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.
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...