KFF Health News

Slow Your Disenroll

The Host

Mary Agnes Carey
KFF Health News


@maryagnescarey


Read Mary Agnes' stories

The Host

Mary Agnes Carey
KFF Health News


@maryagnescarey


Read Mary Agnes' stories

Partnerships Editor and Senior Correspondent, oversees placement of KFF Health News content in publications nationwide and covers health reform and federal health policy. Before joining KFF Health News, Mary Agnes was associate editor of CQ HealthBeat, Capitol Hill Bureau Chief for Congressional Quarterly, and a reporter with Dow Jones Newswires. A frequent radio and television commentator, she has appeared on CNN, C-SPAN, the PBS NewsHour, and on NPR affiliates nationwide. Her stories have appeared in The Washington Post, USA Today, TheAtlantic.com, Time.com, Money.com, and The Daily Beast, among other publications. She worked for newspapers in Connecticut and Pennsylvania, and has a master’s degree in journalism from Columbia University.

The Biden administration this week pleaded with states to slow the post-pandemic removal of beneficiaries from their Medicaid rolls, as government data shows more than a million Americans have lost coverage since pandemic protections ended in April. Meanwhile, the Supreme Court ruled Medicaid beneficiaries may sue over their care.

In an appearance at the U.S. Capitol, the outgoing chief of the Centers for Disease Control and Prevention, Rochelle Walensky, offered no revelations as House Republicans pressed her about the agency’s response to the covid-19 pandemic. And senators are pushing for action on drug pricing, with Sen. Bernie Sanders (I-Vt.) vowing to hold up nominations to press the Biden administration for drug pricing reform.

This week’s panelists are Mary Agnes Carey of KFF Health News, Rachel Cohrs of Stat, Alice Miranda Ollstein of Politico, and Sandhya Raman of CQ Roll Call.

Panelists

Rachel Cohrs
Stat News


@rachelcohrs


Read Rachel's stories

Alice Miranda Ollstein
Politico


@AliceOllstein


Read Alice's stories

Sandhya Raman
CQ Roll Call


@SandhyaWrites


Read Sandhya's stories

Among the takeaways from this week’s episode:

  • Asking states to slow the pace of Medicaid disenrollment, Health and Human Services Secretary Xavier Becerra offered options intended to reduce the number of Americans who lose coverage due to bureaucratic hurdles, such as by allowing community organizations to help people get coverage reinstated. But those options are only guidance for Medicaid programs across the country, and nothing says that states — especially conservative ones that have rushed to trim the number of low-income and disabled people relying on the program — will adopt the administration’s suggestions.
  • A deal in the Braidwood Management v. Becerra court case will preserve, for now, the mandate requiring insurance coverage of preventive services for all but the litigants. The threat of a court order halting that coverage mandate nationwide has contributed to growing concerns about the overuse of injunctions allowing a single judge to bring down an entire program or law.
  • The Supreme Court ruled that a woman is entitled to sue over the nursing home care her husband received that was covered by Medicaid, setting a precedent that allows beneficiaries to pursue legal action over their care.
  • This week, House Republicans pressed CDC Director Walensky about the agency’s response to the pandemic, but, producing few new details, the hearing mostly proved an attempt by Republicans to relitigate concerns over issues like gain-of-function research funding. And Ashish Jha, the White House’s covid coordinator, is preparing to step down without a successor, offering more fodder for the argument that the Biden administration is de-emphasizing covid policy.
  • Reports of threats against an Alabama clinic that does not provide abortions illuminate the realities of the post-Dobbs era: Even the state attorney general has taken issue with the clinic’s efforts to provide non-abortion maternal health care — and 40% of Alabama counties already have no access to maternal care.
  • And on Capitol Hill, Sanders — head of a key Senate health committee — has said he will hold up reviewing nominations in an effort to pressure the Biden administration to produce a comprehensive drug pricing plan. Meanwhile, another key Senate committee releases its proposal to rein in fees charged by pharmacy benefit managers.

Also this week, KFF Health News’ Julie Rovner interviews Dan Mendelson, chief executive of Morgan Health — the successor project to Haven Healthcare, a joint venture by Amazon, Berkshire Hathaway, and JPMorgan Chase that aimed in 2018 to disrupt how Americans get health coverage but quickly disbanded. Rovner and Mendelson discuss the role of employers in insuring American workers.

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

Mary Agnes Carey: The Washington Post’s “I Lost 40 Pounds on Ozempic. But I’m Left With Even More Questions,” by Ruth Marcus.

Alice Miranda Ollstein: Stat’s “AMA Asks Doctors to De-Emphasize Use of BMI in Gauging Health and Obesity,” by Brittany Trang and Elaine Chen.

Rachel Cohrs: Politico’s “Thousands Lose Medicaid in Arkansas: Is This America’s Future?” by Megan Messerly.

Sandhya Raman: The Markup’s “Suicide Hotlines Promise Anonymity. Dozens of Their Websites Send Sensitive Data to Facebook,” by Colin Lecher and Jon Keegan.

Also mentioned in this week’s episode:

click to open the transcript

Transcript: Slow Your Disenroll

KFF Health News’ ‘What the Health?’

Episode Title: Slow Your Disenroll

Episode Number: 302

Published: June 15, 2023

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

Mary Agnes Carey: Hello and welcome back to “What the Health?”. I’m Mary Agnes Carey, partnerships editor at KFF Health News, filling in for Julie Rovner this week. I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, June 15, at 10:30 a.m. As always, news happens fast and things might have changed by the time you hear this. So here we go. We’re joined today by video conference by Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Good morning.

Carey: Rachel Cohrs of Stat.

Rachel Cohrs: Hi, everybody.

Carey: And Sandhya Raman of CQ Roll Call.

Sandhya Raman: Good morning.

Carey: Later in the episode, we’ll have Julie’s interview with Dan Mendelson, CEO of Morgan Health. That’s the successor organization to the ambitious but ultimately unsuccessful effort by JPMorgan Chase, Amazon, and Berkshire Hathaway to remake employee health benefits. But first, let’s go to this week’s news. The Biden administration announced that more than a million Americans have lost their Medicaid coverage since early April as part of the ending of the covid public health emergency. Administration officials said that too many people were losing Medicaid due to red tape. About 4 in 5 people dropped so far either didn’t return paperwork to verify their eligibility or they omitted documents, according to federal and state data from 20 states. Department of Health and Human Services Secretary [Xavier] Becerra has sent a letter to state governors with some ideas on how to help stop this trend. What is he asking states to do?

Raman: So he gave states a few options. He said states could let Medicaid managed care organizations do a renewal on the beneficiaries’ behalf or let states kind of delay some of these cuts to allow for more outreach or let the community organizations in the state help individuals reinstate their coverage if they’ve fallen through some of the gaps here. But I think the thing to keep in mind is that all this is a guidance. All the Medicaid programs are different from each other. So while Becerra says that these are options, it doesn’t mean that any number of states will actually take on any of these opportunities to get more folks back into the program if they’re eligible.

Carey: To your point, some of the biggest drops in the enrollment in Medicaid have been in those more conservative states that are at political odds with the Biden administration. For example, in last week’s podcast, there was a lot of discussion about Arkansas and Indiana. For the panel, what are your thoughts on how state governments will respond to this guidance from HHS?

Ollstein: This is why there was so much anxiety last year when this was all being hashed out in the bill in Congress. Advocacy groups were sounding the alarm that there just weren’t enough guardrails to prevent this from happening. There were carrots; there were incentives for states to go slower and be more deliberate and careful in how they kick ineligible or, you know, can’t-determine-eligibility people off the rolls. But there weren’t a lot of sticks. There were carrots and not a lot of sticks. There weren’t a lot of penalties or repercussions for states that wanted to go as fast as possible and kick as many people off as possible, even if that meant folks falling through the cracks, which is what’s now happening.

Carey: So Sandhya sort of referenced this a moment ago. But I know, I mean, Medicaid is a shared federal-state program, but states, are they legally required to follow any of this guidance? I mean, what happens if a state just doesn’t do anything that’s in the letter? Does it matter?

Raman: I think the issue is that it doesn’t. I mean, there are some requirements that are applied to all programs if it’s in the Medicaid statute and sometimes when states do things that violate that and it ends up going to court. But I think anything here is they still have to follow what has been in the law that had said that after the public health emergency ended, that they could start slowly ripping people off the program. And that’s kind of the issue here.

Carey: Well, we’ll keep our eye on that one. And it sounds like another solution to find its way through the courts. Speaking of the courts, let’s move on to another major news development, and this one is regarding the preventive services coverage under the Affordable Care Act. It’s also known as the ACA. Texas conservatives that challenge the law’s preventive care mandate have reached a tentative compromise with the Justice Department that preserves free coverage for a range of medical services. Alice, I know you wrote about this agreement this week. Could you start us off and take us through the highlights?

Ollstein: Sure. So this was teased during oral arguments. The judges at the 5th Circuit [Court of Appeals] said explicitly, “Can’t you guys work something out?” And it turns out they could. So basically what the deal does is the Justice Department is agreeing not to enforce the preventive services mandate against the folks who are suing. So this is a group of conservative employers and some individual workers who say that the requirement to buy insurance that covers things like the HIV prevention drug PrEP violate their rights. And so the Biden administration is agreeing, OK, we won’t force you to buy the insurance that the law says you are required to buy. And in exchange, they agree not to push for the law to be frozen nationwide. So basically, everybody else’s insurance coverage gets to stay the same for now. There was a lot of anxiety about the nationwide injunction on the mandate that the lower judge ordered. So that is going to be on hold for now. The arguments on this case are going to drag on a lot longer, but this means that, for now, nationwide, the roles stay the same.

Carey: So how, if you know, how usual is this, in the middle of litigation, to come up with a deal that protects the people that are suing to stop a law, but it doesn’t affect the rest of the population, at least for now? I mean, is that unusual to kind of cut this kind of deal?

Ollstein: I think there has been a lot of debate recently about nationwide injunctions and the fact that some judges seem to like handing them out like candy. And just because of one person or a few people suing somewhere can bring down an entire law or program for the entire country. And there has been anxiety in the legal world about this getting kind of too common and out of hand. And so I think this is a sign that even very conservative judges like the ones on the 5th Circuit are looking for ways to rein it in and limit impacts.

Carey: Rachel, do you want to jump in? I see you nodding your head.

Cohrs: Yeah, it is just important to think about that trend, you know, as we see so many lawsuits play out. I know we’re seeing lawsuits over the Inflation Reduction Act as well. It’s a tactic that is being used. And I think if there is some more intention by DOJ to try to kind of limit the reach of these injunctions, then I think that is a really interesting trend, looking to other areas as well.

Carey: So that sounds like there’s no threat to the fall ACA enrollment season, that a ruling wouldn’t come before that enrollment season that could threaten preventive services for the entire ACA enrollment population and for those employer-sponsored plans as well.

Ollstein: So the 5th Circuit, after they blessed this deal officially, put out a briefing schedule that runs into November, so even after that, there could be more arguments, there could be an appeal up to the Supreme Court. So, yes, this is definitely running on into next year, if not longer.

Carey: OK. Well, the Supreme Court had a ruling this week that preserves Medicaid recipients’ right to sue , and policy watchers are saying that this is a major, major civil rights victory for Medicaid recipients. Before we were taping, we were chatting about it a little bit. Alice, fill us in here.

Ollstein: I mean, the specifics are that this is about a woman’s right to sue the state over the treatment of her husband in a nursing home. He was given chemical restraints, which is a horrible thing, if you look it up, that worsened his dementia. He was drugged, you know, in order to be easier to control, essentially, which is a very damaging practice. But that was sort of just the narrow issue at play. But this was seen as a major victory for any Medicaid beneficiary’s right to sue over not getting the care that they’re entitled to., and so this could have implications in the future for things like coverage of reproductive health services, including abortion, and other areas as well. So there was a lot of anxiety that this conservative Supreme Court majority would move to limit Medicaid beneficiaries’ rights to bring challenges. And that didn’t happen here.

Carey: It was a7-2 ruling, right?

Ollstein: Yeah. Yeah. It wasn’t as close as people thought.

Carey: There you go. So let’s move our discussion from the courts to Capitol Hill. Outgoing Centers for Disease Control and Prevention director Rochelle Walensky appeared before a House panel this week to talk about her agency’s response to the covid pandemic. Rachel, you covered the hearing. What were your key takeaways?

Cohrs: I mean, I think my key takeaway is that Republicans are re-litigating some of these comments that were made in early 2021 and that there wasn’t a whole lot of new revelation that came out. Walensky was pretty well prepared to stay on topic. She kind of deflected questions about gain-of-function research at NIH [the National Institutes of Health, a separate division within HHS] and lawsuits around kind of how CDC officials interacted with social media networks and regarding vaccine misinformation. So, I mean, lawmakers brought those things up, and she didn’t really engage on that at all. But she really didn’t give a lot of ground. I mean, there were criticisms of comments she had made about vaccines preventing the spread of covid-19. And I think her position was that her comments were backed by science at the time, and that as the virus has mutated, the truth about covid has changed. So I think she was not apologizing. It was not really engaging with them. And I think it was just kind of this anticlimactic kind of end. I mean, there had been so much buildup. Lawmakers had been requesting her testimony for, like, two months, and it was over and I don’t think she suffered any really significant hits there.

Carey: Were there any sort of agreement on lessons learned from how the CDC and, more broadly, the Biden administration handled its response to the pandemic? I mean, are there lessons learned here? Is there any road map to doing things differently or better next time?

Cohrs: Well, one thing she did bring up was, she said that the CDC didn’t really have visibility into how many people who were hospitalized with covid were also vaccinated. And I think that led to kind of an interesting back-and-forth. I think Republicans were obviously implying that vaccines didn’t work as well as they were initially pitched to. But I think she pivoted that to saying that “CDC would love more data on this. We don’t have the authority to collect it. And doctors are putting all this information into electronic health records and it’s not making its way to public health departments.” And so I think that kind of fits into the administration’s asks for the pandemic preparedness legislation that Congress is kind of working through right now. So I think she pivoted that to ask for more authority for her agency, which I don’t know that Republicans will be particularly enthusiastic about. But I think that was an interesting back-and-forth where she did concede that they just didn’t have a whole lot of information in the moment.

Carey: Would state health departments have to direct hospitals to collect that and then share it with the federal government, if she’s saying she doesn’t have the regulatory authority to do it?

