340B program flexibilities will continue under the eighth 90-day extension of the COVID-19 national public health emergency (PHE) late last week.
U.S. Health and Human Services (HHS) Secretary Xavier Becerra renewed the PHE on Friday, Jan. 14.
In March 2020, the U.S. Health Resources and Services Administration (HRSA) added a page to the 340B program website describing “general flexibilities that covered entities should adhere to during this public health emergency.” In June 2020, it said two flexibilities described on the page—regarding use of telehealth in 340B and use of 340B drugs in offsite outpatient facilities not yet listed as reimbursable on a hospital’s most recently filed Medicare cost report—were not just for the duration of the COVID-19 public health emergency but permanent.
HRSA confirmed yesterday that the 340B program flexibilities due to the COVID-19 emergency remain in place. Flexibilities allowed and denied include:
- HRSA is letting some entities, upon request and review, enroll immediately in 340B.
- It is considering exemptions to 340B site registration requirements on a case-by-case basis.
- It is not waiving the Medicare disproportionate share (DSH) adjustment percentage requirement for certain hospitals to participate in 340B.
- It has not relaxed 340B statutory patient definition requirements related to diversion but is granting some recordkeeping flexibilities.
- It has not relaxed 340B statutory requirements prohibiting DSH, children’s, and free-standing cancer hospitals from obtaining 340B covered outpatient drugs through a group purchasing organization (GPO). It said on the COVID-19 resources page, however, that if a hospital cannot buy a covered drug at the 340B price or wholesale acquisition cost “due to shortages, it may use a GPO (or GPO private label products). Hospitals do not need to report this information to HRSA under the COVID-19 public health emergency. The covered entity should address these situations in their policies and procedures and it must continue to keep auditable records.”
- It told drug manufacturers to contact HRSA if they wish to make private label products that are covered outpatient drugs available to covered entities at or below the 340B price.
- It is conducting some covered entity audits remotely, and in some cases has granted entities chosen for audits extra time to respond to deadlines.
