340B Gets Rebate Remix: HHS Pilots Price Switcheroo
Published Date: 8/3/2026
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. ---------------------------------------------------------------------------
Analyzed Economic Effects
5 provisions identified: 3 benefits, 1 costs, 1 mixed.
Rebates Used Instead of Upfront Discounts
HRSA is launching a revised 340B Rebate Model Pilot that lets qualifying drug manufacturers use rebates (instead of upfront discounts) to effectuate the 340B ceiling price for certain drugs sold to covered entities. The Pilot will apply to a limited set of drugs and builds on existing rebate programs used elsewhere in the drug system.
Pilot Targets Duplicate Discount Prevention
HRSA says the Pilot uses a rebate approach to help prevent duplicate discounts across federal pricing programs (including interactions with Medicaid and the Medicare Drug Price Negotiation Program). The agency frames the Pilot as a tool to improve program integrity and coordination across pricing programs.
Covered Entities May Face Cash-Flow Burdens
Covered entities (including Critical Access Hospitals, rural hospitals, FQHCs, and larger health systems) told HRSA that a rebate model could increase cash-flow and liquidity concerns, add administrative burden, and raise patient access worries. HRSA acknowledges these concerns and says it included implementation features to limit disruption.
Manufacturer Application Deadline Set
Manufacturers that want to participate must submit plans to [email protected] by August 24, 2026. Approved participation is tied to an effective date of January 1, 2027 for selected drugs covering initial price applicability year 2026 and 2027 during their price applicability periods.
HHS Must Pre-approve Rebate Models
HRSA states manufacturers may not unilaterally shift from upfront discounts to a rebate structure and that Secretarial pre-approval is required for rebate mechanisms. Courts have upheld HRSA's authority to require pre-approval.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-18518, Notice of Supplemental Funding, Rural Hospital Stabilization Pilot Program
HRSA is awarding supplemental funding under the Rural Hospital Stabilization Pilot Program to two award recipients in fiscal year (FY) 2026 to provide in-depth technical assistance (TA) to rural hospitals to enhance and/or expand service lines to meet local needs and keep health care services available locally.
2026-18568, Notice of Supplemental Funding, Infant-Toddler Court Program-State Awards
HRSA is giving extra money to 11 states and groups already running Infant-Toddler Court Programs to help them grow and keep their work going through 2027. Each recipient can get up to $417,164 to support these special courts that help young kids and families. This boost means more support and stronger programs starting now and lasting for the next few years.
2026-18570, Notice of Supplemental Funding, Appalachian Region Healthcare Support Program
HRSA is providing additional funding under the Appalachian Region Healthcare Support Program to one award recipient in fiscal year (FY) 2026. This supplemental funding will support additional technical assistance (TA) to help rural healthcare organizations located in the rural counties served by the Appalachian Regional Commission to strengthen healthcare delivery in the region.
2026-18425, Notice of Supplemental Funding, Medicare Rural Hospital Flexibility Program
HRSA is providing additional fiscal year 2026 funding under the Medicare Rural Hospital Flexibility (Flex) Program using the program's established funding methodology, including a baseline increase for all recipients and an additional adjustment for states with newly designated Critical Access Hospitals (CAHs). This funding will support state efforts to strengthen CAHs, improve quality and performance, and sustain access to essential rural health care services.
2026-18283, National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
2026-18235, Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0906-0086-Revision
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Previous / Next Documents
Previous: 2026-15631, Advisory Committee on the Medical Uses of Isotopes: Meeting Notice
The U.S. Nuclear Regulatory Commission (NRC) will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on August 17, 2026, to discuss and provide recommendations from the subcommittee on Regulatory Guide 8.39, "Release of Patients Administered Radioactive Material" review of proposed patient release revisions in the Reforming and Modernizing the NRC's Radiation Protection Framework proposed rulemaking and draft revisions to Regulatory Guide 8.39. Meeting information, including a copy of the agenda and handouts, will be available on the ACMUI's Meetings and Related Documents web page at https://www.nrc.gov/reading-rm/doc- collections/acmui/meetings/2026 or by emailing Ms. Sarah Hoenig at the contact information below.
Next: 2026-15635, Angela Anatilde Baquero: Final Debarment Order
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Angela Anatilde Baquero from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Angela Anatilde Baquero was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Mrs. Baquero was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of May 6, 2026 (30 days after receipt of the notice), Mrs. Baquero has not responded. Mrs. Baquero's failure to respond and request a hearing constitutes a waiver of Mrs. Baquero's right to a hearing concerning this matter.