(1286) Prescription for Reform: A Comparative Study of State Level Regulations on Pharmacy Benefit Managers

Objectives: This research project aims to comprehensively analyze and compare state-level regulations governing Pharmacy Benefit Managers (PBMs) to provide a nuanced understanding of the regulatory landscape in the United States. Our primary objectives are to categorize these regulations, assess variations among states, and uncover the potential implications for healthcare stakeholders and policymakers. This study goes beyond outlining the regulatory landscape.

Methods: We conducted an extensive review of existing state regulations pertaining to PBMs. Our study focused on the 50 U.S. states and the District of Columbia. We utilized a systematic approach, beginning with data collection through a rigorous examination of legislative documents, administrative codes, and regulatory guidelines through searching state legislature online databases. We coded these regulations into distinct categories, such as pricing transparency, patient access and protections, anti-steering provisions, audit integrity, and reporting requirements. Additionally, we employed qualitative content analysis to identify key themes, phrases, and variations across states. Finally, we used a peer review process amongst the researchers to ensure consistency in the coding process.

Results: Results (preliminary):
Our analysis revealed a multifaceted regulatory landscape for PBMs across the United States. The regulations were categorized into five main areas: Pricing Transparency, Patient Access and Protections, Anti-Steering Provisions, Audit Integrity, and Reporting Requirements. Upon completion of the data collection process, we plan to use descriptive statistical analysis to highlight the regulatory variations across the states.
Preliminary data trends include:
Pricing Transparency: Most states have introduced regulations mandating greater transparency in PBM pricing practices. However, the scope and stringency of these regulations varied significantly among states.
Patient Access and Protections: Many states have introduced regulations aimed at enhancing patient access to prescription drugs. These include provisions related to maximum allowable copayments. However, the extent to which these regulations protect patient interests varies from state to state.
Anti-Steering Provisions: Several states have enacted anti-steering regulations that prevent PBMs from directing patients to specific pharmacies or providers. These provisions aim to preserve patient choice, restrictions on mandatory mail order use, and competition within the healthcare market.
Audit Integrity: Most states have implemented measures to ensure PBMs follow clear adhere to transparent procedures during audits. These policies often mandate advance notification and offer explicit guidance on the audit process.
Reporting Requirements: To monitor PBM activities and assess their impact on the healthcare system, some states have imposed reporting requirements on PBMs. These regulations necessitate regular reporting of pricing data and other relevant information.

Conclusions: The diverse landscape of state regulations on PBMs presents both opportunities and challenges for healthcare stakeholders. On one hand, it allows states to tailor regulations to their unique healthcare needs and market dynamics. On the other hand, it can result in a patchwork of rules that create compliance complexities for PBMs operating across multiple states.

This research highlights the importance of continued monitoring and evaluation of PBM regulations to ensure they effectively balance the interests of patients, providers, and payers. Policymakers may benefit from a harmonized approach that encourages consistency in key regulatory areas while allowing flexibility in addressing state-specific concerns. Additionally, policymakers may use this research in discussing similar policies at a national level.

In conclusion, our analysis provides a comprehensive overview of the current state of PBM regulations in the United States. It underscores the need for ongoing research and collaboration among states to optimize the regulatory framework governing PBMs and promote transparency, affordability, and equitable access to prescription drugs in the healthcare system. As PBMs continue to evolve, understanding and adapting to this regulatory landscape will be vital for shaping the future of healthcare in the United States.