On October 27, 2023, the Health Resources and Services Administration of HHS (HRSA) issued a Federal Register Notice (the Notice) requiring hospitals to register their off-site outpatient facilities to continue participating in the federal 340B drug pricing program (340B Program), subject to a 90-day grace period.

As part of the federal government’s response to the COVID-19 public health emergency (PHE), HHS waived requirements that (1) hospitals list their off-site outpatient facilities as reimbursable on their Medicare cost reports prior to participating in the 340B Program; and (2) hospitals register their off-site outpatient facilities in the 340B Office of Pharmacy Affairs Information System (OPAIS) prior to participating in the 340B Program. HRSA advised in the Notice that this waiver added risk and complexity to HRSA’s ability to effectively oversee compliance in the 340B Program, and that there are no longer exigent circumstances that require allowing hospitals to quickly adjust their operations for providing care off-site while maintaining immediate access to the 340B Program.

As a result, HRSA indicated in the Notice that it is ending these waivers and providing the following transition periods for covered hospital entities to comply with the off-site outpatient facility registration requirements:

1. An off-site outpatient facility that is currently listed on the hospital’s most recently filed Medicare Cost Report, but not yet registered in OPAIS, must formally register in OPAIS by the next 340B Program quarterly registration period, occurring January 1–16, 2024.
2. An off-site outpatient facility that began using 340B drugs prior to October 27, 2023, but is not yet listed as a reimbursable facility on the hospital’s most recently filed Medicare Cost Report must provide HRSA, via email to 340Bcompliance@hrsa.gov by January 25, 2024 (i.e., within 90 days after the Notice was published): (a) the name of the facility, (b) the date the facility will be listed on the hospital’s next filed Medicare Cost Report, and (c) the date the facility will register in OPAIS.

HRSA’s Notice is available here.