Navigating Regulatory Pitfalls at the Nexus Between Home Health and Infusion

Randy Fearnow speaks with Jaya White, Partner, Quarles & Brady LLP, about the regulatory landscape surrounding the growing home infusion industry. They discuss issues related to the Medicare HIT benefit; home infusion-specific state licensure requirements; ambulatory infusion suites, IV hydration clinics, and med spas; Indiana’s recent requirement that their Medicaid home care providers must also be certified for Medicare; and the regulatory definition of “homebound.” Jaya co-wrote an article for Health Law Connections about this topic. From AHLA’s Post-Acute and Long Term Services Practice Group.

Watch this episode: https://www.youtube.com/watch?v=9rd5xivY2Yk

Read Jaya’s Health Law Connections article: https://www.americanhealthlaw.org/content-library/connections-magazine/article/488ffc74-684d-4c97-882c-eae034db75fa/Navigating-Regulatory-Pitfalls-at-the-Nexus-Betwee

Learn more about AHLA’s Post-Acute and Long Term Services Practice Group: https://www.americanhealthlaw.org/practice-groups/practice-groups/post-acute-and-long-term-services

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Transcript

SPEAKER_00 0:04

This episode of AHLA Speaking of Health Law is brought to you by AHLA members and donors like you. For more information, visit americanhealthlaw.org.

SPEAKER_03 0:17

Hello, health lawyers. My name is Randy Fierno. I'm a retired partner at Corals and Brady in Chicago. And I'm here today with my longtime colleague and good friend and mentee Jaya White, who's going to talk to us a little bit about an article which she co-authored in the uh March-April print edition of the Health Law Magazine of the American Health Law Association. A little bit of introduction about myself. I practiced law for 44 years, concluding my career at Quarles and Brady. Most of that 44 years was spent in health law, although I did a few other things along the way. During retirement, I kind of view my retirement as a um as a much deserved sabbatical after 44 years of law practice. I'm serving on a couple not-for-profit boards and as a um uh warden in the uh the Episcopal Diocese of uh of Chicago. And um quite honestly, I'm along with traveling, I'm not sure how I ever had time for a full-time job, but um, but I'm enjoying the time away. Um I was getting ready to get on a plane, and I had um tossed in my bag the um March-April edition of the Health Law HLA magazine, thinking, well, you know, I'm I'm retired now, I don't have to read this stuff anymore. Um I can read uh you know a novel or something that I brought along with me. But uh then I looked at the cover and I thought, wait a minute, um, one of these articles sounds somewhat familiar. And then I opened it up uh to page uh page 10, and sure enough, there was uh there was the article written by Jaya, which is called Navigating Regulatory Pitfalls at the Nexus Between Home Health and Infusion. So I'm gonna call on Jaya. I want to introduce her um just briefly. First of all, Jaya is a um very, very distinguished um member uh of the health law group at uh at Quarles and Brady, has been there now, I think 12 years or perhaps longer. Uh Jaya and I go back uh 15 years or so when I um uh interviewed her at a at another firm, and then she uh traveled with us when uh with other partners when we went to uh when we went to Quarles and Brady about 12 or 13 years ago. Um Jaya is a and it kind of pains me a little bit as an Indiana University football fan uh to mention that Jaya is uh a proud alum of the Ohio State University, both the uh both the Moritz College of Law and also uh uh her undergraduate degree, Magna Kumulati, is also from the Ohio State University. Um Jaya, like I said, has been um practicing health law exclusively for uh for her entire career, I believe, and uh has been exposed to uh a number of areas, um, probably more areas than than than she wanted to be exposed to, and practically everything in health law, I think she's tackled at one time or another. But um, but she's uh become uh started to focus uh on the uh several years ago on uh long-term care uh and has um identified this uh nexus uh between the uh between home health, which is an important part of long-term care, and infusion. So Jaya, with that, and and also Jaya has many awards and and recognitions uh throughout her career, uh which you can find on on her website. But Jaya, tell us a little bit about how you how you identified this subject matter uh as appropriate for an article and and what you discovered uh as you got into the into the information.

SPEAKER_01 4:46

Thank you, Randy. I think we can just end this podcast now because you've said all these amazing things about me. And I think we're good. Um, but thank you. That was a great introduction.

