💊340B Program Notice
340B Program Notice: Application Process for the 340B Rebate Model Pilot Program
Summary
The U.S. Department of Health and Human Services (HHS) Health Resources and Service Administration (HRSA), Office of Pharmacy Affairs (OPA), which administers the 340B Drug Pricing Program (340B Program), is issuing this Notice to announce the availability of a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all covered entities, and to collect comments on the structure and application process of the 340B Rebate Model Pilot Program, as outlined in this Notice. OPA will consider comments received but is under no obligation to respond to or act on the comments. This Notice is effective immediately as published, unless revised by a future notice. OPA reserves the right to issue revisions or addenda to this Notice at a later date (including, but not limited to, revisions or addenda informed by public comment).
Agencies
- Health and Human Services Department
- Health Resources and Services Administration
Business Impact
$$ - Med
The content pertains to the 340B Rebate Model Pilot Program, which directly impacts drug manufacturers and covered entities in the healthcare sector by introducing a new rebate model. This could affect pricing strategies and compliance with federal regulations, necessitating adjustments to financial operations.