The AAMC submitted comments (PDF) on Monday to the Health Resources and Services Administration (HRSA) in response to the agency’s request for information (RFI) on a 340B Rebate Model Pilot Program. HRSA sought input on the administrative costs to 340B covered entities of participating in a rebate model program, in addition to operational and compliance considerations related to implementing a rebate model program [refer to Washington Highlights, Feb. 13]. Separately, the AAMC submitted comments on HRSA’s information collection request (PDF) (ICR) to provide feedback on the agency’s estimates of the burden a 340B rebate model program would impose on 340B-covered entities.
In response to the RFI, the AAMC opposed the use of rebate models in the 340B program and urged HRSA not to move forward with the use of these models. Comments highlighted the negative impacts rebate models would have on the 340B Drug Pricing Program and AAMC members, including delays in the ability of 340B hospitals to receive critical 340B savings and substantial administrative costs on 340B hospitals.
Responding to the ICR, the AAMC noted that HRSA’s estimates of the total annual burden per respondent, which amounts to five hours per week, significantly understates the actual time that 340B hospitals will spend on submitting claims data and complying with the requirements of a 340B rebate model. The AAMC urged HRSA to work with 340B program stakeholders to more accurately understand the time and resources required to comply with a 340B rebate model program.
- Washington Highlights