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

David G. (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 CaptureRx. For more than 20 years, CaptureRx has helped safety net providers and pharmacies achieve their objectives through leading 340B solutions. Their solutions handle the complicated time-consuming tasks associated with 340B compliance, giving you more time and resources to achieve your mission, and do what you do best, care for patients in need. Our guest today is Danielle Sestito, the system director for the 340B program at Northwell Health in New York. We spoke with Danielle about her systems experience tackling one of the nation's worst COVID-19 hotspots back in the spring, how Northwell has geared up for the recent rise in cases in the New York area, and what other hospitals might learn from their efforts to prevent drug shortages while ensuring strong 340B operations and compliance. But before we go to that interview, let's take a minute to cover some of the latest news about 340B.

David G. (01:26):
The Trump administration has been putting its final stamps on the healthcare system in the remaining weeks before the Biden administration takes over. One of these recent developments includes regulations to test out how Medicare can start paying hospitals and physician offices for some drugs, based on what other developed countries pay for those same medications. The so-called most favored nation plan could decrease 340B savings for hospitals included in the demonstration, but that will not happen until 2022 at the earliest. And the regulations likely will face legal challenges before then. A separate final rule announced the same day, seeks to replace rebates that drug manufacturers pay Medicare pharmacy benefit managers with upfront discounts that would be passed on to patients. This move also could have 340B implications, because of the way certain prices and discounts would be calculated under the new regulations. The administration noted that it did not model what those 340B effects might be.

David G. (02:37):
This final rule is likely to be subject to litigation as well, and could face scrutiny from the incoming administration. And United Therapeutics officially became the fifth drug manufacturer to cut off 340B pricing to covered entities for drugs dispensed to contract pharmacies. The company which produces several drugs used to treat pulmonary hypertension and pediatric neuroblastoma said it would be phasing in the new restrictions. Starting May 13th, United will accept orders for 340B drugs dispensed at contract pharmacies only from covered entities that agree to submit prescription claims data that the company is demanding. You can learn more about all these developments in the show notes for this episode.

David G. (03:29):
Now, for today's feature interview with Danielle Sestito, with Northwell Health. Northwell is New York's largest healthcare provider, with 23 hospitals and nearly 800 outpatient facilities serving New York City, Long Island, and Westchester County. The national COVID-19 caseload recently hit a new record high for the third time this year. And the virus is affecting regions of the country that have not seen as many cases so far. But hospitals in the Northwell system are aware of what it will take to handle the latest surge. Danielle and her colleagues gained valuable knowledge during the past months that they now are sharing as best practices for the benefit of other 340B systems in the hospitals. Myles Goldman sat down with Danielle to discuss. Let's hear that conversation.

Myles Goldman (04:18):
Hi, I'm Myles Goldman from 340B Health, and I'm joined today by Danielle Sestito, the system director for the 340B program at Northwell Health. Danielle, the third wave of COVID is upon us. And I'm looking forward to discussing with you everything that Northwell learned from the outbreak earlier this spring, welcome to 340B Insight.

Danielle Sestito (04:40):
Thank you, Myles, and thanks to 340B Health for having me here. I'm pleased to be here with you today.

Myles Goldman (04:47):
Before we recap Northwell Health's experiences with COVID from earlier this spring, I wanted to ask how Northwell is doing today. How are you doing?

Danielle Sestito (04:58):
Myles, we've actually seen quite an uptick in cases as we speak here today. At our lowest point over the summer, across our 23 hospitals, we had less than 100 COVID patients admitted. Fast forward to today where we see approximately 300 COVID patients admitted. So there's been a threefold increase. So we're definitely seeing an uptick, and we're preparing for a resurgence.

Myles Goldman (05:25):
How's that been for the pharmacy team in terms of the amount of hours you're all putting in, et cetera?

Danielle Sestito (05:32):
So right now, as far as hours being put in, it's our usual, we always work a lot of hours at the pharmacy team, especially at the corporate level, but we've been preparing for a resurgence since the summer. So we pretty much have all of our ducks in a row at this point. So there's not anything we're doing right now to scramble. We're actually in a really good place if a resurgence were to come about.

Myles Goldman (05:56):
And that's a great segue to discussing what Northwell learned from the spring that has helped you all prepare for this fall. Northwell treated 3,500 inpatients for COVID-19 during the peak of the New York City region's outbreak in April, and 30% of those patients were in the ICU and on ventilators. During the initial stage, what challenges were you facing in the pharmacy?

Danielle Sestito (06:21):
So Myles, our initial challenges, believe it or not were clinical. So at that time there were no evidence-based therapeutics available. There were no FDA-approved medications. There was a ton of speculation. So we really didn't know how to treat these patients at that time. So we rapidly developed a clinical outcomes committee, a clinical kind of sort of a clinical advisory committee. And what they did was they monitored patients that were in the hospital. They looked at the medications they were on and the outcomes, and they started developing clinical guidelines right from the start. And they were constantly updating those guidelines based on whatever evidence or studies were coming through that day, literally. We also leveraged our pharmacists, their expanded clinical privileges to support adherence to those guidelines. Since they were rapidly changing, we required a lot of pharmacy intervention and monitoring, putting pharmacists on the ICUs in places where they may not have been before. And that proved to show pretty positive outcomes.

