- Q: What should a covered entity do in the event that they calculated a ceiling price incorrectly?
A: Covered entities should validate the price they paid for the drug to determine if it was below 340B ceiling price. If it is found that the covered entity can verify an overcharge and can’t resolve the issue with the wholesaler, they should open the dispute resolution process.
- Q: What is a manufacturer required to do if it has charged a covered entity beyond the 340B ceiling price?
A: Manufacturers are responsible for charging covered entities only up to the 340B ceiling price. Charges in excess of this pricing should be refunded and the Office of Pharmacy Affairs should be notified about the situation and solicited for negotiation assistance in the event that the contracted parties are unable to reach an agreement of their own accord within standard business practices.
- Q: How much time does it take for a 340B ceiling price to take effect after FDA approval?
A: 340B medications are available for reduced pricing as soon as they are approved by the FDA. Manufacturers estimate ceiling prices for the first 3 quarters, after which time the costs are retroactively corrected based on the available data at the cost of the manufacturer.
- Q: How has the definition of covered outpatient drugs changed in wake of the HRSA interpretation shift?
A: Covered outpatient drug still maintains the same definition but can now be interpreted to exclude orphan drugs which are used in any capacity towards treating the rare condition that the drug was designed or designated for by section 526 of the FFDCA.
- Q: What is a patient?
A: A patient adheres to 3 factors
- A patient must have an established relationship with a 340B hospital who maintains that patients healthcare records
- That patient must receive care from a physician who is employed or contracted by that hospital
- The services that the patient receives from the hospital must comply with the service range of grant funding to FQHC (Federally Qualified Health Centers). [DSH (Disproportionate Share Hospitals) are exempt from this stipulation.]
340B and Medical/Medicare
- Q: Can 340B drugs be used to fill prescriptions that are written by health care providers that have admitting privileges at a hospital?
A: Covered entities must ensure that a patient meet all requirements of the patient definition before utilized 340B drugs to fill that patients description. Their healthcare provider must be employed or contracted by the covered entity, the covered entity must maintain that patient’s healthcare records, and they must receive services outlined by the range of grant funding to FQHC.
- Q: Can discharge prescriptions be filled with 340B drugs?
A: 340B drugs can be used to fill discharge prescriptions only to the extent that the patient fits the 340B patient definition and guidelines.
- Q: What billing address should covered entities use?
A: It is imperative that the billing address be verifiable as a covered entity address. This is to ensure financial responsibility for all drugs purchased at the 340B discount.
- Q: What are the effective dates for contract pharmacy arrangements?
A: October 1 – October 15 (for an effective start date of January 1) January 1 – January 15 (for an effective start date of April 1)April 1 – April 15 (for an effective start date of July 1) July 1 – July 15 (for an effective start date of October 1)
- Q: If a 340B covered entity falls under common legal control of an umbrella organization, do other sites that fall under that umbrella become eligible for the 340B Program?
A: 340B eligibility is granted based on an individual covered entity basis. Any changes to infrastructure do not automatically extend the scope of 340B eligibility. Other entities falling under the same umbrella must also qualify and register for 340B status in their own right.
- Q: How does a “ship to / bill to” arrangement work?
A: Wholesalers may only sell 340B priced drugs to a covered entity. Since contract pharmacies are not considered covered entities within the 340B program guidelines, wholesalers may not bill their address for 340B discounted drugs. The ship to/ bill to arrangement allows the wholesaler to bill the covered entity and ship directly to the contract pharmacy while avoiding any legal issues that might arise from selling directly to a retail entity.
- Q: What is a Prime Vendor?
A: The Prime Vendor Program (PVP) is an endorsed vendor through HRSA. This means that the only verified sources of informational material comes from these organizations.