Although the guidance has created some confusion around pharmacists’ responsibilities on the federal and state levels, Lanton said it will take time to find cohesive solutions.
In an interview with Pharmacy Times, Ron Lanton III, Esq., discussed the recent guidance for pharmacists released by the Department for Health and Human Services. Although the guidance has created some confusion around pharmacists’ responsibilities on the federal and state levels, Lanton said it will take time to find cohesive solutions.
Aislinn Antrim: Hi, I'm Aislinn Antrim with Pharmacy Times. I'm here again with Ron Lanton, partner at Lanton Law, this time to discuss the recent HHS guidance for pharmacists following the Supreme Court decision in June in Dobbs V. Jackson. So, the Supreme Court decision created a lot of confusion for health care providers in general, including pharmacists. To try and solve some of that, the HHS Office for Civil Rights released guidance for pharmacies. Can you discuss what exactly this guidance is?
Ron Lanton III, Esq.: Sure. The guidance was released on July 13, so if you haven't seen it, that's the date that you can go look up if you want to just Google “July 13, HHS guidance” on this issue. And it was to all the US retail pharmacies, and it just reminded them of the obligations that they had under federal civil rights law, which is very important, because there is a lot of conflicting information out there, as you had said. So basically, what does this guidance mean? Well, it makes clear that as recipients of any federal financial assistance, so they get federal funds, including Medicare and Medicaid payments, pharmacies are prohibited under law from discriminating based on race, color, national origin, sex, age, disability, in their programs and activities. Added include supplying and prescribing medications, making any kind of determinations regarding the suitability of a prescribed medicine for a patient, and advising a patient about a prescribed medicine and how to take them.
I mean, we all know what happened, we have the decision from the Supreme Court. So, okay, we have a lot of different states that feel very differently about this issue, and how are they going to regulate that? So, you're having a lot of different results happen, which we kind of knew was going to happen based on how the Supreme Court wrote the decision, because, in a lot of aspects, it was very ambiguous about what should be and what should not be. So, you're having a lot of states fill in the gaps themselves and some states are saying, “Well, it doesn't really matter what the federal government says, this is how we feel about it and this is the way that it's going to be regulated.”
I remember seeing something a while back from the National Community Pharmacists Association, NCPA, where they were saying, don't put us in the middle of this because we have our directives on what we know is good for the federal level. But you have states that are requiring something different, so it’s really on the states to tell us what it is that we need, because with the pharmacy license, it's by that particular state regulation. So right now, we're in this battlefield. But I know HHS wanted to put something out in order to provide some kind of leadership and guidance on what it is that we need to do.
Aislinn Antrim: Definitely. The guidance has raised a few important questions. So, firstly, it seems to conflict with some state laws around whether pharmacists can dispense certain medications to patients, or whether it's discriminatory to not dispense medications to a patient because of their sex or pregnancy status or another reason. Can you discuss this apparent conflict?
Ron Lanton III, Esq.: Yeah, so I hate to give you a canned answer, because usually when we're having these kinds of discussions, I like to say, “Oh, Ohio, did this,” or “California did this,” right? There's a lot of vagueness in state regulation and I think we have not seen all of the states’ reactions to the Dobbs decision yet, because of when the Supreme Court released its decision. And that means something because the state legislatures, some of them were already out of session. So, we're just kind of hearing “Okay, well, when we get back in the session, this is what we're going to do.” So, we can't really have a hard example to talk about until we actually see it. And I know that I've talked with Pharmacy Times before about trigger laws, zombie laws, things that were on the books that weren't really gotten rid of when the Roe decision happened, and they still may be there. So, we're really not knowing a lot about what's going on.
But what I do know is that for the states that have come out in support of the Dobbs decision, or states that have said, “We're going to go further than the Dobbs decision,” which is really going to throw a lot of questions for health care providers, there comes a point where you see this as a lawyer. You're thinking this is going to be litigation all over again, you know, with this, this is not a done deal simply because it came from the Supreme Court.
So, that is a long way of me saying that with the conflict of state and federal law, you're going to have something called the Supremacy Clause come in. It's in the Constitution, which basically says that if there is this conflict with the federal laws, the one that you refer to now, the states can go further than a federal law. But that's if they're in cooperation with the federal law. So, you've had this Supremacy Clause thing versus 10th Amendment thing that we've had since the very beginning of our country, right? Whether we should be more state government focused or whether we should be more federal government focused, and that's something that's really created a lot of good policies over time. But when it comes to issues like this, that are very controversial, there's this question of, well, do I actually have legal authority to do this? And I think a lot of the answer is going to default to the Supremacy Clause to clear up that confusion.
Aislinn Antrim: Definitely. How should pharmacists handle a situation if dispensing a medication might violate state law or not dispensing it could violate federal law?
Ron Lanton III, Esq.: Easy answers is get a lawyer. And I'm not saying that because I'm a lawyer, I think you really should have a policy in place for if this happens, right? If, you know, your state is going to go the way of Dobbs or go further, you really should have a policy. I think you should have a policy in place regardless, okay. But I think that this is going to come down to how a state regulates the practice of medicine, and what you're allowed to do and what you're not allowed to do. So, I think the pharmacist in this case really should pay attention to the Board of Medicine. I definitely think the pharmacists should pay attention to what's coming out of their own particular or respective boards of pharmacy, but if there are questions about, you know, legal liability, because we've been getting those questions from our clients, talk to a lawyer and just go through the risk analysis and see what you're comfortable with.
