What is 340B?
This law created the 340B program.
(What is the Public Health Service Act?)
These are two types of non-hospital covered entities
Multiple correct answers: What are HRSA-supported health centers (like FQHCs), Ryan White clinics, ADAPs, TB clinics, Black Lung clinics, Title X clinics, STD clinics, or Urban Indian clinics?
The maximum statutory price a manufacturer can charge a covered entity for an outpatient drug.
What is the 340B ceiling price?
This rule applies when the calculated 340B ceiling price is less than one cent.
What is the penny pricing rule?
An arrangement where a covered entity uses a pharmacy not owned by them to dispense 340B drugs.
What is a contract pharmacy?
This is the most common type of entity eligible for 340B.
What is a non-profit hospital?
This financial metric is a key requirement for many hospitals to qualify for 340B
What is a Medicare Disproportionate Share (DSH) adjustment percentage?
These two data points, reported under the Medicaid Drug Rebate Program, are used to calculate the 340B ceiling price.
What are Average Manufacturer Price (AMP) and Unit Rebate Amount (URA)?
This HRSA-designated organization negotiates sub-ceiling prices for covered entities.
What is the Prime Vendor Program (PVP) or Apexus?
A recent major challenge involving manufacturer policies impacting where 340B drugs can be shipped for contract pharmacy arrangements.
What are contract pharmacy restrictions?
This is the main goal of the 340B program
(What is to allow covered entities to stretch scarce federal resources further, reaching more eligible patients and providing more comprehensive services?)
This prohibition prevents certain hospitals from purchasing covered outpatient drugs through a GPO.
What is the GPO Prohibition?
The compliance risk associated with dispensing 340B drugs to individuals who do not meet the patient definition.
What is diversion?
The two main compliance pitfalls covered entities must avoid: diversion and this.
What is duplicate discounts?
This system is where covered entities must register and keep their information updated to participate in the 340B program.
What is the 340B OPAIS?
This federal agency oversees the 340B program
What is HRSA?
For a hospital's off-site outpatient facility to be 340B eligible, it must generally be listed on this documen
What is the Medicare cost report?
One of the key criteria for an individual to be considered a patient of a 340B covered entity, related to maintaining health records.
What is the covered entity maintains records of the individual's healthcare?
The two consequences for a CE found to be non-compliant with 340B requirements
What is repayment of discounted drug pricing or termination of the program
These specific types of drugs are generally excluded from 340B discounts for certain covered entities that became eligible under the Affordable Care Act.
What are orphan drugs?
This is the year that the 340B program was created
What is 1992?
340B priced drugs are eligible for patients receiving this type of care
What is outpatient care?
If a provider under contract with a covered entity refers a patient for a service and a drug is dispensed as part of that service, the patient might be eligible if the entity does this.
What is maintain records and the service is within the scope of practice?
Covered entities typically manage the prevention of duplicate discounts by carving out this payer or using billing data.
What is Medicaid?
This entity is responsible for verifying covered entity eligibility before allowing them to purchase 340B discounted drugs.
What is the manufacturer and/or wholesaler?