HRSA issues proposed guidance for 340B Drug Pricing Program

The Health Resources and Services Administration today released proposed omnibus guidance for the 340B Drug Pricing Program in the form of a notice with a 60-day comment period. The guidance covers: covered entity eligibility; patient definition; Group Purchasing Organization prohibition; contract pharmacy; duplicate discounts; and covered entity audits. It also includes enhanced program integrity requirements for pharmaceutical manufacturers participating in the 340B program. “The AHA is reviewing the guidance, which covers major aspects of this important program, and will seek feedback from our 340B member hospitals,” said Ashley Thompson, AHA’s acting senior executive for policy. “We want to make certain that the new requirements do not over-burden hospitals and strike a balance between hospitals and pharmaceutical companies for ensuring program integrity. More importantly, we want to ensure the stability of this program, which has a track record of improving access to care for poor patients and vulnerable communities.” AHA members received a Special Bulletin with further details.