As President of the Health System Owned Specialty Pharmacy Alliance, I’m proud that HOSP submitted comments responding to HRSA’s latest notice related to the proposed 340B Rebate Model Pilot Program. While this notice is framed as a paperwork approval step, the practical impact is much bigger. HRSA is seeking approval for the data collections that would support a rebate model, including claims-level submissions from covered entities to manufacturers in order to obtain the 340B price.
From the health system specialty pharmacy perspective, this is not a simple data transfer. It would require significant work across pharmacy operations, revenue cycle, compliance, IT, vendors, and care teams. HOSP’s comments urge OMB not to approve the information collection as submitted and call on HRSA to provide far more detail before moving forward, including the actual data elements, submission standards, payment rules, and realistic burden estimates. Most importantly, we continue to believe 340B should remain an upfront discount program that helps covered entities support patient access, not a rebate model that shifts cost, administrative burden, and uncertainty onto safety-net providers.
Sincerely,
Tim Affeldt
HOSP President