Cohrs: I’m not an expert in this area, I’ll say. But my understanding is that the CDC was collecting information and had to, like, have individual agreements with health departments on how that was going to be collected. They couldn’t mandate that. So I think it would just make it a lot faster and I think give CDC a lot more authority to compel states to report some of this information in real time.

Carey: Sure. No, I know, that’s been one of the most interesting things in watching and reporting and reading all the coverage of how so many things changed with the covid pandemic as [we] received new information. I mean, it was a place we hadn’t been before, but we might be back there again, so. There’s another high-profile covid official who’s stepping down. Dr. Ashish Jha is leaving his post. I think today is actually his last day as the White House covid-19 response coordinator. This departure was announced a while ago, and it’s not a surprise, especially with the end of the public health emergency. But what do these departures mean for the administration’s future plans to handle covid? I mean, what message does it send to the public with these two folks leaving at this time?

Ollstein: I think if folks are already primed to think this administration is not making it a priority, this is more fodder for that viewpoint. You know, you could also note that these folks have been serving a long time in a very difficult role and this is, you know, sort of natural turnover. But I think that, with all of the protections lifting right now, and hearing very little about covid at all from the administration — I mean, the president hasn’t talked about it publicly in months; he didn’t say anything on the day the public health emergency ended, which folks were a little upset about. So you could see this as more evidence that it might not be a priority for them going forward. You know, on the other hand, they are setting up this, like, permanent pandemic office in the White House, although it doesn’t have a leader yet. So it’s a little TBD.

Raman: With Jha, you know, we don’t have someone replacing him in the way we do with a lot of other positions. So it’s going to be the first time in 14 months now that he’s not there, but it’s also, there’s not someone else there. And if you’re quietly removing that role, it just is another layer of saying, you know, this is less of a priority compared to some of the other things as it gets phased out.

Cohrs: I was just going to pop in and say that I think there’s a really interesting opening for Mandy Cohen here at CDC. There is this vacuum of leadership here. You know, the White House hasn’t appointed anyone to fill that spot. Secretary Becerra really hasn’t shown any appetite in leading on covid, and Dr. Fauci is gone, Walensky’s gone — just so many of these, like, old-guard kind of the covid response in the Biden administration have turned over. And my colleague Helen Branswell had a great story, I think that was sharp about how, you know, Mandy Cohen really is prepared, unlike a lot of other CDC directors in the past, to navigate these political dynamics. And I think it is a recognition that the CDC is political and public health is now political, and they can’t ignore that any longer. So I will be curious to see if they elevate her to communicate some more of that information in the absence of Dr. Jha.

Carey: Sure. And can you just remind our listeners who Mandy Cohen is and why she’s expected to get this job, or be nominated for this job?

Cohrs: Yes, she’s a longtime federal and state health official. I think she was in North Carolina, and most recently she was at a ACO [accountable care organization] company working with another former Obama administration official. And the White House, I think — there’s been a lot of reporting; I don’t know that they have officially tapped her yet.

Carey: I don’t think that’s happened yet. No, that has not.

Cohrs: Right. But it doesn’t have to go through a confirmation process. So if they do choose to move forward, I think the process would move pretty quickly to have her in place. So that is what our reporting has shown. Many other outlets have reported the same thing. So I think that’s just kind of the expectation for who’s next in line.

Carey: Well, let’s move on to another topic that appears frequently on this podcast, abortion. It continues to be a major news story around the country. And I’d like to start our discussion with a story that Alice did for Politico Magazine. Here’s the headline: “This Alabama Clinic Is Under Threat. It Doesn’t Provide Abortions.” So, Alice, tell us why a clinic that doesn’t provide abortion is being threatened.

Ollstein: Yeah. So when abortion became illegal in Alabama from conception, with no exemptions for rape and incest, abortion clinics either closed their doors, some picked up and moved to other states, but some, like the one I profiled, West Alabama Women’s Center, decided to stay and pivot to nonabortion services. And they have found it’s still a very hostile landscape and they very well might go out of business themselves in the coming months. They’re running into legal threats. The state attorney general has suggested that he views the kind of abortion-adjacent care they provide, you know, such as letting people know what their options are in terms of ordering pills or traveling to another state — that he might consider that aiding and abetting an abortion under the state’s criminal law. And so they are bracing for that at all times. At the same time, they have also really struggled financially. Most of their revenue in the past was from abortions, and they mainly serve a population now that struggles to pay for services and is often uninsured. The state has not expanded Medicaid, and so lots and lots of low-income people are uninsured. And so it’s just showing that what it means to be under threat in the post-Dobbs era is really different than what it meant to be under threat in the pre-Dobbs era and just how sparse the health care landscape is at all. There are just so few providers, hospitals in these areas, lots of places going out of business. And if clinics like this and other red-state clinics can’t survive, there’s going to be a lot of health care consequences.

Carey: I think in your story you said that 40% of the state was considered a maternal health desert.

Ollstein: Yeah. Right. Which means no access in those counties. And even more of the state is considered low-access, and so people are really struggling to find anywhere to go. A lot of rural hospitals have closed entirely. A lot are on the brink of closure. Some have closed their maternal care units. And so there’s just fewer and fewer options, especially fewer and fewer options for people to feel safe going to if they have an abortion either out of state or at home with pills and need follow-up care. Folks are afraid to go to a regular provider or hospital over fear of being reported to law enforcement, which is actually happening in a lot of places.

Carey: We just talked about the South. Let’s move to the Midwest. In Ohio, voters are going to head to the polls in August to weigh in on a proposal that, if passed, would require at least 60% of voters to pass any amendment to the state’s constitution. And that’s up from the current requirement of a simple majority. There would also be new, higher requirements on the number of signatures needed to get a constitutional amendment on the ballot. A Republican lawmaker in favor of the changes said they were aimed at blocking an abortion rights question that abortion rights supporters had hoped to get on the November ballot. So that’s Ohio. So in Indiana, there’s a separate issue. A class-action lawsuit asserts that the state’s abortion ban violates Hoosiers’ religious freedom. That lawsuit, which was filed by the ACLU [American Civil Liberties Union], says that Indiana’s abortion ban violates a religious freedom law that was once championed by former Indiana Gov. Mike Pence, who we know served as vice president to Donald Trump and is now challenging former President Trump and other Republicans for the 2024 GOP presidential nomination. Thoughts from the panel on these developments?

Raman: I think what’s happening in Ohio is pretty interesting because, you know, we’ve had other states before kind of try to change the threshold for passing something by ballot. And a lot of times it’s not said explicitly, but advocates have said that it’s targeting some measure, whether it’s Medicaid expansion or something else. And here we have a representative and the secretary of state kind of being pretty clear that it is about abortion in this case. And I think it being the secretary of state is especially interesting, because the secretary of state is who is certifying ballot measures and who you would look to for being the person in charge of that and making sure, you know, the t’s are crossed, the i’s dotted. So what happens there will be pretty interesting because that’s kind of an unusual play. And already we’re looking at an August ballot versus traditionally the November ballot. And a lot of times when things are pushed for a different date versus, like, traditional election day, it’s kind of, see if we can get a different turnout or kind of discourage people that might vote one way or the other. So it’ll be interesting to see how this kind of plays out in August or if there are changes before then.

Ollstein: And as for Indiana, I mean, this is one of a bunch of cases around the country where religious people are challenging abortion bans as infringing on their beliefs and right to practice. It’s sort of flipping the assumption on its head. You know, you have a lot of religious support of abortion bans. And this is showing that there are folks on the other side as well within the faith community. And it’s especially interesting in Indiana because they’re challenging one law signed by Mike Pence — the state’s pre-Dobbs abortion ban — by using another law signed by Mike Pence, which is the state’s RFRA law [Religious Freedom Restoration Act], the religious freedom law, and saying that, you know, the state law imposes one particular religion’s view of when life begins and when abortion is or is not acceptable. And that’s not shared by all people of faith. And in Judaism, a child is not a child until it takes its first breath, and that conflicts with abortion bans that are much earlier in pregnancy that sort of posit that it is a child and a life before that. So this will be really interesting to watch.

Carey: Sure. We’ll be watching all these cases very closely. But we’re going to turn now to another topic that’s important to millions of Americans, and that’s the cost of prescription drugs. Sen. Bernie Sanders — he’s a Vermont independent who chairs the Senate Health, Education, Labor and Pensions Committee, also known as the HELP Committee — he’s vowed not to move forward with any Biden administration health nominees, including the president’s pick to head the National Institutes of Health. That’s Dr. Monica Bertagnolli. Sen. Sanders is saying he’s going to keep this hold on until he sees a comprehensive plan from the White House on how to lower drug prices. What is he upset about specifically? And is he going to have other senators — have they joined him? Do you think that will be in the cards, or is this kind of a one-man band here?

Cohrs: My take on this is that he knows he can’t get the votes in Congress, so this is kind of his only option, is to try to pressure the administration to do it. And the only lever he has is nominees, so he’s using that. I don’t know how long he’ll hold out on this. I mean, it is — basically he’s arguing that the public has invested research dollars to help develop kind of the basic science that’s the foundation for a lot of important medications. And right now, the government isn’t really getting enough return on that investment. And there’s no requirement that companies that end up actually manufacturing these drugs and bringing them to market would price them in a fair, reasonable way. And so, I think his staff put out a report as well, with a release to the Post, making that argument, that the NIH could have leverage here if they chose to, and that in the past there have been clauses in contracts that could have given the government some leverage to go after these companies more aggressively but they’re just choosing not to. And so far, the Biden administration has shown no appetite to go after companies’ patents because of pricing issues. It’s never been done before. But I think, you know, Sen. Sanders realizes that he has an opening here, and he’s using the bully pulpit as much as he can. But I think ultimately I don’t see how this is resolved. And I think given that the Biden administration has overseen the passage of the most significant drug pricing reform in 20 years — which doesn’t fix all the problems, will say that. I think Sen. Sanders sent a letter about —

Carey: It’s in the Inflation Reduction Act, right?

Cohrs: Yes. Yes. The Inflation Reduction Act.

Carey: Which he voted for, OK.

Cohrs: Yes, he did vote for that. But I think there are outstanding issues about new medications especially that he’s trying to highlight here and saying, The problem isn’t fixed. We need to do more.

Carey: And so separately, a bipartisan group of Senate Finance Committee members have unveiled a proposal that they said would reform pharmacy benefit managers, or PBMs. That’s another entity we talk a lot about on the podcast. And the belief is that this measure would lower the cost of drugs. Rachel, I know that you have been covering this plan. Can you tell us about it?

Cohrs: I don’t know that this would lower the cost of drugs necessarily, and I think it’s more limited than the lawmakers who are sponsoring it have claimed it is. I think the problem that it’s trying to solve is that the payments between drugmakers and PBMs, and PBMs and the insurance companies or the employees that they’re working for, have traditionally been tied to a drug’s price. And so, just kind of like the — if anyone’s familiar with the medical loss ratio from the Affordable Care Act — it’s a similar idea, that if the price is higher, then there’s a bigger piece of the pie for everyone, percentagewise. So this bill aims to delink some of the fees in contracts with PBMs from the price of drugs. Now, this doesn’t change the rebates that drugmakers and PBMs negotiate on themselves, doesn’t touch that at all. It’s just fees. So I think it’s kind of hard to know how these work. You know, we don’t have them. They’re not public, but I think they’re trying to get at regulating this space a little bit more and trying to align those incentives a little bit better to make sure PBMs aren’t preferring more expensive medications for their own gain.

Carey: And what’s been the response from the PBM industry?

Cohrs: It is pretty fresh, but I think in general they have argued that the reason for high prices is drugmakers, because they set the prices. And I think this has been a food fight that’s been going on for a very long time. But I think lawmakers are kind of coming around to the idea of doing some sort of reform to the PBM industry. We’ll just have to wait and see what that ends up looking like.

Carey: All right. Well, we’ll keep our eyes on that one as well. And that’s this week’s news. Now we’re going to play Julie Rovner’s interview with Dan Mendelson of Morgan Health, and then we’ll be back with our extra credits.

Julie Rovner: I am pleased to welcome to the podcast Dan Mendelson, CEO of Morgan Health, a new business unit of the financial services giant JPMorgan Chase. Morgan Health’s goal is to improve health care for the company’s more than a quarter of a million employees and dependents, as well as everyone else with employer-provided insurance. If that sounds familiar, that’s because Morgan Health is the successor organization to Haven Healthcare. That was the high-profile 2018 project of JPMorgan, Amazon, and Berkshire Hathaway to remake the U.S. health care system from the ground up, led by one of the nation’s leading health care thinkers, surgeon, author, and policy wonk Atul Gawande. Today, Gawande is running global health programs at the U.S. Agency for International Development. Haven is no more. And if you listened to our special 300th episode earlier this month, our experts came down pretty hard on employers’ contributions to fixing what ails the health care system. So I’ve asked Dan here to talk about what is going on. Welcome, Dan.

Dan Mendelson: My pleasure.

Rovner: So, Dan may not have as high a public profile as Atul Gawande, but he has broad and long experience in health policy, from overseeing federal health programs at the Office of Management and Budget during the Bill Clinton administration to founding and growing Avalere Health, a successful health care consulting and advisory group. Dan, why did this job appeal to you and what made you think you could succeed where so many have tried before and failed, including very recently?

Mendelson: Look, this is a collaborative effort, and we’re working closely with a whole range of stakeholders from insurers to providers. I mean, the work that we’re doing in Columbus, for example, is with a really innovative primary care practice called Central Ohio Primary Care that has broad experience in delivering value through accountable care models in Medicare. So, I’d say that our belief that we will succeed really comes from the fact that we’re taking a very collaborative approach with other stakeholders in the health care system.

Rovner: Let’s start at the very beginning. Why are employers interested in the nation’s health care system and how it works? For most of them, it’s not their main line of business.

Mendelson: Well, I’d say that employers feel an obligation to provide insurance for their employees, and it’s an important benefit, and it’s one that employees expect. And it’s also an opportunity for employers to provide for the health and well-being of their employees.

Rovner: So employers really did used to drive a lot of health care innovation, probably coming only after Medicare in terms of shifting actual health care delivery. But they seem to have taken a back seat lately. What changed?

