Entities affected by Orphan Drugs
Critical Access Hospitals(CAH)
Rural Referral Hospitals(RRH)
Sole Community Hospitals(SCH)
Free Standing Cancer Centers(CAN)
Orphan Drugs & the 340B Drug Discount Program
Orphan Drugs are not included in the definition of covered outpatient drugs. Manufacturers are not required to provide Orphan Drugs under the 340B Drug Discount Program. At their own discretion, manufacturers may offer special outpatient pricing to the affected entities listed above for orphan drugs in an outpatient setting. The special pricing of the orphan drugs, when offered, is loaded on the customer’s 340B account with their vendor. A quarterly list can be found on the Health Resources & Services Administration (HRSA) website below:
https://www.hrsa.gov/opa/program-requirements/orphan-drug-exclusion/index.html
340B Architect Orphan Drug Testing
Macro Helix maintains its own proprietary list of orphan drugs. As hospital charge data and retail dispensing data is evaluated by 340B Architect, orphan drugs are automatically excluded from earning 340B accumulations.
Figure 1- Utilization Manager –Disqualified Orphan Drugs
340B Architect Orphan Exception Testing
When a manufacturer offers special outpatient pricing for a specific orphan drug, please contact our Support team. They will set up an exception for that specific orphan drug by NDC on your PID(s). The exception allows that NDC to be considered for 340B qualification and to be ordered on the 340B account when full package accumulations are available.
Figure 2 - Utilization Manager –Orphan Exception Test Results
340B Architect Orphan Drugs Terminated Testing
As of August 25, 2018, orphan drugs that have been terminated or lost their orphan status will be tested as regular, non-orphan drugs. The service date of a charge or dispense must occur after the orphan drug termination date to be considered and tested for 340B status.
Figure 3- Utilization Manager –Orphan Termination Test Results
Orphan Standard Reports
Administrative users can generate the following reports pertaining to Orphan Exceptions:
Hospital
458 Orphan Exception Hospital Audit Qualified
459 Orphan Exception Purchase Audit Qualified
Retail
457 Orphan Exception Retail Audit Qualified
View Utilization Manager