Myles Goldman (07:30):
I can't imagine going through all the unknowns that you were trying to determine on the fly.

Danielle Sestito (07:37):
Yeah, it was tough.

Myles Goldman (07:38):
Let's talk about those operational challenges, and specifically what they meant for the 340B program.

Danielle Sestito (07:47):
Sure. So here we have a pandemic where many patients were ventilated, and our first operational issue in the pharmacy was making sure we had all the drugs that were required. And then when you get into a position where you're scrambling to buy drugs, my first concern is how do we maintain 340B compliance when we're just trying to get enough drugs in-house to treat our patients. So we quickly had to start these pharmacy buyer calls three days a week, and we would discuss strategies on how to purchase things, purchasing challenges, what was on back orders, what was on allocation, how to overcome these challenges, how can we leverage each site? How can we borrow and transfer? So we had to employ our 340B borrow and transfer policies very early on. I had to reinforce what those were and proper record keeping for such. The qualification for the patient definition and 340B eligibility, that remained the same throughout COVID.

Danielle Sestito (08:53):
But we did develop, we did open a lot of surge locations, and those were evaluated on a case by case basis to assess 340B eligibility. And as long as the patient definition was met, these were considered 340B eligible locations. We also worked very closely with 340B Health and Apexus to ensure our compliance. We monitored all the updates that 340B Health was providing, all the updates that Apexus was providing. Our main goal, Myles, was to make sure that we never ran out of medication. So we leveraged a warehouse that we have to augment the purchasing for our hospitals. So this warehouse would order. And then if a hospital was running out of something, and they couldn't get it from their wholesaler, we would have the warehouse push it to those hospitals. So we had a really good process in place to ensure that nobody ran out of medications. And we actually never did encounter a situation where we ran out of something.

Myles Goldman (09:55):
The flexibilities that HRSA provided in terms of 340B, can you talk a little further about how those flexibilities provided relief for Northwell?

Danielle Sestito (10:06):
Sure. The surge capabilities with the new surge locations and all of the guidance or recommendations put forth about having those qualify for 340B eligibility really helped us a lot in that we were still able to purchase 340B drugs for those brand new locations. Some of which may have been in a parking lot, or some of which may have been an offsite location that was no longer being used before. So not having to register those on the HRSA database, that worked very well in our favor. Another huge one for us was HRSA allowing us to order on the GPO account if we were able to prove that 340B and WAC were out of stock. The edict from HRSA was that as long as we maintain records, that we couldn't purchase it on a 340B or a WAC account, we were able to purchase it on the GPO account. That really helped us a lot. So I think those are the two huge flexibilities that really came in beneficial for us during that time.

Myles Goldman (11:07):
You had mentioned to me that establishing strong relationships with drug manufacturers was also helpful during the pandemic.

Danielle Sestito (11:16):
We often found them was harder to get the medications through the wholesalers. So what we found to work really well was to go straight to the manufacturers and develop good working relationships with the manufacturers, and having those drugs that we needed sent directly to us from the manufacturers. And we did this for a variety of different medications, and we still have those relationships with those manufacturers today. I think that's one thing that I recommend that other hospitals should look towards doing.

Myles Goldman (11:49):
More patients throughout the country are under financial duress due to high unemployment and uninsurance rates. What role does 340B play in helping Northwell maintain access to care for these patients?

Danielle Sestito (12:05):
So I think the big thing there, Myles is that by leveraging the 340B program, Northwell is able to provide discounts on medications to qualified patients if they're experiencing financial distress. So that's the one way right now that 340B is playing a huge role. Overall, 340B allows the health system to offer programs to patients such as medication therapy management, follow-up calls regarding their medications, checking on adherence, and making sure they refill their medications. So these are all things we did before, but these are things that we did more so during the pandemic and that we will continue to do, but we can say that 340B really does help us for any patient experiencing financial duress. It will allow us to give them a steep discount at some times in order to be able to help them receive that medication.

Myles Goldman (13:01):
And now let's talk about moving forward. We know, as you referenced earlier that Northwell like many hospital systems has spent the summer and the beginning of this fall preparing for the next surge. Are there best practices that you would recommend to other pharmacists who are right in the middle of this as well, which I realize this is most pharmacists at this point.

Danielle Sestito (13:27):
We started resurgence planning I would say most likely around May-ish. And what that looked like is we had, I would say three times a week, maybe more, calls with our buyers and directors of pharmacy outlining our plan for resurgence, the drugs that we needed to flex up on our purchasing, when we should start flexing up that purchasing, because there's only so much space in a pharmacy to be able to store things. So we took a very calculated approach to that. What we did, Myles, also is that we leveraged data analytics. So we would review on a daily basis. Once we knew the drugs that were where the high, high volume drugs being used, we were able to leverage data analytics to determine run rates of those drugs, and be able to order based on those run rates. And then again, if we saw that a site was running low and wasn't able to purchase that from the wholesaler, we had this backup warehouse who would just push drugs to these sites to ensure that they never ran out.

