September 16, 2015
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.

Polsinelli’s summary of the Guidance can be found here.

We encourage all 340B stakeholders to carefully review our summary and HRSA’s Guidance, and to work with Polsinelli to develop comments in areas that will impact your organization. We encourage stakeholders to consider offering solutions to HRSA whenever possible. Comments are due on or before October 27, 2015, and can be submitted here.

Polsinelli will be hosting a complimentary webinar to discuss the Guidance on October 6, 2015. For more information and details about this webinar, click here.