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

David Glendinning (00:13):
Hello from San Diego. And welcome back to 340B Insight, the podcast about the 340B Drug Pricing Program. I'm David Glendinning with 340B Health. We are coming to you from our booth, just outside the exhibit hall at the 340B Coalition Winter Conference, which starts January 31st and runs through February 2nd. We will be speaking with conference presenters and attendees while we are here in San Diego. If you are attending the conference, please come by the booth to see a recording in progress or to say hello. Our guest today is Leslie Pires, Director of Specialty Pharmacy and 340B for Care New England Health System in Rhode Island. We spoke with Leslie about the rise in hospital-owned specialty pharmacies and how this has intersected with the 340B Program. But before we go to that interview, let's take a minute to cover some of the latest news about 340B.

David Glendinning (01:06):
The drug giant Bristol Myers Squibb has announced it will become the 12th drug company to impose restrictions on 340B pricing for drugs dispensed at contract pharmacies. The new policy will take effect March 1st and has two parts. One for a set of Celgene products known as IMiD, drugs, and another for the rest of the BMS drug portfolio. This makes the development more complex than other companies' contract pharmacy policies to date. 340B Health members can access more details about the BMS news in the show notes.

David Glendinning (01:45):
On Capitol Hill, a bipartisan group of representatives has sent a letter about the contract pharmacy issue to Health and Human Services Secretary, Xavier Becerra. The lawmakers from both sides of the political aisle are concerned about the growing number of drug companies imposing contract pharmacy restrictions and are calling on HHS to expedite enforcement actions against these companies. You could read the letter by visiting the show notes.

David Glendinning (02:18):
And now, for our feature interview with Leslie Pires with Care New England Health System. Leslie is a long-time 340B champion and a leading advocate for the program. She also is an expert on specialty pharmacies and she knows what it takes for a 340B covered entity to stand up and operate an effective, compliant specialty pharmacy. Our own Myles Goldman recently sat down with Leslie to hear more about that. Here's that conversation.

Myles Goldman (02:45):
Thank you, David. I'm joined by Leslie Pires. Welcome to 340B Insight.

Leslie Pires (02:51):
Thank you, Myles. It's nice to be here.

Myles Goldman (02:53):
Help us become more familiar with your health system, Care New England. Tell us about the health system and the communities it serves.

Leslie Pires (03:00):
Care New England is a health system that's located in Rhode Island and consists of three hospitals. There's a medical hospital, a woman's specialty hospital and a behavioral hospital. Two of the hospitals are 340B DSH hospitals.

Myles Goldman (03:16):
Let's jump into specialty pharmacy. I've read a lot in healthcare and pharmacy publications about how hospital-owned specialty pharmacies are becoming more common in recent years. Why do you think that is?

Leslie Pires (03:28):
More and more hospital systems are starting their own specialty pharmacy. And I think there's many, many reasons. And I could answer that on different levels, but I'm going to start with my most important mission, and I believe it's our health system's mission, is quality. How do we take care of the patient? If we have a specialty pharmacy owned by a hospital, then it is an integrative care model. And what I mean by that is the pharmacists and the pharmacy are part of the hospital. So we can see the patient's EMR, the medical record. We have an interface and a relationship with the patient's doctors and care providers. We can see the patient's lab results, their diagnostic imaging. We know the plan of care. So we're part of the team. If you're a specialty pharmacy that's external to the health system, you don't have that insight into the plan of care for the patient.

Leslie Pires (04:26):
So quality is definitely our most important advantage, but there are other advantages, Myles. Take service. The patients like not having to get their meds from an external pharmacy that they have to wait for or access. We can get them their specialty meds sooner. There's often a shorter turnaround time. And if you're talking about a disease state, such as oncology, that time to treatment, the time the doctor decides that they're going to put a patient on therapy, the time you can start, if you can shorten that, that's clinically advantageous. And lastly, financial. If you think about these drugs, they're very expensive drugs. And they're getting more and more expensive as we go. And by owning our own specialty pharmacy, we can invest our 340B savings into furthering that safety net mission.

Leslie Pires (05:16):
For example, we have liaisons, which are pharmacy technicians, embedded in our clinics and they can help with obtaining financial assistance for our patients. So they can look for grants, for foundations, for patient assistance programs, or they can tap into our health system's charity care. All of those are 340B supported. The liaison salaries comes directly from 340B dollars. And so we can know that the patient is on the therapy and that there were no barriers, financial barriers, to care that might lead to non-adherence.

