As noted in our previous client alert, the Health Resources and Services Administration (“HRSA”) released its highly anticipated proposed 340B Drug Pricing Program Omnibus Guidance (“Guidance”). The Guidance offers updated HRSA policies and interpretations that apply to 340B stakeholders, including significant changes to the patient definition. The Guidance can be found here. Polsinelli has completed its initial assessment of the Guidance and developed a comprehensive summary of key proposals put forth by HRSA. Our assessment includes:

- A section-by-section review of key changes to existing HRSA guidance;

- Identification of potential implications of the Guidance on Covered Entities;

- Recommended next steps, where applicable.