Our firm recently returned from the Asembia Specialty Pharmacy Summit in Las Vegas, an event that brought together leaders and innovators from across the specialty pharmacy industry. Over the course of 3 ½ days, we engaged in over 30 meetings, spanning a wide array of stakeholders including specialty pharmacies, hospital and health systems, pharmaceutical manufacturers, physician groups, consultants, and investors. These meetings provided us with valuable insights into the current challenges and opportunities facing the specialty pharmacy sector. In this article, we aim to distill some of the key takeaways from our discussions, offering guidance and strategies for navigating the complex regulatory landscape and driving growth in the specialty pharmacy market.
Infusion Services
Infusion services continue to be a significant area of focus and growth within the specialty pharmacy landscape. Many providers are seeking to expand their offerings to include ambulatory infusion services, driven by increasing demand for convenient and accessible care options, as well as unique reimbursement opportunities. However, the expansion into providing infusion services brings with it a host of unique challenges, including navigating complex laws, regulatory environments, and payor policies. Additionally, providers are actively exploring mechanisms to maximize their eligibility for the 340B Drug Pricing Program and achieve significant cost savings on infused drugs. Whether its ambulatory infusion suites, standalone ambulatory infusion centers, provider-based infusion clients or unique management relationships, infusion services continue to be an area where companies of all types have sought guidance on legal compliance, regulatory support, and strategies for optimizing 340B eligibility.
Network Access
Despite efforts to promote transparency and fairness in network access, many pharmacies continue to face barriers of entry into pharmacy and medical benefits networks. Providers have reported instances of network lockouts, with some being denied admission outright, particularly in specialty networks. Credentialing processes are often onerous and confusing, making it difficult for pharmacies to gain access to networks and serve their patients effectively – OptumRx’s specialty network was a recurring topic of discussion. Meanwhile, patient poaching and prescription trolling also remain prevalent issues, further exacerbating the challenges faced by providers. Several laws and legal strategies exist to help overcome these hurdles, including any willing provider laws and efforts to leverage patients’ rights.
Reimbursement Rates
The issue of unreasonably low reimbursement rates continues to be a significant concern for specialty pharmacies. Even when pharmacies are able to gain access to certain networks, they often find themselves receiving below-water reimbursement rates that fail to cover the cost of acquiring the drug. Express Scripts, in particular, has been singled out as a problematic payer in this regard, with rates that are not only wildly unpredictable, but force pharmacies to dispense medications at a loss. While the sunsetting of DIR fees at the beginning of 2024 provided some relief for providers, many are still interested in seeking to recover previously recouped funds. Fortunately, there are legal options available for providers to challenge underwater reimbursement rates, including state and federal any willing provider laws, state minimum drug reimbursement laws, and state anti-340B price discrimination laws.
340B Program
The Genesis Health Care decision has sparked renewed interest in maximizing the benefits of the 340B Program and expanding 340B-enabled care. Providers are exploring new relationships between covered entities, contract pharmacies, and providers, with a particular focus on expanding 340B eligibility to infused drugs and to additional groups of patients. However, increased scrutiny of reconciliations with third-party administrators and contract pharmacies, especially those owned by PBMs, underscores the importance of careful oversight and auditing.
Conclusion
The Asembia Specialty Pharmacy Summit provides a unique opportunity for industry stakeholders to come together, share insights, and address the most pressing issues facing the specialty pharmacy sector. As a firm dedicated to serving the needs of specialty pharmacies, hospital and health systems, pharmaceutical manufacturers, and investors, we remain committed to providing expert legal guidance and support. Whether you attended the conference or not, if you seek assistance with navigating the complex regulatory landscape or driving growth in the specialty pharmacy market, we encourage you to reach out to us today. Our team stands ready to assist you in achieving your business objectives and ensuring compliance with applicable laws and regulations.
