Expanding access to care through physician and medically integrated dispensing: Legal and regulatory considerations.

e13556 Background: Oncology providers face a myriad of challenges, especially in navigating the intricate legal and regulatory aspects of physician dispensing and pharmacy practices. This session will dissect these complexities, offering insights into medically integrated dispensing and its importance in enhancing patient outcomes. We will provide a thorough overview of the current state-of-the-market, highlighting the benefits of a medically integrated model, such as immediate access to patient health records, substantial cost savings, integration of prescription data with patient health information, and the presence of dedicated staff for personalized patient education and monitoring. Methods: This section will elaborate on the structured approach and methodologies employed to navigate and demystify the legal and regulatory challenges in expanding access to care through physician and medically integrated dispensing. It encompasses: 1) Defining the Landscape: Introduces essential terms and concepts to understand legal nuances in oncology. 2) Legal and Regulatory Environment: Examines legal challenges, regulatory influences, and the impact of PBMs on care delivery. 3) Case Studies in Network Access: Presents real-world challenges and legal strategies in oncology performance and medication reimbursement. 4) Coverage & Reimbursement: Discusses complexities and strategies in oncology coverage, reimbursement, and patient steering. 5) Staying Compliant: Highlights compliance with standards like USP 797/800 and the impact of pharmacy regulations on dispensing. 6) Legal Empowerment: Provides legal tools and strategies for effective patient advocacy, network access, and handling disputes. Results: This section will analyze the success of applied methodologies in oncology, highlighting improvements in provider empowerment, patient outcomes, and practice operations within legal boundaries. It will demonstrate how these strategies enhance legal understanding among oncology professionals, improving care delivery and access to health services. Conclusions: Frier Levitt addresses legal issues in oncology dispensing, integrating legal analysis, case studies, and strategies to enhance care delivery. The session focuses on engaging with PBMs, insurers, and regulators for fair treatment and compliance. It aims to empower attendees with practical approaches for improving patient care amidst healthcare changes. The presentation contributes significantly to the Care Delivery/Models of Care track, offering a detailed perspective on legalities in physician dispensing and pharmacy practices.