Mendelson: Well, look, you know, you had employers really active in the quality movement, and NCQA came out of employer interest, for example. So there really was kind of a head of steam. But it did wane. And I think that anyone who’s looking at the scene sees that Medicare and Medicaid have made a lot of progress with respect to driving accountable care and quality, whereas, at this point, there’s really … most of what’s happening through employers is fee for service. And it’s really problematic in terms of driving the quality agenda.

Rovner: And NCQA, that’s …?

Mendelson: National Commission for Quality Assurance.

Rovner: Thank you. The National Commission for Quality Assurance. Yeah, which used to be a big deal. And you’re right, I think most of what we’re seeing is now going on in the Medicare and Medicaid space. I feel like, you know, the millions of people who have employer-provided insurance right now have three main problems: the increasing unaffordability of care, with large and growing deductibles and copays; the increasing time and effort it takes to figure out what is and isn’t covered, and fighting for things that aren’t covered to be covered sometimes; and the fragmentation of the delivery system, making what was already hard to navigate very nearly impenetrable for some people, including people who are sick. I assume you’re trying to address all of those.

Mendelson: Yeah, we’re focused on quality and improving the quality of services, for sure. We’re focused on affordability. And then the one that you didn’t mention is health equity, which is one of the most difficult aspects of health care in America today, and certainly our focus as well. I mean, we see inequity in the health care system in the employer space, as well as in Medicare and Medicaid. So that’s also a target for us.

Rovner: What kind of steps are you taking to fix some of these problems? I mean, I know it’s what people get frustrated most with. It’s, like, they have insurance, but they feel like they can’t use it very well.

Mendelson: Yes. So, the way that we’re structured, there are three things that we’re doing to address these issues. And I’d say that we see our efforts as very collaborative. So we don’t believe that we alone can fix these problems, but rather what we’re doing is really driving innovation and trying to get employers, more broadly, focused on innovation in health care. So there are three ways that we’re doing this. First is that we’re investing, from the JPMorgan Chase balance sheet, in innovative health care companies that are proven to drive quality, improve quality, reduce costs, and better health equity. So that’s the first piece. And we can talk a little bit about some of the investments that we’ve made in the first two years of our operation.

Rovner: Give me one example of a company that’s doing that that you’re investing in.

Mendelson: Yes. An example is apree health. apree is a company that offers a[n] accountable care product to employers. And we’re using apree in Columbus, where we have 40,000 employees and dependents, and we’re now offering their services to our employees as an option to drive better health care.

Rovner: What do you see as the biggest challenge in health care going forward, particularly from the employer point of view?

Mendelson: Well, look, we’ve talked about a number of the issues. I’d say that, you know, we’re focused broadly on accountable care — and “accountable care” meaning making sure that there is a focus on quality and cost that is being held by an organization that can really take responsibility for care. So, to me, it’s really about alignment of incentives and making sure that those incentives are aligned not only in the employer sector but also across in the public programs.

Rovner: So you’re involved in private equity and, you know, the track record of private equity in health care, which was supposed to be an effort to get incentives aligned, hasn’t always worked out so well. I mean, in a lot of cases we’ve seen private equity just sucking money out of the health care system rather than putting it back in.

Mendelson: Look, as an investor, what we’re focused on is finding companies that are driving innovation and helping them succeed. And we’re putting our capital behind these companies, but we’re also really spending the time with them to make sure that they can be effective. And so, you know, we’ve done five investments over the course of two years, and they’re not only in accountable care, but also making sure that there’s good primary care in the system, driving better digital care, shifting expensive care from inpatient and outpatient settings into the home. So these are all facets of how employer-sponsored health care needs to be improved, and that’s the focus of our investing.

Rovner: So what does it look like when you get it all fixed?

Mendelson: When we get it all fixed …? I mean, look, I think we’re going to be at this for quite some time. But it’s really important for employers to articulate their needs and to make sure that those who are offering insurance for their employees are actually being attentive to not only cost but also quality and health equity. And I think that the facet that we’re really looking for is to make sure that health care improves and that these improvements are coming along not only in the public programs but also in the employer sector.

Rovner: Dan Mendelson, thank you so much for joining us.

Mendelson: My pleasure.

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

Ollstein: Sure. I chose a piece in Stat by Brittany Trang and Elaine Chen. It’s called “AMA Asks Doctors to De-Emphasize Use of BMI in Gauging Health and Obesity.” I’ve heard in the medical community there has been a lot of discussion about moving away from using the BMI [body mass index] to evaluate people’s health. It was created to track population-level statistics and was never intended to be used to gauge individual health. It was not invented by someone with a medical background at all. And so people have been saying that, you know, it’s inaccurate and it leads to a lot of stigma. And so it’s interesting to see that sort of bubble up to this very mainstream, leading health care organization saying, “Look, you can’t just rely on the BMI. You also have to look at all these other factors.” Because extremely fit NFL players have really high BMIs, you know. You can’t — someone’s size does not necessarily determine their health. You can have people of all sizes be healthy or unhealthy. So this was encouraging to see.

Carey: Great. And for folks interested in more on that, we have a lot of coverage on that at kffhealthnews.org, so check that out. Rachel, why don’t you go next?

Cohrs: Sure. My piece this week is by one of Alice’s colleagues in Politico, Megan Messerly, and the headline is “Thousands Lose Medicaid in Arkansas: Is This America’s Future?” And she kind of got out beyond the Beltway and just spent some time in Arkansas really talking to everyday people who were having trouble staying on Medicaid. And I think it’s easy to get caught up in just talking about numbers and talking about policies and all of that. But I think she really brought to life the issues and the barriers that some people are facing in Arkansas, which really is the center of these disenrollments that we’re seeing right now. So I think it was really timely, really well done, very much put the human face on both the people who are getting disenrolled, but also kind of some of the on-the-ground efforts to stop that from happening and just kind of the challenges that they are working on with these compressed timelines. I thought it was really well done.

Carey: Yeah, it’s a great story. Sandhya.

Raman: My extra credit this week is called “Suicide Hotlines Promise Anonymity. Dozens of Their Websites Send Sensitive Data to Facebook.” It’s by Colin Lecher and Jon Keegan for The Markup in partnership with Stat. And I thought this was just a really interesting piece that investigated whether crisis center websites that were using Meta Pixel, which is like a piece of code that tracks user behavior for advertising that a lot of sites use — and just, like, the worry here is sharing sensitive information to Facebook, especially when it is personally identifiable. And with the crisis center, it’s much, much more sensitive data than, you know, maybe, like, shopping habits. And so they looked at data from 186 local call center websites. And I will let you read to see how many of them were using this.

Carey: Mine is from Ruth Marcus at The Washington Post. And it’s called “I Lost 40 Pounds on Ozempic. But I’m Left With Even More Questions.” In this article, she talks about her lifelong struggle to lose weight, to keep it off, but how those pounds always find their way back. And Marcus explores the history and the science behind the weight loss drugs. And she also takes on societal debate over obesity itself: Do we think of it as a personal failing, or is it a disease, a chronic condition whose underpinnings are in genetics and brain chemistry? It is a great read. All right. That’s our show for the week. And 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 the amazing Francis Ying, our producer. You can email us with your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me. I’m @maryagnescarey.

Carey: Alice.

Ollstein: @AliceOllstein.

Carey: Rachel.

Cohrs: @rachelcohrs.

Carey: And Sandhya.

Raman: @SandhyaWrites.

Carey: We’ll be back in your feed next week. Until then, be healthy.

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KFF Health News

The Crisis Is Officially Ending, but Covid Confusion Lives On

The Host

Julie Rovner
KFF Health News


@jrovner


Read Julie's stories.

The Host

Julie Rovner
KFF Health News


@jrovner


Read Julie's stories.

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

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

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

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

Panelists

Joanne Kenen
Johns Hopkins Bloomberg School of Public Health and Politico


@JoanneKenen


Read Joanne's stories

Tami Luhby
CNN


@luhby


Read Tami's stories

Margot Sanger-Katz
The New York Times


@sangerkatz


Read Margot's stories

Among the takeaways from this week’s episode:

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

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

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

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

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

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

Also mentioned in this week’s episode:

Click to open the transcript

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

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

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

Tami Luhby: Hello.

Rovner: Margot Sanger Katz, The New York Times.

Sanger-Katz: Good morning.

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

Joanne Kenen: Hi, everybody.

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

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

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

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

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

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

Rovner: After May 11.

Luhby: It’s very confusing.

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

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

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

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

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

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

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

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

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

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

Rovner: Yes, well, I actually —

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

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

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

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

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

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

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

Kenen: We could call it that way every week.

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

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

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

Kenen: Really?

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

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

Rovner: Oh, it is.

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

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

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

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

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

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

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

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

Kenen: The cost.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Kenen: Or people who say they’re voters.

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

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

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

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

Rovner: I know. Joanne.

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

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

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

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

Kenen: Or, not “The Bachelor.”

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

Kenen: @JoanneKenen.

Rovner: Tami.

Luhby: @Luhby.

Rovner: Margot.

Sanger-Katz: @sangerkatz.

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

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PBMs, the Brokers Who Control Drug Prices, Finally Get Washington’s Attention

For two decades, patients and physicians eagerly awaited a lower-cost version of the world’s bestselling drug, Humira, while its maker, AbbVie, fought off potential competitors by building a wall of more than 250 patents around it.

When the first Humira biosimilar — essentially a generic version — finally hit the market in January, it came with an unpleasant surprise. The biosimilar’s maker, Amgen, launched two versions of the drug, which treats a host of conditions including rheumatoid arthritis. They were identical in every way but this: One was priced at about $1,600 for a two-week supply, 55% off Humira’s list price. But the other was priced at around $3,300, only about 5% off. And OptumRx, one of three powerhouse brokers that determine which drugs Americans get, recommended option No. 2: the more expensive version.

As Murdo Gordon, an Amgen executive vice president, explained in an earnings call, the higher price enabled his company to give bigger rebates, or post-sale discounts, to Optum and other intermediaries. Most of that money would be passed on to insurers, and patients, he said. Gordon did not mention that the higher-priced option would leave some patients paying much more out-of-pocket, undermining the whole rationale for generic drugs.

The Optum-Amgen announcements perfectly elucidated why, after years of thundering against drugmakers, Congress and the administration have now focused on regulating the deal-makers known as pharmacy benefit managers, or PBMs. Sen. Bernie Sanders’ health committee grilled a panel of PBM and pharmaceutical executives Wednesday in preparation for a vote on PBM legislation, expected Thursday.

The three biggest PBMs — OptumRx, CVS Caremark, and Express Scripts — control about 80% of prescription drug sales in America and are the most profitable parts of the health conglomerates in which they’re nestled. CVS Health, the fourth-largest U.S. corporation by revenue on Fortune’s list, owns CVS Caremark and the insurer Aetna; UnitedHealth Group, a close fifth, owns Optum; and Cigna, ranking 12th, owns Express Scripts. While serving as middlemen among drugmakers, insurers, and pharmacies, the three corporations also own the highest-grossing specialty drug and mail-order pharmacies.

“John D. Rockefeller would be happy to be alive today,” said David Balto, a former Federal Trade Commission attorney who represents clients suing PBMs. “He could own a PBM and monopolize economic power in ways he never imagined.”

Drug manufacturers claim that exorbitant PBM demands for rebates force them to set high list prices to earn a profit. Independent pharmacists say PBMs are driving them out of business. Physicians blame them for unpredictable, clinically invalid prescribing decisions. And patients complain that PBMs’ choices drain their pocketbooks.

With PBMs driving prices, competition has had the opposite effect from what economic theory predicted Medicare patients would spend out-of-pocket on drugs, one large study showed. Over a five-year period, patients were paying 50% more for branded drugs that had competitors than for those that didn’t.

All this makes the PBMs ripe targets for politicians of both parties. Yet the complexity and obscurity of their role in the drug marketplace have skeptics wondering whether legislation advancing in the House and Senate will actually help patients or lower prices at the pharmacy counter.

“We may try to make things better and actually make things worse,” Sen. Rand Paul (R-Ky.) said at Wednesday’s hearing.

The PBMs pass along most of their rebates to health plans, which will bear a larger share of patient drug costs in coming years under Medicare changes that are part of the 2022 Inflation Reduction Act. It’s likely that pressure on insurers will be passed along to PBMs and result in even more aggressive limits on physician prescription decisions, said Troyen Brennan, an adjunct Harvard University professor who was chief medical officer for CVS Health from 2008 to 2022.

Several congressional bills target drug company rebates to PBMs and what’s known as “spread pricing” — the extra money PBMs collect from insurers over what they pay pharmacies for drugs.

But those aren’t the big PBM revenue sources anymore, Brennan said. PBMs today mostly make money by owning mail-order and specialty pharmacies and from the government’s 340B program, created to help hospitals that treat a disproportionately elderly and poor population. Medicare requires drugmakers to provide big discounts to participating hospitals and the growing rosters of affiliated physician groups they own, and some of those discounts end up with PBMs.

Employers and the federal government decide where most of the rebate money goes, PBM leaders testified Wednesday — and health plans decide what out-of-pocket costs their covered members will pay.

In other words, drug companies blame PBMs for high drug counter prices, PBMs blame insurers, and insurers blame the drug companies, all part of a health care system that hinges on an unspoken bargain: Make life comfortable for some — mostly the upper and middle classes — at the expense of lower-income and poorly insured people who get what they get.

 PBMs’ extraction of money from patients in the name of “copayments” at the pharmacy counter “reintroduces medical underwriting” that was stripped away by the Affordable Care Act, Craig Garthwaite, a health care researcher at Northwestern’s Kellogg School of Management, told a Senate panel last year. Insurers can no longer pick and choose whom to insure, as they could before the landmark 2010 health law. But they are finding ways to make the sickest pay.

“People with expensive conditions are paying more for insurance so healthy people can pay less,” he said.

PBMs Evolve From Minnows to Whales

In 1967, a year before the first PBM was founded, spending on prescription drugs outside of a hospital in the U.S. totaled around $3.3 billion, compared with more than $600 billion in net payments last year. By 2005, when Medicare expanded to include coverage of outpatient drugs, government and private insurers depended on PBMs’ negotiating power to keep rising drug prices in check.

The Federal Trade Commission and Justice Department allowed the largest PBMs to gobble up competitors and merge with insurers during the Bush and Obama administrations on the grounds that bolstering their powers might rein in prices. The FTC fought state investigations of anti-competitive behavior, saying that pressure on PBMs would benefit consumers.