Danielle Sestito (14:33):
I think communication, Myles is really, really key. So keeping in constant communication with the site level directors of pharmacy and buyers was also something that we learned, worked exceptionally well. So not only did we talk to these buyers about what they should be and what they should be storing, and three 40 B compliance, we also let them know everything that was happening in the health system on a day-to-day basis. How many COVID patients do we have? How many vented patients do we have? What's going on in New York City as a whole? What's going on in New York state as a whole? So there was a lot of communication at all times.

Myles Goldman (15:13):
I appreciate you sharing all those best practices with our listeners. I find the data analytics piece that you were talking about really interesting. How long has that been in place for prior to the pandemic?

Danielle Sestito (15:25):
So that was something that we started during the pandemic, especially for those drugs, such as Remdesivir or many of the drugs that were used for the vented patients, so that we would be able to establish a run rate. And we felt that that would be the best way to stay on top of everything, is trying to estimate what the run rate is, and being able to have certain par levels of drugs based on the run rate.

Myles Goldman (15:51):
We are encouraged to see that several promising COVID-19 vaccines are in development. And some of them require being stored in extremely cold temperatures. What is Northwell doing to prepare for the distribution of these COVID-19 vaccines once they're ready?

Danielle Sestito (16:11):
Great question Myles. We've actually built a cold chain infrastructure for receipt and storage of the vaccines. So that's been done. That's completed. We have all the means necessary to store these vaccines. And then once our hospitals have been enrolled to be able to receive the vaccine, and that's as soon as that emergency use authorization is approved, we'll be able to go ahead and start distributing that vaccine now. So Myles, we're working closely with state and federal governments, as well as the local community leaders regarding the distribution of the vaccine. So that part of the process is still in talks, but we're working for a distribution plan at this time. And we're anticipating that by the end of December or early January, we should have the vaccine in hand in our facilities.

Myles Goldman (17:02):
And how does Northwell plan to help patients with chronic conditions that aren't directly COVID-19 related, still maintain access to services and medications for what could be a very long and difficult winter?

Danielle Sestito (17:18):
We have ways that we're going to work through that. So we have medication access coordinators. We've always had those, and they follow-up with patients regarding their medications and perform MTM, medication therapy management services. So that's something that was still employed during COVID where these pharmacists would be doing these things in person, but they were relegated to making phone calls and doing everything from home. So that, in tandem with our mail order pharmacy, we feel that we'll be able to get medications to patients, even if they can't come out of their home, or if there's a shutdown and they don't want to come out of their home.

Myles Goldman (18:01):
340B plays a role in the mail order pharmacy, right?

Danielle Sestito (18:05):
So yeah, 340B definitely plays a role. Fortunately, our mail order pharmacy is a contract pharmacy to all of our 340B covered entities. So we see no gaps there regarding 340B eligibility. Those scripts will remain 340B eligible as they did during the pandemic. So fortunately we won't have any losses there regarding 340B eligibility.

Myles Goldman (18:30):
We've covered a lot of innovations today. And so wanted to see if you sort of wanted to recap for us which of these innovations you see continuing post-pandemic.

Danielle Sestito (18:43):
So Myles, I think the one thing we didn't talk about, which I was waiting to talk about is telemedicine. So telemedicine was something that pre-pandemic maybe wasn't widely used, but really gained a lot of traction during the pandemic. And luckily HRSA, as long as these visits are registered in a 340B eligible manner, we get the 340B credit for those, which is great. So I think that telemedicine, for patients who can't come out of their house, to dovetail off of your previous question, the telemedicine combined with the mail order pharmacy are two great innovations that occurred that I think will continue post-pandemic. The telemedicine is really taking off. And I think that's something that was a great, if we can say that, great outcome of the pandemic.

Myles Goldman (19:32):
For sure. Well, Danielle, we have covered a lot of ground around COVID-19 and Northwell's response and what's ahead. And I certainly thank you so much for joining us today. It's been inspiring to hear Northwell's story.

Danielle Sestito (19:48):
Thank you, Myles. I'm happy to be here today.

David G. (19:53):
Our thanks again to Danielle for sharing Northwell Health's experience with other hospitals that are heading into an uncertain winter. We're happy to hear that Northwell and others are preparing to start distributing COVID-19 vaccines soon to the healthcare providers and patients who need them the most. Do you have any unanswered questions about COVID-19, or any of your own pandemic best practices to share after hearing today's episode? As always, if you have any questions or comments about any of the items we cover here at 340B Insight, please email us at Podcast@340Bhealth.org. We will be back in a couple of weeks for the final podcast episode of our 2020 season, during which we will check in again with 340B Health CEO Maureen Testoni on our response to the latest drug manufacturer moves against 340B, and recap some of the other important developments for the program that occurred this year. Until then, thanks for listening, and be well.

Speaker 1 (20:57):
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, @340BHealth. And submit a question or idea to the show by emailing us at Podcast@340Bhealth.org.