Aislinn Antrim: Definitely. How could this issue potentially be resolved between states and federal regulations?
Ron LantonIII, Esq.: I don't know if it can. So, we already talked about the conflict between states that either want to go with the Dobbs decision or go further, and what HHS has put out, and that's in conflict. A state could pass a regulation backing up what that state believes, even though the state knows that it's in conflict with the federal law. So, I don't know if we get a resolution there. I think what happens is you ultimately end up in court. If you end up in the state court that wants to go against federal law, chances are the state judges are going to side with what that state believes, right? If you fight it in federal court, who knows? It depends. I mean, you really don't know.
Usually, in federal court when you have very contentious issues—I mean, we saw it with the ACA, some states that didn't believe in the ACA, they went to the federal level. And because it was a Texas judge that was in the federal court system, they said, “No, you know, this is the way it's going to be.” Not to pick on Texas, but just as just one example of how this is going to work. This probably will go back to the Supreme Court. Now, I don't think they're going to take it, because they just ruled on this. So, it's like, are you going to overrule yourself? If it's, like, on the fringes of the issue that they had talked about in Dobbs? I don't know. I mean, maybe they'll take it to solidify Dobbs? You never know.
So, I don't know if there's really a good way to say, “Can this be resolved with a federal or state regulation.” I think to resolve it, which we're not going to know until after midterms, because the midterms are going to formulate how Congress looks. And if something can pass the Senate with 60 votes, or if they decide to drop it to 51, and there's all kinds of procedures about that. That's a different conversation. But the only thing that can override the US Supreme Court decision is a congressional act. So, do we get one clarifying it one way or the other? Do we get a law that goes with Dobbs? Or do we get a law that goes pre-Dobbs? It would be interesting.
Aislinn Antrim: The confusion around this has also impacted medications that are not exclusively used for reproductive health, such as methotrexate. Are there different ways that pharmacists should handle confusion around methotrexate? Just, for example, in order to protect themselves while also providing care.
Ron Lanton III, Esq.: Yeah, that's an interesting question around this particular prescription, because it's for rheumatoid arthritis as well as a lot of other comorbidity conditions. cancer being one of them. But it could also be used to terminate a pregnancy, up to about 7 weeks of gestation. I cannot remember, I was trying to remember—it was the Arthritis Association. I think it was them, I think they had a good idea. Which was, if you're worried about that, as a pharmacist, and being able to comply with your particular state requirements, maybe having what the prescription is for, having the prescriber write that out, might be helpful. Maybe using a diagnosis code would be helpful. You know, I don't want to say go to mail order, because you know, I'm for independent pharmacies. But I guess you could do that. I guess you can go to mail and get around that. Yeah, I mean, it's a tough issue. And I think that particular medication is just in the line of fire, and it shouldn't be. And it's unfortunate, because I think a lot of people are going to realize that it's not just about abortion, you know. These drugs are used for other things. And I think this is going to come to a head very soon, because the Dobbs decision is fairly recent, and I don't really think we understand the implications of it. And so, several months after it's been in place, we're already starting to see stories about it now.
Aislinn Antrim: Yeah, absolutely. Well, you say, do you think it'll come to a head soon? Where do you see this going? You know, will this maybe have a resolution soon or is this going to be a very long road to get some sort of cohesive, clear policies around it?
Ron Lanton III, Esq.: Oh, it's a long road. It's a long road. Well, you know, it depends on what side of the fence you sit on with this issue, right? I've seen all kinds of things where, you know, the majority of this country wants the Roe decision. I'm not taking a side personally; I'm just saying what's out there. You know, I see a lot of litigation. Whether it ends up back at the Supreme Court who just ruled on this, I just have a hard time seeing how they overturn it. I think the resolution to solve this would be a congressional one. But again, we don't know the makeup of what the midterms are going to be. So, I think this will be a very interesting conversation after that election. Because we don't know if the Democrats are going to retain control over 1 or both of the houses. We don't know. And even though it's August, and we've seen trends go back and forth—I've seen things earlier this year, where they're like, oh, yeah, Republicans are going win the Senate. And now, I'm seeing some other trends. But politics is a funny game. You know, you're up and down one day, and you know, one day is 100 years in politics. So, we're just going to have to wait and see. But I think unfortunately, there's not going to be any closure until we get some kind of certainty on what the congressional makeup is.
Aislinn Antrim: Definitely, and I'm sure I'll talk with you again after the midterms to hear your thoughts. Is there anything you want to add or anything I didn't ask about on this topic?
Ron Lanton III, Esq.: No, I think you guys are doing a really good job with it, you know, as far as looking at the implications legally of this, as well as just from a practice perspective. Because these are real issues. You know, this isn't something that's put over here on a shelf. The pharmacist needs to know how to operate and how to comply, and I don't think anybody wants to lose their license or anything. But these are very tough issues to navigate. And, you know, I think that I've never really had to look so much at the board of medicine as I have recently when it comes to a pharmacy issue. But that's really the world that we live in right now. Just have to adjust and I think that you've asked these questions and there are good ones, and we need to know what the health care provider needs to do in order to take care of the patient.