Myles Goldman (05:53):
So Care New England decided to launch this specialty pharmacy. Tell us what then went into the planning of putting it together and making it a reality.

Leslie Pires (06:03):
Well, that was kind of a fun project. We started in June of 2019, when the Chief Financial Officer of the entire system called me to an appointment and said, "We'd like you to open a specialty pharmacy." That was a meeting that changed the next two years of my life, dramatically. We had to identify the departments and the key stakeholders, because the key stakeholders, it really takes the entire health system and it was good that we had support right from the start from our executive leadership. Some of the departments we needed were Facilities, where the pharmacy is today was grass at that time. We needed IT, because we had no health system. We had no ambulatory pharmacy at all. We obviously, needed Finance involved. We needed Operations. We were going to have to hire staff, and a manager, and pharmacists and technicians, so we needed HR, Human Resources.

Leslie Pires (07:01):
We needed help with contracting. We had no contracts with anybody. So we had to figure out how we were going to be paid for these medications. We needed to work on licensing. So that was a lot of legal involvement. We had to get just a basic pharmacy license. And then later on in the process, we had to learn how to become accredited, which we can talk about later. But accreditation is very important for a specialty pharmacy. One of the most important things I think we did was we took four hours and we did mapping. We called it mapping the critical path. We basically made a Visio flow chart that included every goal on a timeline that went from June until when we wanted to open. And we had to figure out the intersections between the two teams. We couldn't have licensing happen before we had the facility, because the Board of Pharmacy had nothing to come in and inspect.

Leslie Pires (07:53):
So that came up with a very long Visio diagram, which I've kept as a souvenir. So then we had leaders from each team who would meet weekly so that we had cross pollination between the groups. We didn't want the groups working in silos. We established an Executive Leadership Governance Committee and that had leadership and executives, the presidents from health systems and the operating units, which are our hospitals to keep them informed. The Governance Committee also did a few other things for us. One is it held each team accountable. We knew that we were going to be reporting on our milestones and our deadlines. And we did not want to report to our upper executives that we weren't on time.

Leslie Pires (08:35):
And the other thing that the Governance Committee could do for us was resolve barriers. If we had an internal barrier that was maybe freeing up labor resources, those executives could say to the departments, "This is a priority." And that did happen. And we were very lucky that we had executive sponsorship. We went from that initial conversation in June of 2019 to opening on April 5th, 2020 in the middle of the pandemic. So that wasn't very long to build an entire pharmacy, to order all the equipment, to stand up IT and to get all those licensings. It was because of the team.

Myles Goldman (09:14):
You mentioned earlier some of the advantages for having a hospital-owned pharmacy. What are the pitfalls, potentially?

Leslie Pires (09:22):
Some of the pitfalls are going to be similar to other independent pharmacies and that is going to be payer and drug access. I think those are the biggest challenges for us, is that a commercial payer is not going to let us into their specialty network without accreditation. And they also really don't want to let us in, because they'd rather give it to their specialty pharmacy that they own, that's within their business model.

Myles Goldman (09:51):
I want to segue into talking more about the intersection between specialty pharmacy and 340B. So just to start off with, how does the 340B Program come into play with specialty pharmacy operations?

Leslie Pires (10:06):
It means that we have to meet all of the compliance requirements of the 340B Program. So we need to make sure that the dispenses that we make using a 340B purchase drug are compliant, so that if your doctor is eligible, your location of care is eligible. We can demonstrate responsibility for care. We can make sure that there's no Medicaid fee for service. So we have all of the same requirements, but we need to operationalize those. So we did this through our EMR and we basically, wrote some rules that were pretty creative. We worked very closely with our IT team. So that at the point of dispense in real time, we know if it's a 340B dispense or not, because in Epic we have loaded our eligible doctor list. And we update that every month. We have loaded our locations of care that are acceptable. We know the patient's insurance.

Leslie Pires (11:07):
So the pharmacist, at the point of dispensing, knows whether it's a 340B dispense or not, all right? That's really helpful, because the pharmacists actually double check us. So we have both a computer trying to determine eligibility and a pharmacist that's educated in 340B.

Myles Goldman (11:26):
In terms of the compliance aspect to 340B in specialty pharmacy, do you think there's unique elements to specialty pharmacy that make 340B compliance more or challenging, or less challenging for that matter?

