely testing and adequate treatment during pregnancy contributed to 88% of cases of congenital syphilis,” said a report from the CDC released in November. “Testing and treatment gaps were present in the majority of cases across all races, ethnicities, and U.S. Census Bureau regions.”
Hamilton County’s syphilis rates have mirrored the national trend, with an increase in cases for all groups, including infants.
In November, the maternal and infant health advocacy organization March of Dimes released its annual report on states’ health outcomes. It found that, nationwide, about 15.5% of pregnant people received care beginning in the fifth month of pregnancy or later — or attended fewer than half the recommended prenatal visits. In Tennessee, the rate was even worse, 17.4%.
But Miller said even those who attend every recommended appointment can run into problems because providers are required to test for syphilis only at the beginning of a pregnancy. The idea is that if you test a few weeks before birth, there is time to treat the infection.
However, that recommendation hinges on whether the provider suspects the patient was exposed to the bacterium that causes syphilis, which may not be obvious for people who say their relationships are monogamous.
“What we found is, a lot of times their partner was not as monogamous, and they were bringing it into the relationship,” Miller said.
Even if the patient tested negative initially, they may have contracted syphilis later in pregnancy, when testing for the disease is not routine, he said.
Two antibiotics are used to treat syphilis, the injectable penicillin and an oral drug called doxycycline.
Patients allergic to penicillin are often prescribed the oral antibiotic. But the World Health Organization strongly advises pregnant patients to avoid doxycycline because it can cause severe bone and teeth deformities in the infant.
As a result, pregnant syphilis patients are often given penicillin, even when they’re allergic, using a technique called desensitization, said Mark Turrentine, a Houston OB-GYN. Patients are given low doses in a hospital setting to help their bodies get used to the drug and to check for a severe reaction. The penicillin shot is a one-and-done technique, unlike an antibiotic, which requires sticking to a two-week regimen.
“It’s tough to take a medication for a long period of time,” Turrentine said. The single injection can provide patients and their clinicians peace of mind. “If they don’t come back for whatever reason, you’re not worried about it,” he said.
The Metro Public Health Department in Nashville, Tennessee, began giving all nonpregnant adults with syphilis the oral antibiotic in July, said Laura Varnier, nursing and clinical director.
Turrentine said he started seeing advisories about the injectable penicillin shortage in April, around the time the antibiotic amoxicillin became difficult to find and physicians were using penicillin as a substitute, potentially precipitating the shortage, he said.
The rise in syphilis has created demand for the injection that manufacturer Pfizer can’t keep up with, according to the American Society of Health-System Pharmacists. “There is insufficient supply for usual ordering,” the ASHP said in a memo.
Even though penicillin has been around a long time, manufacturing it is difficult, largely because so many people are allergic, said Erin Fox, associate chief pharmacy officer for the University of Utah health system and an adjunct professor at the university, who studies drug shortages.
“That means you can’t make other drugs on that manufacturing line,” she said. Only major manufacturers like Pfizer have the resources to build and operate such a specialized, cordoned-off facility. “It’s not necessarily efficient — or necessarily profitable,” Fox said.
In a statement, Pfizer confirmed the amoxicillin shortage and surge in syphilis increased demand for injectable penicillin by about 70%. Representatives said the company invested $38 million in the facility that produces this form of penicillin, hiring more staff and expanding the production line.
“This ramp up will take some time to be felt in the market, as product cycle time is 3-6 months from when product is manufactured to when it is available to be released to customers,” the statement reads. The company estimated the shortage would be significantly alleviated by spring.
In the meantime, Miller said, his clinic in Chattanooga is continuing to strategize. Each dose of injectable penicillin can cost hundreds of dollars. Plus, it has to be placed in cold storage, and it expires after 48 months.
Even with the dramatic increase in cases, syphilis is still relatively rare. More than 7 million people live in Tennessee, and in 2019, providers statewide reported 683 cases of syphilis.
Health departments like Miller’s treat the bulk of syphilis patients. Many patients are sent by their provider to the health department, which works with contact tracers to identify and notify sexual partners who might be affected and tests patients for other sexually transmitted infections, including HIV.
“When you diagnose in the office, think of it as just seeing the tip of the iceberg,” Miller said. “You need a team of individuals to be able to explore and look at the rest of the iceberg.”
This story is part of a partnership that includes WPLN, NPR, and KFF Health News.
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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KFF Health News' 'What the Health?': Health Enters the Presidential Race
The Host
Julie Rovner
KFF Health News
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.
Based on the results of the first-in-the-nation primary in New Hampshire, it appears more likely than ever before that the 2024 presidential election will be a rerun of 2020: Joe Biden versus Donald Trump. And health is shaping up to be a key issue.
Trump is vowing — again — to repeal the Affordable Care Act, which is even more popular than it was when Republicans failed to muster the congressional votes to kill it in 2017. Biden is doubling down on support for contraception and abortion rights.
And both are expected to highlight efforts to rein in the cost of prescription drugs.
This week’s panelists are Julie Rovner of KFF Health News, Alice Miranda Ollstein of Politico, Anna Edney of Bloomberg News, and Jessie Hellmann of CQ Roll Call.
Panelists
Alice Miranda Ollstein
Politico
Anna Edney
Bloomberg
Jessie Hellmann
CQ Roll Call
Among the takeaways from this week’s episode:
- Trump had a strong showing in the New Hampshire GOP primary. But Biden may be gathering momentum himself from an unexpected source: Drug industry lawsuits challenging his administration’s Medicare price negotiation plan could draw attention to Biden’s efforts to combat rising prescription drug prices, a major pocketbook issue for many voters.
- Biden’s drug pricing efforts also include using the government’s so-called march-in rights on pharmaceuticals, which could allow the government to lower prices on certain drugs — it’s unclear which ones. Meanwhile, Sen. Bernie Sanders of Vermont is calling on his committee to subpoena the CEOS of two drugmakers in the latest example of lawmakers summoning Big Pharma executives to the Hill to answer for high prices.
- More than a year after the Supreme Court overturned the constitutional right to an abortion, abortion opponents gathered in Washington, D.C., for the March for Life rally, looking now to continue to advance their priorities under a future conservative presidency.
- One avenue that abortion opponents are eying is the 19th-century Comstock Act, which could not only prohibit the mailing of abortion pills to patients, but also prevent them from being mailed to clinics and medical facilities. Considering the abortion pill is now used in more than half of abortions nationwide, it would amount to a fairly sweeping ban.
- And state legislators continue to push more restrictive abortion laws, targeting care for minors and rape exceptions in particular. The ongoing quest to winnow access to the procedure amid public reservations reflected in polling and ballot initiatives highlights that, for at least some abortion opponents, fetuses are framed as an oppressed minority whose rights should not be subject to a majority vote.
Also this week, Rovner interviews Sarah Somers, legal director of the National Health Law Program, about the potential effects on federal health programs if the Supreme Court overturns a 40-year-old precedent established in the case Chevron USA v. Natural Resources Defense Council.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: Health Affairs’ “‘Housing First’ Increased Psychiatric Care Office Visits and Prescriptions While Reducing Emergency Visits,” by Devlin Hanson and Sarah Gillespie.
Alice Miranda Ollstein: Stat’s “The White House Has a Pharmacy — And It Was a Mess, a New Investigation Found,” by Brittany Trang.
Anna Edney: The New Yorker’s “What Would It Mean for Scientists to Listen to Patients?” by Rachael Bedard.
Jessie Hellmann: North Carolina Health News’ “Congenital Syphilis — An Ancient Scourge — Claimed the Lives of Eight NC Babies Last Year,” by Jennifer Fernandez.
Also mentioned on this week’s podcast:
Stat’s “Pharma’s Attack on Medicare Drug Price Negotiation Might Benefit Biden,” by John Wilkerson.
click to open the transcript
Transcript: Health Enters the Presidential Race
KFF Health News’ ‘What the Health?’Episode Title: Health Enters the Presidential RaceEpisode Number: 331Published: Jan. 25, 2024
[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It 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, Jan. 25, at 10 a.m. As always, news happens fast, and things might’ve 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: Hi there.
Rovner: And Anna Edney of Bloomberg News.
Anna Edney: Hello.
Rovner: Later in this episode we’ll have my interview with Sarah Somers of the National Health Law Program. She’s going to explain what’s at risk for health care if the Supreme Court overturns the Chevron doctrine, and if you don’t know what that is, you will. But first, this week’s news. We’re going to start this week with politics. To absolutely no one’s surprise, Donald Trump won the first-in-the-nation New Hampshire primary, and even though he wasn’t even on the ballot, because Democrats no longer count New Hampshire as first, President [Joe] Biden handily won a write-in campaign.
Since it seems very likely at this point that the November ballot will pit Trump versus Biden once again, I thought we’d look, briefly at least, at both of their health agendas for now. Trump has once again vowed to try and repeal the Affordable Care Act, which not only didn’t go well in 2017, we learned this week that the federal marketplace enrolled a record 21.3 million people for this year. In 2017, that number was 12.2 million. Not to mention there are now a half a dozen more states that have expanded Medicaid to low-income childless adults.
So with so many more millions of Americans getting coverage via Obamacare, even if Trump wants to repeal and replace it, is there any chance Republicans would go along, even if he wins back majorities in the House and the Senate? They have seemed rather unwilling to reopen this box of worms.
Edney: I mean, certainly, I think that currently they’re unwilling. I don’t want to pretend that I know what the next several months will hold until November, but even before they’re willing or not, what would the plan be? We never saw one, and I don’t anticipate there would be any sort of real plan, particularly if it’s the Trump White House itself having to put the plan together to repeal Obamacare.
Rovner: Yes. How many times did he promise that “we’ll have a plan in two weeks” throughout most of his administration? Alice, you were saying?
Ollstein: Yes. I think what we should be thinking about, too, is this can happen not through Congress. There’s a lot of President Trump could do theoretically through the executive branch, not to repeal Obamacare, but to undermine it and make it work worse. They could slash outreach funding, they could let the enhanced tax credit subsidies expire — they’re set to expire next year. That would also be on Congress. But a president who is opposed to it could have a role in that; they could slash call center assistance. They could do a lot. So I think we should be thinking not only about could a bill get through Congress, but also what could happen at all of the federal agencies.
Rovner: And we should point out that we know that he could do some of these things because he did them in his first term.
Ollstein: He did them the first time, and they had an impact. The uninsured rate went up for the first time under Trump’s first term, for the first time since Obamacare went into effect. So it can really make a difference.
Rovner: And then it obviously went down again. But that was partly because Congress added these extra subsidies and even the Republican Congress required people to stay on Medicaid during the pandemic. Well, I know elsewhere, like on abortion, Trump has been all over the place, both since he was in office and then since he left office. And then now, Alice, do we have any idea where he is on this whole very sensitive abortion issue?
Ollstein: He has been doing something very interesting recently, which is he’s sort of running the primary message and the general message at the same time. So we’re used to politicians saying one thing to a primary audience. These are the hard-core conservatives who turn out in primaries and they want to hear abortion is going to be restricted. And then the general audience — look at how all of these states have been voting — they don’t want to hear that. They want to hear a more moderate message and so Trump has been sort of giving both at once. He’s both taking credit for appointing the Supreme Court justices, who overturned Roe v. Wade. He has said that he is pro-life, blah, blah, blah. But he has also criticized the anti-abortion movement for going too far in his view. He criticized Ron DeSantis’ six-week ban for going too far. He has said that any restrictions need to have exemptions for rape and incest, which not everyone in the movement agrees with. A lot of people disagree with that in the anti-abortion movement. And so it has been all over the place.
But his campaign is in close contact with a lot of these groups and the groups are confident that he would do what they want. So I think that you have this interesting tension right now where he is saying multiple mixed messages.
Rovner: Which he always does, and which he seems to somehow get away with. And again, just like with the ACA, we know that all of these things that he could do just from the executive branch about reproductive health, because he did them when he was president the first time. Meanwhile, President Biden, in addition to taking a victory lap on the Affordable Care Act enrollment, is doubling down on abortion and contraception, which is pretty hard because, first, as executive, he doesn’t have a ton of power to expand abortion rights the way Trump would actually have a lot of power to contract them.
And, also, because as we know, Biden is personally uncomfortable with this issue. So Alice, how well is this going to work for the Biden administration?
