Speaker 1 (00:04):
Welcome to 340B Insight from 340B Health.

David (00:12):
Hello from Washington DC, and welcome back to 340B Insight, the podcast about the 340B Drug Pricing Program. I'm David Glendinning with 340B Health. This episode is sponsored by Comprehensive Pharmacy Services. CPS guides covered entities in achieving audit preparation and compliance through a robust suite of 340B solutions. Serving more than 800 hospitals and health systems, CPS implements processes that ensure clinical, operational, and financial excellence. For more information, please visit 340Bexperts.com.

David (00:48):
Our guest today is Dr. John Carlo, the CEO of Prism Health North Texas. Prism participates in the 340B program as a Ryan White Clinic. Ryan White Clinics care for people living with HIV/AIDS and are a vital ally in the 340B community. We wanted to hear more about how safety net hospitals and clinics work hand in hand to provide vital care to the communities they serve. But before we go to that interview, let's take a minute to cover some of the latest news about 340B.

David (01:27):
Since we last came to you, there have been several developments in the battle over drug company denials of 340B discounts to covered entities that partner with community pharmacies. The federal government has filed strongly worded motions in federal courts pushing back hard against drug manufacturer attempts to block the department from enforcing the 340B law on this issue.

David (01:50):
A separate joint federal lawsuit that 340B Health and allied hospital and pharmacy groups had filed against the Department of Health and Human Services over this matter has been dismissed on procedural grounds. These government filings in the active cases, make it clear that HHS is fully aligned with 340B hospitals in stating that these drug company actions are unlawful. This will be critical in the weeks to come as the Biden administration takes control of department policy and determines how to proceed against these companies.

David (02:24):
In his Senate confirmation hearings, the person nominated to take over HHS, California Attorney General Xavier Becerra said 340B is indispensable and vowed to enforce the 340B law once he is in office. In another sign of the powerful support for 340B providers, more than half of the house of representatives, 226 lawmakers from both sides of the aisle, signed a letter to the acting HHS secretary calling for immediate enforcement actions against the manufacturers. Check out the show notes for the latest information on the contract pharmacy issue.

David (03:09):
Now for our feature interview with Dr. John Carlo, CEO of Prism Health North Texas based in Dallas. Dr. Carlo, a surgeon by training, is a member of the Council on Science and Health at the American Medical Association, and he previously served as President of the Dallas County Medical Society. Myles Goldman sat down with Dr. Carlo to discuss some of his more recent experience serving patients with the help of 340B, how Prism Health is working to overcome the challenges of serving its patients during the pandemic, and innovations in HIV care. Here's Myles with that conversation.

Myles Goldman (03:46):
Thank you, David. I'm joined by Dr. John Carlo, the CEO Prism Health North Texas. John, thank you for joining us, especially given the circumstances of the last few weeks for you in Prism Health. I'm sure many of our listeners have heard or read about the devastating and unusual winter storm that hit Texas hard a couple of weeks ago, causing power and water outages across many parts of the state for days. How has the storm affected the community Prism Health serves and how has the storm affected your ability to serve your patients?

Dr. John Carlo (04:17):
Well, first, thanks for having me on today. It is an honor to be here and it has been an especially difficult week. Texas has had cold weather before. It's not normal, of course, but we do occasionally see it, but this was completely different. In addition, to our roads being really dangerous, what we really lost was infrastructure and without power and electricity, without communications, and without water, it's hard to do just about anything in terms of the health services that we provide, and so this was an unprecedented loss.

Dr. John Carlo (04:51):
We were closed for over a week, which we have never had happened before. In addition, it's somewhat ironic, I guess, that even our telehealth services, which really came into its own thanks to the coronavirus pandemic, we couldn't even connect to our patients via telehealth because none of our docs had internet connection in their homes. Thankfully, we've gotten all of our health services backup with the exception of one clinic, which had a bursted pipe and that's going to take weeks to repair, but we're coming out of this okay and trying to catch up as best we can.

Myles Goldman (05:23):
Well, I'm glad to hear things are starting to turn around. Let's take a step back now and tell us more about Prism Health North Texas and the demographics of the patients you serve.

