Speaker 1 00:00:00 And we brought this suit to challenge the HHS secretary, in a broad sense, to stop him from a steady stream of actions that undermine vaccine access and vaccine confidence in the United States.

Speaker 2 00:00:24 Welcome to Off the Chart, a Business of Medicine podcast featuring lively and informative conversations with health care experts, opinion leaders and practicing physicians about the challenges facing doctors and medical practices. My name is Austin Littrell, I'm the assistant editor over at Medical Economics, and I'd like to thank you for joining us today. Last week, a collection of major physician groups, including the American Academy of Pediatrics, the American College of Physicians, the Society for Maternal-Fetal Medicine, along with an unnamed Jane Doe, filed a lawsuit against the Health and Human Services Secretary Robert F Kennedy Jr. They're looking to overturn his May directive removing the COVID-19 vaccine from the nation's immunization schedule for pregnant women and healthy children between the ages of six months and 17 years. In this week's episode, we're taking a deep dive into that lawsuit, as Medical Economics senior editor Richard Payerchin is joined by Richard H.

Speaker 2 00:01:10 Hughes, an attorney representing the plaintiffs in the lawsuit against HHS. He also serves as a voting director for the nonprofit vaccine advocacy organization Vaccinate Your Family. Thank you to Richard for joining us this week, and with that, let's get into the episode.

Speaker 3 00:01:31 Hi. Good afternoon.

Speaker 1 00:01:33 Good afternoon. How are you?

Speaker 3 00:01:34 You're good. And yourself.

Speaker 1 00:01:36 Good, good.

Speaker 3 00:01:37 Excellent. Thank you for taking the time.

Speaker 1 00:01:40 Of course. Yeah. Happy to.

Speaker 3 00:01:42 Excellent. You represent a group of health care organizations that have filed a lawsuit against the US Department of Health and Human Services. Can you give an overview of that situation?

Speaker 1 00:01:52 Yes. Happy to. So we filed a lawsuit yesterday on behalf of the American Academy of Pediatrics, the American College of Physicians, the society for Maternal Fetal Medicine, and other groups, including a Jane Doe plaintiff who's a pregnant woman who believes that she will have difficulty accessing the Covid vaccine if she wants to protect herself and her unborn child. And we brought this suit to challenge the HHS secretary, in a broad sense, to stop him from a steady stream of actions that undermine vaccine access and vaccine confidence in the United States, and then in a specific sense, so that we could bring the legal claims that we need to bring focus really on the final agency action in the form of the video that he produced with Marty McCary and Jay Bhattacharya.

Speaker 1 00:02:46 And that was the video where they announced that they were rescinding the Covid vaccine recommendations. And so, basically, that prevents many people from having access to, to vaccines, to Covid vaccines. And that's the action that, you know, that we're challenging specifically.

Speaker 3 00:03:07 And in full disclosure, I always tell people I'm not a physician. So if I ask a silly question.

Speaker 1 00:03:13 I'm not either.

Speaker 3 00:03:14 I appreciate your patience. Yeah, but you know what? And this is this has been one thing that I've been kind of curious about, because when we talk about a recommendation, perhaps it's not as strong a language as as some people might want. And I guess, can you talk a little bit more about that whole notion of the recommendation and how it affects access?

Speaker 1 00:03:32 Sure. so it's important for many reasons. So, you know, first of all, it's it's used in clinical practice as a standard of care. You know, professional societies have their guidelines, but this is really a recommendation that has been considered by a whole body of, of experts across different, disciplines and specialty areas of practice.

Speaker 1 00:03:56 And, you know, really in consideration Iteration of the harmonization of various recommendations. And so, Clinical practice is one area. And then you actually have various policies and laws that do rely on ACIp recommendations, whether that's pharmacist scope of practice laws or, the requirement under the ACA that coverage, you know, be tied to ACIp recommendations and that patients receive vaccines with zero out of pocket cost, you know, so there's a lot of, access that's determined, through these recommendations. ACIp recommendations are not mandatory. And I think that's something that is often confused is is, you know, that they're sort of, you know, mandatory. And that's simply not the case. they are recommendations. Many states will then use those recommendations, to, you know, actually implement, requirements, for, say, like school entry, or that certain health care professionals you know should should be immunized.