SPEAKER_02 4:57

Welcome. Where did you close your?

SPEAKER_01 4:59

I think you mentioned that I'm the vice chair of the AHLA practice group for long-term care providers, but I am also the national practice group leader of the long-term care group of Quarles and Brady. So that has historically been a large part of my practice. And then in addition to long-term care, I also have a pretty robust pharmacy practice. And as a young lawyer, um, I grew up learning both. So I would learn long-term care would traditionally be home health, hospice, assisted living, skilled nursing facilities, general regulatory, transactional. And then pharmacy would be a lot of the same, but it'd be the pharmacy providers. And as you know, Randy, you've got a pharmacy, but then it might ship into oftentimes 50 states. So in the pharmacy world, you've got the facility, and then you've got licenses in all the other states. So with the pharmacy framework, you're kind of thinking about okay, I'm in Illinois, I'm shipping into Indiana, what do I need to think about? What laws apply? Um, and then we've got infusion. And it's kind of a nice world for me to be in that's in between the two, because you've got the home health component or some like facility license component similar to the long-term care, and then I've got the pharmacy piece because you've got to get those drugs to the patients. And so setting aside traditional home health, um, the general infusion model has been in the home. And so we can talk about this in a little bit, but um, states kind of handle that different ways. And I would say the majority of them haven't really thought that through yet. There's the traditional home health, um, which is generally covered under Medicare Part A on the reimbursement side. And so in order to get reimbursed under Medicare Part A, you need to be certified by a physician via face-to-face encounter, and then need to be determined to be homebound. Home infusion is different. And so what we've been seeing with a lot of our pharmacy clients in particular is they're kind of they're navigating this home infusion world. How do we fit into home health? And then they're also looking at alternate arrangements, and that's a lot of what we're talking about in the article. So um ambulatory infusion suites, and we can talk about that in a little bit, um, ambulatory centers, um, infusion in hospitals, physicians' clinics. There are all different ways that it's kind of being approached, but you have to think about it from the individual licensure, potentially a facility license. How are we gonna account for any drugs in the space? Who's administering the drugs? What's their scope of practice? Uh you could have a field day as a regulatory lawyer as to um what all is going to be involved in the infusion space.

SPEAKER_03 7:53

Well, it sounds like there's a lot going on. Um, it's difficult for uh both the uh the consumers and also the providers to figure out um how to provide the service, although it sounds like there's a great, apparently a great need for this service. Um you mentioned in the article, Jaya, the um the Medicare uh HIT benefit, um, which may be uh driving uh part of the growth here. I don't know. Um is it uh can you tell us a little bit about that benefit? How does it differ, if at all, from uh from Medicare Part A?

SPEAKER_01 8:29

Um thanks, Renean. Sure. Uh so I touched on that really briefly, but traditional um home health services are gonna be covered under Medicare Part A. And so you need to have that face-to-face encounter, and the patient needs to be determined to be homebound. That is not what um infusion, as we think about it, is so that general reimbursement model is not gonna work in the infusion space. Now, the home infusion therapy hit benefit, that's about five years old now. I still think it's new. It's a post-COVID development, and it's it's a step in the right direction. Um and CMS has recognized that, you know, we have the HHA, the Medicare Part A reimbursement. We also have a DME reimbursement that would cover the drugs and the supplies. But what was missing was the nursing piece, the home nursing, the administration, the education, the monitoring. That's what that HIT benefit is trying to do. But it's still, I think it's still a work in progress. We've got Medicare, and as we're gonna, as you'll see from the article, and maybe we'll talk about it today, states are trying to tie that into Medicaid. And then you've got the home licensure piece or the state licensure piece, excuse me.

SPEAKER_03 9:47

Yeah, you mentioned um, I want to talk about the state. Looks like the states are getting involved as well. And you mentioned in the article the state licensure, some of the state licensure issues. Um, you report that uh there are apparently only two states. Um, I think one's one's can it's one Kentucky. I think it's one Kentucky. I've forgotten from the article now. Um, and the other is Montana. Montana. Montana, okay. So uh Kentucky and Montana uh require specific home infusion licensure, apparently. Um is uh just those two states now. Um you've studied this area. Do you think that's is there a discernible trend or is it uh is is going the other other direction?