Ollstein: So what was announced is mostly sort of reiterating what is already the law, saying we’re going to do more to educate people about it and crack down on people who are not following it. So this falls into a few different buckets. Part of it is Obamacare’s contraception mandate. There have been lots of investigations showing that a lot of insurers are denying coverage for contraceptives they should be covering or making patients jump through hoops. And so it’s not reaching the people it should be reaching. And so they’re trying to do more on that front.
And then, on the abortion front, this is mostly in this realm of abortions in medical emergencies. They’re trying to educate patients on “you can file this complaint if you are turned away.” Of course, I’m thinking of somebody experiencing a medical emergency and needing abortion and being turned away, and I don’t think “I’m going to file an EMTALA [Emergency Medical Treatment and Active Labor Act] complaint with the federal government and hope that they do something” is maybe the first thing on their mind. But the new executive order also includes education for providers and hospitals on their obligations.
This is also something a Trump administration could completely change. They could come in and say, “Forget that guidance. Here’s our guidance, which is no abortions in these circumstances.” So this is a really sensitive issue, but I think that the Biden campaign has seen how people have been voting over the last two years and feels that this is a really good message for them to do something on.
Rovner: Meanwhile, one issue both Republicans and Democrats are trying to campaign on is bringing down the cost of prescription drugs. Stat News has a story this week suggesting that all the lawsuits against the Medicare drug negotiation program could actually help Biden with voters because it shows he’s going after Big Pharma. Frankly, it could also tell voters that the Biden administration actually did something to challenge Big Pharma. Polls show most people have no idea, but Trump can point to lots of lawsuits over things he tried to do to Big Pharma.
Does one or the other of them have an advantage here, Anna? I mean, I know they’re going in different directions, but when you sort of boil it into campaign-speak, it’s going to sound pretty similar, right?
Edney: I think that that’s true, but one of the differences is, at least currently, what Biden’s done and doing some price negotiation through Medicare so far for 10 drugs under his administration is going forward. And you can name the drugs, name the prices, talk about it a little bit more specifically. What Trump ran up against was the lawsuits not falling in his favor. So he wanted more transparency as far as the drug companies having to say the price of their drugs in TV ads, and that wasn’t able to happen. And also reference pricing, so that the prices would be benchmarked to other countries. And certainly that never went forward either. And Trump really used the going after pharma hard in the last campaign, I would say, in 2016. And it worked in the beginning, and you would see the stock of these companies start going down the second he said pharmaceutical companies are getting away with murder or whatever big comment he was making. But it eventually lost any real effect because there didn’t seem to be plans to do anything drastic.
He talked about potentially doing negotiation, like is happening currently, but then that never came to fruition once he was in office. So I don’t know if that will come across to voters, but certainly the pharma industry doesn’t seem to be as afraid of Trump as what Biden’s doing right now.
Rovner: Jessie, I know Congress is still working on this PBM [pharmacy benefit managers] transparency, big bill. Are we getting any closer to anything? I think members of Congress would also like to run on being able to say they’ve done something about prescription drug prices.
Hellmann: I was just talking to [Sen.] Chuck Grassley [R-Iowa] about this because he is the “OG PBM hater.” And he was like, “Why is nothing happening?” He was just very frustrated. There are several bills that have passed House and Senate committees, and so I think, at this point, it’s just a matter of cobbling them all together, finding ways to pay for things. And since there’s also so many other health care things that people want to get done, it’s a matter of “Do we have enough money to pay for everything? What’s going to save money? What’s going to cost money?”
There’s also these health care transparency measures that Congress is looking at. There’s this site-neutral hospital payments thing that could be a money saver. So I think there’s just a lot going on in trying to figure out how it all fits together. But PBMs, I could definitely see them doing something this year.
Rovner: Sometimes, I mean, often it’s like you can’t get things onto the agenda. In this case, it sounds like there’s lots of things on the agenda, but they’re going to need to pay for all of them and they’re going to fight over the few places where they could presumably get some savings.
Edney: I was going to say, I saw that Grassley and some other senators wrote the Federal Trade Commission because they are due for a report on PBMs they’ve been working on for about a year and a half. And I think that the senators who want to go after PBMs are kind of looking for that sort of backup and that deep dive into the industry to make those statements about cost savings and what this would do for pharmaceutical prices.
Rovner: Well, to ratchet this up one more step, the Biden administration has proposed a framework for when march-in rights might be used. Is this the real deal or a threat to get pharma to back down on complaints about the Medicare price negotiations? Anna, why don’t you explain what march-in rights are?
Edney: March-in rights, which have never been used on a pharmaceutical company, were something that were put into law — I think it was around 1980 with the Bayh-Dole Act — and what it allows the government to do is say we invested a ton of money, either through giving money to university research or in the company itself, to do the very basic science that got us to this breakthrough that then the company took across the finish line to get a drug on the market. But usually, I think the main reason you might use it is because then the company does nothing with it.
Say they bought it up and it could be a competitor to one of their drugs, so they don’t use it. But it seems like it could also be used if the price is prohibitive, that it’s something that’s really needed, but Americans aren’t getting access to it. And so the government would be able to take that patent back and lower the price on the drug. But I haven’t heard a specific drug that they want to use this on. So I don’t know if they’re serious about using the march-in rights.
There is a request for information to find out how people feel about this, how it might affect the industry. The argument being that it could hamper the innovation, but we hear that a lot from the pharmaceutical industry as well. So unclear if that’s a true defense to not using march-in rights.
Rovner: Although march-in rights are a pretty big gun. There’s a reason they’ve never been used. I’ve seen them … lawmakers sometimes trot it out kind of as a cudgel, but I’ve never … the only time I think I saw them come close was after the anthrax scare, right after 9/11, when there was potentially a shortage of the important antibiotic needed for that. There was muttering about this, but then I think the drug company decided on its own to lower the price, which got us over that.
Well, yet another tack is being pursued by Sen. Bernie Sanders, chairman of the Senate Health Committee. He’s going to make the committee vote next week on whether to subpoena the CEOs of Johnson & Johnson and Merck to require them to “provide testimony about why their companies charge substantially higher prices for medicine in the U.S. compared to other countries.” Well, we all know the answer to that. Other countries have price controls and the U.S. does not. So is this a stunt or not? And is he even going to get the rest of the committee to go along with the subpoena?
Edney: This wouldn’t be the first hearing on high drug prices pulling in CEOs. And it’s so opaque that you never get an answer. You never get something … I mean, certainly, they’ll blame PBMs and talk about that, and the finger-pointing will go somewhere else, but you never have some aha insight moment. So when the CEOs are coming in, it does feel a bit more like a show. And Bernie Sanders, the ones he wants to subpoena are from companies that are suing the Biden administration.
So there’s talk about whether that’s sort of a bit of a revenge him for that as well. I don’t know what exactly he would expect to hear from them that would change policy or what legislation they’re trying to work out by having this hearing.
Rovner: For an issue that everybody cares about, high drug prices. It sure has been hard to figure out a way into it for politicians.
Ollstein: We have seen public shaming, even without legislation behind it, can have a difference. I think we’ve seen that on the insulin front. And so I think it’s not completely a fool’s errand here, what Bernie’s trying to do. It will be interesting to see if the rest of the committee goes along with it. There’s been some tensions on the committee. There’s been bipartisan support for some of his efforts, and then others — less on the health front, I think more on the labor front — you’ve had a lot of pushback from the Republican members, and so it’ll be very telling.
Rovner: I was actually in the room when the tobacco industry CEOs came to testify at the House Energy and Commerce Committee, and that was pretty dramatic, but I feel like that was a very different kind of atmosphere than this is. I know everybody’s been trying to repeat that moment for — what is it? — 25, 30 years now. It was in the early 1990s, and I don’t think anybody really successfully has, but they’re going to keep at it.
All right, well, let us turn to abortion. Last Saturday would have been the 51st anniversary of Roe v. Wade, and the day before was the annual March for Life, the giant annual anti-abortion demonstration that used to be a march to the Supreme Court to urge the justices to overrule Roe. Well, that mission has been accomplished. So now what are their priorities, Alice?
Ollstein: Lots of things. And a lot of the effort right now is going towards laying the groundwork, making plans for a potential second Trump administration or a future conservative president. They see not that much hope on the federal level for their efforts currently, with the current president and Congress, but they are trying to do the prep work for the future. They want a future president to roll back everything Biden has done to expand abortion access. That includes the policies for veterans and military service members. That includes wider access to abortion pills through the mail and dispensing at retail pharmacies, all of that.
So they want to scrap all of that, but they also want to go a lot further and are exploring ways to use a lot of different agencies and rules and bureaucratic methods and funding mechanisms to do this, because they’re not confident in passing a bill through Congress. We’ve seen Congress not able to do that even under one-party rule in either direction. And so they’re really looking at the courts, which are a lot more conservative than they were several years ago.
Rovner: Largely thanks to Trump.
Ollstein: Exactly, exactly. So the courts, the executive branch, and then, of course, more efforts at the state level, which I know we’re going to get into.
Rovner: We are. Before that, though, one of the things that keeps coming up in discussions about the anti-abortion agenda is something called the Comstock Act. We have talked about this before, although it’s been a while, but this is an 1873 law, which is still on the books, although largely unenforced, that banned the mailing of anything that could be used to aid in an abortion, among other things. Could an anti-abortion administration really use Comstock to basically outlaw abortion nationwide?
I mean, even things that are used for surgical abortion tend to come through … it’s not just the mail, it’s the mail or FedEx or UPS, common carrier.
Ollstein: Yes. So this is getting a lot more attention now and it is something anti-abortion groups are absolutely calling for, and people should know that this wouldn’t only prohibit the mailing of abortion pills to individual patients’ homes, which is increasingly happening now. This would prevent it from being mailed to clinics and medical facilities. The mail is the mail. And so because abortion medication is used in more than half of all abortions nationwide, it could be a fairly sweeping ban.
And so the Biden administration put out a memo from the Justice Department saying, “Our interpretation of the Comstock Act is that it does not prohibit the mailing of abortion pills.” The Trump administration or whoever could come in and say, “We disagree. Our interpretation is that it does.” Now, how they would actually enforce it is a big question. Are you going to search everyone’s mail in the country? Are you going to choose a couple of people and make an example out of them?
That’s what happened under the original Comstock Act. Back in the day, they went after a few high-profile abortion rights activists and made an example out of them. I think nailing them down on how it would be enforced is key here. And of course there would be tons of legal challenges and battles no matter what.
Rovner: Absolutely. Well, let us turn to the states. It’s January, which is kind of “unveil your bills” time in state legislatures, and they are piling up. In Tennessee, there’s a bill that would create a Class C felony, calling for up to 15 years in prison, for an adult who “recruits, harbors or transports a pregnant minor out of state for an abortion.” There’s a similar bill in Oklahoma, although violators there would only be subject to five years in prison.
Meanwhile, in Iowa, Republican lawmakers who are writing guidelines for how to implement that state’s six-week ban, which is not currently in effect, pending a court ruling, said that the rape exception could only be used if the rape is “prosecutable,” without defining that word. Are these state lawmakers just failing to read the room or do they think they are representing what their voters want?
Edney: I don’t really know. I think clearly there are a lot of right-wing Republicans who are elected to office and feel that they have a higher calling that doesn’t necessarily reflect what their constituents may or may not want, but more is that they know better. And I think that that could be some of this, because certainly the anti-abortion bills or movements have been rejected by voters in places you might not exactly expect it.
Rovner: It feels like we’re getting more and more really “out there” ideas on the anti-abortion side at the same time that we’re getting more and more ballot measures of voters in both parties wanting to protect abortion rights, at least to some extent.
Ollstein: And I think going off what Anna said, I think that anti-abortion leaders, including lawmakers, are being more upfront now, saying that they don’t believe that this should be something that the democratic process has a voice in. The framing they use is that fetuses are an oppressed minority and their rights should not be subject to a majority vote. That’s their framing, and they’re being very upfront saying that these kinds of ballot referendums shouldn’t be allowed, and that states that do allow them should get rid of that. We’ll see if that happens. There are obviously lots of attempts to thwart specific state efforts to put abortion on the ballot. There are lawsuits pending in Nevada and Florida. There are attempts to raise the signature threshold, raise the vote threshold, just make it harder to do overall. But I found it very interesting and a pretty recent development that folks are coming out and saying the quiet part out loud. Saying, “We don’t believe The People should be able to decide this.”
