Facing Regulatory, Reimbursement Changes, Pharmacy Execs Also See Opportunities
•February 13, 2026
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Why It Matters
These dynamics directly affect health‑system revenue, patient access to high‑cost therapies, and the competitive positioning of pharmacy operations in a rapidly evolving care landscape.
Key Takeaways
- •Specialty pharmacy faces payer, manufacturer, capacity barriers.
- •Home infusion market projected to double by 2034.
- •AI streamlines prior authorizations, reduces claim denials.
- •340B rebate model adds compliance complexity.
- •Pharmacists now required to blend clinical and business expertise.
Pulse Analysis
The pharmacy function is evolving from a dispensing unit to a strategic hub that links clinical, financial, and operational teams. As specialty drugs become more complex and costly, health systems rely on pharmacists to negotiate payer contracts, secure manufacturer allocations, and design patient‑centric workflows. This shift requires leaders who can speak the language of both clinicians and C‑suite executives, positioning pharmacy as a revenue‑generating, value‑based service rather than a cost center.
Regulatory pressures, especially around the 340B program and the now‑shelved rebate‑model pilot, have introduced new compliance layers that strain existing resources. Payers often direct patients to external pharmacies, eroding in‑house capture rates, while manufacturers impose limited‑distribution constraints. To mitigate these hurdles, organizations are adopting AI‑enabled prior‑authorization platforms that auto‑populate forms, flag eligibility issues, and accelerate claim adjudication, thereby reducing denial rates and freeing staff for direct patient care.
Meanwhile, the home‑infusion market is set to surge from $15.1 billion in 2025 to $31.4 billion by 2034, driven by consumer demand for convenient care and payer incentives for lower‑cost settings. Tech‑enabled, team‑based models that combine automated workflow engines with skilled pharmacists enable rapid scaling of these services. Companies like Cencora’s Accelerate Pharmacy Solutions provide the infrastructure—people, technology, and accreditation support—to help health systems capture this growth while maintaining compliance and financial performance.
Facing Regulatory, Reimbursement Changes, Pharmacy Execs Also See Opportunities
LeeAnn Miller, PharmD, of Cencora’s Accelerate Pharmacy Solutions – interview by David Raths
Feb. 13, 2026
Key Highlights
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Pharmacy is increasingly serving as a connector across departments, especially in specialty and ambulatory care, requiring new skill sets in business and clinical areas.
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Addressing payer and manufacturer access, capacity, and technology barriers is critical for the growth of specialty pharmacy programs and home‑infusion services.
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Emerging therapies like cell and gene treatments present new opportunities but require significant preparation, manufacturer access, and reimbursement strategies.
Image credit: ID 60711231 © Irada Pashayeva / Dreamstime.com
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 inter‑departmental 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 with our payer‑access team, with our finance team, and all of our corporate partners 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.
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.
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Payer access. The report says that about 50 % of scripts are still leaving and being filled externally. One primary reason is that the payer may require the patient to go to an external pharmacy, so enabling payer access is really important.
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Manufacturer access. Even if you’re in the payer network, you have to be able to obtain the medication from the manufacturer.
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Capacity. That can be staffing, facilities, or technology. Accelerate Pharmacy Solutions meets 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 our relationships 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: What I find is it’s usually a speed‑to‑execution issue. 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 way we partner with health systems is to bring pharmacists into the organization and expand their staff. A nice model is what I call tech‑enabled, team‑based care, where people and technology handle prior authorizations, documentation, and patient financial assistance in the background, allowing pharmacists and technicians to focus on direct patient care.
Pharmacists are now in a unique position to enter collaborative practice agreements. Once a patient is diagnosed and the physician says they are a good candidate for a biologic therapy, the physician can refer them to a pharmacist to manage that therapy, ensure understanding, affordability, and navigate 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: Two main drivers:
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Consumerism. Patients want care where it works for them. Many prefer to receive therapy at home or in a convenient satellite location rather than navigating a large campus.
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Payer restrictions and employer benefits. Home infusion sites are typically lower‑cost‑of‑care locations, and employers are designing benefits that incentivize employees to use these alternative sites.
Diversifying infusion strategy is important for health systems. Many still rely on hospital‑based infusion, but there is strong demand for alternative sites. Only about a third of the surveyed systems have executed on home‑infusion expansion, leaving a large opportunity.
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 allows those covered entities to purchase outpatient pharmaceuticals at a lower cost so they can stretch dollars to care for more patients. Regulatory guidance defines what entities qualify as covered entities.
HCI: And there are audits as well, right?
Miller: Yes. The federal government, through HRSA, audits covered entities to ensure compliance with the program’s guidance. Manufacturers that participate can also audit you. If you use contract pharmacies, you must audit them as well. In practice, it can feel like you’re getting audited every week.
HCI: HHS announced a 340B rebate‑model pilot program, then lawsuits, and now it’s been scrapped for now. What was that rebate pilot supposed to do?
Miller: Under the standard 340B model, you dispense a drug, verify that the patient, drug, and location qualify, and you purchase the drug at the lower 340B price. The rebate model would have you purchase the drug at the higher price and later be reimbursed the difference, essentially treating the lower price as a rebate rather than an upfront discount.
The model would have required health systems to maintain three new electronic databases, transmit data, self‑audit, and submit reconciliations to the government. The administrative and financial burden was significant, and many health systems were not prepared for those logistical hurdles.
HCI: But HHS may come back with some other version of this?
Miller: They likely will. I don’t know if it will be a rebate model, but I don’t think the conversation is over.
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: Yes, that’s part of it. For example, at Yale I learned that a pulmonary clinic was “under water” because of a large number of claim denials. The clinic lacked an electronic workflow for prior authorizations, and nurses were manually navigating insurance requirements without corporate business‑office support.
When the clinic added high‑cost biologics for asthma, the need for an electronic prior‑authorization process became urgent. We assembled the right team members and corporate office, implemented the workflow, and turned the situation around within a year. The savings were reinvested to add pharmacists and technicians who provided patient education, ensured proper documentation in the EHR, and facilitated prior authorizations. This allowed the clinic to see more patients and reduced the administrative burden on staff.
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. New solutions use large‑language models to read the electronic health record, populate insurance forms, and submit them through an integrated portal. Human review is still required, but the “human‑in‑the‑loop” approach dramatically speeds up submissions and improves accuracy. There is huge value in applying AI to this area.
HCI: Last question: Were there any responses in the survey that surprised you?
— End of interview —
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