The FTC under President Joe Biden has switched course, at least partly because of the arrival of Chair Lina Khan, a vigorous proponent of antitrust policy who launched an investigation of the PBMs last June.

It came partly at the request of independent pharmacists, who rely on PBM reimbursements for the drugs they purchase and provide consumers. Thousands of pharmacists complained to the FTC that PBMs force them to accept unfairly low reimbursements — then slam them with opaque rules requiring them to pay back some of the money months later. Pharmacists returned $12.6 billion to PBMs in 2021, according to a recent Medicare Payment Advisory Commission report.

During a recent week, said Ashley Seyfarth, who owns Kare Drug in Aztec, New Mexico, a PBM reclaimed money from one prescription because the paperwork was faxed. It clawed back cash from another sale because Kare had kept the drug on the shelf an extra day, beyond the PBM’s time limit, to accommodate a patient delayed getting to the store.

And her reimbursements are “beyond low,” Seyfarth said. She laughed when asked whether contract terms with the PBMs were negotiable. “You aren’t negotiating anything,” she said. “It’s take it or leave it.”

PBMs “have the right to audit whether contract terms are agreed to,” Angela Banks, vice president of policy at the Pharmaceutical Care Management Association, the PBM trade group, said at a recent conference. “A lot of the complaints about PBMs come from two parties from whom we are extracting money: manufacturers and pharmacists.”

PBM pricing decisions are often murky. According to a recent study, in 2018 Medicare spent $2.6 billion more through PBMs for a year’s worth of 184 generic drugs than they would have cost at Costco. Doctors and hospitals find PBM formularies baffling, with dozens of variations depending on a patient’s health plan.

When Philadelphia-area internist Amy Davis writes a prescription, she has no idea what the pharmacy will bill her patients, she said, or whether a PBM has decided the drug needs prior authorization. Sometimes she doesn’t find out until a patient returns months later saying they skipped the drug because it was too expensive.

“We physicians are completely in the dark,” she said. “And it’s designed that way.”

The PBMs’ growing use of proprietary pharmacies, including mail-order operations, can interfere with the care of patients like Jasmine St. Clair, a 45-year-old restaurant manager and mother of six in Mount Juliet, Tennessee.

In October 2021, St. Clair’s treatment for a rare, non-smoking-related lung cancer was delayed three weeks after PBM giant Express Scripts insisted her prescription be filled by Accredo, the mail-order pharmacy it owns.

In the meantime, her fatigue and lower-back and neck pain became so bad “I couldn’t pick up my daughter, who was 2,” St. Clair said. “And I was really getting scared.”

After St. Clair started the four-pills-twice-a-day regimen, her tumor rapidly shrank. But in January, her husband’s insurance changed and the medications didn’t arrive on time. When she called Accredo to see what was wrong, “they said, ‘You owe $8,000. Would you like to pay by card?’”

The pharmacy attached to her oncology practice straightened out the payment issue and ensured her continued use of the drug, St. Clair said. Her oncologist, Johnetta Blakely, said these are daily occurrences in her practice.

“The problem with the PBMs and the specialty pharmacies they own is that they are so complicated and intertwined it’s hard to figure out what the heck they are doing,” Blakely said. “All this bureaucratic stuff is a distraction and takes away from things I could be doing, like asking Jasmine about her kids.”

What’s the Remedy?

Bipartisan House and Senate bills would require PBMs to reimburse pharmacies serving Medicaid patients based on an authorized price list, rather than using standards that allegedly allow PBMs to lowball pharmacies. The Congressional Budget Office has estimated the bills would save the federal government $1 billion over 10 years. Another Senate bill would require PBMs to report more of their earnings to the FTC, and would ban deceptive and unfair fees.

But PBMs have shown themselves adept at finding ways around regulation. A federal rule scheduled to take effect next year would curtail PBM “clawbacks” on independent pharmacies. But PBM contracts sent out to pharmacies in recent weeks get around that by lowering reimbursement fees and putting a percentage of their payments to pharmacies into a kind of escrow, said Douglas Hoey, CEO of the National Community Pharmacists Association.

When the Trump administration considered banning brand-name drug rebates in 2017, PBMs set up companies in Ireland and Switzerland to take over the negotiations and purchases. Doing so offered a tax advantage and allowed the PBMs to avoid scrutiny of the quantity and nature of those deals. Recently, Express Scripts set up another company to purchase generic drugs, in the Cayman Islands.

And PBMs appear adept at moving money from one pocket to another. “Yesterday’s rebates are today’s fees and potentially tomorrow’s something else,” said John O’Brien, CEO of the pharmaceutical industry-funded research group, the National Pharmaceutical Council.

Every arrangement that PBMs make with manufacturers, employers, and insurers is secret and proprietary, said Barak Richman, a Duke University Law School professor. This makes it nearly impossible to examine what kind of deals PBMs are making.

Antitrust law could be brought to bear on the PBMs, Richman said. And the Biden administration has shown an eagerness to possibly reverse mergers that have increased PBM clout. The Justice Department has taken similar steps.

But federal officials will have to move fast to slow the PBMs. Insurers that don’t have PBMs as part of their business have been shrinking in recent years because of the growing clout and buying power of the companies.

“I predict that any health insurer that doesn’t have a PBM is going to disappear in 10 years,” said Neeraj Sood, a professor at the University of Southern California Sol Price School of Public Policy. “Otherwise, there is no way to compete with the big three.”

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2 years 5 months ago

Health Care Costs, Health Industry, Pharmaceuticals, Biden Administration, Drug Costs, Legislation, New Mexico, Pennsylvania, Prescription Drugs, Tennessee, U.S. Congress

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Marihuana legal es más potente que nunca pero no está bien regulada

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

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

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

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

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

Pero los organismos reguladores no están a la altura.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Derecho a desintoxicación.

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

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

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

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

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

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

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

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

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

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

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

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

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

Regulación estatal desigual

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

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

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

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

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

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

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

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

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

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

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

Eso fue en 2019 y poco ha cambiado desde entonces.

¿Dónde está la FDA?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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Health Industry, Mental Health, Noticias En Español, Colorado, Connecticut, FDA, Latinos, Legislation, marijuana, New Jersey, Substance Misuse, texas, Vermont

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Tension Builds in Transgender Policy Debate in Montana

On April 13, Democratic Rep. Zooey Zephyr was sitting in the basement of Montana’s Capitol building reflecting on her time as one of the state’s first two openly transgender legislators.

On April 13, Democratic Rep. Zooey Zephyr was sitting in the basement of Montana’s Capitol building reflecting on her time as one of the state’s first two openly transgender legislators. She wondered whether she needed to display more anger over anti-LGBTQ+ legislation, or whether she should focus on promoting more of what she called “transgender joy.”

“The thing that keeps me up at night is, am I doing a good job for my community?” Zephyr said.

Five days later, the anger bubbled over as Zephyr spoke against amendments from Republican Gov. Greg Gianforte to Senate Bill 99, which would prohibit minors with gender dysphoria from receiving certain medical and surgical treatments. Zephyr said the lawmakers who voted for the measure should be ashamed.

That prompted Republican Majority Leader Sue Vinton to speak. “We will not be shamed by anyone in this chamber,” Vinton said.

“Then the only thing I will say is: If you vote yes on this bill, and yes on these amendments, I hope the next time there’s an invocation, when you bow your heads in prayer, you see the blood on your hands,” Zephyr said in response.

Later that day, the Montana Freedom Caucus, a conservative group of lawmakers, released a statement calling for Zephyr’s censure for using “inappropriate and uncalled-for language.” The release and a Freedom Caucus post on Twitter used male pronouns to refer to Zephyr, leading to fresh outrage by LGBTQ+ supporters accusing Republicans of deliberately misgendering her.

Two days later, Republican House Speaker Matt Regier would not allow Zephyr to speak during a debate on another bill. Regier said it was because she had committed a breach of decorum.

With two weeks to go in the legislative session, Republican lawmakers, who are in the majority, are sponsoring anti-LGBTQ+ bills. There are at least four related measures, including the bill to ban gender-affirming care for minors.

Many similar bills are being heard in conservative-led statehouses across the U.S. The American Civil Liberties Union has tracked more than 460 anti-LGBTQ+ bills so far in 2023 legislative sessions.

Back in the Capitol on April 13, Zephyr stopped at a storytelling event presented by drag performers on the second floor. Parents, children, and supporters sat in folding chairs and on the floor while drag performers read stories.

Zephyr was visibly emotional. A short time later, former Democratic lawmaker Moffie Funk, who also attended the storytelling event, approached Zephyr to thank her for her work.

“I have just been so impressed to see the way Rep. Zephyr has handled questions on the floor, just keeps her calm, stays cool, and is so powerful in her words and so powerful in the way she represents her community and Montana,” Funk said.

Before the session, Zephyr said she had a goal of changing at least one person’s heart on LGBTQ+ issues.

One lawmaker who typically votes in favor of anti-transgender bills told Zephyr about having read something about her in a far-right blog and said, “That doesn’t sound like Zooey; she wouldn’t do that.” The lawmaker, whom Zephyr didn’t name, subsequently stopped reading the blog.

Proponents of measures like SB 99 and House Bill 359, a bill that would have banned minors from drag shows and would have banned events like drag storytelling in public schools or libraries, frame the legislation as necessary to protect children.

In a small victory for LGBTQ+ supporters, HB 359 was amended to remove references to drag performers and now would prohibit minors from attending “adult-oriented” shows.

Democratic Rep. SJ Howell, who is transgender and nonbinary and uses the pronouns “they” and “their,” has been working at the Capitol for a decade, first as a lobbyist and now as a lawmaker representing Missoula. In all their work, Howell said, it’s very clear that relationships matter. Progress is a long game, and it may take years to pass legislation that promotes the rights and recognition of transgender and nonbinary people, Howell said.

One thing that could hinder that progress is the national debate over anti-LGBTQ+ policy proposals.

Erin Reed, who describes herself as a queer writer and content creator, has been tracking the LGBTQ+ bills nationwide and is also Zephyr’s partner of almost a year.

Four years ago, the debate playing out in statehouses was over transgender rights in sports, Reed said, but that’s shifted. Now, a third of the bills target health care — like gender-affirming hormone therapy, mostly related to minors — and the rest focus on banning drag shows or the use of preferred pronouns and bathrooms, or targeting the rights of transgender people in insurance coverage and workplace protections.

But beyond the flood of anti-LGBTQ+ bills, at least 15 states have passed LBGTQ+ protections, Reed estimated.

Howell said it’s challenging being a state representative trying to focus on Montana when so much focus has been on this national issue.

Personally, Howell said, they came to the legislature to build relationships and make good policy, and they see many of their colleagues as friends.

“When the mutual respect isn’t present, it can be deeply frustrating and harmful, and we can do better as a body,” Howell said.

Republican Rep. Neil Duram sits between Zephyr and Howell on the House Judiciary Committee, which has heard all the LGBTQ+ bills this session. He said having both in the legislature better represents Montana.

“If it was just me, and 99 other people like me on the House floor, we may not set the best policy for the people of Montana,” Duram said.

Duram spoke during a House floor session discussing House Bill 361, which would allow classmates to refer to a transgender student by their birth name or gender assigned at birth, unless it crossed into bullying. He said he’s enjoyed getting to know Judiciary seatmate Zephyr and that he’ll make sure people aren’t “inflicting bullying behavior.”

Duram voted for HB 361. He said his decision was encouraged by his community.

“And, ultimately, that’s where my conscience is going to sit,” he said.

On the morning of April 13, Howell and Zephyr were hearing testimony before the House Judiciary Committee on a bill that would define sex in Montana law, Senate Bill 458. The vibe in the room felt heavy.

Sen. Carl Glimm, sponsor of SB 458, said the bill seeks to define the terms “sex,” “male,” and “female” in state law. Glimm said the bill was necessary because people conflate sex and gender and maintained the bill wasn’t about gender fluidity or expression.

“Gender is obviously something different than biological sex. Biological sex is immutable and that means you can’t change it, and there’s only two biological sexes,” Glimm said. “You may claim to be able to change your gender or express your gender in a different way, but you can never change your biological sex.”

LGBTQ+ advocates, like the Montana Human Rights Network, say that by defining people as simply male and female, the bill would legislate “transgender, nonbinary, and intersex people out of existence.” The Montana Human Rights Network said the definitions used in SB 458 were based “on an unscientific and archaic understanding of basic biology.”

About an hour after the hearing, people gathered outside the Capitol in an April snowstorm for a drag show.

Performers lip-synced for a crowd ranging from kids to college students to retired folks who were waving rainbow-colored flags and carrying umbrellas.

As “Rise Up” by Andra Day played in the background, Katie Fire Thunder said she came to the drag show from Bozeman to show her allyship with the LGBTQ+ community.

Fire Thunder called this session’s anti-LGBTQ+ bills “disgusting,” and said they don’t represent Montana or what young people care about. But having both Zephyr and Howell serving in the Capitol has made a major difference, Fire Thunder said.

“When things are really hard and there’s all these hateful people, they’re a little glimmer of hope,” Fire Thunder said.

Kole Burdick, 20, also of Bozeman, said it’s important to “uplift queer people and show moments of queer joy,” and commended Zephyr and Howell for their work.

“I think they’ve been working really hard to protect our community and keep our community safe, and I really appreciate them for that,” Burdick said.

Keely Larson is the KFF Health News fellow for the UM Legislative News Service, a partnership of the University of Montana School of Journalism, the Montana Newspaper Association, and KFF Health News. Larson is a graduate student in environmental and natural resources journalism at the University of Montana.

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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2 years 6 months ago

States, The Health Law, Legislation, Montana, Transgender Health

Kaiser Health News

Montana May Require Insurers to Cover Monitoring Devices for Diabetes

In between sets of tumbling warmups, Adrienne Prashar crossed the gym to where she had stashed her diabetes supplies and tested her blood sugar. Prashar, who was diagnosed with Type 1 diabetes the day before her 13th birthday, said tumbling usually drops her blood sugar levels.

Prashar, now 14, did a finger stick, saw her blood sugar was 127, and went back to the mat. For most people with diabetes, the target range is about 80-130, and up to 180 two hours after meals.

Prashar doesn’t have to check her blood sugar often. She wears a continuous glucose monitor, or CGM, that gives her blood glucose readings on her phone every five minutes. When she’s feeling differently than her CGM is showing, as on that March day at the gym, she checks her level by doing a finger stick.