Rovner: Well, obviously not an issue that is going away anytime soon. All right, well that is this week’s news. Now we will play my interview with Sarah Somers, and then we will come back and do our extra credits.
I am pleased to welcome to the podcast Sarah Somers, legal director of the National Health Law Program. She’s going to explain, in English hopefully, what’s at stake in the big case the Supreme Court heard earlier this month about herring fishing. Sarah, welcome to “What the Health?”
Sarah Somers: Thank you for having me, Julie. I’m glad to be here.
Rovner: So this case, and I know it’s actually two cases together, is really about much more than herring fishing, right? It seems to be about government regulation writ large.
Somers: That’s right. The particular issue in the case is about a national marine fisheries regulation that requires herring fishing companies to pay for observers who are on board — not exactly an issue that’s keeping everyone but herring fishermen up at night. And the fishing company challenged the rule, saying that it wasn’t a reasonable interpretation of the statute. But what they also asked the court to do was to overrule a Supreme Court case that requires courts to defer to reasonable agency interpretations of federal statutes. That’s what’s known as “Chevron deference.”
Rovner: And what is Chevron deference and why is it named after an oil company?
Somers: Why aren’t we talking about oil now? Yes, Chevron deference is the rule that says that courts have to defer to a reasonable agency interpretation of a federal statute. So, under Chevron, there’s supposed to be a two-step process when considering whether, say, a regulation is a reasonable interpretation. They say, “Does the statute speak directly to it?” So in this case, did the statute talk about whether you have to pay for observers on herring boats? It didn’t.
So the next question was, if it doesn’t speak directly to it or if it’s ambiguous or unclear, then the court should defer to a reasonable interpretation of that statute. And what’s reasonable depends on what the court determines are sort of the bounds of the statute, whether the agency had evidence before it that supported it, whether it showed the proper deliberation and expertise.
Rovner: One of the reasons that regulations are sometimes 200 pages long, right?
Somers: Exactly. And sometimes courts do say, “You know what? The statute spoke right to this. We don’t have to go any further. We know what Congress wanted.” Other times they take a step further. And the reason it’s called Chevron is it’s named after a case that was decided 40 years ago in 1984 during the Reagan administration, and it was Chevron Inc. USA v. the Natural Resources Defense Council. That case was about a regulation interpreting the Clean Air Act and about regulating air pollution.
Rovner: So, as you point out, you helped write one of the amicus briefs in the case about what overturning Chevron would mean for health care. It’s not just about herring fishing and Clean Air Act. Can you give us the CliffsNotes version of what it would mean for health care?
Somers: One of the purposes of our amicus brief was just to give another angle on this, because we were talking a lot about regulations in the context of air pollution, clean water, and the environment, but it touches so many other things, and this is just one aspect of it. So this brief, which we authored along with the American Cancer Society Action Network, and a Boston law firm called Anderson Kreiger, was signed by other health-oriented groups: the American Lung Association, American Heart Association, Campaign for Tobacco-Free [Kids], and then the American Academy of Pediatrics, American Academy of Public Health.
You get the picture. These are all groups that have a vested interest in programs of the Department and Health and Human Services. The brief talks about regulations promulgated by the Centers for Medicare & Medicaid Services. I’m going to call them CMS for short when we’re talking. And CMS is responsible for regulating the vast and complex Medicare and Medicaid programs. And, as you know, Medicare and Medicaid cover more than half of the population and touch the lives of almost everyone, regulating hospitals, some aspects of insurance, some aspects of practice of medicine.
You can’t escape the consequences of problems with these programs. And so that’s why the agency … Congress specifically gave HHS and CMS the power to regulate all of the issues in its purview. So that already have the power, and so the question is whether they use it wisely. We are arguing in this brief that for 40 years it’s worked just fine. That Congress has set the outer limits and been content to let the agency determine the specifics of these programs to fill in the gaps, as one Supreme Court case said. And this has implications for how hospitals operate, how insurance programs operate, and whether they operate smoothly.
And in our brief, we’re not really arguing for or against a particular interpretation or either for or against what the agency says. It’s just a matter of stability and certainty. The agency has the expertise, has the time, has the resources, and has the duty to figure out what these particular terms and statutes mean and how the programs should work. Just two examples we gave in the brief of the kind of issues that the agency should be determining are: What’s the definition of geographic area in the Medicaid Act for the purpose of setting hospital wages?
If your listeners are still listening, I hope, because that is boring, arcane, hyper-technical, and courts don’t have the expertise, much less the time, to do that. And CMS does. Or another question in a different area, whether feeding activities in a nursing home regulated by Medicaid: Are those nursing or nursing related services? The court’s not going to know. The courts doesn’t have expertise or time. And again, that’s what CMS is for.
So not only is this something that you need these interpretations in these rules to have the programs operate smoothly and consistently, and that’s the first part that’s important. But the second part is that you need consistency across the country. As you know well, there are hospital systems that operate across multi-states. There are Medicaid managed-care plans operating across multi-states. All aspects of health care is nationalized. If you have hundreds of district courts and courts of appeals coming up with different interpretations of these terms, you’re going to have a lot of problems. It’s not going to operate smoothly. So I heard some of the justices arguing, “Well, Congress just needs to do its job.”
Congress has obstacles to doing even the big, mega issues that are before them, these kinds of arcane specific issues. They don’t have the time or again, the expertise. That’s why they said, “CMS, you go do this.”
Rovner: When they were writing the Affordable Care Act, there were so many times in that legislation where it says, “The secretary shall” or “The secretary may.” It’s like, we’re going to punt all this technical stuff to HHS and let them do what they will.
Somers: Exactly. You figure out what the definition of a preventive service is, that’s not something that we are going to do. And there are also questions raised about is this … these unelected agency personnel, well, agencies — they are political appointees, and they also serve at the pleasure of the head of the agency. So they’re accountable to the executive branch and indirectly to the voters. The courts, at this point, once they’re on the court and the federal courts, they’re not accountable to the voters anymore. And so this would be a big shift of power towards the courts, and that is what we argued would be antithetical to the system working well.
Rovner: What would be an example of something that could get hung up in the absence of Chevron?
Somers: I thought that Justice [Ketanji Brown] Jackson, during the argument, gave a really good example. Under the Food and Drug Administration’s power to regulate new drugs and determining what is an adequate and well-controlled investigation. The idea of courts, every single drug that’s challenged in every single forum, having to delve into what that means without deference to the agency would be just a recipe for chaos, really.
Rovner: So some people have argued that Chevron is already basically gone, as far as the Supreme Court is concerned, that it’s been replaced by the major questions doctrine, which is kind of what it sounds like. If a judge thinks a question is major, and they will assume that the Congress has not delegated it to the agency to interpret. So what difference would it make if the court formally overturned Chevron or not here? I guess what you’re getting at is that we’re more worried about the lower courts at this point than the Supreme Court, right?
Somers: That’s right. The Supreme Court has not cited Chevron in something like 15 years. And they talked about that in the argument, but it’s for the lower courts. The lower courts still follow it. It is still very commonly cited and gives them a lot of guidance not to have to decide these issues in the first instance. It’s true that the major questions doctrine — and there are other threats to the power of the administrative agencies, and we should all be concerned about them. But this one is really the grease that keeps the machine going and keeps these systems going. And throwing all that up in the air would make a big difference. If only because the question in all of these Chevron cases, and so many of them was not the ultimate issue — about whether the regulation was a good policy — but the question was, was the statute ambiguous or not? And so that’s the part that would be up in the air and everyone can go back and re-litigate these, including the big interests that have a lot of time and resources to devote to litigation. And that would cause a great deal of uncertainty, a lot of disruption, and a lot of problem for the courts and for all the entities that function under these systems.
Rovner: And that’s a really important point. It’s not just going forward. People who are unhappy with what a regulation said could go back, right?
Somers: Oh yeah. They could go back. They could go to different courts. We’ve seen how litigants can forum-shop. They can find a judge that they think is going to be sympathetic to their argument and make a determination that affects the whole country.
Rovner: Well, we will be watching. Sarah Somers, thanks so much for joining us.
Somers: My pleasure. Thank you for having me.
Rovner: 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. Jessie, you were the first to join in this week. Why don’t you tell us about your extra credit?
Hellmann: Yeah. Mine is from North Carolina Health News. They wrote about how congenital syphilis is killing babies in the state. They had eight cases of deaths last year — compared to a decade ago, they had one. So it’s something that’s been on the rise in North Carolina, but also nationwide, and it’s caused a lot of alarm among public health officials because it’s pretty preventable. It’s something that doesn’t need to happen, but the story is about what the state is doing to improve their outreach to pregnant people. They’re doing media campaigns, they’re trying to make sure that people are doing their prenatal care and just trying to stop this from happening. So I thought that was a good story. It’s definitely kind of an under-reported issue. It’s something that public health officials have been raising an alarm about for a while now, but there’s just not enough funding or attention on the issue.
Rovner: For all the arguing about abortion, there’s not been a lot of discussion about maternal and child health, which obviously appears to be the one place that both sides agree on. Anna.
Edney: Mine’s in The New Yorker by Rachael Bedard. It’s “What Would It Mean for Scientists to Listen to Patients?” And it’s interesting, it’s about two Yale researchers who are doing a long-covid study, but it’s unique in the sense that when the CDC or anyone else does a long-covid study, they typically are trying to say, “Here are the exact symptoms. We’re going to work with 12 of them.” Whereas we know long covid, it’s seemingly a much more expansive symptom list than that, but researchers really like to have kind of metrics to go by.
But what these Yale researchers are doing is letting all of that go and just letting anybody in this and talking to them. They’re holding monthly town halls with people who are in this, whoever wants to show up and come and just talk to them about what’s going on with them and trying to find out, obviously, what could help them. But they’re not giving medical advice during these, but just listening. And it just was so novel, and maybe it shouldn’t be, but I found it fascinating to read about and to get their reactions. And it’s not always easy for them. I mean, the patients get upset and want something to happen faster, but just that somebody is out there doing this research and including anybody who feels like they have long covid. It was really well-written too.
Rovner: It’s a really good story. Alice.
Ollstein: So I’m breaking my streak of extremely depressing, grim stories and sharing kind of a funny one, although it could have some serious implications. This is from Stat, and it’s from an inspector general report about how the White House pharmacy, which is run by basically the military, functioned under President Trump. And it functioned like sort of a frat house. There was no official medical personnel in charge of handing out the medications, and they were sort of handed out to whoever wanted them, including people who shouldn’t have been getting them. People were just rifling through bins of medications and taking what they wanted. These included pills like Ambien and Provigil, sort of uppers and downers in the common parlance. And so I think this kind of scrutiny on something that I didn’t even know existed. The White House pharmacy is pretty fascinating.
Rovner: It was a really, really interesting story. Well, I also have something relatively hopeful. My extra credit this week is a journal article from Health Affairs with the not-so-catchy headline “‘Housing First’ Increased Psychiatric Care Office Visits and Prescriptions While Reducing Emergency Visits,” by Devlin Hanson and Sarah Gillespie. And if they will forgive me, I would rename it, calling it maybe “Prioritizing Permanent Housing for Homeless People Provides Them a Better Quality of Life at Potentially Less Cost to the Public.”
It’s about a “Housing First” experiment in Denver, which found that the group that was given supportive housing was more likely to receive outpatient care and medications and less likely to end up in the emergency room. The results weren’t perfect. There was no difference in mortality between the groups that got supportive housing and the groups that didn’t. But it does add to the body of evidence about the use of so-called social determinants of health, and how medicine alone isn’t the answer to a lot of our social and public health ills.
OK. That is our show. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us, too. Special thanks as always to our technical guru, Francis Ying, and our editor, Emmarie Huetteman. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X, @jrovner, or @julierovner at Bluesky or @julie.rovner at Threads. Anna, where are you these days?
Edney: Mostly just on Threads, so @anna_edneyreports.
Rovner: Alice?
Ollstein: @AliceOllstein.
Rovner: Jessie.
Hellmann: @jessiehellmann on Twitter.
Rovner: We will be back in your feed next week. Until then, be healthy.
