Facing Regulatory, Reimbursement Changes, Pharmacy Execs Also See Opportunities  

A new report from pharmaceutical company Cencora is based on a survey of more than 100 health system pharmacy leaders. LeeAnn Miller, PharmD, vice president of business development and growth at Cencora’s Accelerate Pharmacy Solutions, spoke with Healthcare Innovation about some of the ways regulatory and reimbursement changes are reshaping pharmacy operations.
 
HCI: Before we dive into the survey and report, could you talk briefly about your career? I saw that before joining Cencora, you had been chief pharmacy officer at Yale New Haven Health. 
 
Miller: I was at Yale New Haven Health for over 20 years, and the last six as chief pharmacy officer. Yale New Haven Health is a five-hospital health system across Connecticut and Rhode Island, and the pharmacy enterprise is about 1,200 people, and approximately $2 billion in revenue just from the pharmacy — so a pretty large pharmacy program. We had specialty, retail, and home infusion in addition to our ambulatory clinical care services, where pharmacists partner with the physicians in clinics, and then, of course, we had our acute care pharmacy operations supporting the hospitals.
 
HCI: So you have a lot of experience with the issues that this report dives into.
 
Miller: Absolutely. And this report really resonated with me in terms of both the challenges as well as the opportunities that exist in pharmacy. So it was a good validation of what I experienced and that a lot of my colleagues that I work with across the nation also experience in being a pharmacy leader — a ton of changes and demands put on you, but from a positive standpoint, a ton of opportunity to really connect care with the health system and the patient.
 
HCI: I read that the report this year was intentionally expanded in scope to highlight how pharmacy leaders are serving as connectors across interdepartmental programs and emerging areas of care. Did you see yourself playing that role increasingly at Yale New Haven Health, and are pharmacy execs having to develop new skill sets to play that role?
 
Miller: 100% yes. Pharmacy is definitely a connective tissue within the organization. If you look at the pipeline of pharmaceuticals, it is continuing to grow, and medications represent the primary therapy and treatment for many chronic diseases. With cancer you typically have surgery, radiation and medications. And medications are eclipsing both radiation and surgery, and that’s true for many chronic illnesses. That really puts pharmacy at the forefront of care. I definitely saw that at Yale New Haven Health in my role as chief pharmacy officer, starting just with specialty. 
 
Specialty continues to grow, and many health systems are expanding ambulatory services. That is where care is moving — to the ambulatory side, which is really great for patients, but in order to keep up with that, you’ve got to have a way to connect care to those patients. When you think about specialty medications, these are very complex medications. They're extremely expensive, and they require special handling and education for patients to take it properly. I was able to bring together our clinicians together with our payer access team, with our finance team, and all of our corporate partners together to say, ‘What do we need in order to get these therapies to our patients? There's a lot involved in that, and I was very happy to be able to be that connector. And being able to message the value and the opportunities that exist to our C-suites is really critical, and pharmacists are well equipped to do that, because pharmacy is just as much a business as it is a clinical area now, so having that sort of business acumen as well as a clinical acumen really serves us well.
 
HCI: You mentioned specialty pharmacy, and the report notes that they're entering a new phase of maturity, and that while many health systems have them, there are several challenges remaining. Could you talk a little bit about what some of those challenges are?
 
Miller: This is where Accelerate Pharmacy Solutions is really well positioned to partner with health system pharmacy leaders. There are three main areas I'll focus on. One is payer access. If you look at the report, I believe it says that 50% of scripts are still leaving and being filled externally. One of the primary reasons is, despite best efforts, and I actually saw this at Yale, too, you may not be able to fill it because the payer requires the patient to go to an external pharmacy. So enabling payer access is really important. 
 
The second is manufacturer access. You may not have access to the drug, so even if you're in the payer network, you have to be able to access that medication from the manufacturer. 
 
Last, I'll call it capacity. That might be from a staffing perspective, from a facility perspective, or maybe not having enough advanced technology. Accelerate Pharmacy Solutions meets the health systems where they are. Our patient services technology platform can help health systems do prior authorizations much more efficiently and at scale. With our payer network, we can remove those barriers and get them access, and our relationship with manufacturers can lower the barriers to what they call limited- distribution drugs.
 
HCI: For community hospitals that don't yet have a specialty pharmacy program, and are thinking of launching one, do they tend to partner with an organization like yours? Would it be hard for them to launch it on their own?
 
Miller: Well, what I find is it's usually speed to execution. We can bring you the people, the technology, the workflows needed. There's a lot of administrative lift to get started. You typically have to have two accreditations before payers will even let you into their network.
 
HCI: The report said that while oncology dominates in this space, there are opportunities in other areas of therapy as well, such as rheumatology. What are some health system strategies to retain those therapies in house?
 
Miller: One of the ways that we partner with health systems is to bring pharmacists to the health systems and expand their staff. A nice way to do it is what I call tech-enabled, team-based care, where you have people and technology in the background doing things like prior authorization and documentation or patient financial assistance. We can actually support that through Accelerate Pharmacy Solutions. That allows your pharmacists and technicians to do the direct patient care. 
 
Pharmacists are in a unique position now to enter into collaborative practice agreements. Once a patient gets diagnosed and the physician says they are a good candidate for a biologic therapy, they can refer them to a pharmacist to manage that therapy, make sure you understand it, make sure you can afford it, and navigate all of those financial challenges.
 
HCI: The report notes that the home infusion market is poised for remarkable growth. It showed projections of going from $15.1 billion in 2025 to $31.4 billion in 2034. Why is that area expected to grow so much? And what are some of the benefits to patients and to the health system?
 