Leslie Pires (11:41):
Yes, definitely. I think some, when you're getting into the LDD, limited distribution drugs, some manufacturers will only sell to a 340B account. And then some, as we know, Myles, with the manufacturer's challenge, will not sell to a contract pharmacy. So there's challenges in both directions, right? Some will sell to us and some won't sell to us. Some want data. Some want modifiers. Every manufacturer and every payer wants different reporting and different sets of information. So there's a lot of reporting requirements around specialty drugs, and especially around 340B.

Myles Goldman (12:21):
You talked about it earlier with 340B supporting services in the specialty pharmacy. Can you speak a little bit more to that?

Leslie Pires (12:30):
Sure. There's a patient right now that we're giving a free drug to. Our liaisons have been trying diligently to get assistance for this patient, who has limited means. She has metastatic breast cancer. She was started on [Verzenio 00:12:43] in the summer. And we were unable to get her financial support, so we have been giving her free medication. These are fairly expensive medications. In October, she switched to [IBRANCE 00:12:56], which is another drug used for metastatic breast cancer. And we are still waiting and trying to get that through a patient assistance program. And so we have been providing her drug free of charge. And that's been going on for seven months now. But if we didn't have our 340B dollars and we were not able to, that would be a significant, significant dollar outlay to be able to provide that medication to our patient.

Myles Goldman (13:21):
For 340B hospitals looking to further develop a specialty pharmacy program, what would your top piece of advice be for them in terms of building or growing their specialty pharmacy program?

Leslie Pires (13:36):
I think I'd borrow from a quote that, "It takes a village." And that village needs executive support. If you do not have that executive support, right from the top of your organization, I wouldn't even start. I could call this executive sponsor one-on-one any time that I needed help and he would break down barriers or give me advice. The other thing I would do is I would go into with my eyes wide open and anticipate that you will lose money for at least one to two years. We, basically, put in a negative budget anticipating losses for the first two years. So I think anticipating that budget so that you have the funds that you need to bring the project to completion.

Myles Goldman (14:20):
You've mentioned, Leslie, a couple times the importance of the accreditation process for specialty pharmacy. So I want to make sure we get a chance to delve into that. Tell me more about why is accreditation important, who does the accreditation and what the process is like.

Leslie Pires (14:36):
Let me start, Myles, with who, because that's the easy part. There is a company named URAC. And URAC is generally, I would say, the one that some payers and manufacturers list specifically. And then there's your ACHC, the joint commission. We at Care New England Pharmacy are accredited by URAC and ACHC. And accreditation is vital in many ways. If I think about it altruistically, it's important because it holds us accountable. It gives us an organized structure to make sure we have policies and procedures and that we haven't forgotten any important aspects, such as patient rights or anything, employee protection, education. There's so many different areas that accreditation addresses and it keeps us honest.

Leslie Pires (15:26):
But from a practical point of view, the many payers, or all commercial payers, and many manufacturers will not allow you to enter the specialty space unless you are accredited by at least two accrediting bodies. And so you can get into the dispense specialty meds for your government payers, such as Medicare, or TRICARE with the military, right away, right out of the gate. So that's where you get your experience. And that's where you get your volume. And that's where you get the data that you can support that you are meeting these standards. But to get into the commercial space and to get into the LDD, the limited distribution drug space you do require accreditation.

Myles Goldman (16:09):
Well, that's definitely helpful for people to know that's part of their journey as well to specialty pharmacy. Leslie, thank you for joining us to share your insights and experiences managing your specialty pharmacy. You've given us certainly a lot to think about.

Leslie Pires (16:26):
Well, thank you, Myles. It's been a pleasure to speak with you.

David Glendinning (16:29):
Our thanks again, to Leslie Pires for the tutorial on 340B specialty pharmacies and for all her advocacy on behalf of the 340B Program, safety net hospitals, and the patients they serve. And we thank all those who are here with us in San Diego to attend the 340B Coalition Winter Conference. Although we have enjoyed staying connected virtually with you over the past two years, we are excited to be back in person with you again. Again, please stop by the booth to say hi. And if you're listening from somewhere else, we would still like to hear from you. Please email episode ideas and feedback to podcast@340bhealth.org. We will be back in a few weeks. As always, thanks for listening and be well.

Audio (17:16):
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.