Speaker 4 00:05:06 Say, Keith, this is all well and good, but what if someone is looking for more clinical information? Oh.

Speaker 5 00:05:12 Then they want to check out our sister site, Patient Care Online.

Speaker 5 00:05:15 Com the leading clinical resource for primary care physicians. Again, that's patient care online. Com.

Speaker 3 00:05:24 I wanted to definitely ask about with your clients, the client organizations that have brought this case. How do they believe the directive or perhaps the the lack of a recommendation or directive? How will that affect public health, particularly for pregnant women and children?

Speaker 1 00:05:40 Yes, it really does complicate the ability of providers to practice according to the standard of care because it, you know, creates certainly, patient doubts. Patients have a lot of conversations and it makes it excuse me, patients have a lot of questions. It makes it really difficult to counsel patients effectively. And it takes up, you know, a lot of time in clinic to to have to spend, counseling patients and then, you know, given the issues around coverage and payment, the uncertainty that, you know, a vaccine will be covered can certainly discourage patients, can discourage providers from offering it. So there's a real, you know, concern that this is just all around something that makes practice really complicated.

Speaker 3 00:06:27 Regarding the secretary and his directive, you know, for the Covid 19 vaccine, do you believe that they have been relying on established scientific evidence in making that directive or decision?

Speaker 1 00:06:41 You know, no, I don't I mean, I don't think that they gave a lot of thought at all to the actual evidence or gave it, you know, a hard look, as we say, under administrative procedure law. you know, I think that what they did was engaged in a decision that reflects a lot of bias, you know, against vaccines and in particular against Covid vaccines. and so I don't think they considered a lot of the access issues in the United States, for vaccines. I think that, you know, by overturning the recommendation, they really, did not consider the fact that a lot of people might not have access because of the issues that I, that I just, that I just described. And so, and they also, you know, really ran roughshod over a lot of processes and procedures that are normally undertaken.

Speaker 1 00:07:29 You know, as the ACIp applies its evidence to recommendation framework as it, you know, really goes through the process of, discussing, considering, the evidence in order to formulate its recommendations, which the director of the CDC, you know, ultimately, the secretary have the authority to, reject or approve. But none of that process happened in this case.

Speaker 3 00:07:55 And one of the things that I also noted in the complaint was that it described some of the recent actions surrounding members of the ACIp. Can you talk a little bit about maybe some of their deliberations, some of the members? Are they are they going to get a chance to advise the Secretary on the directive?

Speaker 1 00:08:16 yeah. So they, will likely move on to other vaccines that I believe will become a target of the Secretary and the new committee. And so, you know, will they continue to revise Covid recommendations in the future? I could see that as a possibility, but I think they have their sights set on other, specific vaccines at this time.

Speaker 3 00:08:39 Can you name names?

Speaker 1 00:08:40 Sure. I mean, obviously at the last meeting, they, you know, voted to no longer recommend thimerosal containing flu vaccines, which was a vaccine, you know, containing, the preservative thimerosal so that Multi-dose files could remain shelf stable. They looked at the measles, mumps, rubella and varicella combination vaccine. you know, basically revisiting, evidence that was looked at 15 years ago by the ACIp, and considering the safety of, of those combination vaccines. And so, you know, I think that what we're going to see and what's really been indicated by directly by the chair of the ACIp, but also by the secretary, is that they will wholesale evaluate, reevaluate the childhood immunization schedule.

Speaker 3 00:09:30 Okay. And then to go back to the lawsuit, if I may. Because one of the things you had mentioned earlier in our conversation was some of the different medical organizations and, you know, professional groups, they're made up of doctors and they can advise each other frankly, on they can do research and advise each other on various medical treatments and technology.

Speaker 3 00:09:50 I mean, not just vaccines, but all kinds of stuff. And where I'm going with this one is why is legal action necessary when you do have some of the medical organizations who, for example, the American Academy of Pediatrics. I think a lot of parents say, wow, if this group of doctors who treat children specifically, if they say this is a good thing, I believe them.

