ACE ACE Contract Pharmacy & Third Party Administration 1 — Questions and Answers
Question 1: What is a contract pharmacy in the context of the 340B Drug Pricing Program?
- A pharmacy owned and operated by the covered entity
- An outside pharmacy that dispenses 340B drugs on behalf of a covered entity under a written agreement (Correct answer)
- A pharmacy that sells drugs at wholesale prices to hospitals
- A government-operated pharmacy that processes Medicaid prescriptions
Correct answer: An outside pharmacy that dispenses 340B drugs on behalf of a covered entity under a written agreement
A contract pharmacy is an outside pharmacy that has a written agreement with a covered entity to dispense 340B-priced drugs to the entity's eligible patients.
Question 2: What document is required to formalize a 340B contract pharmacy relationship?
- A verbal agreement witnessed by a HRSA representative
- A Business Associate Agreement (BAA) only
- A written agreement signed by both the covered entity and the pharmacy (Correct answer)
- A letter of intent filed with the state pharmacy board
Correct answer: A written agreement signed by both the covered entity and the pharmacy
HRSA requires a written agreement between the covered entity and the contract pharmacy before any 340B drugs may be dispensed through that arrangement.
Question 3: Who bears ultimate responsibility for compliance in a contract pharmacy arrangement under 340B?
- The contract pharmacy's licensed pharmacist-in-charge
- The Third Party Administrator (TPA) managing the arrangement
- The covered entity (Correct answer)
- HRSA directly
Correct answer: The covered entity
The covered entity retains full accountability for ensuring that all 340B requirements are met, even when a contract pharmacy or TPA is involved.
Question 4: Which information must a covered entity track in a contract pharmacy arrangement to prevent drug diversion?
- Pharmacist license renewal dates and DEA numbers only
- Patient eligibility, prescription dispensing records, and 340B purchase data (Correct answer)
- Insurance reimbursement rates and copay amounts
- Wholesale acquisition cost (WAC) and retail pricing benchmarks
Correct answer: Patient eligibility, prescription dispensing records, and 340B purchase data
Covered entities must track patient eligibility, dispensing records, and 340B purchase data to demonstrate that drugs are used only for eligible patients and not diverted.
Question 5: How many contract pharmacy arrangements may a 340B covered entity establish?
- Only one per covered entity
- Up to five per covered entity location
- There is no statutory limit on the number of contract pharmacy arrangements (Correct answer)
- A maximum of ten per calendar year
Correct answer: There is no statutory limit on the number of contract pharmacy arrangements
HRSA has not set a statutory cap on the number of contract pharmacy arrangements a covered entity may have, though each arrangement must meet all program requirements.
Question 6: What is the primary purpose of registering a contract pharmacy on the HRSA 340B database?
- To allow the pharmacy to bill Medicare Part D directly
- To make the arrangement official and ensure manufacturers recognize it for 340B pricing (Correct answer)
- To obtain a DEA registration number for controlled substances
- To qualify for state Medicaid supplemental rebates
Correct answer: To make the arrangement official and ensure manufacturers recognize it for 340B pricing
Registering a contract pharmacy on the HRSA 340B OPAIS database makes the arrangement official, enabling the covered entity to purchase 340B drugs dispensed at that location.
ACE ACE Contract Pharmacy & Third Party Administration 1
What is a contract pharmacy in the context of the 340B Drug Pricing Program?