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1 year 2 months ago
Courts, Elections, Health Care Costs, Multimedia, Pharmaceuticals, Public Health, States, The Health Law, Abortion, Drug Costs, KFF Health News' 'What The Health?', New Hampshire, Podcasts, Women's Health
What the Health Care Sector Was Selling at the J.P. Morgan Confab
SAN FRANCISCO — Every year, thousands of bankers, venture capitalists, private equity investors, and other moneybags flock to San Francisco’s Union Square to pursue deals. Scores of security guards keep the homeless, the snoops, and the patent-stealers at bay, while the dealmakers pack into the cramped Westin St.
Francis hotel and its surrounds to meet with cash-hungry executives from biotech and other health care companies. After a few years of pandemic slack, the 2024 J.P. Morgan Healthcare Conference regained its full vigor, drawing 8,304 attendees in early January to talk science, medicine, and, especially, money.
1. Artificial Intelligence: Revolutionary or Not?
Of the 624 companies that pitched at the four-day conference, the biggest overflow crowd may have belonged to Nvidia, which unlike the others isn’t a health care company. Nvidia makes the silicon chips whose computing power, when paired with ginormous catalogs of genes, proteins, chemical sequences, and other data, will “revolutionize” drug-making, according to Kimberly Powell, the company’s vice president of health care. Soon, she said, computers will customize drugs as “health care becomes a technology industry.” One might think that such advances could save money, but Powell’s emphasis was on their potential for wealth creation. “The world’s first trillion-dollar drug company is out there somewhere,” she dreamily opined.
Some health care systems are also hyping AI. The Mayo Clinic, for example, highlighted AI’s capacity to improve the accuracy of patient diagnoses. The nonprofit hospital system presented an electrocardiogram algorithm that can predict atrial fibrillation three months before an official diagnosis; another Mayo AI model can detect pancreatic cancer on scans earlier than a provider could, said Matthew Callstrom, chair of radiology at the Mayo Clinic in Rochester, Minnesota.
No one really knows how far — or where — AI will take health care, but Nvidia’s recently announced $100 million deal with Amgen, which has access to 500 million human genomes, made some conference attendees uneasy. If Big Pharma can discover its own drugs, “biotech will disappear,” said Sherif Hanala of Seqens, a contract drug manufacturing company, during a lunch-table chat with KFF Health News and others. Others shrugged off that notion. The first AI algorithms beat clinicians at analyzing radiological scans in 2014. But since that year, “I haven’t seen a single AI company partner with pharma and complete a phase I human clinical trial,” said Alex Zhavoronkov, founder and CEO of Insilico Medicine — one of the companies using AI to do drug development. “Biology is hard.”
2. Weight Loss Pill Profits and Doubts
With predictions of a $100 billion annual market for GLP-1 agonists, the new class of weight loss drugs, many investors were asking their favorite biotech entrepreneurs whether they had a new Ozempic or Mounjaro in the wings this year, Zhavoronkov noted. In response, he opened his parlays with investors by saying, “I have a very cool product that helps you lose weight and gain muscle.” Then he would hand the person a pair of Insilico Medicine-embossed bicycle racing gloves.
More conventional discussions about the GLP-1s focused on how insurance will cover the current $13,000 annual cost for the estimated 40% of Americans who are obese and might want to go on the drugs. Sarah Emond, president of the Institute for Clinical and Economic Review, which calculates the cost and effectiveness of medical treatments, said that in the United Kingdom the National Health Service began paying in 2022 for obese patients to receive two years of semaglutide — something neither Medicare nor many insurers are covering in the U.S. even now.
But studies show people who go off the drugs typically regain two-thirds of what they lose, said Diana Thiara, medical director for the University of California-San Francisco weight management program. Recent research shows that the use of these drugs for three years reduces the risk of death, heart attack, and stroke in non-diabetic overweight patients. To do right by them, the U.S. health care system will have to reckon with the need for long-term use, she said. “I’ve never heard an insurer say, ‘After two years of treating this diabetes, I hope you’re finished,’” she said. “Is there a bias against those with obesity?”
3. Spotlight on Tax-Exempt Hospitals
Nonprofit hospitals showed off their investment appeal at the conference. Fifteen health systems representing major players across the country touted their value and the audience was intrigued: When headliners like the Mayo Clinic and the Cleveland Clinic took the stage, chairs were filled, and late arrivals crowded in the back of the room.
These hospitals, which are supposed to provide community benefits in exchange for not paying taxes, were eager to demonstrate financial stability and showcase money-making mechanisms besides patient care — they call it “revenue diversification.” PowerPoints skimmed through recent operating losses and lingered on the hospital systems’ vast cash reserves, expansion plans, and for-profit partnerships to commercialize research discoveries.
At Mass General Brigham, such research has led to the development of 36 drugs currently in clinical trials, according to the hospital’s presentation. The Boston-based health system, which has $4 billion in committed research funding, said its findings have led to the formation of more than 300 companies in the past decade.
Hospital executives thanked existing bondholders and welcomed new investors.
“For those of you who hold our debt, taxable and tax-exempt, thank you,” John Mordach, chief financial officer of Jefferson Health, a health system in Pennsylvania and New Jersey. “For those who don’t, I think we’re a great, undervalued investment, and we get a great return.”
Other nonprofit hospitals talked up institutes to draw new patients and expand into lucrative territories. Sutter Health, based in California, said it plans to add 30 facilities in attractive markets across Northern California in the next three years. It expanded to the Central Coast in October after acquiring the Sansum Clinic.
4. Money From New — And Old — Treatments for Autoimmune Disease
Autoimmunity drugs, which earn the industry $200 billion globally each year, were another hot theme, with various companies talking up development programs aimed at using current cancer drug platforms to create remedies for conditions like lupus and rheumatoid arthritis. AbbVie, which has led the sector with its $200 billion Humira, the world’s best-selling drug, had pride of place at the conference with a presentation in the hotel’s 10,000-square-foot Grand Ballroom.
President Robert Michael crowed about the company’s newer autoimmune drugs, Skyrizi and Rinvoq, and bragged that sales of two-decades-old Humira were going “better than anticipated.” Although nine biosimilar — essentially, generic — versions of the drug, adalimumab, entered the market last year, AbbVie expects to earn more than $7 billion on Humira this year since the “vast majority” of patients will remain on the market leader.
In its own presentation, biosimilar-maker Coherus BioSciences conceded that sales of Yusimry, its Humira knockoff listed at one-seventh the price of the original, would be flat until 2025, when Medicare changes take effect that could push health plans toward using cheaper drugs.
Biosimilars could save the U.S. health care system $100 billion a year, said Stefan Glombitza, CEO of Munich-based Formycon, another biosimilar-maker, but there are challenges since each biosimilar costs $150 million to $250 million to develop. Seeing nine companies enter the market to challenge Humira “was shocking,” he said. “I don’t think this will happen again.”
This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
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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1 year 2 months ago
california, Health Industry, Pharmaceuticals, States, Health IT, Hospitals, Prescription Drugs
STAT+: Klobuchar urges drugmakers to remove patents FTC calls improper and inaccurate
Amid a push to crack down on patent abuse by the pharmaceutical industry, a key U.S. lawmaker is urging six large drug companies to remove dozens of patents that were identified by regulators as improperly or inaccurately listed with a federal registry.
In a series of letters sent on Thursday, Sen. Amy Klobuchar (D-Minn.) demanded the companies explain why they have, so far, not responded to warnings issued two months ago by the Federal Trade Commission to remove more than 100 patents from the registry. The agency threatened the drug companies with litigation if they failed to comply.
The FTC had challenged a total of 10 companies over listings for patents on such medicines as asthma inhalers and epinephrine auto-injectors as part of an effort to mitigate actions that thwart competition. Among the companies to which the agency sent warnings are AbbVie, AstraZeneca, Mylan Specialty, Boehringer Ingelheim, and subsidiaries of GSK and Teva Pharmaceutical.
1 year 2 months ago
Pharma, Pharmalot, patents, Pharmaceuticals, STAT+
KFF Health News' 'What the Health?': 2023 Is a Wrap
The Host
Julie Rovner
KFF Health News
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.
Even without covid dominating the headlines, 2023 was a busy year for health policy. The ever-rising cost of health care remained an issue plaguing patients and policymakers alike, while millions of Americans lost insurance coverage as states redetermined eligibility for their Medicaid programs in the wake of the public health emergency.
Meanwhile, women experiencing pregnancy complications continue to get caught up in the ongoing abortion debate, with both women and their doctors potentially facing prison time in some cases.
This week’s panelists are Julie Rovner of KFF Health News, Rachel Cohrs of Stat, Sandhya Raman of CQ Roll Call, and Joanne Kenen of Johns Hopkins University and Politico Magazine.
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Rachel Cohrs
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Johns Hopkins Bloomberg School of Public Health and Politico
Sandhya Raman
CQ Roll Call
Among the takeaways from this week’s episode:
- As the next election year fast approaches, the Biden administration is touting how much it has accomplished in health care. Whether the voting public is paying attention is a different story. Affordable Care Act enrollment has reached record levels due in part to expanded financial help available to pay premiums, and the administration is also pointing to its enforcement efforts to rein in high drug prices.
- The federal government is adding staff to go after “corporate greed” in health care, targeting in particular the fast-growing role of private equity. The complicated, opaque, and evolving nature of corporate ownership in the nation’s health system makes legislation and regulation a challenge. But increased interest and oversight could lead to a better understanding of the problems of and, eventually, remedies for a profit-focused system of health care.
- Concluding a year that saw many low-income Americans lose insurance coverage as states reviewed eligibility for everyone in the Medicaid program, there’s no shortage of access issues left to tackle. The Biden administration is urging states to take action to help millions of children regain coverage that was stripped from them.
- Also, many patients are all too familiar with the challenges of obtaining insurance approval for care. There is support in Congress to scrutinize and rein in the use of algorithms to deny care to Medicare Advantage patients based on broad comparisons rather than individual patient circumstances.
- And in abortion news, some conservative states are trying to block efforts to put abortion on the ballot next year — a tactic some used in the past against Medicaid expansion.
- This week in health misinformation is an ad from Florida’s All Family Pharmacy touting the benefits of ivermectin for treating covid-19. (Rigorous scientific studies have found that the antibacterial drug does not work against covid and should not be used for that purpose.)
Also this week, Rovner interviews KFF Health News’ Jordan Rau about his joint KFF Health News-New York Times series “Dying Broke.”
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Julie Rovner: Business Insider’s “‘I Feel Conned Into Keeping This Baby,’” by Bethany Dawson, Louise Ridley, and Sarah Posner.
Joanne Kenen: The Trace’s “Chicago Shooting Survivors, in Their Own Words,” by Justin Agrelo.
Rachel Cohrs: ProPublica’s “Doctors With Histories of Big Malpractice Settlements Work for Insurers, Deciding if They’ll Pay for Care,” by Patrick Rucker, The Capitol Forum; and David Armstrong and Doris Burke, ProPublica.
Sandhya Raman: Roll Call’s “Mississippi Community Workers Battle Maternal Mortality Crisis,” by Lauren Clason.
Also mentioned in this week’s episode:
- Stat News’ “Humana Used Algorithm in ‘Fraudulent Scheme’ to Deny Care to Medicare Advantage Patients, Lawsuit Alleges,” by Casey Ross and Bob Herman.
- USA Today’s “Cigna Denied a Lung Transplant for a Cancer Patient. Insurer Now Says That Was an Eerror.’ By Ken Alltucker.
- Politico’s “Conservatives Move to Keep Abortion off the 2024 Ballot,” by Alice Miranda Ollstein and Megan Messerly.
- The New York Times’ “Why Democracy Hasn’t Settled the Abortion Question,” by Kate Zernike.
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Transcript: 2023 Is a Wrap
KFF Health News’ ‘What the Health?’Episode Title: 2023 Is a WrapEpisode Number: 327Published: Dec. 21, 2023
[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It 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, Dec. 21, at 10 a.m. As always, news happens fast and things might’ve 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 University and Politico Magazine.
Joanne Kenen: Hi, everybody.
Rovner: Sandhya Raman of CQ Roll Call.
Sandhya Raman: Good morning.
Rovner: And Rachel Cohrs of Stat News.
Rachel Cohrs: Hi.
