HRSA published a document stating “HRSA’s Office of Pharmacy Affairs (OPA) intends to introduce a revised 340B Rebate Model Pilot Program (Pilot) as a mechanism for qualifying drug manufacturers… to effectuate the 340B ceiling price on a limited set of drugs.
OPA plans to publish a Federal Register Notice to notify 340B stakeholders of criteria and standards for implementation of the Pilot.” The document is officially an Information Collection Request, and HRSA is requesting public comments on its revised estimates on how much time covered entities will need to implement the rebate model. The new estimate is 5 hours per week per covered entity. Comments are due in 30 days. NACHC and others are working on putting together a comment template.
Note that HRSA only wants comments about the burden estimate – they have explicitly stated that they will ignore comments about the rebate model overall.