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”.
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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Compliance
Every aspect of 340B regulations is determined and your compliance is reported.
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Identity Management System
Cirrus' Identity Management System is a two-tiered cloud-based system for matching sets of person identities.
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About 340B
The 340B Drug Pricing Program was enacted by Congress in 1992 as part of the Veterans HealthCare Act.
Give us a call for a free evaluation of your 340B opportunity
We're located in the Pioneer Square neighborhood of Seattle, one of our local hubs for technology and healthcare. If you're in the neighborhood, we'd love to meet you.
Give us a call and we'll take you to coffee.
Advantages for Hospitals
- Orphan Drug Exclusion support
- Full 340B Compliance
- Best-in-class patient matching
- 24x7 access to compliance and financial reports
- Dispense-level control
Advantages for Pharmacies
- Positive cash-flow guarantee
- No changes to inventory or procedures
- Flexible financial models
- No true-up required
Interesting News
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Maintaining an Orphan Drug List Thu Apr 16, 2015
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Requests for Information from 340B ESP Thu Aug 20, 2020
As a covered entity, you probably have already received one or more requests from drug manufacturers requesting information on your Contract Pharmacy programs. An example letter is attached here.
Starting in July 2020, we’ve seen that several drug manufacturers have begun using a contracted third-party, Second Sight, to request information from you on your Contract Pharmacy relationships. The stated purpose of the requested data is for manufacturers to validate and directly audit that they are not paying both a Medicaid rebate and 340B rebate on the same claim.
Cirrus is committed to providing you all the information you need in order to comply with one or more of these requests, if you choose to. We share the concerns of industry group 340B Health on the extent of these requests, the HIPAA status of the requested information, and the possible financial ramifications to Covered Entities beyond merely demonstrating full compliance to the program.
We continue to monitor the situation and are refining our response to these requests. Please feel free to reach out directly to us for a consultation.
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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...