Rovner: Later in this episode, we’ll have my interview with KFF Health News’ Jordan Rau, co-author of a super scary series done with The New York Times about long-term care. It’s called “Dying Broke.” But first, this week’s news. I thought we would try something a little bit different this week. It just happened that most of this week’s news also illustrates themes that we’ve been following throughout the year. So we get a this-week update plus a little review of the last 12 months, since this is our last podcast of the year. I want to start with the theme of, “The Biden administration has gotten a ton of things done in health, but nobody seems to have noticed.”
We learned this week that, with a month still to go, Affordable Care Act plan sign-ups are already at historic highs, topping 15 million, thanks, at least in part, to extra premium subsidies that the administration helped get past this Congress and which Congress may or may not extend next year. The administration has also managed to score some wins in the battle against high drug prices, which is something that has eluded even previous Democratic administrations. Its latest effort is the unveiling of 48 prescription drugs officially on the naughty list — that’s my phrase, not theirs — for having raised their prices by more than inflation during the last quarter of this year, and whose manufacturers may now have to pay rebates. This is something in addition to the negotiations for the high-priced drugs, right, Rachel?
Cohrs: Yeah, this was just a routine announcement about the drugs that are expected to be charged rebates and drugmakers don’t have to pay immediately; I think they’re kind of pushing that a little further down the road, as to when they’ll actually invoice those rebates. But the announcement raised a question in my mind of — certainly they want to tout that they’re enforcing the law; that’s been a big theme of this year — but it brought up a question for me as to whether the law is working to deter price hikes if these companies are all doing it anyway, so just a thought.
Rovner: It is the first year.
Cohrs: It is. This started going into effect at the end of last year, so it’s been a little over a year, but this is assessed quarterly, so the list has grown as time has gone on. But just a thought. Certainly there’s time for things to play out differently, but that’s at least what we’ve seen so far.
Rovner: They could say, which they did this week, it’s like, Look, these are drugs because they raised the prices, they’re going to have to give back some of that money. At least in theory, they’re going to have to give back some of that money.
Cohrs: In Medicare.
Rovner: Right. In Medicare. Some of this is still in court though, right?
Cohrs: Yes. So I think at any moment, I think this has been a theme of this year and will be carrying into next year, that there are several lawsuits filed by drugmakers, by trade associations, that just have not been resolved yet, and I think some of the cases are close to being fully briefed. So we may see kind of initial court rulings as to whether the law as a whole is constitutional. It is worth noting that most of those lawsuits are solely challenging the negotiation piece of the law and not the inflation rebates, but this could fall apart at any moment. There could be a stay, and I expect that the first court ruling is not going to be the last. There’s going to be a long appeals process. Who knows how long it’s going to take, how high it will go, but I think there is just a lot of uncertainty around the law as a whole.
Rovner: So the administration gets to stand there and say, “We did something about drug prices,” and the drug companies get to stand there and say, “Not yet you didn’t.”
Cohrs: Exactly. Yes, and they can both be correct.
Rovner: That’s basically where we are.
Cohrs: Yes.
Rovner: That’s right. Well, meanwhile, in other news from this week and from this year, the Federal Trade Commission, the Department of Justice, and the Department of Health and Human Services are all adding staff to go after what Biden officials call “corporate greed” — that is their words — in health care. Apparently these new staffers are going to focus on private equity ownership of health care providers, something we have talked about a lot and so-called roll-ups, which we haven’t talked about as much. Somebody explain what a roll-up is please.
Kenen: Julie, why don’t you?
Rovner: OK. I guess I’m going to explain what a roll-up is. I finally learned what a roll-up is. When companies merge and they make a really big company, then the Federal Trade Commission gets to say, “Mmm, you may be too big, and that’s going to hurt trade.” What a roll-up is is when a big company goes and buys a bunch of little companies, so each one doesn’t make it too big, but together they become this enormous — either a hospital system or a nursing home system or something that, again, is not necessarily going to make free trade and price limits by trade happen. So this is something that we have been seeing all year. Can the government really do anything about this? This also feels like sort of a lot of, in theory, they can do these things and in practice it’s really hard.
Cohrs: I feel like what we’ve seen in this space — I think my colleague Brittany wrote about kind of this move — is that the corporate structures around these entities are so complicated. Is it going to discourage companies from doing anything by hiring a couple people? Probably not. But I think the people power behind understanding how these structures work can lay the groundwork for future steps on understanding the landscape, understanding the tactics, and what we see, at least on the congressional side, is that a lot of times Congress is working 10 years behind some of the tactics that these companies are using to build market power and influence prices. So I think the more people power, the better, in terms of understanding what the most current tactics are, but it doesn’t seem like this will have significant immediate difference on these practices.
Kenen: I think that the gap between where the government is and where the industry is is so enormous. I think the role of PE [private equity] in health care has grown so fast in a relatively short period of time. Was there a presence before? Yes, but it’s just really taken off. So I think that if those who advocate for greater oversight, if they could just get some transparency, that would be their win, at the moment. They cannot go in and stop private equity. They would like to get to the point where they could curb abuse or set parameters or however you want to phrase it, and different people would phrase it in different ways, but right now they don’t even really know what’s going on. So, even among the Democrats, there was a fight this year about whether to include transparency language between [the House committees on] Energy and Commerce and Ways and Means, and I don’t think that was ever resolved.
I think that’s part of the “Let’s do it in January” mess. But I think they just sort of want not only greater insight for the government, but also for the public: What is going on here and what are its implications? People who criticize private equity — the defenders can always find some examples of companies that are doing good things. They exist. We all know who the two or three companies we hear all the time are, but I think it’s a really enormous black box, and not only is it a black box, but it’s a black box that’s both growing and shifting, and getting into areas that we didn’t anticipate a few years ago, like ophthalmology. We’ve seen some of these studies this year about specialties that we didn’t think of as PE targets. So it’s a big catch-up for roll-up.
Rovner: Yeah, and I think it’s also another place that the administration — and I think the Trump administration tried to do this too. Republicans don’t love some of these things either. The public complains about high health care costs. They’re right; we have ridiculously high health care costs in this country, much higher than in other countries, and this is one of the reasons why, is that there are companies going in who are looking to simply do it to make a profit and they can go in and buy these things up and raise prices. That’s a lot of what we’re seeing and a lot of why people are so frustrated. I think at very least it at least shows them: It’s like, “See, this is what’s happening, and this is one of the reasons why you’re paying so much.”
Kenen: It’s also changing how providers and practitioners work, and how much autonomy they have and who they work for. It’s in an era when we have workforce shortages in some sectors and burnout and dissatisfaction. There are pockets at least, and again, we don’t really know how big, because we don’t have our arms around this, but there are pockets; at least we do know where the PE ownership and how they dictate practice is worsening these issues of burnout and dissatisfaction. I’m having dinner tomorrow night with a expert on health care antitrust, so if we were doing this next week, I would be so much smarter.
Rovner: We will be sure to call on you in January. Workforce burnout: This is another theme that we’ve talked about a lot this year.
Kenen: It’s getting into places you just wouldn’t think. I was talking to a physical therapist the other day and her firm has been bought up, and it’s changing the way she practices and her ability to make decisions and how often she’s allowed to see a patient.
Rovner: Yeah. Well, another continuing theme. Well, yet another big issue this year has been the so-called Medicaid unwinding, as states redetermine eligibility for the first time since the pandemic began. All year, we’ve been hearing stories about people who are still eligible being dropped from the rolls, either mistakenly or because they failed to file paperwork they may never have received. Among the more common mistakes that states are making is cutting off children’s coverage because their parents are no longer eligible, even though children are eligible for coverage up to much higher family incomes than their parents. So even if the parents aren’t eligible anymore, the children most likely are.
This week, the federal government reached out to the nine states that have the highest rates of discontinuing children’s coverage, including some pretty big states, like Texas and Florida, urging them to use shortcuts that could get those children’s insurance back. But this has been a push-and-pull effort all year between the states and the federal government, with the feds trying not to push too hard. At one point, they wouldn’t even tell us which states they were sort of chiding for taking too many people off too fast. And it feels like some of the states don’t really want to have all these people on Medicaid and they would just as soon drop them even if they might be eligible. Is that kind of where we are?
Raman: You can kind of look to see the tea leaves at what some of these states are. The states that the health secretary wrote to, that have 60% of the decline in the kids being disenrolled, align pretty well with the states that have not expanded Medicaid. So they’re already going to have much fewer people enrolled than states where the eligibility levels are a lot more generous. So it’s not surprising, and some of these states have been just a little bit more aggressive from the get-go or said that they wanted to do the eligibility redeterminations a lot faster than some of the other states that wanted to take the longer time, reevaluate different ways to see if someone was still eligible, whether they were maybe getting SNAP [Supplemental Nutrition Assistance Program] benefits or other things like that. So it’s not surprising.
Rovner: You mean do it more carefully.
Raman: Yeah, yeah, so I think that the letter is one step, but if those states are really going to take up implementing these other strategies to kind of decrease that drop-off, unclear, just because they have been pretty proactive about doing this in a quick process.
Rovner: I also noticed that the states that the HHS secretary wrote to kind of tracked with the states that didn’t expand Medicaid under the Affordable Care Act, but interestingly, that meant that there would’ve been fewer parents who were eligible in the first place. So there shouldn’t have been as many children cut off, because there weren’t as many parents who ever got onto Medicaid in those states, which is why it made me raise my eyebrows a little bit. Again, I think this is something that we shall continue to follow going into next year.
Kenen: But we should also point out that even the more pro-Medicaid, liberal states have not done a great job with unwinding. It’s been bumpy pretty much across the board. It’s been very problematic. It’s a clumsy process in a normal year, and trying to catch up on three years’ worth — this is a population where people’s income varies a lot. Are you just over the line? Are you just under the line? It’s fluctuating, the eligibility changes. But you try to do three years at once after all the chaos, with political undercurrents such as the nonexpansion states, and it makes it harder and messier.
Rovner: Which was predicted and came true. So yet another theme from this year is what I’m calling the managed care backlash redux. In the late 1990s, when lots of people were herded into managed care for the first time, there were lots of horror stories about patients being denied care, doctors being put through bureaucratic hoops, unqualified people making medical decisions. There’s a bipartisan bill that almost came to fruition in 2001 for what was called a patient’s bill of rights, but it was pushed off the agenda by 9/11. Most of the protections in that bill, however, were eventually included in the Affordable Care Act.
So now it’s 2023, and lo and behold, those same issues are back. A top issue for the American Medical Association this year is reining in prior authorization requirements, which require doctors to actually get permission before their patients can get recommended care. In one particularly painful story recently, a woman who’d been approved for a lung transplant had her surgery canceled by her insurer, literally on the way to the OR [operating room]. Later, and not coincidentally after a public outcry, the insurer, Cigna, called the whole thing, quote, “An error.” So she did finally get her lung transplant. Joanne, you covered the patient’s bill of rights fight with me back in the day. Most things that are being complained about now are now illegal. So why are we seeing so much of it again?
Kenen: Because there’s confusion about — patients don’t know what their rights are. All of us are savvy and all of us have had something in our own insurance that we don’t understand, or maybe we end up navigating it, but it’s not ever easy. Things like prior authorization — they say, “Well, we have to make sure people are getting appropriate care.” There is an element of truth there; there is overuse in American health care. There are people who get things they don’t really need or should try something less intrusive and less expensive first. So you have this genuine issue of overtreatment, back surgery being the classic example. Many people will do just as well with physical therapy and things like that than they will with an $80,000 operation. In fact, they might do better with the PT and not with the $80,000 operation.
So is there any validity to the idea of making sure people get appropriate care? Yes, but they say no to stuff that they should be covering. That’s clear, and that patients don’t always know what the right pathway is, because doctors also have incentives, or just the way they’re trained and the way they look at their — surgeons like to cut. It’s what they’re trained to do. They trained for years. So it’s really complicated, because there’s this collision between overuse and overtreatment and overcharging and all the over, over, over stuff that comes from the provider world and the no, no, no, no, no, no, no, “you can’t have that” stuff that comes from the insurer world, sometimes appropriately, but often not appropriately.
Rovner: Then I guess you load onto that the private equity and now the providers whose overlords are in it to make a profit. Then you have sort of private equity butting heads with insurance, which is one of the reasons I think we are sort of ending up here. But it certainly does feel very reminiscent of things that I’ve been through before. We’re seeing yet a similar story with Medicare Advantage, which is the private Medicare managed care program that now enrolls more than half of the Medicare population and makes lots of money for its private insurance companies that offer them.
