Health and Human Services Department, Health Resources and Services Administration
The U.S. Department of Health and Human Services (HHS), Health Resources and Services 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 revised 340B Rebate Model Pilot Program (Pilot). The Pilot provides a rebate mechanism through which qualifying drug manufacturers may effectuate the 340B ceiling price for certain drugs sold to covered entities. Consistent with HRSA's longstanding statutory authority, rebates will be used instead of upfront discounts. HRSA issued a Request for Information (RFI) \1\ to gather input from interested parties regarding the potential use of rebates to effectuate the ceiling price under the 340B Program, including the standards and procedures that should govern the approval of manufacturer rebate plans and the impacts on all stakeholders. After carefully considering all comments from interested parties and different policy alternatives, HRSA is announcing this Pilot, which will implement a rebate approach for a limited set of drugs, and which builds on established and successful rebate programs. ---------------------------------------------------------------------------
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Health Resources and Services Administration AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: The U.S. Department of Health and Human Services (HHS), Health Resources and Services 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 revised 340B Rebate Model Pilot Program (Pilot). The Pilot provides a rebate mechanism through which qualifying drug manufacturers may effectuate the 340B ceiling price for certain drugs sold to covered entities. Consistent with HRSA's longstanding statutory authority, rebates will be used instead of upfront discounts. HRSA issued a Request for Information (RFI)  [ 1 ] to gather input from interested parties regarding the potential use of rebates to effectuate the ceiling price under the 340B Program, including the standards and procedures that should govern the approval of manufacturer rebate plans and the impacts on all stakeholders. After carefully considering all comments from interested parties and different policy alternatives, HRSA is announcing this Pilot, which will implement a rebate approach for a limited set of drugs, and which builds on established and successful rebate programs. This Notice is effective immediately as published, unless revised by a future notice. HRSA reserves the r…
Citation: 91 FR 48883