But most of the time, she simply glances at her phone to see whether her numbers are trending low or high, which beats repeatedly pricking her finger, she said.

“I would hate it so much,” Prashar said. “It’s such a pain and it’s harder to see trends.”

Montana lawmakers are considering a bill that would require insurance companies to cover CGMs for people with Type 1 and Type 2 diabetes. Multiple studies and experts back up the effectiveness of the devices, showing better blood test results, fewer long-term complications, and a reduction in health care costs.

Studies show CGMs can greatly benefit people with Type 1 diabetes. There are also promising results for people with Type 2 diabetes, the more prevalent of the two types, but the research is limited compared with that on Type 1.

House Bill 758 has broad support from lawmakers, but it faces opposition from insurance companies and some providers. That opposition focuses on the cost, whether a CGM is medically necessary at all stages of diabetes, and the possibility that CGM manufacturers will raise their prices if there is an insurance mandate.

CGMs can be worn on the legs, stomach, or arms, and they stay in place with an adhesive patch. A thin tube goes under the skin and measures blood glucose levels from tissue fluid. The data is transmitted via Bluetooth to a phone or similar device. Instead of a finger prick, which provides a reading for a single point in time, a CGM gives the wearer a continuous stream of data.

According to GoodRx Health, CGMs can cost between $1,000 and $3,000 each year out-of-pocket.

Blue Cross and Blue Shield of Montana, the state’s largest insurer, estimates the bill, if passed, would cost the organization nearly $5 million a year, spokesperson John Doran said.

CGMs aren’t medically necessary in all circumstances, Doran said, and medical necessity should be determined through a partnership between provider and payer. But Doran said that he understands there are instances in which a CGM may be necessary and that Blue Cross already covers CGMs in those cases.

“These things are a convenience,” Doran said. “They provide you real-time information and there is some benefit to a person’s lifestyle to these monitors.”

Lawmakers in several states are considering bills to regulate coverage of CGMs, and Illinois’ governor signed one such bill into law last year.

A study published in the Journal of Diabetes Science and Technology in 2022 says about 30 million Americans have diabetes, a condition in which a person’s body can’t make enough insulin (as in Type 1) or use it effectively (as in Type 2). By 2030, the study estimated, 55 million people in the U.S. will have diabetes, with total medical and societal costs of more than $622 billion — a 53% increase from 2015. According to the American Diabetes Association, nearly 78,000 Montanans have been diagnosed with diabetes.

Various studies, diabetes educators, and health care providers say that CGMs can help people with diabetes reduce their A1C levels, a common measure of blood sugar levels used in diabetes management. Proper management can reduce complications from diabetes — like retinopathy, heart attack, and nerve damage — that lead to higher costs in the health care system through emergency room visits and hospitalizations.

Dr. Brian Robinson, an endocrinologist at St. Peter’s Health in Helena, said supplies for people with Type 1 diabetes are generally covered by insurance. When he considers recommending a glucose monitor for a patient, he said, the decision is driven by insurance rules that are informed by the American Diabetes Association’s standards of care.

“My patients are better because of CGMs, there’s no doubt about that,” Robinson said. But he noted the science doesn’t yet support his opinion that CGMs should be given to everyone with diabetes, no matter what.

Not all physicians, especially in endocrinology, agree that a person with Type 2 diabetes needs a continuous glucose monitor, Robinson said. But if a person needs a shot each day to manage diabetes, he said, that patient should have access to a CGM.

Lisa Ranes, manager of the diabetes, endocrinology, and metabolism center at Billings Clinic, said the benefits of a CGM are the same for people with Type 1 and Type 2 diabetes.

Many studies have shown that CGMs are just as effective for patients on lower quantities of insulin, like some people with Type 2 diabetes, as for people with Type 1 diabetes, who rely on insulin throughout the day.

“It gives patients that complete picture to help them make the decisions on what they need to do to keep their blood sugar safe,” Ranes said, giving examples like upping the frequency or dose of insulin, having some food, or exercising.

For people with Type 2 diabetes, Ranes said, CGMs could be helpful in early diagnosis. Type 2 diabetes is progressive, Ranes said, so the sooner it is under control, the better.

When Cass Mitchell, 76, was diagnosed with Type 2 diabetes over 30 years ago, her doctor told her that people with Type 2 diabetes don’t live long because they have a hard time managing their care.

Mitchell, who lives in Helena, warmed to finger pricks. But test strips were expensive, about $1 each at the time, she said.

About 10 years ago, she got a CGM. Mitchell went from testing maybe twice a day to looking at her blood sugar on an app 20 to 25 times each day. She said she’s more in tune with her diabetes and uses her device’s time-in-range reports — showing how often blood glucose stays within a set range — to make lifestyle changes.

Mitchell has lowered her A1C from around 11% to 7%. According to the ADA, the target for most adults with diabetes is less than 7%.

Mitchell’s device is covered under Medicare and supplemental insurance and would remain so with the passage of HB 758. She said if she had to pay out-of-pocket she wouldn’t be able to afford her CGM and that she was excited about the potential of the bill to give more people access to CGMs.

Dr. Hayley Miller, medical director of Mountain States Diabetes in Missoula, initially thought HB 758 sounded good, but now she isn’t so sure. She thinks the biggest risk of the bill passing is that prices for CGMs go up.

“It seems like I’m against it, but it really is, when insurance gets involved everything gets tricky,” Miller said.

Emma Peterson, a former diabetes educator for St. Vincent Healthcare in Billings and Providence Endocrinology in Missoula, said most people working in diabetes care think everyone diagnosed should just have a continuous glucose monitor.

“At the end of the day, both forms of diabetes and all the other many forms of diabetes have the same complications and still face the same struggles of trying to keep blood sugars in range,” Peterson said.

Keely Larson is the KHN fellow for the UM Legislative News Service, a partnership of the University of Montana School of Journalism, the Montana Newspaper Association, and Kaiser Health News. Larson is a graduate student in environmental and natural resources journalism at the University of Montana.

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

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2 years 6 months ago

Health Care Costs, Insurance, States, diabetes, Legislation, Montana

Kaiser Health News

In Texas, Medicaid Coverage Ends Soon After Childbirth. Will Lawmakers Allow More Time?

Victoria Ferrell Ortiz learned she was pregnant during summer 2017. The Dallas resident was finishing up an AmeriCorps job with a local nonprofit, which offered her a small stipend to live on but no health coverage. She applied for Medicaid so she could be insured during the pregnancy.

“It was a time of a lot of learning, turnaround, and pivoting for me, because we weren’t necessarily expecting that kind of life change,” she said.

Ferrell Ortiz would have liked a little more guidance to navigate the application process for Medicaid. She was inundated with forms. She spent days on end on the phone trying to figure out what was covered and where she could go to get care.

“Sometimes the representative that I would speak to wouldn’t know the answer,” she said. “I would have to wait for a follow-up and hope that they actually did follow up with me. More than 476,000 pregnant Texans are currently navigating that fragmented, bureaucratic system to find care. Medicaid provides coverage for about half of all births in the state — but many people lose eligibility not long after giving birth.

Many pregnant people rely on Medicaid coverage to get access to anything from prenatal appointments to prenatal vitamins, and then postpartum follow-up. Pregnancy-related Medicaid in Texas is available to individuals who make under $2,243 a month. But that coverage ends two months after childbirth — and advocates and researchers say that strict cutoff contributes to rates of maternal mortality and morbidity in the state that are higher than the national average.

They support a bill moving through the Texas legislature that would extend pregnancy Medicaid coverage for a full 12 months postpartum.

Texas is one of 11 states that has chosen not to expand Medicaid to its population of uninsured adults — a benefit offered under the Affordable Care Act, with 90% of the cost paid for by the federal government. That leaves more than 770,000 Texans in a coverage gap — they don’t have job-based insurance nor do they qualify for subsidized coverage on healthcare.gov, the federal insurance marketplace. In 2021, 23% of women ages 19-64 were uninsured in Texas.

Pregnancy Medicaid helps fill the gap, temporarily. Of the nearly half a million Texans currently enrolled in the program, the majority are Hispanic women ages 19-29.

Texans living in the state without legal permission and lawfully present immigrants are not eligible, though they can get different coverage that ends immediately when a pregnancy does. In states where the Medicaid expansion has been adopted, coverage is available to all adults with incomes below 138% of the federal poverty level. For a family of three, that means an income of about $34,300 a year.

In Texas, childless adults don’t qualify for Medicaid at all. Parents can be eligible for Medicaid if they’re taking care of a child who receives Medicaid, but the income limits are low. To qualify, a three-person household with two parents can’t make more than $251 a month.

For Ferrell Ortiz, the hospitals and clinics that accepted Medicaid near her Dallas neighborhood felt “uncomfortable, uninviting,” she said. “A space that wasn’t meant for me” is how she described those facilities.

Later she learned that Medicaid would pay for her to give birth at an enrolled birthing center.

“I went to Lovers Lane Birth Center in Richardson,” she said. “I’m so grateful that I found them because they were able to connect me to other resources that the Medicaid office wasn’t.”

Ferrell Ortiz found a welcoming and supportive birth team, but the Medicaid coverage ended two months after her daughter arrived. She said losing insurance when her baby was so young was stressful. “The two-months window just puts more pressure on women to wrap up things in a messy and not necessarily beneficial way,” she said.

In the 2021 legislative session, Republican Gov. Greg Abbott signed a bill extending pregnancy Medicaid coverage from two months to six months postpartum, pending federal approval.

Last August, The Texas Tribune reported that extension request had initially failed to get federal approval, but that the Centers for Medicare & Medicaid Services had followed up the next day with a statement saying the request was still under review. The Tribune reported at the time that some state legislators believed the initial application was not approved “because of language that could be construed to exclude pregnant women who have abortions, including medically necessary abortions.”The state’s application to extend postpartum coverage to a total of six months is still under review.

The state’s Maternal Mortality and Morbidity Review Committee is tasked with producing statewide data reports on causes of maternal deaths and intervention strategies. Members of that committee, along with advocates and legislators, are hoping this year’s legislative session extends pregnancy Medicaid to 12 months postpartum.

Kari White, an associate professor at the University of Texas-Austin, said the bureaucratic challenges Ferrell Ortiz experienced are common for pregnant Texans on Medicaid.

“People are either having to wait until their condition gets worse, they forgo care, or they may have to pay out-of-pocket,” White said. “There are people who are dying following their pregnancy for reasons that are related to having been pregnant, and almost all of them are preventable.”

In Texas, maternal health care and Pregnancy Medicaid coverage “is a big patchwork with some big missing holes in the quilt,” White said. She is also lead investigator with the Texas Policy Evaluation Project (TxPEP), a group that evaluates the effects of reproductive health policies in the state. A March 2022 TxPEP study surveyed close to 1,500 pregnant Texans on public insurance. It found that “insurance churn” — when people lose health insurance in the months after giving birth — led to worse health outcomes and problems accessing postpartum care.

Chronic disease accounted for almost 20% of pregnancy-related deaths in Texas in 2019, according to a partial cohort review from the Texas Maternal Mortality and Morbidity Review Committee’s report. Chronic disease includes conditions such as high blood pressure and diabetes. The report determined at least 52 deaths were related to pregnancy in Texas during 2019. Serious bleeding (obstetric hemorrhage) and mental health issues were leading causes of death.

“This is one of the more extreme consequences of the lack of health care,” White said.

Black Texans, who make up close to 20% of pregnancy Medicaid recipients, are also more than twice as likely to die from a pregnancy-related cause than their white counterparts, a statistic that has held true for close to 10 years with little change, according to the MMMRC report.

Stark disparities such as that can be traced to systemic issues, including the lack of diversity in medical providers; socioeconomic barriers for Black women such as cost, transportation, lack of child care and poor communication with providers; and shortcomings in medical education and providers’ implicit biases — which can “impact clinicians’ ability to listen to Black people’s experiences and treat them as equal partners in decision-making about their own care and treatment options,” according to a recent survey.

Diana Forester, director of health policy for the statewide organization Texans Care for Children, said Medicaid coverage for pregnant people is a “golden window” to get care.

“It’s the chance to have access to health care to address issues that maybe have been building for a while, those kinds of things that left unaddressed build into something that would need surgery or more intensive intervention later on,” she said. “It just feels like that should be something that’s accessible to everyone when they need it.”

Extending health coverage for pregnant people, she said, is “the difference between having a chance at a healthy pregnancy versus not.”

As of February, 30 states have adopted a 12-month postpartum coverage extension so far, according to a KFF report, with eight states planning to implement an extension.

“We’re behind,” Forester said of Texas. “We’re so behind at this point.”

Many versions of bills that would extend pregnancy Medicaid coverage to 12 months have been filed in the legislature this year, including House Bill 12 and Senate Bill 73. Forester said she feels “cautiously optimistic.”

“I think there’s still going to be a few little legislative issues or land mines that we have to navigate,” she said. “But I feel like the momentum is there.”

Ferrell Ortiz’s daughter turns 5 this year. Amelie is artistic, bright, and vocal in her beliefs. When Ferrell Ortiz thinks back on being pregnant, she remembers how hard a year it was, but also how much she learned about herself.

“Giving birth was the hardest experience that my body has physically ever been through,” she said. “It was a really profound moment in my health history — just knowing that I was able to make it through that time, and that it could even be enjoyable — and so special, obviously, because look what the world has for it.”

She just wishes people, especially people of color giving birth, could get the health support they need during a vulnerable time.

“If I was able to talk to people in the legislature about extending Medicaid coverage, I would say to do that,” she said. “It’s an investment in the people who are raising our future and completely worth it.”

This story is part of a partnership that includes KERA, NPR, and KHN.

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

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2 years 7 months ago

Health Care Costs, Insurance, Medicaid, Multimedia, States, Audio, Legislation, Pregnancy, texas, Women's Health

Kaiser Health News

Congressman Seeks to Plug ‘Shocking Loophole’ Exposed by KHN Investigation

A U.S. lawmaker is taking action after a KHN investigation exposed weaknesses in the federal system meant to stop repeat Medicare and Medicaid fraud and abuse.

Rep. Lloyd Doggett (D-Texas) said he decided to introduce a bill in the House late last week after KHN’s reporting revealed what he called a “shocking loophole.”

“The ability of fraudsters to continue billing Medicare for services is outrageous,” Doggett said. “This is an obvious correction that is needed to safeguard our system. Wherever there are large amounts of government money available, someone tries to steal it.”