Dr. John Carlo (05:35):
So we are an organization that started in 1986 in the midst of the HIV and AIDS crisis. We started as an organization named AIDS Arms Incorporated, and we've recently changed our name because thankfully, because of today's treatment, it's less about what we were dealing with in the eighties and more about really providing good healthcare and effective treatment for people living with HIV and even preventing HIV.

Dr. John Carlo (06:01):
So today we're an organization that takes care of just over 5,000 people living with HIV. We have an additional 2,000 who are on prep or pre-exposure prophylaxis for HIV, and then we have an additional 8,000 folks that are in our primary care systems. We operate a fairly large system with four health centers and really as remarkable as that sounds with the amazing growth, what we still continue to focus on is the number of people that lack health insurance or are under-insured. And so we have a large percentage, up to 30% overall, in a couple of our clinics it's as high as 80%, of individuals that don't have insurance. And really, that's where our primary focus is to make sure that we can provide healthcare for everybody.

Myles Goldman (06:50):
Ryan White Clinics are grantees of the Health Resources and Services Administration's Ryan White HIV/AIDS Program. The clinics provide HIV/AIDS treatment and related services to people who are at risk of or living with HIV/AIDS and who are uninsured, or as you mentioned, under-insured. Ryan White Clinics are one of 16 340B covered entities. Can you share with us how 340B drug pricing helps Ryan White Clinics and Prism Health specifically serve your patients?

Dr. John Carlo (07:21):
Well, the 340B program is absolutely critical for Ryan White funded clinics and really, the overall goal that we now have in front of us, which is actually to remarkably end the HIV and AIDS epidemic in this generation, and we couldn't do it without the 340B program. The main way I look at it from a basis of HIV care, the Ryan White system is one of the only systems and is actually the only disease in this country that has its own specific independent, legislatively funded, healthcare delivery. There's really no other disease or condition that's got independent treatment dollars allocated to it from the federal government.

Dr. John Carlo (08:01):
But with that being said, just like all of our federal funding that has been not up to the amount that's necessary to provide the increasing number of people that need the services, particularly in our community here in North Texas. This 340B program has just been critical because without that the grant funds would certainly not be enough, and we've continued to see more and more patients here in Texas where we don't have a Medicaid expansion.

Myles Goldman (08:29):
And 340B helps, I would imagine as well, because HIV medications are expensive, right?

Dr. John Carlo (08:35):
We have just come a long way. For those of us that have been with this evolution to come from the nineties where we had nothing to today where we have one pill once a day with almost no side effects. So we've come a long way, but the medications are very, very expensive, and that's the other thing. I think we forget about in the 340B program, is that without it we wouldn't be able to purchase the drugs at the prices that we do so that we would not be able to deliver the number of medications that we can, particularly for our uninsured or under-insured patients.

Myles Goldman (09:11):
Does it help you with providing wraparound services?

Dr. John Carlo (09:14):
Absolutely. There's so many things about HIV today that it's more than the treatment, so in addition to the great treatment we have, that's not enough. And often what we're dealing with now is not really the HIV condition itself, it's all of the other things that our patients are faced with on a day-to-day basis that we really have to help tackle that together because otherwise the treatment is not effective and they won't come see us. So everything from transportation, access to additional services, assistance with enrollment into various programs, case management, and also very, very importantly for us, behavioral health.

Myles Goldman (09:54):
Many of our listeners work at 340B hospitals. How does Prism Health and Ryan White Clinics in general work with local hospitals?

Dr. John Carlo (10:04):
I like to think of the network that we create among the hospital systems and Ryan White funded entities and others that are a part of the 340B program as really the medical neighborhood. We simply could not do everything on our own and so we rely on our 340B hospital partners to help us with tertiary care, specialty care, everything from diagnostics and imaging and things that obviously we cannot do on our own as a primary care provider. But we also are a partner in that we can continue to see patients that are unfortunately often first seen at the hospital in the emergency departments.

