The key facts to know about the FDA's new 340B drug discount guidance
- The Health Resources and Services Administration (HRSA) has released updated proposed guidance outlining six criteria a patient must meet to receive discounted drugs.
- Previously there were only three criteria. The goal of this update is to bring clairty to guidance, which was considered somewhat confusing.
- The 340B Drug Pricing Program was designed to provide a safety net for underserved patients.
Note that this guidance from the HRSA is only a proposal, meaning that comments are currently being accepted. The upshot of the newly proposed guidance is to clarify eligibilty criteria, which some people perceived of as murky.
Overall, in order to qualify under the newly proposed guidelines, a patient must be receive healthcare at a 340B-qualfied facility, by a qualified provider, who prescribes the drugs that are intended to be covered with 340B funds.
In addition, the individual's health care must be "consistent with the scope of the federal grant, project, designation, or contract," and the patient must be receiving care as an outpatient and his or her records must be "accessible to the covered entity and demonstrate that the covered entity is responsible for care."