KHN found a laundry list of weaknesses that allows people accused or convicted of fraud to easily sidestep bans imposed by federal officials. Among those gaps is the Centers for Medicare & Medicaid Services’ lack of authority to deny or revoke National Provider Identifier, or NPI, numbers after federal regulators have prohibited a person or business from receiving payments from government programs.

Doctors, nurses, other practitioners, and health businesses use the unique, 10-digit NPI numbers to bill and file claims with insurers and others, including Medicare and Medicaid.

Taking away the NPI would “be equivalent of prohibiting a practitioner from practicing in total,” Dara Corrigan, director of CMS’ Center for Program Integrity, wrote in an email response to questions about KHN’s investigation. CMS declined to comment on Doggett’s proposed legislation.

The bill, HR 1745, would give CMS the authority to deactivate NPIs tied to anyone convicted of waste, fraud, or abuse and whose name appears on the exclusions list kept by the Office of Inspector General for the U.S. Department of Health and Human Services. The proposed law would also require CMS to implement recommendations that the inspector general has made to improve NPI reporting and provider transparency.

“This strikes me as what should be an easy bipartisan measure,” Doggett said, adding that he had presented the bill in a face-to-face meeting with Rep. Jason Smith (R-Mo.), who chairs the House Ways and Means Committee. Doggett also alerted that panel’s health subcommittee chair, Rep. Vern Buchanan (R-Fla.).

“They both talk about the need to eliminate fraud, and this is one modest but important way to do it,” Doggett said. Neither Smith’s nor Buchanan’s offices responded to requests for comment.

The OIG declined to comment.

Former Justice Department officials told KHN that repeat violators are savvy and find ways to circumvent the system. KHN examined a sample of 300 health care business owners and executives who are among more than 1,600 on the OIG’s exclusion list since January 2017. Journalists reviewed court and property records, social media, and other publicly available documents.

KHN found:

  • Eight people appeared to be serving or served in roles that could violate their bans.
  • Six transferred control of a business to family or household members.
  • Nine had previous, unrelated felony or fraud convictions, and went on to defraud the health care system.
  • And seven were repeat violators, some of whom raked in tens of millions of federal health care dollars before getting caught by officials after a prior exclusion.

Doggett’s bill is “a pretty smart step in the right direction in fixing this issue,” said John Kelly, a former assistant chief of health care fraud at the Department of Justice who is now a partner for the law firm Barnes & Thornburg. Kelly had previously recommended that NPIs should be “essentially wiped clean” when a person is on the exclusions list.

Kelly, who confirmed that Doggett’s office reached out to him after KHN’s investigation was published in December, said taking the NPI number away “certainly doesn’t eliminate all risk” but it’s a move “in the right direction.”

“If you want to bill Medicare, you have to have a valid NPI,” Kelly said.

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

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2 years 7 months ago

Health Industry, Medicare, Rural Health, CMS, Hospitals, Legislation, U.S. Congress

Kaiser Health News

Judging the Abortion Pill

The Host

Julie Rovner
KHN


@jrovner


Read Julie's stories.

The Host

Julie Rovner
KHN


@jrovner


Read Julie's stories.

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

This week, the eyes of the nation are on Texas, where a federal judge who formerly worked for a conservative Christian advocacy group is set to decide whether the abortion pill mifepristone can stay on the market. Mifepristone is half of a two-pill regimen that now accounts for more than half of the abortions in the United States.

Meanwhile, Novo Nordisk, another of the three large drug companies that dominate the market for diabetes treatments, has announced it will cut the price of many of its insulin products. Eli Lilly announced its cuts early this month. But the push for more affordable insulin from activists and members of Congress is not the only reason for the change: Because of quirks in the way the drug market works, cutting prices could actually save the companies money in the long run.

This week’s panelists are Julie Rovner of KHN, Jessie Hellmann of CQ Roll Call, Sarah Karlin-Smith of the Pink Sheet, and Alice Miranda Ollstein of Politico.

Panelists

Jessie Hellmann
CQ Roll Call


@jessiehellmann


Read Jessie's stories

Sarah Karlin-Smith
Pink Sheet


@SarahKarlin


Read Sarah's stories

Alice Miranda Ollstein
Politico


@AliceOllstein


Read Alice's stories

Among the takeaways from this week’s episode:

  • The federal judge examining the decades-old approval of mifepristone could issue a decision at any time after a hearing largely behind closed doors, during which he appeared open to restricting access to the drug.
  • Democratic governors seek to counter the chill of Republican states’ warnings to pharmacies about distributing mifepristone, and a separate lawsuit in Texas seeks to set a precedent for punishing people who aren’t medical providers for assisting someone in obtaining an abortion.
  • In pandemic news, Congress is moving forward with legislation that would force the Biden administration to declassify intelligence related to the origins of covid-19, while the editor of Cochrane Reviews posted a clarification of its recently published masking study, noting it is “inaccurate” to say it found that masks are not effective.
  • Top federal health officials sent an unusual letter to Florida’s surgeon general, warning that his embrace of vaccination misinformation is harmful, even deadly, to Americans. While covid vaccines come with some risk of negative health effects, contracting covid carries a higher risk of poor outcomes.
  • Novo Nordisk’s announcement that it will cut insulin prices puts pressure on Sanofi, the remaining insulin maker that has yet to adjust its prices.
  • The Veterans Health Administration will cover Leqembi, a new Alzheimer’s drug. The decision comes as Medicare considers whether it will also cover the drug. Experts caution that new drugs shaking up the weight-loss market could prove costly for Medicare.
  • Washington is eyeing changes to federal rules that would affect the practice of medicine. One change would force health plans to speed up “prior authorization” decisions by health insurers and increase transparency around denials, which supporters say would help patients better access needed care. Another proposal would ban noncompete clauses in contracts, including in health care. Arguments for and against the change both cite the issue of physician burnout — though they disagree on whether the ban would make the problem better or worse.

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

Julie Rovner: “Tradeoffs” podcast’s “The Conservative Clash Over Abortion Bans,” by Alice Miranda Ollstein and Dan Gorenstein

Alice Miranda Ollstein: Politico’s “Sharpton Dodges the Spotlight on Latest Push to Ban Menthol Cigarettes,” by Julia Marsh

Sarah Karlin-Smith: Allure’s “With New Legislation, You Can Expect More Recalls to Hit the Beauty Industry,” by Elizabeth Siegel and Deanna Pai

Jessie Hellmann: The New York Times’ “Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs,” by Christina Jewett and Ellen Gabler

Also mentioned in this week’s podcast:

click to open the transcript

Transcript: Judging the Abortion Pill

KHN’s ‘What the Health?’Episode Title: Judging the Abortion PillEpisode Number: 289Published: March 16, 2023

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

Julie Rovner: Hello and welcome back to KHN’s “What the Health?” I’m Julie Rovner, chief Washington correspondent at Kaiser Health News. And I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, March 16, at 10 a.m. As always, news happens fast, and things might have changed by the time you hear this. So here we go. We are joined today via video conference by Alice Miranda Ollstein of Politico.

Alice Miranda Ollstein: Good morning.

Rovner: Jessie Hellmann of CQ Roll Call.

Jessie Hellmann: Hello.

Rovner: And Sarah Karlin-Smith the Pink Sheet.

Sarah Karlin-Smith: Hi, Julie.

Rovner: So, we have more than enough news. Let us get right to it. We will start this week with abortion. And, of course, that means we will start in Texas. On Wednesday, federal District Judge Matthew Kacsmaryk held a four-hour hearing in Amarillo on a lawsuit charging that the FDA wrongly approved the abortion pill mifepristone back in the year 2000 and that he, Judge Kacsmaryk, should substitute his legal judgment for the FDA’s medical judgment and order the FDA to take it off the market. What was said at the hearing? Well, we don’t really know because only 18 reporters were allowed in. They weren’t allowed to take any electronic devices in with them. And there’s no audio and no transcript. But, Alice, I know you’ve been trying to follow this from afar, like I have. What do we know about what happened and when might we expect a ruling?

Ollstein: So we can expect a ruling literally at any time. Hopefully not while we are taping right now. The judge did say that he would rule as soon as possible, although with four hours of oral arguments to sift through, that could take a bit of time. I always bank on a Friday evening news dump, because that’s when it tends to happen.

Rovner: I keep reminding people that’s when the ACA [Affordable Care Act] ruling came down.

Ollstein: Exactly.

Rovner: Came down on the Friday before Christmas at 7:30 at night.

Ollstein: Exactly. Thankfully, some great reporters were able to make it and provided us with some updates about this. It was really fascinating. The judge definitely, as we anticipated from his record of working for conservative, explicitly anti-abortion organizations before he was confirmed to this judgeship, he did seem open to taking the steps that the challengers were asking for in restricting access to this medication. I think the question really is whether he is going to go for a full ban or — what a lot of the questions during oral arguments centered around — was around rolling back more recent FDA rules that allowed people to get the pills by telemedicine, by mail delivery. And so there is some question as to … if going all the way back to a 20-year-old FDA approval and overturning it is a bridge too far. Maybe these more recent agency rules are sort of more justifiable in having the court go after them. So, we’re all just on high, high alert, refreshing pages over here.

Rovner: Yeah. Once again, remind us of why this could have national impact, this one judge in Amarillo, Texas?

Ollstein: Yeah. So these anti-abortion medical groups incorporated in Amarillo specifically so that they could get in front of this judge who has a record of being an abortion opponent. And so this is an example of “judge shopping,” which is an increasingly common practice. So this could have national implications because it’s going after the federal regulations around these pills. Really, this will mainly impact blue and purple states, where the pills are still legal and still used today. A bunch of states have already banned them and put restrictions on all forms of abortion or just the pills. And so this really will squeeze states where their use is protected.

Rovner: And I think abortion rights organizations are freaked out because everybody thinks, well, it’s just one judge. You’ll go up to the next level and you’ll get it, you know, you’ll get it stayed. Except in this case, the next level is the 5th Circuit Court of Appeals, which is just as conservative. And we seem to do a lot of anti-abortion rulings. And then if you go above the 5th Circuit Court of Appeals, you’re at the Supreme Court, which just overturned Roe v. Wade. So if this judge rules for the plaintiffs in this case, there’s not a lot of hope, I guess, from the abortion rights side that anything could be overturned, right?

Ollstein: It also gets into really interesting stuff about what is on the labels of these different drugs. Pro-abortion rights and other medical groups have been pushing the FDA to officially add miscarriage management to the label of mifepristone, so that if it is banned in this case, people can still access it for that. That has not happened. It is used for miscarriage management off-label. That is the real risk of people losing access; they’re not just for abortion. Again, there are two pills that have been used for abortions together for the past 20 years, and the other one, misoprostol, there could be restrictions put on it through this case, but because it officially is labeled and marketed for non-abortion purposes, it’s harder to ban.

Rovner: It’s a stomach ulcer drug.

Ollstein: Exactly.

Rovner: All right. Well, assuming that the pill is not pulled from the market, the squabble over whether pharmacies will stock it continues. As we discussed at some length last week, Walgreens caved to threats of prosecution from Republican attorneys general and waffled on whether they’ll sell the pills, even in some states where abortion remains legal. Now, a group of Democratic governors are not so subtly urging seven other national pharmacy chains to pay no attention to those Republican attorneys general threats. Have we heard from any of the other pharmacy chains about whether they will or won’t sell mifepristone in the wake of Walgreens getting raked over the coals by both sides?

Ollstein: Total radio silence. And I think that the backlash to Walgreens is the reason for that. I think they saw what happened. They saw Walgreens getting really slammed from both sides. You know, you have anti-abortion folks slamming Walgreens for saying they’ll sell the pills anywhere in the country. And you have pro-abortion rights people mad at Walgreens for saying that they won’t sell them in some places. So it’s kind of a no-win situation. And the other pharmacies, I’m sure, are looking at that and saying, why would we stick our necks out getting certification from the drugmakers to sell the pills in the first place? It’s going to still take a while and who knows what could happen by the? And so why would we prematurely come out and say what we’re doing when we have no idea?

Rovner: Yeah, and I remind people for the millionth time that it’s not that Walgreens was going to stop selling them. None of the pharmacies have started selling them yet because it was only in January that FDA said for the first time that they could, which, as Alice points out, may be one of the things that this judge in Texas rolls back, if he doesn’t try to roll back the entire approval of the pill. One more on abortion: Also in Texas, the ex-husband of a woman who got an abortion last summer is suing three of her friends for, quote, “wrongful death” for allegedly helping her obtain abortion medication. His evidence largely comes from screenshots from a group chat, raising more calls for better privacy protections for electronic information. Meanwhile, it’s not even totally clear that the abortion was illegal last July, because there was some legal back and forth about whether Texas’ trigger law abortion ban was actually triggered when Roe was overturned the month before. If the ex-husband wins this suit, though, I’m wondering how much of a reaction there is going to be to nonmedical providers being found liable for damages. He’s suing them for $1,000,000. We keep hearing about this, but to my knowledge, it hasn’t actually happened yet, that nobody’s been convicted, I don’t think anywhere of, you know, abetting someone having an abortion, particularly a nonmedical provider.

Karlin-Smith: And then I mean, it seems like, again, it’s designed to have these chilling effects on people and get people to think twice before they do things they otherwise would. And I know this story raises the issue of whether there’ll be more pressure on tech companies to encrypt all data and messages, which would be interesting to see, you know, how companies react going forward. But we already know that …

Rovner: How the tech companies react.

Karlin-Smith: Right. I think we already have seen that doctors who take oaths and hold certain ethical standards to protect people’s health and life have felt like they’ve been put in very challenging situations between the law and what the best care they normally provide for their patients with abortion. So if doctors feel this way, if regular people feel like they’re also going to be on the hook for something, I would be more concerned, in the sense that regular people would feel even less protected. The medical providers, which tend to work for companies that have, you know, lawyers to help them guide them through their decision-making. And, you know, they have various types of insurance as well to help them through this stuff. So it does seem like it could have a big chilling effect if this ex-husband wins in any way.