SPEAKER_01 10:32

I I don't see a trend yet. Um, but I think we're gonna get there. It's just, you know, it may be when I'm at 44 years of practice, I'm gonna say that yes, here's this licensed category for home infusion providers. So um I would say Kentucky's very very unique. So they have a very specific category called ambulatory care agency or something to that effect. And that is exactly what this is. Um, Montana's a little interesting because they do have a home infusion therapy provider, but it requires a pharmacist in charge to be tied to that license. And so for our pharmacy clients, they would have that pharmacist that they could probably um oversee the infusion therapy license. But for just a nursing agency, they're not going to have that um individual who can supervise the services. So it's, I think the rationale behind it makes sense. I just don't think it fully got you there. So what you typically see, um, states kind of the way it's uh the language is in the state licensing laws is kind of in a few buckets. So you've got several states are gonna say um licensures required if you provide skilled nursing services and another therapy service, which is exactly what the Medicare Part A requirement is. It's skilled nursing facilities, skilled nursing services and a therapy. So speech therapy, occupational therapy, physical therapy, something like that. Um, when you see that language, if you're just a home infusion therapy provider providing this one limited service, you can land on a comfortable conclusion that that license doesn't apply to you because you're not providing that and therapy service. Other states are gonna say, and an example of that would be um actually, I'm kind of blanket on a state example right now, but I think Illinois is an example of something like that. What Illinois has that's a little bit different though, is it has its separate nursing agency category. So that's where a state like Illinois, if it's got the and, you don't fall into that, but then you would fall into the home nursing. There are other states where it's gonna be any type of service. So just the nursing alone can trigger, like Kansas is an example of that. Um, and so then if you're just providing the nursing service, you're gonna need to be licensed. And then you've got states like California and New York, where just contracting out services is gonna trigger licensure, which I've tried to understand how they've landed on that. But if you are a home health agency and then you contract with a nursing agency to provide the infusion services, they're gonna say you need a license to contract out of the services, even if the nursing agency that you contracted with also has a license.

SPEAKER_03 13:26

And is that whether you're doing it in the home or someplace else or or generally in the home.

SPEAKER_01 13:32

In the home. Um interesting question though, because some states like California, um, based on anonymous outreach, we've learned that even if you're providing it in a different location, for example, in the infusion suite, it will also require a home health agency license. So California, New York, it's kind of the usual suspects in terms of states that may create a little bit more of a regulatory um hurdle to get to where you need to be. New York's also a state with a certificate of need, so you have to think about that.

SPEAKER_03 14:05

So if you're gonna set up an infusion suite, uh there's certain states where you'd have to get you'd have to get a certificate of need to uh to be able to do that.

SPEAKER_01 14:14

Potentially for the home infusion therapy or a suite.

SPEAKER_03 14:18

Okay. Um let me talk about the the suites a little bit. The um I had some experience in years ago in the practice of of dealing with um with um with dialysis centers, uh, where Medicaid recipients would be transported um three times a week for uh for dialysis and transport at home. And I think that's all the dialysis centers did. I and I think they were licensed uh to do that. Does this statutory or this regulatory framework envision something akin to that on the on the infusion side or or not?

SPEAKER_01 14:57

Not yet.

SPEAKER_03 14:58

Okay.

SPEAKER_01 14:58

So when you're thinking about an infusion suite, and when I'm talking about an infusion suite, the general model that a lot of the pharmacies are looking at is really simple. It's gonna be a room with a chair, a nurse, and maybe an emergency kit or some emergency meds. We're gonna table a conversation on pharmacy law as to whether they can store those meds, but that's generally the model. And so on the day of an infusion, the pharmacy is gonna deliver the patient-specific medication to the AIS, the ambulatory infusion suite. The registered nurse is going to take possession of the drug, store it, secure it, and then when the patient arrives, they're gonna administer it. Um, there are other models, and we can talk about those if we have time, but um potentially you could have an APRN, an advanced practice nurse involved, or a physician. Um, and that would change the what they're allowed to do. So, for example, if it's an MD, you'd be able to store drugs under their medical license. You can't do that with an RN. They don't have the high enough scope of practice. But with that RNAIS model, the overwhelming majority of states have no um license category for that. So it's generally going to be operating under that individual's license.

SPEAKER_03 16:21

Okay.