Speaker 1 00:10:11 Sure. And I think it is important right now more than ever that we look to professional societies for those guidelines. you know, the ACIp really began its work to help simplify the immunization schedule, because we were seeing new vaccines at the time and lots of new vaccines come out, and we have seen additional vaccines developed since then. There's a lot of evidence that that really does need to be reviewed and digested, and we're looking at immunization across the lifespan and policies that, again, rely back on the ACIp. And so it's really important that we have a central body that is being, you know, looked to, as as we try to determine the standard of care for immunization Holistically across the lifespan.

Speaker 3 00:11:00 And as far as you know, do you think those medical organizations will continue to make their recommendations?

Speaker 1 00:11:06 Yeah. Oh, absolutely. I don't think there's any question about that. Yeah.

Speaker 3 00:11:09 Okay. Okay, good.

Speaker 5 00:11:13 Oh, you say you're a practice leader or administrator. We've got just the thing. Our sister site, Physicians Practice. Com your one stop shop for all the expert tips and tricks that will get your practice really humming again. That's physicians practice.

Speaker 3 00:11:31 You know, not everybody, is always familiar with some of the ins and outs of legal procedures. And can you explain a little bit about actually at the courthouse door, so to speak? What has to happen next?

Speaker 1 00:11:43 Yeah. So we are requesting a preliminary hearing for, a preliminary injunction, consolidated with an evidentiary hearing as we seek our permanent injunction. So what we hope for is a is a hearing within the next few weeks and then potentially a decision by mid-September.

Speaker 3 00:12:04 And based on the timing. Again, not to belabor the point, but I can remember from my days, covering courthouses sort of at the local level, because the legal process does take time.

Speaker 3 00:12:15 There's, you know, legal, notifications, you know, people have deadlines in which to respond. Where I'm going with this is you mentioned about a ruling by September. Do you think that court action can take place quickly enough to make a difference in the upcoming respiratory and flu season?

Speaker 1 00:12:34 that remains to be seen. You know, the season, tends to run, you know, hit or miss through early spring. And so, I think that there certainly is some time, will it happen ahead of the season? You know, the season starts in August. And so, we'll we'll just have to see how the timing plays out.

Speaker 3 00:12:54 I always like to ask this question. Our main audience is primary care physicians. What would you like to say to them, or what would you like to them to know, either in general or about the case specifically?

Speaker 1 00:13:05 Yeah. So I think it's important more than ever, that because of the state of affairs that we're in, is that we double down on professional society guidelines and talking with patients about what's in those guidelines, why vaccines are important, and, you know, really clarifying that there is a lot of misinformation and disinformation out there and that there's an effort, you know, that we're undertaking, you know, to to really put a stop to this.

Speaker 1 00:13:32 And that's what our lawsuit is about.

Speaker 3 00:13:35 Excellent. Well, I'll tell you what I think. Like I said, I think that's a really good introduction for the moment. if I have questions, I'll reach out by email here. But I do appreciate you taking the time.

Speaker 1 00:13:45 Yeah. Yeah, absolutely. My pleasure. Thanks so much. I'm glad you reached out, Richard.

Speaker 3 00:13:49 Oh, absolutely. You know what? Have a good rest of the day here. And in all seriousness, please do keep in touch. Hopefully we'll meet again real soon.

Speaker 1 00:13:55 Absolutely. Likewise. All right. Talk soon. Okay.

Speaker 6 00:13:58 Bye bye.

Speaker 2 00:14:10 Once again, you just heard from Richard H. Hughes, an attorney representing the plaintiffs in the lawsuit against HHS and the voting director for the nonprofit vaccine advocacy organization Vaccinate Your Family. My name is Austin Littrell, and on behalf of the whole medical economics and physicians practice teams, I'd like to thank you for listening to the show and ask that you please subscribe on Apple Podcasts, Spotify, or wherever you get your podcasts so you don't miss the next episode.

Speaker 2 00:14:33 Also, if you'd like the best stories that Medical Economics and physicians practice publish delivered straight to your email six days of the week, and subscribe to our newsletters at MedicalEconomics.com and PhysiciansPractice.com. Off the chart: A Business of Medicine Podcast, is executive produced by Chris Mazzolini Keith Reynolds and produced by Austin Littrell. Medical economics, Physicians Practice and Patient Care Online are all members of the MJH Life Sciences family. Thank you.