Rovner: Yes. I mean, the point here is to just further isolate women who are pregnant and don’t want to be, for whatever reason, from reaching out, not just to medical providers, but to their friends, or at least, I guess, reaching out in some way other than in person. We will see how this one plays out. All right. Well, let’s talk about covid, which we haven’t done for a while. First, the reignited fight over the lab leak versus wet-market-origin theory. I have studiously tried to steer away from this because the one thing just about every expert agrees on is that we will probably never know for sure where covid-19 came from. And to quote Michael Osterholm, the esteemed epidemiologist at the University of Minnesota, we have to be prepared for the future for both events: another spillover event and for the lab leak. Still, the House moved forward with a bill this week, already passed by the Senate the week before, to require the declassification of some intelligence related to covid’s origins. Jessie, you covered it. What would the bill do? And is … do we think the president is going to sign this?

Hellmann: So the president hasn’t said yet if he will veto it, but if he does, it would be his first time vetoing something, if I’m not mistaken. So it could be a bad look if he does decide to make that decision. It passed the House 419 to 0. There were 16 non-voting members. It passed the Senate unanimously a few weeks ago, so I can’t imagine that he would veto it. And, basically, what the bill does, it would require the director of national intelligence to declassify information on covid-19 origins within 90 days and send the declassified report to Congress. It’s not clear how much that will illuminate. There’s so many questions about this. The intelligence community is still pretty divided on this issue, despite the Department of Energy, intelligence community saying a few weeks ago that they think it could have arose from a lab leak, though they said that with low confidence. So, it’s not really clear what information we’ll get from this.

Rovner: And this is just basically Congress saying, well, we don’t know, but we want to know what you know.

Hellmann: Yeah.

Rovner: Is that basically where we are?

Hellmann: Exactly. And there’s also, like, a lot of hearings going on right now in Congress where they’re starting to bring people and talk about this. And I think last week, or was it this week, a select committee had a closed meeting with the Department of Energy about their report. So there’s definitely a lot of interest in this.

Rovner: We will definitely see how this plays out. Well, another thing, we are still fighting about, three years in, the efficacy of masks. A couple of weeks ago, the gold-standard scientific organization, the Cochrane Review[s], put out a meta-analysis of mask studies conducted over the years that concluded there was not sufficient evidence to demonstrate that masks help stop the spread of respiratory illnesses. Well, as so often happens with conditional findings like those, mask opponents immediately trumpeted that the study shows that masks don’t work, which is not what the study showed. Now, in a fairly rare step, the editor of the Cochrane Review herself has posted a clarification of the summary of the study, which we will post in the show notes, but I will quote from it: “Commentators have claimed that a recently updated Cochrane Review shows that, quote, ‘Masks don’t work,’ quote, which is an inaccurate and misleading interpretation.” So what’s that line again? A lie travels around the world before the truth can even get out of bed. Is that where we are with masks now? We’ve gotten to the point where there’s this huge belief that masks don’t work. And the fact is, like the origin of covid, we don’t actually know.

Karlin-Smith: I think that the “don’t actually know” is maybe not the best way to put it. There are things we do know, and that’s some of what, you know, has tried to be clarified in the past week or so from this, although there is that ultimate question of: Is it too little, too late, and are people already sort of set in their views? And that’s the sort of thing for different types of researchers to figure out in terms of how you convince people of various evidence and stuff. But, you know, I think one line that stuck out to me is, in The New York Times piece, trying to dissect the nuance of this review. And it is really nuanced and you really have to appreciate those nuances. You know, they say is what we learn from the Cochrane Review is that particularly before the pandemic, distributing masks didn’t lead people to wear them. And thus, if a mask is going to work, but you don’t wear it, it’s not going to work. And you know, people who have been sort of anti-mask to some degree have said, well, but that does show masks don’t work, because if we can’t get people to wear masks, what does it matter? Of course, for people that want to wear a mask or, you know, are comfortable wearing a mask, there’s also plenty of evidence that shows well-fitting, quality masks will block covid. So you shouldn’t think on an individual level, “Let me throw away my N95. It’s not doing me any good.” It certainly is doing you good. And we have, you know, laboratory research and other research to prove that. So, you know, The New York Times did a really good job of dissecting what was really studied, how much was studied, pre-covid, post-covid, what they looked at, and to try and help people understand where we’re at, which is definitely, again, that there can be benefits to wearing masks. There are differences in population benefits versus individual benefits. And when you think about the population benefits, too, sometimes I think you also have to think about even small, subtle benefits on a population level can make a big difference. So even if mask-wearing isn’t the be-all and end-all some people maybe want you to think about, but it helps lower transmission and lowers cases on a population level, you know, that can translate to hundreds of thousands or even millions less cases, which can then lead, you know, to whatever corresponding number of deaths. So I think it’s also thinking about that, you know, something doesn’t have to be 100% effective in stopping transmission to be really valuable on a societal level.

Rovner: They could have summarized it as “Masks don’t work if people don’t wear them, and it’s hard to get people to wear them.” That would have been accurate. Right?

Karlin-Smith: But the other question is: How do we figure out how to get people to wear them if they do work?

Rovner: Well, but that’s not what this study was about.

Karlin-Smith: Right.

Ollstein: I found this whole reaction really depressing. And it’s been huge on Capitol Hill. It’s been coming up at all of these hearings with Republican members citing this and flatly declaring that it shows that masks don’t work, using it to go after officials like CDC Director [Rochelle] Walensky and excoriate her for recommending masks. And it just feels like we’ve learned nothing. Like Sarah was saying, we have not learned the difference between individual and population-level benefits. Everything is so black and white. Either something is completely effective or completely ineffective. There’s no nuance around reducing risk, and everyone keeps talking about how the next pandemic is inevitable. And it just feels like we absolutely have not learned anything from this one.

Rovner: Yeah, if you’d asked me three years ago where we would be in three years, this is not the place I would have predicted. Speaking of covid misinformation, this week the directors of the Food and Drug Administration and the Centers for Disease Control and Prevention took the rare step of writing a joint letter to Florida Surgeon General Joseph Ladapo — I assume that’s how he pronounces his name — warning that his claims that the covid vaccine is causing an upswing in adverse events are, quote, “incorrect, misleading and could be harmful to the American public.” Sarah, I’ve never seen a joint letter from the FDA and the CDC, certainly not to a state official. I mean, they must have been very unhappy about this.

Karlin-Smith: Yeah, I think it was a unique step. But also, Robert Califf at the FDA has made going after what he calls, you know, scientific misinformation, a key part of his commissionership. He often makes the claim that he feels like misinformation is what is killing so many Americans. So it wasn’t surprising in the sense that he felt the need to publicly respond in this way, particularly when you have an individual of such high stature in the state making claims that he feels are potentially dangerous to people. And a lot of what the Florida surgeon general said, again, has a little nugget of truth, but has largely been debunked in the way he’s framing it. So, yes, we do know there is some risk of these myocarditis, these negative heart effects from these covid mRNA vaccines. But we also know that getting covid actually poses a higher risk of these heart events. So it’s a trade-off that most people argue you would prefer to go with the vaccine than that. And so, the fact that, you know, you have such a high-level health official in a state perpetuating anti-vaccine sentiments, I think is why you see Califf and Walensky really feeling like they had to respond, though I’m a little bit perplexed as to why they decided to do it at this particular moment. But I think it’s because he actually addressed them first with a letter. But, you know, this surgeon general has been doing this for a while now.

Rovner: He’s been the surgeon general for a while, and he’s been saying things outside the mainstream, shall we say, for a while. Well, I want to turn to drug prices because there’s a lot of news there, too. Another one of the big three diabetes drugmakers, Novo Nordisk, has followed Eli Lilly’s lead in announcing it will slash the cost of many of its insulin products by up to 75%. First question, how much pressure will this put on Sanofi, the last of the drug companies that dominate the diabetes drug market? Are they almost inevitably going to follow?

Karlin-Smith: I think most people think it is inevitable, although maybe not for the reasons we’re all thinking. Some of it is just that peer pressure. But a big thing that sort of comes out in this: Sean Dickson, to give him credit, at West Health was sort of the first person I saw point this out. There’s changes in the law related to Medicaid rebates and what these companies will essentially, you know, the discounts they have to give Medicaid coming up, that when you raise your prices faster than inflation, because these insulin products have had their prices raised so much over the years, they were going to have to start owing the government money soon for their drugs instead of the government reimbursing them. So that’s seen as really probably one of the key reasons why these changes are happening when they’re happening, which is not to, like, take any credit away from all the advocates who have pushed for lower insulin prices over the years. Certainly, this law and regulation that was passed was designed, in fact, to motivate companies to do this. So, you know, there’s a cynical way of looking at it, and there’s another way of working at it. But, you know, I do think most people expect Sanofi to follow through, particularly if they think it’s going to impact their formulary placement, in terms of how they compete with these products. But then also just, you know, from a PR perspective, it’s not going to look good for them to be that last holdout.

Rovner: But this sort of leads to my next question. I haven’t seen anybody mention this yet, but I can’t help but think that particularly Lilly and Novo Nordisk are happy to cut the prices on insulin and get lots of good press, as you point out, because both of them are sitting on giant blockbuster drugs to treat obesity. Novo already has FDA approval for Wegovy, which is the same drug as its diabetes drug Ozempic, just in a larger dose. While Lilly already has the diabetes drug Mounjaro, whose clinical trials for obesity have shown it may be even more effective than Wegovy in helping people lose weight. Am I missing something here, or are these companies about to make a killing on other drugs?

Karlin-Smith: No, I mean, that’s one point. And I think, you know, Novo Nordisk is more reliant on insulin and diabetes products in general than Eli Lilly and Sanofi, which have broader profiles. But one thing to note is most of the insulin drugs that are getting list price cuts are older insulin. So, you know, Novo Nordisk notably did not cut the price of one of their newer insulins … in their announcement this week. So again, you have to look at which particular products they’re cutting and why. But there’s big concern about how the use of some of these diabetes medicines to treat obesity will impact budgets because such a large percentage of the U.S. population is overweight.

Rovner: You’re just getting to my next question.

Karlin-Smith: That’s what … I assumed you were thinking of this Medicare issue. Right now Medicare does not cover drugs for weight loss, but the thought process is, if they change that, because these drugs are much more effective than prior weight loss drugs have been, you know how will Medicare pay for these? So that’s another big drug pricing debate coming down the pike.

Rovner: I was just going to say, I mean, this is the thing that I’ve been thinking about, you know, and I guess the complication with Medicare … there’s a piece in the New England Journal of Medicine this week by a bunch of drug price researchers that said, well, maybe the cost-benefit for Medicare wouldn’t be quite as good as it would be for the younger population, because obesity is not such a factor for shortening your life if you’re over 65 than if you’re under 65. But as others point out, it’s unlikely that private insurers are going to start covering this medication if Medicare doesn’t. So you’ve got this sort of place where you’ve got these very promising drugs that are currently very expensive, many in the neighborhood of $1,300 a month, which is not what most people can afford, if insurance isn’t covering it. But the promise of working … and you’ve got all these rich people buying it from heaven-knows-what doctor. So there is actually a shortage. But this is expensive enough that if they can’t push the price down, it has the potential to really impact the entire cost of the health care system. Right?

Karlin-Smith: Right. I’ve seen people writing about this the way we were talking about the Alzheimer’s drugs if Medicare was decided to cover it for all patients who qualify for Alzheimer’s, some of the drugs that came out, how they would essentially have to raise premiums and the implications there. They remind me also of, a number of years ago now, when some new cholesterol-lowering medicines came out that were really pricey. And what would happen to Medicare if they got prescribed and used widely? That, of course, didn’t happen. In part, perhaps, because payers curtail these to some degree. This is going to become a really interesting public discussion because the costs issue, but it’s also sort of about how we think about obesity and weight loss. And for a long time, there’s been sort of a stigma attached to weight loss and weight loss products and people not thinking about it as a medical condition, something where you really need to try other things before you get a medicine or get a medical procedure. It’s sort of a personal failure, a cosmetic issue, issues of self-control … and the fact that these drugs are much more successful than previous weight loss medicines, which tended to not help people lose very much weight and had a lot more side effects, some of them were fairly dangerous.

Rovner: And got pulled off the market.

Karlin-Smith: Right.

Ollstein: For killing people.

Karlin-Smith: You’re going to confront a lot of issues head-on in figuring out how to deal with this, because it’s not just about price. It’s sort of thinking about what we consider a disease and what we’re willing to treat as a medical condition.

Rovner: Yeah, I think this is going to be a really big debate going forward. Well, you mentioned Alzheimer’s. And speaking of Alzheimer’s, the Veterans [Health] Administration has announced that it will offer patients with Alzheimer’s disease, that newest Alzheimer’s drug, Leqembi, is that how you pronounce it? It received accelerated approval from the FDA in January. That means more evidence needs to be presented to assure its safety and efficacy. Sarah, is this drug really better/safer than Aduhelm, which it’s a chemical cousin of, right? And that’s the one that we had all the fighting over last year. So what do we think Medicare is going to do with this drug?

Karlin-Smith: So we do have some evidence that this drug does seem to be an improvement over Aduhelm, even though Leqembi only got an accelerated approval so far from the FDA. FDA is already evaluating the drug for full approval because in that interim between when they filed the accelerated approval, they actually pretty much wrapped up a Phase 3 clinical trial that looked at outcomes and did show some benefit on cognition and so forth. There’s certainly a debate out there as to how meaningful that benefit was, but they have shown a hard clinical benefit in trials, not just changed a laboratory marker that is predictive of Alzheimer’s. So that is significant for the company. But it’s just that FDA and then I think CMS hasn’t really considered that further data yet. And so I think there is a good chance that if FDA grants the drug full approval, which I think is pretty likely, will reconsider it, and they maybe were just sort of buying them some time because, again, it is going to be a bit of a challenge to figure out how to operationalize this. The VA, if you compare to Medicare, I was looking yesterday, you know, the VA probably has a few hundred thousand people that might qualify for this drug versus Medicare potentially has upwards of 6 million or so forth. So the different budget process and the VA also has more ability to negotiate drug prices with the company than Medicare does right now for this particular product.

Rovner: So very first-world problems. We finally have drugs to treat things that we’ve been trying to treat effectively for a long time, except that we can’t afford them. So we’re going to … I imagine this debate is going to also continue. Well, finally this week, I wanted to talk briefly about the practice of medicine and the role of the federal government, even though that’s sort of what we’ve been talking about this entire time. Jessie, you wrote about the Biden administration’s rules barring noncompete clauses in employment this week. Obviously, this is something that transcends health care. Apparently, even Starbucks doesn’t want its trained baristas going to work for local competitors. But how does this affect health care?

