Guidance to 340B providers participating in relief efforts during a Declared Public Health Emergency
HRSA recognizes that the circumstances surrounding disaster relief efforts warrant additional flexibility to affected 340B entities. An individual receiving 340B drugs must be a patient of the covered entity (as defined by the 340B Program), however, the context of the situation may be taken into account in determining whether an individual can qualify to receive 340B drugs.
- First, the services provided must be consistent with the scope of grant or other eligibility (this is not a requirement for eligible hospitals that participate in the 340B Program).
- Second, the covered entity must maintain health records of care provided to the individual.
- Finally, the individual must receive services from a health care professional who is employed by the covered entity, under contract with the covered entity, or has another arrangement with the covered entity such that responsibility for the care remains with the covered entity.
In a declared emergency, an abbreviated health record may be adequate for purposes of the 340B Program. The record must identify the patient, record the medical evaluation (including any testing, diagnosis or clinical impressions) and the treatment provided or prescribed. For purposes of 340B Program eligibility, the record may be a single form or note page. It is the recorded information that creates a record. For example, under these circumstances the patient may be without insurance cards or identity papers and providers may not have access to documented medical histories. In the event of a declared emergency, self-reporting of identity, condition and history are adequate for purposes of 340B recordkeeping requirements.
In the event of a declared emergency, where volunteer health professionals are providing health care, emergency documentation should be generated to make the relationship between the provider and the covered entity clear and to make clear the covered entity’s responsibility for providing care. This documentation should recognize the emergency nature of the situation, the name and address of the volunteer, and his/her relationship to the clinic, and should be kept on file by the covered entity. A covered entity in an emergency situation should continue to ensure it has policies and procedures in place to address the situation and it must continue to keep auditable records.
Finally, HRSA recognizes that circumstances surrounding disaster relief efforts warrant additional flexibility for entities eligible for participation in the 340B Drug Discount Program. Therefore, HRSA will allow entities in areas affected by a disaster to immediately enroll during the declared public health emergency, rather than having to wait for the normal quarterly update. HRSA believes this will enable these entities to meet the needs of the residents affected by the disaster.