We wanted to provide an update from HRSA on the latest information regarding COVID-19 and the impact on the 340B Program. The current public health emergency has created circumstances where a covered entity’s COVID-19 response may affect its 340B Program’s compliance and eligibility. HRSA states that while they cannot waive statutory requirements of the 340B Program, they do feel that there is flexibility in the interpretation of the requirements. Below are a few highlights from the update:
- A covered entity in this public health emergency should continue to ensure it has policies and procedures in place to address the proper dispensing of 340B drugs and it must continue to keep auditable records.
- An abbreviated health record may be adequate for purposes of the 340B Program. The record should identify the patient, record the medical evaluation (including any testing, diagnosis or clinical impressions) and the treatment provided or prescribed.
- When utilizing volunteer health professionals to provide health care, emergency documentation should be generated to define the relationship between the provider and the covered entity and to clarify covered entity’s responsibility for providing care.
- Hospitals subject to GPO prohibition may use a GPO to purchase medications due to shortages and if it is unable to purchase the medication at either 340B or WAC. Hospitals do not need to report this information to HRSA under the COVID-19 public health emergency.
- HRSA will be moving towards conducting 340B audits virtually for the next several months.
The full update can be found at https://www.hrsa.gov/opa/COVID-19-resources.
We will continue to monitor the ever-changing impact of COVID-19 and work to provide additional updates. However, if you have any questions, please contact one of our 340B experts.