Health Resources and Services Administration

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 Clinics

On September 6, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion No. 19-05 (Advisory Opinion) permitting a community health center (Requestor) to purchase real estate from a limited liability company (LLC) owned and managed by an individual excluded from participation in federal health care programs (Proposed Arrangement). The OIG indicated the Proposed Arrangement would not result in the imposition of sanctions under the civil monetary penalties law because no claims for reimbursement from federal programs would be sought by the Requestor, nor would they use federal grant funds to finance the purchase.
Continue Reading HHS Issues Favorable Advisory Opinion Permitting Community Health Center to Purchase Real Estate from an Excluded Individual

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)