Hellmann: Yeah, so from what I’ve heard, noncompetes are really rampant in the health care. Especially between physicians and group practices in hospitals. So I’ve seen a lot of doctors submitting comments to the FTC telling them, and some of these is begging them to finalize this rule. There have been … the American Academy of Family Physicians has come out really strongly in favor of the rule. Basically, the argument is that it contributes to burnout, when doctors can’t leave jobs they’re unhappy in. And it also contributes to workforce shortages. If you’re in a noncompete agreement saying that you can’t work at a competitor within a 10- or 20-mile radius and you’re really unhappy in your job, but you might feel compelled to just go work somewhere else. On the other side, you have the American Hospital Association coming out really forcefully against this rule, which is not a good sign and, obviously, very powerful in Washington. And they’re kind of using the covid pandemic as the impetus to try to block this, arguing that providers are really burned out right now. People are leaving the workforce. We really can’t afford to lose people at this time to competitors, and this will make it harder for us to retain and recruit workers. Both sides are making the same arguments in different ways.

Rovner: We’ll wait on these rules. Well, the other big intra-health care dispute that federal officials are being asked to weigh in on is prior authorization. That’s when insurers make it cumbersome for patients to get care their doctors want them to have. The idea is to prevent doctors from providing unnecessary or unnecessarily expensive care. But doctors say it just throws up barriers that make it harder even to get fairly typical care and puts patients at risk by delaying their treatment. I honestly thought this got taken care of in the Affordable Care Act, which incorporated the provisions of the patients’ bill of rights that Congress had been arguing about for the entire decade leading up to the ACA. But now the Biden administration has proposed rules that would require insurers to at least respond faster to prior authorization requests, although that wouldn’t start until 2026. This is actually one of the American Medical Association’s top issues. Is this just another example of people who are not doctors trying to practice medicine, i.e., the insurance companies, and does the federal government really have a role in all of this?

Karlin-Smith: I think this is a tough issue because usually the insurance companies do have doctors that are trying to make these decisions. What you see are doctors actually in medical practice, not an insurance company, complaining about as they’re often not the peers that they say they are. So, you know, you might have a cardiologist making a decision regarding a prior authorization that relates to something in the orthopedic field. So there’s questions about whether the people that really have enough knowledge are making the calls.

Rovner: Or, God forbid, they have nurses making these calls, too.

Karlin-Smith: But it’s one of these issues that’s really tough because there is a sort of in some cases, I think, a need and a reason to have prior authorization. And it can be useful because not all doctors are willing to, you know, maybe try the cheapest alternative for patients when one does exist. There are some, you know, to use the term, sort of, “quacks” out there that sometimes recommend things that the medical establishment overall would agree you shouldn’t be using on patients. But it’s just that the way this is, like, in the real world, it’s sort of gotten out of control, I guess, in some ways. The best way … where legitimate medical care is being denied, patients are going through prior authorization for refills of prescription drugs they clearly have benefited from and have been on for years. So it’s a tricky situation because there is certainly, for the government, an economic reason to have some degree of prior authorization. It’s just figuring out how to get the good out of it, where it actually can benefit and help, even both protect patients financially and medically without hurting patients, and particularly patients that don’t understand how to navigate the system and push back against bad decisions on prior auth.

Hellmann: There is also a really interesting story in Stat this week about the role of artificial intelligence and algorithms in making some of these decisions. So I do have questions about that. It does seem like I have been hearing more and more from doctors lately about how burdensome prior auth has been. I did a story a few months ago about prior authorization requirements for opioid treatment programs, and providers are saying it takes a long time to get approval. Sometimes you get denials for seemingly no reason, like people who need opioid treatment. Some of these people are really vulnerable, and once you decide you need care, you kind of want to get them at that moment. And they might not want to go through an appeals process. And that’s something that the administration has acknowledged is an issue, too. They say that they’re going to look at it.

Rovner: I remember when most of the health beat was actually refereeing these disputes between pieces of the medical establishment, so … there are other things that the administration is busy with in the health care realm. Well, that is the news for this week. Now it is time for our extra-credit segment — that’s where we each recommend a story we read this week we think you should read, too. As always, don’t worry if you miss it. We will post the links on the podcast page at khn.org and in our show notes on your phone or other mobile device. Sarah, why don’t you go first this week?

Karlin-Smith: I took a look at a story in Allure magazine: “With New Legislation, You Can Expect More Recalls to Hit the Beauty Industry.” And it’s a good explainer on modernizations to FDA’s regulations of cosmetics that passed in the end of the year in Congress. It’s the first overhaul since World War II. They say it gives the FDA some pretty big new authorities, like they can mandate the recall of a beauty product if it’s contaminated. Before they basically just had to beg companies to voluntarily do that, which in many cases companies don’t want products that might harm people to be on the market. But sometimes for whatever reason, they might not move as you want. And so it’s important for FDA to have that authority. You know, it also will do things like disclose common allergens to protect people, gives FDA a lot of new funding to help implement this. You know, I think it’s a pretty big consumer bill and it was kind of like an interesting thing to look at a different part of health policy we don’t often talk about. One thing that the story brings up that’ll be interesting to see and I know has been sort of a tension with leading up to whether this law would ever get passed, was how small companies will be able to handle this, and will it put basically small beauty out of business over big companies that know how to handle FDA and its regulations? So we’ll look to see what happens to your smaller cosmetic brands moving forward.

Rovner: Indeed. Jessie.

Hellmann: My extra credit is a story from The New York Times called “Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs.” And this is an angle I hadn’t really thought about: That $21 billion opioid settlement came with an agreement that distributors place stricter limits on drug suppliers to individual pharmacies and scrutinized their dispensing activity. But it doesn’t just apply to opioids. It applies to all controlled substances. So we’re seeing medications like Xanax and Adderall get caught up in this. And pharmacies are saying, like, it’s making it hard for them to fill prescriptions for patients and some of whom have had them for a really long time. And I don’t know, like, if anyone else has heard about the Adderall shortage — I don’t know if you would classify this as a shortage — but it’s an angle that I hadn’t really thought of. Like, it might not just be supply-chain issues.

Rovner: Yeah, I’ve heard about the Adderall shortage. I mean, I think there’s been a lot of coverage of that. So, yeah, I thought that was a really interesting story, too. Alice.

Ollstein: Yes. I chose a story by my colleagues up in New York, my colleague Julia Marsh, which is about the debate in New York over a flavored-cigarette ban and how it is dividing the civil rights community. And so, you have some civil rights leaders saying that we should ban menthol cigarettes because they have caused a lot of health harms to the Black community. They have long been marketed in ways that target the Black community. They’re in some ways more addictive than non-flavored tobacco. So they’re in support of this ban. And then you have Al Sharpton and some other civil rights leaders on the other side warning that such a ban and the enforcement of such a ban will lead to more police interaction with the Black community, more targeting, and potentially more deaths, which is what we’ve seen in the past. And so a fascinating piece about some …

Rovner: Deaths from law enforcement. Not from cigarettes.

Ollstein: Exactly. Well, yes, it’s kind of “damned if you do, damned if you don’t” on this issue. But a fascinating look at this and what could be a preview as the debates around this at the national level ramp up. So we’ve already seen this happen in California and some other states. Now, the debate is really hot in New York, but it could indicate some of the arguments we might hear if it really moves forward at the national level.

Rovner: Well, my extra credit this week is the latest episode of our competitor podcast “Tradeoffs,” which you really should also listen to regularly, by the way. It’s called “The Conservative Clash Over Abortion Bans,” and it’s actually by Alice here. And it’s a really close look at those exceptions to abortion bans, like for life or health. That’s something that we’ve talked about quite a bit here, except this looks at it from the viewpoint of how it’s dividing the anti-abortion community, which is really interesting. So, super helpful. Everybody listen to it. Thank you, Alice. OK. That is our show for this week. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review — that helps other people find us, too. Special thanks, as always, to our ever-patient producer, Francis Ying. As always, you can email us your comments or questions. We’re at whatthehealth — all one word — @kff.org. Or you can tweet me. I’m @jrovner. Alice?

Ollstein: @AliceOllstein

Rovner: Sarah?

Karlin-Smith: @SarahKarlin

Rovner: Jessie.

Hellmann: @jessiehellmann

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

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Kaiser Health News

Montana Seeks to Insulate Nursing Homes From Future Financial Crises

Wes Thompson, administrator of Valley View Home in the northeastern Montana town of Glasgow, believes the only reasons his skilled nursing facility has avoided the fate of the 11 nursing homes that closed in the state last year are local tax levies and luck.

Valley County, with a population of just over 7,500, passed levies to support the nursing home amounting to an estimated $300,000 a year for three years, starting this year. And when the Hi-Line Retirement Center in neighboring Phillips County shut down last year as the covid-19 pandemic brought more stressors to the nursing home industry, Valley View Home took in some of its patients.

Thompson said he foresees more nursing home closures on the horizon as their financial struggles continue. But lawmakers are trying to reduce that risk through measures that would raise and set standards for the Medicaid reimbursement rates that nursing homes depend on for their operations.

A study commissioned by the last legislative session found that Medicaid providers in Montana were being reimbursed at rates much lower than the cost of care. In his two-year state budget proposal before lawmakers, Republican Gov. Greg Gianforte has proposed increases to the provider rates that fall short of the study’s recommendations.

Legislators drafting the state health department budget included rates higher than the governor’s proposal, but still not enough for nursing homes to cover the cost of providing care. Those rates are subject to change as the state budget bill goes through the months-long legislative process, though majority-Republican lawmakers so far have rejected Democratic lawmakers’ attempts for full funding.

In a separate effort to address the long-term care industry’s long-term viability, a bipartisan bill going through Montana’s legislature, Senate Bill 296, aims to revise how nursing homes and assisted living facilities are funded. The bill would direct health officials to consider inflation, cost-of-living adjustments, and the actual costs of services in setting Medicaid reimbursement rates.

SB 296, which received an initial hearing on Feb. 17, has generated conflicting opinions from experts in the long-term care field on whether it does enough to avoid nursing home closures.

Republican Sen. Becky Beard, the bill’s sponsor, said that although the bill comes too late for the nursing homes that have already closed, she sees it as shining a light on a problem that’s not going away.

“We need to stop the attrition,” Beard said.

Sebastian Martinez Hickey, a research assistant at the Economic Policy Institute, a nonprofit think tank, said wages for nursing home employees had been extremely low even before the pandemic. He said the focus needs to be on raising Medicaid reimbursement rates beyond inflationary factors.

“Increasing Medicaid rates for inflation is going to have positive effects, but there’s no way that it’s going to compensate for what we’ve experienced in the last several years,” Martinez Hickey said.

Colorado, Illinois, Massachusetts, and North Carolina are among the states that have adopted laws or regulations to increase nursing home staff wages since the pandemic began. Michigan, North Carolina, and Ohio adopted increases or one-time bonuses.

In Maine, a 2020 study of long-term care workforce issues suggested that Medicaid rates should be high enough to support direct-care worker wages that amount to at least 125% of the minimum wage, which is $13.80 in that state. In combination with other goals outlined in the study, after a year there had been modest increases in residential care homes and beds, improved occupancy rates, and nods toward stabilization of the direct-care workforce.

Rose Hughes, executive director of the Montana Health Care Association, which lobbies on behalf of nursing homes and senior issues, said many of the problems plaguing senior care come down to reimbursement rates. There’s not enough money to hire staff, and, if there were, wages would still be too low to attract staff in a competitive marketplace, Hughes said.

“It’s trying to deal with systemic problems that exist in the system so that longer term the reimbursement system can be more stable,” Hughes said.

The governor’s office said Gianforte has been clear that Montana needs to raise its provider rates. For senior and long-term care, Gianforte’s proposed state budget would raise provider rates to 88% of the benchmark recommended by the state-commissioned study. Gianforte’s budget proposal is a starting point for lawmakers, and legislative budget writers have penciled in funding at about 90% of the benchmark rate.

“The governor continues to work with legislators and welcomes their input on his historic provider rate investment,” Gianforte spokesperson Kaitlin Price said.

Democratic Rep. Mary Caferro is sponsoring a bill to fully fund the Medicaid provider rates in accordance with the study.

“What we really, really need is our bill to pass so that it brings providers current with ongoing funding for predictability and stability so they can do the good work of caring for people,” Caferro said at a Feb. 21 press briefing.

But Thompson said that even the reimbursement rate recommended by the study — $279 per patient, per day, compared with the current $208 rate — isn’t high enough to cover Valley View Home’s expenses. He said he’s going to have to have a “heart to heart” with the facility’s board to see what can be done to keep it open if the local tax levies in combination with the new rate aren’t enough to cover the cost of operations.

David Trost, CEO of St. John’s United, an assisted-living facility for seniors in Billings, said the current reimbursement rate is so low that St. John’s uses savings, grants, fundraising revenue, and other investments to make up the difference. He said that while SB 296 looks at factors to cover operating costs, it doesn’t account for other costs, such as repairs and renovations.

“In addition to paying for existing operating costs as desired by SB 296, we also need to look at funding of capital improvements through some loan mechanism to help nursing facilities make improvements to existing environments,” Trost said.

Another component of SB 296 seeks to boost assisted-living services by generating more federal funding.

Additional money could help reduce or eliminate the waiting list for assisted-living homes, which now stands at about 175 people, Hughes said. That waiting list not only signals that some seniors aren’t getting service, but it also results in more people being sent to nursing homes when they may not need that level of care.

SB 296 would also ensure that money appropriated to nursing homes can be used only for nursing homes, and not be available for other programs within the Department of Public Health and Human Services, like dentists, hospitals, or Medicaid expansion. According to Hughes, in 2021 the nursing home budget had a remainder of $29 million, which was transferred to different programs in the Senior and Long Term Care division.

If the funding safeguard in SB 296 had been in place at that time, Hughes said, there may have been more money to sustain the nursing homes that closed last year.

Keely Larson is the KHN fellow for the UM Legislative News Service, a partnership of the University of Montana School of Journalism, the Montana Newspaper Association, and Kaiser Health News. Larson is a graduate student in environmental and natural resources journalism at the University of Montana.

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

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Aging, Cost and Quality, Health Industry, Rural Health, States, Colorado, Illinois, Legislation, Maine, Massachusetts, Michigan, Montana, North Carolina, Nursing Homes, Ohio

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