Rachel, your colleagues wrote about a Humana algorithm that was being used to deny care after a patient had received it for, quote-unquote, “an average period of time, regardless of the patient’s condition,” meaning that if patient is sicker than average, they were saying, “Too bad, we’re only going to give this to you for 18 days because that’s what the average patient needs. If you need more, sorry about that.” So Congress is now trying to get into the act, trying to ensure that Medicare patients, who tend to vote in disproportionate numbers, get their needed care. The insurance industry is pushing back against the pushback. What’s the outlook for Congress actually getting something done on this issue? I’ve heard a lot of talk. I haven’t seen a whole lot of action.
Cohrs: Yeah, I mean certainly there has been talk — and just to point out that the Humana lawsuit is related to the UnitedHealth Group lawsuit that we saw earlier; it’s the same company making the algorithm. Bob and Casey’s reporting was just more focused on UnitedHealth Group, because they got internal documents showing the correlation between the quote-unquote “recommendation” of this algorithm and care decisions and denials and people being cut off from their rehab services. So I think certainly, I think there has been a lot of outcry. We’re seeing this play out in the legal system beforehand. This is an issue that we’ve discussed as well.
Are we going to regulate through the courts, because everything else is too slow? I think AI is certainly a hot topic on the Hill at the moment, and there is lawmaker interest, but this is just a very complicated space. Lawmakers, though they might try their best, are not the most tech-savvy people. These are very powerful interests that I would imagine would oppose some of these regulations if they were to actually materialize. So, there’s nothing imminent. Certainly if we see these lawsuits keep piling up, if we see discovery, if we see some more examples of this happening where other companies are using the algorithms as well, a groundswell — as you mentioned, Medicare patients are an important constituency — I think we could see some action, but it’s not looking imminent at this time.
Kenen: The other thing is there’s been a number of reports from a number of media outlets, Stat and others, that these algorithms are being used without any people to work with them. Like, OK, here’s this algorithm and it’s doing these batches of like, I’m going to say no to 50,000 people in 20 seconds. I’m exaggerating a little bit there, but yes, is there legitimate questions about what is appropriate treatment? Yes.
Or you hear these stories about people told, “You can’t have this drug; you have to have that drug at first,” but they would try that drug and it didn’t work for them, and there’s just no way of — the reason we have five or six similar drugs is that in some cases, those slight differences, people respond differently, mental health being a huge example of that, right? Where it could be very hard to get people on the right drugs, if person A doesn’t respond the same way as person B, even if they have the same condition. But 50,000, I don’t know if that’s the right number, but I think I remember reading one where it was 50,000 going through an algorithm. That’s not appropriate use; that’s mass production of saying no to some legitimate needs.
Rovner: Sandhya, I see you nodding there. I know that this is something that’s kind of bipartisan, right? Members of Congress get complaints about Medicare, which is something that they do, members of Congress, oversee. It is a government program, even though these are being run by private companies. I’m sort of wondering when this is going to reach a boiling point that’s going to require something to be done.
Raman: I think with some of these issues that we face that are kind of evergreen here, there has been a bipartisan push to find kind of ways to reform the prior authorization process. We’ve had people as different as Sen. Elizabeth Warren (D-Mass.) and Sen. Mike Crapo (R-Idaho) say they want reform, or Sen. James Lankford (R-Okla.) is very different from Rep. Pramila Jayapal (D-Wash.), and they’ve both said that, similar things that …
Rovner: Some of the most conservative and the most liberal members of Congress.
Raman: Yeah, so we’ve got a broad stretch, but I think at the same time, if you look at some of the other things that we have to deal with here — Congress is out for the year, but for next year, we are fairly behind in that we have a long list of things that need to be extended by mid-January. Then we have just funding all of HHS and a number of other government things by early February. So getting something from start to finish next year, which is also an election year, is going to be tough. So I think that there’s interest there, but I don’t know that getting something hashed out is going to be the easiest next year of all years.
Rovner: Yeah, I think it’s fair to say that Congress took an incomplete in most subjects this year. Well, finally this week, the topic that I think has been in every podcast this year, which is abortion. One of the threads that has wound through this year’s coverage is the strong support for abortion rights from voters, even in red and red-ish states. This year, Ohio voters affirmed a right to abortion, twice actually; there was a technical vote back in the summer. And in Virginia, Democrats flipped the legislature by running against Republican promises to impose a compromise 15-week ban, which apparently did not seem to be a compromise to most of the voters. That was after a half a dozen states voted in favor of the abortion rights position in the 2022 midterms. So this week we have a pair of stories, one from Politico and one from The New York Times, about how anti-abortion forces are working to keep future abortion-related questions off of the ballot in states where there’s still that possibility, including Florida, Missouri, Arizona, and Nevada.
One Republican Missouri lawmaker said that the right to life, quote, “should not be taken away because of a vote by a simple majority,” which frankly felt a little breathtaking to me. He has filed a bill that would require ballot measures to pass not just statewide, but with a majority in more than half of the state’s congressional districts. So basically in the really red parts of the states, a majority there would also have to vote for this. These people are getting very creative in their attempts to stop these votes from happening, maybe because they don’t think they can win them if it’s just straight up or down.
Raman: I think one thing to look at is kind of how we see some of these similar tactics in the same way that we saw with Medicaid. When Medicaid expansion started winning on different ballots, there were states that tried to put in measures to kind of tamp that down, saying, “You need a higher threshold,” and maybe that doesn’t pass, but still putting in different tactics to reduce the likelihood of that passing. I think that’s kind of what we’ve been seeing here, whether or not it’s Ohio trying to change its threshold, or we’ve had states say that even if something passed, let’s try to tear that back so that it doesn’t actually get implemented, or ahead of the ones for next year, let us find tactics to reduce the likelihood they’ll get the signatures to be on the ballot or reduce the likelihood of it passing by changing the language or pushing for challenging the language.
So there’s kind of what we saw right after the Dobbs decision, which was just a very “throw spaghetti at the wall, see what sticks,” just kind of ramp up things and see what will work, given that the last — all of the elections that we’ve had post-Dobbs have been in the favor of abortion rights. Even when we’ve tried to pass an anti-abortion measure, it’s not passed at the ballot. In the stories that you mentioned, there was another quote that stuck out to me, where they’d also mentioned that maybe this should not be subject to majority vote, I think in the Politico piece as well. So I think that’s something that is interesting that I haven’t really seen vocalized before, that this should be done in a different manner rather than this is how the majority of people feel one way or the other.
Rovner: Yeah, it felt so ironic because when in the Dobbs decision, Justice [Samuel] Alito wrote, “Well, now we’re turning this back to the states to be decided by their voters.” Well, here are their voters deciding, and it turns out the anti-abortion side don’t like the way the voters are voting, so they’re going to try to not have the voters vote, basically. We will see how this one all plays out. The other continuing story this year is women being prosecuted basically for bad pregnancy outcomes. Last week we talked about the case of Brittany Watts, an Ohio woman who was sent home from a hospital emergency room twice, had a miscarriage, and this week had formal charges filed against her for, quote, “abusing a corpse.” This case hasn’t gotten nearly the attention of the case of Kate Cox, the Texas woman whose fetus was diagnosed with fatal defects and who filed suit to be allowed to have an abortion.
She eventually had to go to another state, and that was even before the permission that had been granted by a lower-court judge was overturned by the Texas Supreme Court. It may be at least in part because Brittany Watts is black, or that she didn’t put herself out in public the way Kate Cox did, but this is a way that prosecutors can punish women even in states where abortion remains legal. Remember Ohio voted twice this year to keep abortion legal, and this wasn’t even an abortion; it was a miscarriage. The medical examiner determined that the fetus was already dead when it passed. What are the prosecutors trying to do here? We talk about chilling effects. This is kind of the ultimate chilling effect, right?
Raman: It really is, because here we have someone that was not, as you said, seeking an abortion. She miscarried, and I think that she was 21 weeks and five days pregnant, and then they had the 21-week cutoff. So it gets sent into really murky waters here because I’m not sure what they’re going for, kind of picking this case to prosecute and go with. We’ve had this happen before where people have self-managed or miscarried, and then they’ve ended up being prosecuted. But at this point, I’m not sure why they’re making a case out of this particular woman, kind of dragging this into the debate.
Rovner: Yeah, there was a famous case in Indiana — 2013, may have been even before that — a pregnant woman who tried to kill herself and failed to kill herself, but did kill her fetus, and she was put in jail for several years. There have been, at least there was sort of the question there, were you trying to self-abort at that point? But there was nothing here. This was a woman with a wanted pregnancy whose pregnancy ended via natural circumstances, which happens, I think we’ve discovered now, a lot more than people realize.
I think people don’t talk about unhappy pregnancy outcomes, so people don’t realize how common they actually are. But I wonder — and I’ve been saying this all year — again, if women are fearing prosecution, even women who want babies, they may fear getting pregnant. I’ve seen some stories about more permanent types of birth control happening because women don’t want to get pregnant, because they don’t want to end up in a place where their health is being risked or they’re trying to get health care they need and their doctor or they could be facing prison time.
Kenen: And in this case, she had gone to the hospital. It’s complicated. She went in and out of the hospital. She went to the ER; they sent her home. I think then once they sent her home another time, she left against medical advice, but she wasn’t trying to get an abortion. She was having pregnancy complications. It’s documented. She was in and out of medical care. Pregnancies can fail, and early, the first trimester, it’s a very high rate. It’s less common later on, but it still happens. There are times when an early miscarriage, you might not even know that it’s a miscarriage. It’s early. You don’t know what’s even going on with your own body, or you’re not certain. So she didn’t know what to do at home when she did miscarry. It seems very punitive. Did she behave in an absolutely ideal, textbook-perfect, the way you wish she might have? But she did what she could do at the time.
Rovner: Yeah, it’s hard to know what to do. Well, we will watch this case, I think, even though it’s not, as I say, it’s not getting quite the attention of some of the other cases. Our final this week in health information of 2023 goes to an ad that came to my email from the All Family Pharmacy in Boca Raton, Florida. The headline is “Miracle Drug Ivermectin for Covid-19 Could Save Lives,” and it claims that, quote, “a growing body of evidence from dozens of studies worldwide demonstrates ivermectin’s unique and highly potent ability to inhibit SARS-CoV-2 replication and aid in the recovery from covid-19.”
That sounded not quite right to me, so I looked up some of the studies that they cited and found that most had been thoroughly debunked, that ivermectin is not really good treatment for covid-19. I even found one study from an open-access journal that had to publish a correction, noting that two of its authors were paid consultants to ivermectin manufacturers, though they had failed to disclose that conflict. Meanwhile, if you don’t want ivermectin or hydroxychloroquine, which the All Family Pharmacy also sells, they will also sell you semaglutide, which is the scientific name of the hard-to-get weight loss drug Ozempic. And they say their price even includes a doctor consult. I will post the links in the show notes. All right, that is this week’s news. Now we will play my interview with Jordan Rau about his long-term care financing series. Then we’ll come back with our extra credits.
I am pleased to welcome to the podcast my KFF Health News colleague Jordan Rau. I asked Jordan to join us to talk about his latest project, “Dying Broke,” done in partnership with The New York Times. It’s about the growing expense of long-term care and the declining ability of Americans to pay for it. Jordan, welcome to “What the Health?”
Jordan Rau: Glad to be here, Julie.
Rovner: So I want you to start with the 30-second elevator pitch about what you found working on this, for two years?
Rau: Just about. The big-picture view is that when you’re elderly, if you need long-term care, by which we’re talking about nonmedical things, like personal aides, if you need help in your daily activities going to the bathroom or eating or such, or if you have a cognitive impairment like dementia, it’s exceedingly expensive, except if you are destitute. The private market solutions, which are long-term care insurance, really don’t work, and most people don’t hold it. The government solution, which is Medicaid, is only available to you once you’ve exhausted just about all of your assets and have very low income. And that’s led the vast majority of people out on their own financially to either rely on themselves or their family or other people to take up the burden. And that burden is significant for the children of older people.
Rovner: So it’s not just nursing home care that costs more than all but the richest can afford; assisted living and home care, which people assume are going to be a lot cheaper and that maybe their retirement savings will cover — they’re also increasingly out of reach. Why has the price of long-term care gone up so much faster than Americans’ retirement savings?
