The challenges for 340B covered entities attempting to comply with the orphan drug exclusion are two-fold: First, the list of orphan drugs issued by HRSA is description-based, and does not include NDCs necessary to definitively identify which drugs carry the orphan exclusion and should therefore be excluded from the program. Second, a covered entity wishing to obtain 340B pricing on orphan-designated drugs used for non-orphan conditions must match the dispenses of the drug against patient diagnoses to identify the context of “usage”.
Cirrus specializes in 340B Contract Pharmacy.
Our sensible fee model, virtual inventory management system, and transparent reporting make it business as usual for participating pharmacies.
Use your 340B discount to benefit your patients. Contact us for an evaluation of your 340B opportunity.
Show you’re fully in compliance at any time with our live audit reports. Track every pill from patient encounter to dispense at the pharmacy.
The Cirrus staff have been helping 340B eligible hospitals with 340B since 2010
Cirrus Pharmacy Systems offers its next-generation 340B Contract Pharmacy system to all 340B-eligible entities. We've designed our system to be a win-win-win for pharmacies, hospitals, and patients. Hospitals get their maximum possible 340B opportunity by opportunistic ordering; pharmacies have no cash-upfront costs and no impact on their physical inventory; and patients get the benefit of the programs 340B eligible hospitals are able to provide as a result of their savings.
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- Orphan Drug Exclusion support
- Full 340B Compliance
- Best-in-class patient matching
- 24x7 access to compliance and financial reports
- Dispense-level control
- Positive cash-flow guarantee
- No changes to inventory or procedures
- Flexible financial models
- No true-up required
Maintaining an Orphan Drug List Thu Apr 16, 2015
Using Orphan Drugs for Non-orphan Conditions Mon Nov 05, 2018
Critical access hospitals, rural referral centers, and sole community hospitals are not permitted to purchase designated “orphan drugs” under 340B prices except where manufacturers have opted to extend their 340B prices to all covered entities. Many of our customers wishing to maximize the value of their 340B program have asked us about the legitimacy of utilizing orphan drugs when administered to patients for conditions other than those for which the drug was granted an orphan designation. Many drugs are used to treat common conditions, although the drug is designated as an orphan for a rare condition. In consultation with our auditing colleagues...
Court Strikes Down 340B Orphan Drug Discounts Fri Oct 16, 2015
Rural Referral Centers, Critical Access Hospitals, Cancer Centers, and some Children’s Hospitals will no longer be able to purchase orphan drugs at 340B prices, even if the application of those drugs is for non-orphan conditions. Prozac, for example, is classified as an orphan drug for its treatment of body dysmorphic disorder, although its typical application is for depression. This week’s ruling means that Prozac and all other listed drugs must be completely excluded for these covered entity categories. What Does This Mean? Many Critical Access Hospitals we’ve worked with have already been excluding all drugs indicated as orphan without regard to the...