SPEAKER_01 16:21

There are some exceptions, and it's um it's it's very much state to state. It kind of depends, I think, on the enforcement and regulatory structure in that state. So one that I can think of, oh well, a couple, uh, Arizona, they do regulate. It's um an outpatient treatment center with the department of DHS, is who you would have to get that license with. And that they want that license that they know what exactly is happening in that suite. So you're gonna have a clinic director, there are uh requirements around storage of drugs. It's just to give them that oversight to be comfortable with that model.

SPEAKER_03 16:59

No, sorry. Oh no, but I'd be oversimplifying. I it seems like I I see these um these standalone facilities, um, people operate as med spas or IV hydration centers just in and resort areas uh for uh hangover cures. You can go in and get an inf is is uh I'm just kind of curious, are um have those places fallen under the under the purview of the uh state licensure authorities, or do you have to get a license to do things like that?

SPEAKER_01 17:31

Well, it's interesting. It's it's almost the opposite analysis on the infusion side. So because we're seeing these med spas that may be providing medical services or may be providing cosmetic services, and we're seeing these IV hydration clinics and and who's operating those? Who when you go into the IV hydration clinic, is it a nurse? Is it a doctor? Is it you know a saline solution with um vitamins added to it? Are they mixing it on site for you based on a menu? Um, because of that, and when I say, you know, we don't know who's administering this, that's where the states are starting to pay attention. And so there are, I don't know, maybe we're up to about 10 states where there is a there are guidance documents that are out there. Um, Wisconsin recently had one, Ohio has one, um, Rhode Island has one, Kentucky. Um, there are a handful of states where they're saying, okay, if you're doing these things, this is the practice of medicine, the practice of nursing. If you're adding um drugs into or vitamins into the saline, that's compounding in their eyes. And so therefore, it needs to be under the correct licensure.

SPEAKER_03 18:42

Interesting.

SPEAKER_01 18:43

We're talking about those guidance documents. Ohio, um, Wisconsin, they're just kind of explaining how this works and how this is regulated, and we can't just have anybody out there operating these clinics. Um, Rhode Island went a little bit further and said, if you're doing all these things and it's not um owned by certain individuals that might have an exception, you need a specific facility license. You need um, I think it's like an ambulatory care center license in Rhode Island.

SPEAKER_02 19:12

Okay.

SPEAKER_01 19:13

Um, so because that industry is out there and doing these things and catching the eyes of regulators, um, that's where infusion kind of falls in. It's almost, I don't want to say it's forgotten. It's just not quote on the radar, but they're getting pulled into the guidance.

SPEAKER_03 19:31

It'll be interesting to see how the professional organizations uh respond to that. Um, say uh let's go back to the states uh briefly. You mentioned um my uh home state of Indiana in the article, and I was uh found it interesting that uh apparently there's a new requirement they've imposed. Um Indiana's imposed to make um home care providers also have to be certified, not just licensed by the state of Indiana, certified by Medicaid, but also certified for Medicare. Um what's the what's the rationale for that? What is the state trying to accomplish by by that imposing that requirement?

SPEAKER_01 20:14

That's a good question. So it's not required to provide the services. Um in fact, Indiana is an interesting state where they do have language that says if you're only providing infusion services, it doesn't trigger HHA license. So if you're providing the services, you have appropriate licensure, you can still operate in the state. Um the question is how are you going to get reimbursed? And so Medicaid about a year or so ago had a very short bulletin that said, you know, by I think it's you know, July 1, 2026, you need to be enrolled in Medicare as a part A provider. You need to complete an 855A. Um that takes a while. Even even if you have all of the right tools in place, um, you know, the associations are recommending go through an accrediting organization, it'll speed up the process. It's still a very long process. And so the state actually extended that timeline. So if you have all the paperwork in and you're in process with Medicare, you're okay as long as you get licensed by I think July 1, 2027 now. And what is really interesting to see, well, I guess I have two comments on it. One, our home infusion providers are still not going to be able to do that. So they were previously able to be enrolled with Medicaid. Now you need a part A enrollment. I don't know if they'll be able to do that because do you provide or can you contract out for that second service for that therapy service? Will you be able to see patients who are going to meet the requirements, the criteria for the conditions of participation? I don't know. Um, it it would be a good opportunity to have some outreach with the state, I think. Um, but the other Interesting update that I think it just published on Friday is that there's now a nationwide moratorium on enrollments for HHAs. So if you're an Indiana provider and you're trying to get enrolled in Medicaid and you need this Medicare enrollment as well, what do you do now if you weren't paying attention, you weren't in process by April 1? I don't know what you do. I mean, I think, you know, there are some things you can think about. When I was a much younger associate, there was the HHA moratorium in like 2012, 2013. And so you had to kind of think outside the box a little bit. Well, you can't have a new enrollment, but you could um purchase an agency. And as long as you didn't trigger the 36-month rule, that would be one way to get um the appropriate certification. So I think things like that are where we're gonna have to be looking at, or um communications with the state. You know, this is what we're doing. It's not Medicare Part A, it's Medicare Part B. Does Medicare Part B satisfy? I don't know the answer to that. It's been kind of an ongoing concern.