Rau: All of medical inflation has gone up enormously, but I think a lot of it is that there’s so little regulation on prices. There’s frankly no regulation on prices of assisted living, and you don’t have a large payer that can control prices. That’s one of the good things about Medicare, is that they set their own prices and that’s helped keep prices down. That’s why it’s less expensive for Medicare to send someone to a nursing home than for someone to pay out-of-pocket. But there’s none of that. So the prices have just gone where they’ve gone, and now you have a scarcity of workers as well. So that’s driving up wages.
Rovner: People who’ve been socking away money and thinking they’re going to be able to pay for this themselves get kind of a rude awakening when they need, and it’s not — as you say, it’s not even medical long-term care; it’s just help with activities of daily living.
Rau: Yeah, yeah, yeah. I think one of the problems is that people assume they have the best-case scenario when they’re envisioning their retirement. They’re going to be off golfing, they’re going to be playing around with their grandkids, they’re going to be taking trips. The fact is, you’re very likely — if you live well into your 80s and 90s, as many people do — to not be able to live independently anymore, to need help with at least a little bit of things, and in worst-case scenario everything. People just don’t expect that that’s going to happen.
Rovner: So why do so many Americans still not know that Medicare doesn’t pay for long-term care? I feel like I’ve been saying this since 1980-something.
Rau: I wonder how much of it would’ve been different if they had decided to name Medicaid something that isn’t so close to Medicare. Maybe that would’ve helped, but realistically, everyone I think has a sense. Well, first of all, who’s paying attention to this stuff when you’re in your 30s and 40s, right? You’re not thinking about what’s going to happen to you in the 60s. And then I think that people just don’t expect that this is going to happen to them, and Medicare has a well-earned reputation as being pretty comprehensive. It doesn’t cover certain things, and there is a “donut hole” situation, so you’ve got to get supplemental. But people know that for the most part, it’s covered. And people don’t understand that long-term care, the nonmedical side, is — not just here, everywhere — it’s the backwater of health care. It’s not even considered health care in some ways.
So you just assume — I mean, I would assume, right, if Medicare is going to cover my heart transplant, why would I not think that it’s going to cover someone to come to my house a couple hours a day to help me with stuff or to put me in an assisted living facility if it covers nursing home care? It’s such a complicated, Byzantine system. You and I, we’ve been doing this probably combined, well, I don’t want to say how long, but it’s been a long time, and it’s hard for us to untangle exactly what is covered and what overlaps with what and what are the eligibility rules. So to expect a regular person, who isn’t paid to do this 50 hours a week, to know it is highly unrealistic.
Rovner: Yeah, and I was going to say the fact that Medicare actually has a home care benefit and it has a nursing home benefit; they’re just super limited. I think that sort of adds to the confusion too, doesn’t it?
Rau: Yeah. Well, even Medicare is confused about its home care benefit, right? There’s the whole Jimmo case and a whole debate about what you need to qualify for it.
Rovner: So listeners will know that long-term care and our country’s complete lack of a long-term care policy is a pet issue of mine and has been since I started writing about it in 1986. It isn’t like the government hasn’t tried to do something. There was the ill-fated Medicare Catastrophic Coverage Act in 1988 that ended up getting repealed. There were efforts to subsidize private long-term care insurance in the 1990s that didn’t really go anywhere, and there was the CLASS [Community Living Assistance Services and Supports] Act that was briefly part of the Affordable Care Act when it passed in 2010, only to be abandoned as financially unfeasible. Why has this been such a hard issue to address from a policy point of view?
Rau: The one-word answer obviously is money. It’s incredibly expensive. So to have that type of lift, it would be to expand either Medicaid or Medicare or to create a new program; would be inordinately expensive. But beyond that, I think basically, to do this, you either have to tag on something to one of those existing programs, which is a major expansion, or you have to have a mandatory insurance program. It could be a public one; it can be a private one. I think that it’s hard because it’s not universal. Auto insurance — everybody drives, right? So if you say, OK, you all know you’re going to drive, and people know like, Oh, I may get into an accident. So then you have a functioning insurance market.
Health insurance, sort of the same thing. Everyone knows that they’re going to need health insurance maybe next year. So that’s an easier sell. Even that, right, with the Affordable Care Act — that passed by just one vote. That was a heavy lift. So here you’re saying, here’s something that you may need but you very well may never tap. By the way, we want you to pay for it now or buy into it now, and it’s not relevant for your life until 30 years. I just think that’s a hard sell politically to the population, to the political system. It’s a hard sell.
Rovner: So if there was just one message that you hope people take away after reading this exhaustive series, what do you think it should be?
Rau: Printing the series out and frame it and put it on your wall would be my main message. But I would say that this stuff is so unpredictable that you really have to have some flexibility in your expectations and planning, because you can’t plan to not get early-onset dementia. You can’t plan to need help. So I think that you need to — people obviously need to have as much of a cash cushion as they can, and they need to bone up on this before it’s a crisis, because by the time it’s a crisis — and this is a problem, right, with health insurance too. By the time you’ve got the emotional and health issues, to throw on top of it a bureaucratic sort of financial issue is just so hard for most people to juggle. So there isn’t an easy solution, but it is important for people to realize that this is as much of a risk as smashing your car into a telephone pole and that you cannot have one answer.
Your answer cannot be like, “Oh, well I’m just going to stay in my house, because you may not be able to stay in your house.” Or your answer can’t be, “Well, I’m going to go into a fancy assisted living facility with a great chandelier and great food,” because unless you save an inordinate amount of money, even if you go in there, you may not be able to afford to stay there. So it’s really a recognition that you can’t really concretely plan for this, but you may very well not be able to live independently if you are lucky enough to live into your eighth and ninth decade.
Rovner: Great. Jordan Rau, anything I didn’t ask?
Rau: Never. Never, Julie.
Rovner: Jordan Rau, thank you so much for joining us.
Rau: Great to see you.
Rovner: OK. We are back, and it’s time for our last extra credit segment of the year. 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. Rachel, why don’t you go first this week?
Cohrs: Sure. The story I chose is in ProPublica. The headline is “Doctors With Histories of Big Malpractice Settlements Work for Insurers, Deciding If They’ll Pay for Care,” by Patrick Rucker at The Capitol Forum and David Armstrong and Doris Burke at ProPublica. I think this article very much fits into the larger theme we were talking about earlier about insurance denials. This was pretty shocking still to me, of these instances of doctors with big malpractice settlements that had been disciplined by medical boards failing up essentially and getting jobs. If they can’t practice anymore, then they’re getting jobs in insurance companies instead, deciding whether a much larger volume of patients get care. So I think it was just a fascinating, really well-done investigation. It sounded like it was really difficult to match up all the records with the lawsuits and the settlements, and there aren’t necessarily databases that exist of what doctors work for insurance companies. So it was just really well done and just a really important space that we’ll continue to talk about.
Kenen: That was a great piece. These doctors are making $300,000 to $400,000 a year, these people who failed up, as Rachel just put it. Yeah.
Rovner: Yeah. That’s the perfect phrase. Sandhya.
Raman: My extra credit this week is called “Mississippi Community Workers Battle Maternal Mortality Crisis,” and it’s from my colleague at Roll Call Lauren Clason. This story also illustrates a combination of themes from this year. It touches on some of the maternal health inequities, the racial inequities, and rural health inequities, and how politics kind of comes into all of that. Mississippi Black women die at a rate four times higher than white women, and the state also leads in infant mortality rates nationwide. At the same time, it’s also a nonexpansion state for Medicaid. So Lauren went to Mississippi to look at some of the community and state-led groups that are trying to reduce these inequities that are caused by the different racial, socioeconomic, and access factors that are happening at the same time that an increasing number of hospitals are closing in the state.
Rovner: Also another really good story. Joanne?
Kenen: The theme of the day is yearlong, or decades-long in some cases, but ongoing health stories that have dominated the year. Another one that we didn’t touch on today but clearly is an ongoing multiyear health crisis is gun violence, which is a public health problem as well as a criminal justice problem. The Trace did a fantastic end-of-year project by Justin Agrelo. It’s called “Chicago Shooting Survivors, in Their Own Words.” They worked with both people who had survived shootings as well as people who had lost family members to shootings, and they worked with them about how to write and tell stories.
These five stories are in these people’s own words, and it was partnered with a bunch of other Chicago-based publications. They’re very powerful. In the introduction, they wrote that the Chicago media has been really good about trying to cover every homicide but that these people end up being defined by their death, not everything else about their life. These essays, they didn’t just talk about grief, which is obviously a huge — grief and trauma — but also the lives, not just the deaths. It’s really, really worth spending some time with.
Rovner: Yeah, and we haven’t talked as much as we probably should have about gun violence, but we will put that on the list for 2024. My extra credit this week is from Business Insider. It’s called “I Feel Conned Into Keeping This Baby.” It’s by Bethany Dawson, Louise Ridley, and Sarah Posner. It’s about an anti-abortion group that promised pregnant women financial support for their babies if they agreed not to get an abortion. But even though the women signed contracts, the group, called Let Them Live, did not provide the aid promised. Apparently they promised more money than they could raise in contributions. Now, I have heard of pregnancy crisis centers promising things like diapers and formula, but this group said it would help with groceries and rent and other significant expenses until it didn’t. Apparently the small print in the contract said the benefits could be reduced or stopped at any time. This was supposed to help answer the criticism that anti-abortion groups don’t actually care about the women, particularly after they give birth, except maybe promising things that you can’t deliver isn’t the best way to do that.
OK. That is our show for this week and for this year. 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 technical guru, Francis Ying, and our editor, Emmarie Huetteman. Also as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can still find me at X, @jrovner, or @julierovner at Bluesky and @julie.rovner at Threads. Sandhya, where are you on social media these days?
Raman: I’m @SandhyaWrites on both X and Bluesky.
Rovner: Rachel.
Cohrs: I’m @rachelcohrs on X, @rachelcohrsreporter on Threads.
Rovner: Joanne.
Kenen: @joannekenen1 on Threads. I’m occasionally on X — or, as you all know, I’ve been calling it Y — @JoanneKenen.
Rovner: We will be back in your feed in 2024. Until then, have a great holiday season, and be healthy.
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1 year 3 months ago
Health Care Costs, Medicaid, Medicare, Multimedia, Pharmaceuticals, Public Health, Abortion, Drug Costs, Hospitals, KFF Health News' 'What The Health?', Legislation, Medicare Advantage, Podcasts, Women's Health
STAT+: Patent thickets and terminal disclaimers: How pharma blocks biosimilars from the marketplace
To ring the register, a pharmaceutical company may create a patent thicket, which involves filing dozens of patents that, in some cases, add little value to their medicines but extend precious monopolies.
To ring the register, a pharmaceutical company may create a patent thicket, which involves filing dozens of patents that, in some cases, add little value to their medicines but extend precious monopolies. And one crucial, but little-known tool for making this happen is something called a terminal disclaimer.
In short, a terminal disclaimer is a stipulation provided to the U.S. Patent & Trademark Office that a continuation or follow-on patent – essentially, a minor patent that makes few substantive changes to a medicine – will expire at the same time as the original patent filed by a pharmaceutical company. By doing so, a drugmaker can circumvent prohibitions on awarding more than one patent for an invention.
As a result, a drug company can quickly add a number of patents that can be used to protect its medicines from would-be rivals. How so? As patents pile up, companies that want to sell generic or biosimilar versions of these medicines find themselves fighting longer and more expensive patent infringement lawsuits that are designed to delay their plans.
1 year 3 months ago
Pharma, Pharmalot, patents, Pharmaceuticals, STAT+
A New Test Could Save Arthritis Patients Time, Money, and Pain. But Will It Be Used?
SAN DIEGO — Erinn Maury knew Remicade wasn’t the right drug for Patti Schulte, a rheumatoid arthritis patient the physician saw at her Millersville, Maryland, practice. Schulte’s swollen, painful joints hadn’t responded to Enbrel or Humira, two drugs in the same class.
But the insurer insisted, so Schulte went on Remicade. It didn’t work either.
SAN DIEGO — Erinn Maury knew Remicade wasn’t the right drug for Patti Schulte, a rheumatoid arthritis patient the physician saw at her Millersville, Maryland, practice. Schulte’s swollen, painful joints hadn’t responded to Enbrel or Humira, two drugs in the same class.
