Legal Hot Topics in Oncology Pharmacy

Program Description

Community oncology practices face increasing legal and regulatory complexity in 2026, particularly related to pharmacy benefit manager (PBM) contracting and reimbursement. Underwater reimbursement continues to challenge practice sustainability across Medicare Advantage, Managed Medicaid, and commercial plans, while recent federal actions—including the Consolidated Appropriations Act of 2026, the Department of Labor’s proposed fiduciary rule, and the Federal Trade Commission settlement with Express Scripts—are reshaping the PBM regulatory landscape. At the same time, evolving cost-plus contracting models introduce both opportunities and risks, particularly for specialty oncology practices with significant non-dispensing responsibilities that may not be adequately reimbursed. In parallel, emerging state-level PBM reform laws provide new enforcement mechanisms, though many pharmacists are not fully aware of how to interpret or utilize these tools in practice. This activity is designed to address key knowledge and competence gaps by helping community oncology pharmacists understand recent federal and state policy changes, evaluate PBM contracting models, and identify appropriate legal and operational strategies to address below-cost reimbursement. Through this session, pharmacists will be better prepared to support practice-level decision-making, navigate evolving reimbursement models, and contribute to efforts that promote sustainable oncology care delivery and patient access.

Target audience: Oncology pharmacists
Type of activity: Application
Release date: May 29, 2026
Expiration date: May 28, 2027
Learner level: Foundational, Intermediate
Time to complete activity: 0.75 hour
Fee: Free

Educational Objectives

At the completion of this activity, participants will be able to:

1. Describe the key provisions of the Consolidated Appropriations Act of 2026, the Department of Labor proposed rule, and the Federal Trade Commission (FTC) settlement with Express Scripts, and how each impacts pharmacy benefit manager (PBM) contracting with oncology practices
2. Evaluate cost-plus contracting models currently being implemented by major PBMs, including their definitions of "cost," reimbursement structures, and potential weaknesses for specialty oncology practices
3. Apply federal and state legal strategies, including Centers for Medicare & Medicaid Services (CMS) complaints, FTC monitor filings, maximum allowable cost appeals to challenge below-cost PBM reimbursement in an oncology setting
4. Develop a practice-specific action plan for responding to PBM contract changes, tracking acquisition and dispensing cost data, and engaging in the CMS rulemaking process over the next 3 years