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AHPA submitted comments on: Agency Information Collection Activities; Proposed Collection; Public Comment Request –Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program (OMB No. 0915-0327) Click here for the full summary. Below are some key takeaways.

• Limit the information collection to routine enrollment and recertification requirements: AHPA cautions that the proposed Information Collection Request goes beyond collecting information and would effectively establish new 340B eligibility and compliance requirements. It recommends that HRSA avoid using the information collection process to make substantive program changes that could threaten covered entities’ access to 340B savings.
• Do not require every hospital child site to maintain separate trial-balance costs and charges: AHPA opposes requiring each registered outpatient service to have “unique and separate” reimbursable costs and charges on a hospital’s trial balance. Integrated and multispecialty clinics may not align with discrete accounting categories, so the requirement could force hospitals to restructure accounting systems, artificially separate departments, or discontinue otherwise eligible child sites without a clear program-integrity benefit.
• Establish clear and objective standards for shipping-address relationships: AHPA raises concerns about allowing HRSA to reclassify centralized shipping locations as child sites or contract pharmacies, which could trigger additional registration requirements and duplicative verification. If HRSA proceeds, AHPA recommends clear guidance, objective approval criteria, and realistic estimates of the resources required to obtain and maintain shipping-address approval.
• Treat routine shipping-address changes as operational updates, not eligibility events: AHPA recommends that HRSA avoid requiring extensive documentation and eligibility justification when a covered entity changes an address because of growth, renovation, a lease change, or service consolidation. Without evidence of widespread abuse, routine address updates should not expose registered locations to denial or termination and potentially disrupt patient access.
• Continue using the Medicare cost report file date to determine eligibility: AHPA opposes using a cost report’s “Date/Time Prepared” as the eligibility benchmark and recommends retaining the established file date. AHPA warns that using the prepared date could cause facilities to lose 340B eligibility earlier than expected because of administrative timing differences, even when their substantive eligibility has not changed.