SPEAKER_03 23:14

Um, well, again, uh congratulations on the article. It's it's it's a good article. I I commend it to anyone uh to take a look at. Um one of the questions, like final questions I had uh based on the article, there are plenty of other things to talk about. But um I jotted down um this concern. Uh if uh if you do have to to leave and go to an infusion uh suite, but you're a um a home care recipient, do you risk not being homebound uh by the fact that you have to go outside the home in order to get uh the infusion therapy that you need?

SPEAKER_01 23:53

Yeah, I mean it's an interesting question, and because homebound doesn't necessarily mean you're trapped there. You can leave for medical appointments. You know, I'm thinking my mom just had a knee replacement, so she's receiving home health, traditional home health. She can leave, but it requires her walker. So if you can satisfy those requirements potentially, I I think it would still meet their requirements, but I think that's a slippery slope too, because am I gonna get an infusion every month and still be considered homebound and go to this appointment? I don't know.

SPEAKER_03 24:31

Yeah, I don't, yeah.

SPEAKER_01 24:32

They they just they're not married very well together. And and it's the different layers. It's the license, it's potentially pharmacy license, home health license, it's the Medicaid, it's the two different types of Medicare or three different types of Medicare, if you think about DME. Um, they're all kind of layered on top of each other.

SPEAKER_03 24:50

And and is the demand for infusion um growing, or are there more uh conditions that can be treated in the home or in the infusion centers than previously?

SPEAKER_01 25:01

Or it's definitely growing. Um, and I think you know, a lot of it's probably the reimbursement-driven decisions that are being made. And I'm not talking about Medicare, Medicaid, but more on the private pay side. Um for pharmacies to be able to deliver the drugs and have them administered. I think sometimes the reimbursement effect could be improved in different locations. And so they're looking at those different issues or even reimbursed at all.

SPEAKER_03 25:31

Well, those are all the questions I have. Do you have a closing statement you'd like to any final comments as we close out our podcast here?

SPEAKER_01 25:41

Yeah, I mean, thank you for the opportunity to you and to the practice group and to HLA generally. You know, it's an area that's been really fun for me to learn. Um, you know, it's been, I don't know, maybe 10 years that we've been kind of tackling these issues. And it's a very slow moving process. I think the IV hydration and med spa uh, the guidance, the regulators kind of paying attention, I think that's gonna be the movement to change in this industry. But other than that, you know, as a regulatory lawyer, it's really kind of fun. What does the license say and or or? You know, there's a lot of that going on.

SPEAKER_03 26:24

Well, it looks like a good area to keep an eye on. And if you want to do that closely, why get involved with the American Health Law Association, specifically our practice group, the uh the POWs group, which is the long-term care uh group within the AHLA. Lots of opportunities to uh uh matter of fact, um when I first um started my first health law job, I didn't know anything about health law. Um, and everything I ended up learning other than on the job, I learned by going to AHLA seminars. So uh so you can uh you can really stay on top of uh what's going on in our field uh through through this organization. So Jaya, thank you very much for um undertaking uh this article and for uh participating in the podcast today. And I'm sure if people have questions, they can contact you at Corals and Brady at the Chicago office and you'll be glad to chat with them.

SPEAKER_01 27:23

So that sounds good. Thank you very much.

SPEAKER_03 27:25

Thank you.

SPEAKER_00 27:31

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