At this year’s Asembia Specialty Pharmacy Summit, my partners and I had the privilege of sitting down for more than two dozen meetings with specialty pharmacies, home infusion providers, ambulatory infusion centers, hospital and health system pharmacy leaders, private equity firms, technology platforms, and hub service companies. These conversations spanned everything from day-to-day operational pain points to broader regulatory developments reshaping the industry. While each meeting had its own nuances, four unmistakable trends emerged across nearly every conversation.
1. Major Medical Insurers Are Systematically Denying Infusion Claims
The most emotionally charged issue at the conference, and the one raised by the greatest number of stakeholders, was the wave of claim denials and non-payment by major medical insurers, including UnitedHealthcare, Anthem, and Aetna. Infusion providers and specialty pharmacies alike reported an alarming increase in retrospective denials for medical necessity, artificial intelligence (AI)-driven claim denials, and refusals to reimburse for standard-of-care therapies. In some cases, insurers are paying for partial doses but classifying the remainder as limited distribution drugs that the dispensing pharmacy purportedly cannot fill, effectively creating payment gaps for medically necessary treatments.
Other providers described denials of nursing and per diem charges that are integral to home infusion services, as well as below-water reimbursement rates that make it financially unsustainable to continue servicing patients. The cumulative effect is mounting bad debt and margin compression that threatens the viability of independent infusion providers. Stakeholders in this space need to understand their contractual rights, develop robust appeals strategies, and consider whether legal remedies are available to combat these practices.
2. Manufacturer Contract Pharmacy Restrictions and the IRA’s Medicare Fair Price Are Creating a Regulatory Maze
The Inflation Reduction Act’s (IRA) Medicare Fair Price provisions and the ongoing 340B contract pharmacy restrictions imposed by drug manufacturers have collided and are now beginning to generate confusion and operational friction across the supply chain. Hospital systems and covered entities reported spending significant time and resources navigating the Maximum Fair Price portal, reconciling dispensing data against third-party administrator (TPA) information, and trying to understand why some claims are receiving manufacturer rebates while others (dispensed under seemingly identical circumstances) are not.
At the same time, manufacturers are increasingly restricting 340B contract pharmacy arrangements, forcing covered entities to explore creative purchasing strategies or face access issues. Notably, recent efforts by manufacturers to condition any access to 340B pricing on the provision of claims-level data through the ESP platform have triggered serious concern, especially for covered entities seeking to dispense through in-house pharmacies. Covered entities must not only develop updated strategies for maintaining 340B access but also proactively evaluate their compliance frameworks, data reconciliation processes, and contracting strategies to avoid losing out on Medicare Transaction Facilitator (MTF) rebates, 340B savings, or both.
3. PBM Network Access Barriers and Reimbursement Compression Are Squeezing Providers
Across meetings with specialty pharmacies, infusion providers, and private equity-backed platforms alike, one theme was nearly universal: gaining and maintaining access to pharmacy benefit manager (PBM) networks has become one of the most significant operational and financial challenges in the industry. Multiple stakeholders described being locked out of national PBM specialty and mail order networks or being squeezed out of networks they had previously participated in, sometimes on pretextual grounds, such as failure to provide timely notice of an ownership change or the use of accreditation as a gatekeeping mechanism in states with Any Willing Provider laws.
Even pharmacies with the clinical infrastructure and accreditations to serve complex patient populations reported difficulty obtaining admission to major PBM networks, leaving them unable to fill prescriptions for a significant portion of the commercially insured patient population. Compounding the access problem, the shift toward cost-plus contracting models by PBMs such as Express Scripts (ESI) is driving reimbursement rates below acquisition cost for many providers, creating an untenable financial model. For providers navigating this landscape, understanding the legal and regulatory tools available to challenge network exclusions, and developing a contracting strategy that anticipates the continued migration toward cost-plus and value-based models, is essential.
4. Artificial Intelligence Is Arriving in Pharmacy and Raising New Questions
A less obvious but increasingly important trend that surfaced across several meetings was the growing role of AI in pharmacy operations. This has had both positive and negative impacts on pharmacy providers. From the negative side, some insurers have already begun deploying AI to adjudicate and deny claims on a retrospective basis, raising serious questions about due process and the adequacy of clinical review. This has further compounded issues of unpaid or denied claims.
On the positive side, pharmacy providers have begun to explore the use of AI to automate benefit investigation and verification services, augment business intelligence, and even replace certain pharmacy technician functions. These applications hold significant promise for reducing costs and improving efficiency, but they also implicate a host of regulatory considerations, including HIPAA compliance, PBM data use restrictions, state privacy laws, and the contractual limitations embedded in provider agreements with PBMs and manufacturers. As AI adoption accelerates, healthcare stakeholders should carefully evaluate how they structure AI-driven operations in a manner that is both legally defensible and operationally sustainable.
Looking Ahead
The conversations we had at Asembia 2026 reinforced what we see every day in our practice: the specialty pharmacy and infusion services landscape is evolving at a pace that demands constant vigilance. Whether you are an infusion provider fighting claim denials, a health system grappling with 340B and IRA compliance, a private equity firm evaluating an acquisition target, or a specialty pharmacy locked out of a critical payer network, the legal and regulatory challenges are real, and they require tailored, strategic solutions.
How Frier Levitt Can Help
Our firm works at the intersection of all of these issues, and we welcome the opportunity to help stakeholders across the healthcare continuum navigate these challenges. If you missed the opportunity to connect with us at Asembia, we encourage you to reach out to discuss these trends and the solutions we can provide.