Miller: I think it's projected to grow so much for a couple of different reasons. One is consumerism. Patients want care where it works for them, and it's not always easy to navigate a very large health system campus. Bring care to me when it's convenient to me, and sometimes that's in the home, and sometimes home infusion is what I'll call sort of a virtual home in that it's at a convenient suite in a strip mall on the way to work. 
 
Another reason involves payer restrictions. These are typically much lower cost-of-care sites. Employee benefits design can impact this, too. Employers are also looking for lower costs of care. They're designing the benefits to incentivize their employees to find these alternative sites of care. 
 
It's really important for health systems to diversify their infusion strategy. Many health systems have hospital-based infusion, but there is this strong demand for alternative sites. The good news is there is a ton of opportunity for health systems to execute on this. Only about a third that we surveyed have executed on it. 
 
HCI: I want to switch to the 340B program. I know it is quite controversial. Could you give me a little primer on its origins and goals and how it has evolved?
 
Miller: The 340B program was designed to help entities that provide a disproportionate amount of care to the underserved. It was provided to them so that they could purchase pharmaceuticals at a lower cost in the outpatient setting to extend dollars to be able to care for more patients. There are regulatory guidance documents on what needs to be done to qualify to be what's called a covered entity, meaning that you qualify to buy drugs at this lower price.
 
HCI: And there are audits as well, right? 
 
Miller: The federal government, through HRSA, audits covered entities to ensure that they are maintaining compliance with the guidance that they've put forth. And because they are providing the drug at that lower cost, the manufacturers that participate can audit you at any time. And as a covered entity, if you use other pharmacies, which are called contract pharmacies, you are required to audit them. If you add all that up, it's pretty much like every week you are getting an audit.
 
HCI: HHS announced a 340B rebate model pilot program, and then there were lawsuits about it, and then they announced they were scrapping it for now. What was that rebate pilot supposed to do?
 
Miller: We have a system in place where you dispense a drug and assure that the patient qualified, the drug qualified, and the location qualified. Then you purchase the next drug at that lower 340B price. What this rebate model wanted you to do is purchase it at the higher price, and then later, at some point in time, they are going to reimburse you for the difference, because it should have been at the lower price. 
 
When you think about the volume of patients that covered entities see, that is a big financial float they were asking health systems to carry and hoping that all of the transactions that need to take place to reconcile that it truly was qualified for the lower price work seamlessly. We know that there can be challenges there. The administrative burden was really on the health system to have three new electronic databases they need to set up and transmit data to, and you audit yourself, and you need to submit them to the government if you think an error happened. It just was a very long trail of reconciliations that needed to happen, and financially I'm not sure if every health system is prepared to do that, so I don't think they thought through all of the logistic hurdles that this presented, 
 
HCI: But HHS may come back with some other version of this?
 
Miller: They likely will come back with something. I don't know that it will be a rebate model, but I don't think it's the end of the conversation for certain.
 
HCI: The report talks about optimizing rebilling. Why is rebilling a key issue? Does this have to do with how to deal with prior authorization and claims denials?
 
Miller: That is part of it, yes. I'll give you a good example. When I was at Yale, I was meeting with our heart and vascular executive, and he brought to my attention that we had a pulmonary clinic that was under water. He asked if I could find out why. It surprised him, and it surprised me, too. When I looked into it, we had a very large number of denials from that clinic. When I dug into it further, I found out there was not an electronic workflow to support prior authorization. Their staff — it was mainly the nurses who were providing the therapy — was trying to navigate all the insurance requirements, and we did not have our corporate business office supporting them. 
 
One reason was that initially that clinic provided relatively inexpensive therapies like steroids, so just from an efficiency standpoint, there wasn't a huge need to have this back-end office support. Within that year that I was speaking to our executive, however, we had added some biologics that came out for asthma. These were tens of thousands of dollars per treatment, so it changed things drastically, and really highlighted the need to make sure you have electronic processes in place and the staff to support prior authorization. 
 
We brought all the right team members and corporate office together, and we were able to turn that around within one year. We actually reinvested the savings that we saw from that to add pharmacists and technicians who then provided patient education and ensured that the right documentation was in the electronic health record, so there was justification that these appropriate therapies were being given and the prior authorizations would flow through. We were able to see more patients, and the care teams were supported so that they could provide the care to the patients, rather than trying to figure out these insurance forms. 
 
HCI: I’ve been interviewing people both on the payer side and the provider side about better interoperability, the use of APIs, but also the use of AI in these prior authorization processes. Are you hearing a lot about that, too?
 
Miller: Yes. These solutions feature large language models that read your electronic health record and populate the insurance forms. They fill the forms out and bring them directly to you through an integrated portal. They require human review. It is not fully automated. There is a human in the loop, but it speeds the number that you can do and the accuracy of those submissions tremendously. There is huge value with AI in that area.
 
HCI: Last question: Were there any responses in the survey that surprised you? 
 
Miller: I think one that I would call out is the explosion in cell and gene therapy. And I guess it's not surprising, but the readiness isn’t there. It’s a huge lift to be prepared. Only 4% said they were fully prepared. I see the need to partner in this area. You need manufacture access. Cencora is building a comprehensive foundation of manufacturer access to these cell and gene therapies. That's critical. Manufacturers are now in the process of creating accreditation for health systems to be able to access that —so very similar to specialty, but on steroids. Payer relations are important. These are millions of dollars per therapy, so there needs to be almost a guarantee that health systems are going to get reimbursed for that cost.


HCI: With those therapies, is the pharmacist the quarterback or somebody else in the health system that they're partnering closely with?
 
Miller: Pharmacy tends to be the connector in cell and gene therapy. To make sure that patients have access to it, you need to bring the clinicians and the finance team together. The fact that pharmacy is already playing that role in specialty and infusion management is a key reason why they are the quarterback.