Skip Navigation HRSA - U.S Department of Health and Human Services, Health Resources and Service Administration HHS
Home
Questions
Order Publications
 
Grants Find Help Service Delivery Data Health Care Concerns About HRSA

Pharmacy Affairs & 340B Drug Pricing Program

 

340B Drug Pricing Program Flexibilities During Disasters

During disasters, HRSA can help by making it easier for entities already covered by the 340B Drug Pricing Program to dispense pharmaceuticals to displaced patients and by making it easier for eligible new entities (including DHHS grantees, DSH hospitals, and FQHC look-alikes) to register for the 340B Program in counties with federal major disaster declarations, federal emergency declarations, and federal public health emergency declarations.

340B Dispensing

Q: Can drugs purchased under the 340B Program be dispensed by an FQHC or other 340B Covered Entity within a county covered by a Federal Declaration during the declaration period to an individual from another State under a prescription written in another state?

A: Yes, provided that the individual is a patient (as defined by the 340B Program) of the covered entity. First, in order to be considered a patient under the 340b Program the services provided to the individual must be within the scope of eligibility of the covered entity. 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.

Health Record:

In a declared emergency, an abbreviated health record is adequate for purposes of the 340B program. However, the record must identify the patient, record the medical evaluation (including any testing, diagnosis or clinical impressions) and the treatment provided or prescribed.

Where staff and supplies are an issue: For purposes of 340B Program eligibility, the record may be a single form or note page with no folder. It's the recorded information that creates a record. You may not have the resources to meet standard health record practice standards. For example, under these circumstances the patient may be without insurance cards or identity papers and you will probably have no access to documented medical histories. Self reporting of identity, condition and history are adequate for purposes of 340B record keeping requirements.

340B Refills:

Q: Are entities within a county covered by a Federal Declaration able to refill prescriptions for disaster victims unknown to them with 340B drugs during the declaration period without medical staff intervention?

A: No. Prescriptions cannot be refilled using 340B drugs without the personal involvement of medical or health professionals with prescribing authority who are employed by, are under contract with, or maintain another arrangement with the covered entity. In the event of a declared emergency, where volunteer health professionals may be used, emergency paperwork 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 document should recognize the emergency nature of the situation, the relationship of the volunteer(s) to the clinic, and should be kept on file by the covered entity.

Expediting New 340B Registrations

Q: Normally, HRSA issues new 340B registrations on a quarterly basis. Can HRSA do anything to expedite these registrations during a federal declaration?

A: Yes. Upon request, within a county covered by a Federal Declaration during the declaration period, HRSA can initiate ‘rolling registrations’ to get temporary (or permanent) address changes on the database as soon as we get the information rather than on the normal quarterly basis.

Contacting the 340B/Office of Pharmacy Affairs