On February 17, 2026, the Health Resources and Services Administration (HRSA) issued a Request for Information (RFI) regarding the use of rebates within the 340B Program. After an unsuccessful first attempt at deploying a rebate model late last year (as we previously wrote about here and here), HRSA is now seeking “input from interested
HRSA Publishes 340B Rebate Pilot Program FAQs
By Ivy Miller & Robinson+Cole's Health Law Group on
As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently, the Health Resources and Services Administration (HRSA), which administers the 340B program, issued a set of FAQs providing additional guidance…
HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics
By Robinson+Cole's Health Law Group on
On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA requirement that off-site, outpatient facilities be (1) listed as reimbursable on the hospital’s Medicare Cost Report (MCR) prior to participating in the 340B Program; and (2) registered and listed in the Office of Pharmacy Affairs Information System (OPAIS) prior to participating in the 340B Program.
Continue Reading HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based ClinicsHHS Delays 340B Program Final Rule on Drug Ceiling Price and Manufacturer Civil Monetary Penalties (Again)
By Robinson+Cole's Health Law Group on
On June 1, 2018, the Health Resources and Services Administration (HRSA) announced it was once again delaying the final rule that had set forth the calculation for the 340B Program ceiling price and drug manufacturer civil monetary penalties (Final Rule). Enforcement on the Final Rule is delayed to July 1, 2019.
Continue Reading HHS Delays 340B Program Final Rule on Drug Ceiling Price and Manufacturer Civil Monetary Penalties (Again)