Valued Voice

HRSA Clarifies it is Reinstating Pre-pandemic 340B Child-Site Registration Requirements

On Oct. 26, the federal Health Resources and Services Administration (HRSA) published a notice clarifying that it is returning to its pre-pandemic policy regarding the registration of off-site outpatient hospital facilities as 340B child sites.

During the COVID-19 pandemic, HRSA had relaxed its registration requirements for 340B child sites with the goal of allowing hospitals and related sites the flexibility to expand patient treatment capacity without losing their ability to access 340B prescription drug discounts. It was unclear at the time whether this would be permanent or temporary flexibility.

With the new notice, HRSA says it is returning to its previous policy of requiring 340B child sites to both register with the 340B Office of Pharmacy Affairs Information System (OPAIS) and list such sites on a hospital's Medicare Cost Report. HRSA says that with the expiration of the public health emergency last May, hospitals no longer need this flexibility "to accommodate these exigencies or adjust operations."

In the notice, HRSA says it will give hospitals whose child sites were already operating prior to the notice a 90-day grace period to come into compliance. Such sites that are already listed on the hospital's most recently filed Medicare Cost Report but not yet registered with the 340B OPAIS must register with OPAIS during the next quarterly registration period of January 1-16, 2024. Sites that are not yet on a hospital's cost report must e-mail HRSA within 90 days of the publication of this notice to alert HRSA when the site will be listed on the hospital's Medicare Cost Report (and it must be the next filed Medicare Cost Report), as well as when they will be registered with OPAIS.