The bill seeks to enhance the integrity of the federal 340B drug pricing program in Washington State by prohibiting drug manufacturers from restricting covered entities' ability to acquire and dispense 340B drugs. It introduces new reporting requirements for covered entities, such as federally qualified health centers and certain hospitals, mandating them to provide detailed information about their participation in the program, including acquisition costs and how savings are utilized. Additionally, a tiered filing fee structure is established for both manufacturers and covered entities to support the costs associated with 340B data collection and reporting. The legislation also empowers covered entities to take civil action against manufacturers for violations, with penalties of up to $5,000 per day for each infraction, while the Attorney General is given authority to enforce these provisions.

Moreover, the bill imposes new reporting obligations on drug manufacturers regarding price increases and acquisition costs of existing drugs, requiring them to submit historical pricing data and details about their participation in the 340B program. It increases the maximum fine for non-compliance with reporting requirements from $1,000 to a higher amount, and mandates the compilation and analysis of data from various stakeholders to produce an annual report on drug costs and their impact on healthcare premiums. The report will include specific data related to the 340B program while ensuring confidentiality for individual manufacturers. Additionally, the bill stipulates that data collected under this act is not subject to public disclosure, with certain exceptions for legislative access.

Statutes affected:
Substitute bill: 43.71C.100
Second substitute: 43.71C.010, 43.71C.050, 43.71C.090, 74.09.215
Engrossed second substitute: 43.71C.010, 43.71C.050, 43.71C.090, 74.09.215
Bill as passed Legislature: 43.71C.010, 43.71C.050, 43.71C.090, 74.09.215
Session law: 43.71C.010, 43.71C.050, 43.71C.090, 74.09.215