Dr. John Carlo (10:46):
We still have many patients who are not tested for HIV and come into the hospital settings with PCP pneumonia after years living with HIV and they recover but then they need to go to a medical home after they've been in the hospital. And we can provide that, even for those that don't have insurance. So we like to feel that it's a good partnership where we can come to the table with a lot of support for the hospitals, and then we are very much benefiting from the hospital's support with all of those other things that the hospitals can provide.

Myles Goldman (11:17):
I really like that term, medical neighborhood. Ryan White Clinics in 340 hospitals are both facing drug manufacturers denying 340B discounts to covered entities that contract with community pharmacies. How are the drug company's actions affecting your organization?

Dr. John Carlo (11:36):
This has been really an unfortunate situation that we're seeing. Keep in mind, we are a large health center but we certainly can't operate our own pharmacies, and so we rely on contract pharmacy partnerships to ensure that we can have effective prescription drug access. But in addition to that, we need the network of extended pharmacies because many of our patients are not local. We take care of people several hundred miles away from us in rural communities and other parts, and it is really hard and a lot to ask for a patient that far away to come in for refills, if it's just a refill.

Dr. John Carlo (12:16):
So these actions that are being taken right now, we see as a huge detriment to our care delivery and really run our unfortunate, most risky patients at risk for not getting their prescriptions. And that's really what concerns us the most is how much this impacts our patients. And we have been able to receive waivers in some conditions, but keep in mind that any type of switches like this, it's going to impact our patients. We rely on certain contract pharmacies for our uninsured patients, and when these actions came in we weren't able to use those contract pharmacies for those manufacturers.

Dr. John Carlo (12:55):
And so we had a choice to either figure out how to move prescriptions or how to address kind of that issue because now the patient without insurance, we would either have to buy the drug at that pharmacy location at the retail price, which doesn't make sense because we're using grant funds for those purchases, or we have to figure out how to migrate those prescriptions around. And our experience is anytime you're doing that, moving prescriptions or doing things like that, it's going to result in missed bills, people not getting their prescriptions filled on time, and that's a harm to care and that's exactly what we saw. And really, that's what concerns us about these types of actions.

Myles Goldman (13:36):
Switching gears, I've read a lot about how people with chronic conditions like HIV are delaying care during COVID. Do you see that happening at Prism, and how can we address that so people's health doesn't deteriorate?

Dr. John Carlo (13:50):
I think we're just now getting to a point where we're starting to see the impact and the effects of what COVID has done for much of our extended chronic illnesses like HIV. We're looking at last year, and we saw fewer patients for the first time since our organization really began. It's very frequently that we do lose people, that stop coming to see us, that stop getting their medications filled, but this added crisis, I think just really hit people hard to the point where we lost many, many more than we normally would.

Dr. John Carlo (14:21):
And I'm worried because every time we lose somebody in our care delivery, every time we miss a prescription, that not only hurts that individual and runs the risk of their HIV progressing to severe illness, it also runs the risk of transmission to other people as well. So this is a public health impact that I think will be felt unfortunately, for years to come, and what we're trying to do now is really locate those that missed visits that we didn't see.

Myles Goldman (14:50):
Do you have an example of what outreach looks like when you're trying to reconnect with a patient?

Dr. John Carlo (14:55):
We try to outreach through our patient portal. Many of our patients do not, or had not, elected to be a part of that, but when it is available we can reach out through text messaging, email, and keeping up those messages. But a lot of times, it's really a telephone call. And unfortunately, what we do find is many times our patient's phone number has changed or been disconnected. So then we move to the next step and look for the emergency contact information that is in the record, and sometimes that's not a good contact either and so we miss them there.

Dr. John Carlo (15:29):
And at that point we are at a loss, but one of the things we can do is work with our county health department and see if they have additional information through some of their public health data to see if we can reach folks from that mechanism as well in partnership with the health department. But a lot of times that's as far as we get. One of the things that we focus on with our case management team is that they are mobile.