But the insurer insisted, so Schulte went on Remicade. It didn’t work either.
What’s more, Schulte suffered a severe allergic reaction to the infusion therapy, requiring a heavy dose of prednisone, a steroid with grave side effects if used at high doses for too long.
After 18 months, her insurer finally approved Maury’s drug of choice, Orencia. By then, Schulte’s vertebrae, weakened by prednisone, had started cracking. She was only 60.
Schulte’s story of pain, drug-hopping, and insurance meddling is all too common among patients with rheumatoid arthritis, who often cycle agonizingly through half a dozen drugs in search of one that provides a measure of relief. It’s also a story of how doctors are steered by pharmacy benefit managers — the middlemen of the drug market — as well as by insurers.
Once people with inflammatory conditions such as rheumatoid arthritis reach a certain stage, the first prescription offered is typically Humira, the best-selling drug in history, and part of a class known as tumor necrosis factor inhibitors, or TNFis, which fail to significantly help about half of the patients who take it.
“We practice rheumatology without any help,” said Vibeke Strand, a rheumatologist and adjunct clinical professor at Stanford. She bemoaned the lack of tools available to choose the right drug while bristling at corporate intervention in the decision. “We are told by the insurer what to prescribe to the patient. After they fail methotrexate, it’s a TNF inhibitor, almost always Humira. And that’s not OK.”
If there’s a shred of hope in this story, it’s that a blood test, PrismRA, may herald an era of improved care for patients with rheumatoid arthritis and other autoimmune conditions. But first, it must be embraced by insurers.
PrismRA employs a predictive model that combines clinical factors, blood tests, and 19 gene patterns to identify the roughly 60% of patients who are very unlikely to respond to a TNFi drug.
Over the past 25 years, drug companies have introduced five new classes of autoimmune drugs. TNFis were the first to market, starting in the late 1990s.
Some 1.3 million Americans have rheumatoid arthritis, a disease in which a person’s immune system attacks their joints, causing crippling pain and, if improperly treated, disfigurement. The newer drugs, mostly so-called biologics, are also used by some of the 25 million or more Americans with other autoimmune diseases, such as lupus, Crohn’s disease, and psoriasis. Typically costing tens of thousands of dollars annually, the drugs are prescribed after a patient fails to respond to older, cheaper drugs like methotrexate.
Until recently, rheumatologists have had few ways to predict which of the new drugs would work best on which patients. Often, “it’s a coin flip whether I prescribe drug A or B,” said Jeffrey Curtis, a rheumatology professor at the University of Alabama-Birmingham.
Yet about 90% of the patients who are given one of these advanced drugs start on a TNFi, although there’s often no reason to think a TNFi will work better than another type.
Under these puzzling circumstances, it’s often the insurer rather than the doctor who chooses the patient’s drug. Insurers lean toward TNFis such as adalimumab, commonly sold as brand-name Humira, in part because they get large rebates from manufacturers for using them. Although the size of such payments is a trade secret, AbbVie is said to be offering rebates to insurers of up to 60% of Humira’s price. That has enabled it to control 98.5% of the U.S. adalimumab market, even though it has eight biosimilar competitors.
PrismRA’s developer, Scipher Medicine, has provided more than 26,000 test results, rarely covered by insurance. But on Oct. 15, the Centers for Medicare & Medicaid began reimbursing for the test, and its use is expected to rise. At least two other companies are developing drug-matching tests for rheumatoid arthritis patients.
Although critics say PrismRA is not always useful, it is likely to be the first in a series of diagnostics anticipated over the next decade that could reduce the time that autoimmune disease patients suffer on the wrong drug.
Academics, small biotechs, and large pharmaceutical companies are investing in methods to distinguish the biological pathways involved in these diseases, and the best way to treat each one. This approach, called precision medicine, has existed for years in cancer medicine, in which it’s routine to test the genetics of patients’ tumors to determine the appropriate drug treatment.
“You wouldn’t give Herceptin to a breast cancer patient without knowing whether her tumor was HER2-positive,” said Costantino Pitzalis, a rheumatology professor at the William Harvey Research Institute in London. He was speaking before a well-attended session at an American College of Rheumatology conference in San Diego in November. “Why do we not use biopsies or seek molecular markers in rheumatoid arthritis?”
It’s not only patients and doctors who have a stake in which drugs work best for a given person.
When Remicade failed and Schulte waited for the insurer to approve Orencia, she insisted on keeping her job as an accountant. But as her prednisone-related spinal problems worsened, Schulte was forced to retire, go on Medicaid, and seek disability, something she had always sworn to avoid.
Now taxpayers, rather than the insurer, are covering Schulte’s medical bills, Maury noted.
Precision medicine hasn’t seemed like a priority for large makers of autoimmune drugs, which presumably have some knowledge of which patients are most likely to benefit from their drugs, since they have tested and sold millions of doses over the years. By offering rebate incentives to insurers, companies like AbbVie, which makes Humira, can guarantee theirs are the drugs of choice with insurers.
“If you were AbbVie,” Curtis said, “why would you ever want to publish data showing who’s not going to do well on your drug, if, in the absence of the test, everyone will start with your drug first?”
What Testing Could Do
Medicare and commercial insurers haven’t yet set a price for PrismRA, but it could save insurers thousands of dollars a year for each patient it helps, according to Krishna Patel, Scipher’s associate director of medical affairs.
“If the test cost $750, I still only need it once, and it costs less than a month of whatever drug is not going to work very well for you,” said Curtis, a co-author of some studies of the test. “The economics of a biomarker that’s anything but worthless is pretty favorable because our biologics and targeted drugs are so expensive.”
Patients are enthusiastic about the test because so many have had to take TNFis that didn’t work. Many insurers require patients to try a second TNFi, and sometimes a third.
Jen Weaver, a patient advocate and mother of three, got little benefit from hydroxychloroquine, sulfasalazine, methotrexate, and Orencia, a non-TNFi biologic therapy, before finding some relief in another, Actemra. But she was taken off that drug when her white blood cells plunged, and the next three drugs she tried — all TNFis — caused allergic reactions, culminating with an outbreak of pus-filled sores. Another drug, Otezla, eventually seemed to help heal the sores, and she’s been stable on it since in combination with methotrexate, Weaver said.
“What is needed is to substantially shorten this trial-and-error period for patients,” said Shilpa Venkatachalam, herself a patient and the director of research operations at the Global Healthy Living Foundation. “There’s a lot of anxiety and frustration, weeks in pain wondering whether a drug is going to work for you and what to do if it doesn’t.” A survey by her group found that 91% of patients worried their medications would stop working. And there is evidence that the longer it takes to resolve arthritis symptoms, the less chance they will ever stop.
How insurers will respond to the availability of tests isn’t clear, partly because the arrival of new biosimilar drugs — essentially generic versions — are making TNFis cheaper for insurance plans. While Humira still dominates, AbbVie has increased rebates to insurers, in effect lowering its cost. Lower prices make the PrismRA test less appealing to insurers, since widespread use of the test could cut TNFi prescriptions by up to a third.
However, rheumatologist John Boone in Louisville, Kentucky, found to his surprise that insurers mostly accepted alternative prescriptions for 41 patients whom the test showed unlikely to respond to TNFis as part of a clinical trial. Boone receives consulting fees from Scipher.
Although the test didn’t guarantee good outcomes, he said, the few patients given TNFis despite the test results almost all did poorly on that regimen.
Scientists from AbbVie, which makes several rheumatology drugs in addition to Humira, presented a study at the San Diego conference examining biomarkers that might show which patients would respond to Rinvoq, a new immune-suppressing drug in a class known as the JAK inhibitors. When asked about its use of precision medicine, AbbVie declined to comment.
Over two decades, Humira has been a blockbuster drug for AbbVie. The company sold more than $3.5 billion worth of Humira in the third quarter of 2023, 36% less than a year ago. Sales of Rinvoq, which AbbVie is marketing as a treatment for patients failed by Humira and its class, jumped 60% to $1.1 billion.
What Patients Want
Shannan O’Hara-Levi, a 38-year-old in Monroe, New York, has been on scores of drugs and supplements since being diagnosed with juvenile arthritis at age 3. She’s been nauseated, fatigued, and short of breath and has suffered allergic reactions, but she says the worst part of it was finding a drug that worked and then losing access because of insurance. This happened shortly after she gave birth to a daughter in 2022, and then endured intense joint pain.
“If I could take a blood test that tells me not to waste months or years of my life — absolutely,” she said. “If I could have started my current drug last fall and saved many months of not being able to engage with my baby on the floor — absolutely.”
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.
USE OUR CONTENT
This story can be republished for free (details).
1 year 3 months ago
Health Care Costs, Health Industry, Pharmaceuticals, Autoimmune Diseases, Drug Costs, Prescription Drugs
The Market for Biosimilars Is Funky. The Industry Thinks PBMs Are To Blame
Over the past year there’s been movement to rein in the three big PBMs, which face little regulation though they help set drug prices and drug choices for 80 percent of Americans and their doctors.
The House voted Dec. 11, 320-71, for legislation that would require the PBMs to change some of the ways they do business. The big three — CVS Health, Express Scripts, and OptumRx — have all announced their own reform measures in recent months.
The bill looks unlikely to pass the Senate, though some of its provisions might eventually become law. Meanwhile, some of the most baffling contradictions of PBM drug pricing are coming to a head.
Take AbbVie’s Humira, the highest-earning drug ever. Eight biosimilars — what ordinary people would call generics — came onto the market this year, raising hopes of big savings for patients and insurers. Some cost as little as $995 a month, compared to Humira’s wholesale price of $6,992.
The Pharmaceutical Care Management Association, which represents the big PBMs, told KFF Health News in a statement that its members are pushing to use more of the biosimilars. Why then, asks Juliana Reed, CEO of the Biosimilars Forum trade group, did Humira account for 98.5 percent of all sales of the drug and its biosimilars as recently as November?
I’ve been told that AbbVie has threatened to withhold rebates it pays PBMs for some of its other medicines unless they give Humira good placement on formularies, the all-important lists of drugs available to their customers. The PBMs say their formularies provide the best deal for employers, but these are “assertions impossible to verify,” says James Gelfand, president and CEO of The ERISA Industry Committee, which represents large employers.
The PBMs’ strategy is purposefully obscure. Negotiations with drugmakers constitute their special sauce and they aren’t sharing the ingredients. But given that it costs up to $300 million to develop a biosimilar, the Humira battle is key to the future of biosimilars in general, and to more competition to lower expensive drug prices.
“If you can’t break into anti-inflammatory drugs it will be hard to break into any model,” Gelfand said. “It’s the weather vane, the shape of things to come.”
There’s more weird stuff going on with biosimilars. To get Inflectra, its biosimilar to Johnson & Johnson’s blockbuster Remicade, onto formularies, Pfizer pays large rebates to insurers, I’ve been told.
That’s driven down average net prices for Inflectra as well as other versions of the drug.
Good, right? Not according to rheumatologists, the doctors who typically administer these complicated, infused drugs in their offices.
The doctors say they still have to pay much higher prices to obtain Inflectra from distributors. But their reimbursement from Medicare is reduced because of the rebates, they say. Several rheumatologists told me that the way the math works out — or rather, doesn’t — they could lose as much as $20,000 a year on each patient.
The choice is “lose money, or divert the patient to a hospital infusion center,” said Chris Phillips, a doctor in Paducah, Ky., who chairs the American College of Rheumatology’s insurance subcommittee. The latter is “more expensive and usually not as good an experience for the patient.”
Payment imbalances also have developed for Amgen’s Avsola, another Remicade biosimilar, and for biosimilar forms of Genentech’s Rituxan, a cancer drug also infused to treat autoimmune conditions, rheumatologists say.
“The whole point of biosimilars is to make these drugs more accessible, but they’re becoming unaffordable,” said Madelaine Feldman, immediate past president of the Coalition of State Rheumatology Organizations.
Spokespeople for Pfizer and for the Pharmaceutical Care Management Association acknowledged the rheumatologists’ dilemma. Each said it was up to the other to resolve the problem.
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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.
USE OUR CONTENT
This story can be republished for free (details).
1 year 3 months ago
Health Care Costs, Health Industry, Pharmaceuticals, Prescription Drugs, The Health 202