Dr. John Carlo (15:54):
We find that if somebody is not going to come see us, we'll do our best to come see them, and so our case management and outreach team will get in their cars and go out into the neighborhoods, work with our partners that deal with housing and homelessness to often find people when they've come into those systems. Or sometimes we are out on the streets looking for them under the places in homeless camps as well. So it is a huge effort and it does go back to what the 340 program does for an organization like us, because I can tell you, the grant funds don't support all of those extra amount of hours.

Myles Goldman (16:31):
You mentioned prep earlier, and I wanted to make sure we covered that. Many in public health and the policy community are working to improve uptake of prep as a key strategy for ending the HIV epidemic. What do you see working, and where's there room for improvement? What's the role of 340B?

Dr. John Carlo (16:49):
Well, I think that prep is a great example of where the 340B program is absolutely critical. Somebody can take a single pill once a day and it can prevent HIV infection with remarkable efficacy. We're talking up to a hundred percent if it's taken correctly. While we have grant funds for HIV treatment under the Ryan White Care Act, by statute it explicitly says that you can only take care of somebody that is living with HIV using those grant funds.

Dr. John Carlo (17:18):
So we have this new tool, this great new ability, but yet there's no funding because we haven't gotten around to putting that new infrastructure together. The way we are supporting prep right now is through the sexually transmitted disease 340B program, which allows for us to intervene with prep medications and services as HIV is a sexually transmitted infection, particularly in our community. We now have over 2,000 patients that are on our prep services and programs. We're doing almost a complete, what we call, status neutral approach at this point where we are attempting to make sure we have almost the same case management, behavioral health, linkage services, that we have for our patients, living with HIV.

Myles Goldman (18:05):
And looking at sort of the big picture, what progress do you see being made over this decade towards ending the HIV epidemic? President Biden has talked about ending the epidemic in the United States by 2025. Is that possible?

Dr. John Carlo (18:21):
I think it is possible. I think it's going to take more commitment and support, particularly for those of us that live in the south. We're still seeing rates of new infections continue, and there's more and more people today living with HIV than ever before, thankfully, from the treatment that we have. But that also means we have to have the necessary resources to support that continued care.

Dr. John Carlo (18:46):
It's important to remember that the grant funds that have been allocated for HIV services under Ryan White, they haven't increased at all, a single dollar increase really effectively since 2007. But yet, there's incredibly more and more people that are living with HIV in our community. We have unfortunately, 800 new infections a year still, and so if you look at how much more patients that we have now since 2007, that's where the 340B program has come in to really help us and needs to be absolutely part of what we continue to do.

Myles Goldman (19:20):
Well, John, I know care for HIV is so important to our listeners. It's been great to take a closer look at it with you and hear the perspective of a Ryan White Clinic. We appreciate your time and best wishes with the storm recovery and with the continued efforts against COVID-19 as well.

Dr. John Carlo (19:37):
My pleasure. Thank you for having me and I see us all as partners around this program. It's been so critical for us in the HIV and AIDS community, and we're just happy to have such strong partnerships and share where we have been successful and how important this program is.

David (19:55):
Our thanks again to Dr. John Carlo for discussing how crucial 340B savings are to preventing and treating HIV/AIDS in the Dallas area and throughout the U.S. 340B hospitals are grateful for the partnership of Ryan White Clinics that help support comprehensive patient care networks and provide medical homes for those in need. Keep up the great work, John.

David (20:19):
Thank you to all our listeners who attended the 340B Coalition Winter Conference. Please remember that many sessions were recorded and will remain on demand for 60 days so you can catch up on what you missed and earn continuing education credits where applicable. As always we welcome your episode, ideas and feedback as we plan out future episodes of 340B Insight. You can email us at podcast@340BHealth.org.

David (20:48):
We'll be back later this month. As always, thanks for listening and be well.

Speaker 1 (20:58):
Thanks for listening to 340B Insight. Subscribe and rate us on Apple podcasts, Google Play, Spotify, or wherever you listen to podcasts. For more information, visit our website at 340Bpodcast.org. You can also follow us on twitter at 340BHealth and submit a question or idea to the show by emailing us at podcast@340BHealth.org.